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T2D: Real benefits of new oral antidiabetic drugs

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Cardiovascular disease is the most common cause of death in people living with type 2 diabetes (T2D). It is true that patient prognoses have improved with the use of metformin and by addressing cardiovascular risk factors. But the new oral antidiabetic drugs, SGLT2 (sodium glucose cotransporter-2) inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1Ra) offer fresh therapeutic approaches. Several recent controlled studies and meta-analyses have demonstrated the possibility of a cardioprotective and nephroprotective effect, even in patients without diabetes, especially with regard to SGLT2 inhibitors.

A cohort of more than 2 million patients with T2D

What about in the real world, far away from the ideal conditions of randomized trials? Could combining SGLT2 inhibitors with GLP-1R agonists be even more effective?

These are the questions answered by a large retrospective cohort study in which 2.2 million patients with T2D receiving insulin were initially enrolled and monitored at 85 specialist centers spread throughout three countries (Denmark, the United Kingdom, and the United States).

Three groups were formed from this cohort according to whether they received monotherapy or combination treatments: SGLT2i (n = 143,600), GLP-1Ra (n = 186,841), and SGLT2i + GLP-1Ra (n = 108,5040). A control group received none of these treatments.

Propensity score matching took into account the following relevant variables: age, sex, ischemic heart disease, hypertension, chronic kidney disease, heart failure, and glycated hemoglobin. The data was analyzed using the Cox’s proportional hazards model, with follow-up at 5 years.
 

Real-world benefits – Even better when combined

The inter-group comparison suggests that oral antidiabetic agents are effective when taking into account three major events:

All-cause mortality: SGLT2i (hazard ratio, 0.49; confidence interval 95% 0.48-0.50); GLP-1Ra (HR, 0.47; CI 95% 0.46-0.48); SGLT2i + GLP-1Ra (HR, 0.25; CI 95% 0.24-0.26).

Admissions rate: respectively HR: 0.73 (0.72-0.74); 0.69 (0.68-0.69); 0.60 (0.59-0.61).

Myocardial infarction rate: respectively HR: 0.75 (0.72-0.78); 0.70 (0.68-0.73); 0.63 (0.60-0.66).

A complementary sub-analysis also revealed a more significant reduction in all-cause mortality in the event of exposure to the combination of two antidiabetic drugs versus SGLT2i alone (HR, 0.53 [0.50-0.55]) and GLP-1Ra as monotherapy (HR, 0.56 [0.54-0.59]).

This real-world retrospective cohort study involves a large sample size: more than 400,000 patients with T2D treated with new oral antidiabetic drugs and as many control patients. It suggests that SGLT2 inhibitors and GLP-1R agonists have a significant effect on overall mortality, as well as on the risk of myocardial infarction and the admissions rate. Yes, it is retrospective, but its findings are in line with those from the most recent and conclusive randomized trials that suggest a cardio- and nephroprotective effect, at least with regard to SGLT2 inhibitors.

This article was translated from JIM and a version appeared on Medscape.com.

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Cardiovascular disease is the most common cause of death in people living with type 2 diabetes (T2D). It is true that patient prognoses have improved with the use of metformin and by addressing cardiovascular risk factors. But the new oral antidiabetic drugs, SGLT2 (sodium glucose cotransporter-2) inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1Ra) offer fresh therapeutic approaches. Several recent controlled studies and meta-analyses have demonstrated the possibility of a cardioprotective and nephroprotective effect, even in patients without diabetes, especially with regard to SGLT2 inhibitors.

A cohort of more than 2 million patients with T2D

What about in the real world, far away from the ideal conditions of randomized trials? Could combining SGLT2 inhibitors with GLP-1R agonists be even more effective?

These are the questions answered by a large retrospective cohort study in which 2.2 million patients with T2D receiving insulin were initially enrolled and monitored at 85 specialist centers spread throughout three countries (Denmark, the United Kingdom, and the United States).

Three groups were formed from this cohort according to whether they received monotherapy or combination treatments: SGLT2i (n = 143,600), GLP-1Ra (n = 186,841), and SGLT2i + GLP-1Ra (n = 108,5040). A control group received none of these treatments.

Propensity score matching took into account the following relevant variables: age, sex, ischemic heart disease, hypertension, chronic kidney disease, heart failure, and glycated hemoglobin. The data was analyzed using the Cox’s proportional hazards model, with follow-up at 5 years.
 

Real-world benefits – Even better when combined

The inter-group comparison suggests that oral antidiabetic agents are effective when taking into account three major events:

All-cause mortality: SGLT2i (hazard ratio, 0.49; confidence interval 95% 0.48-0.50); GLP-1Ra (HR, 0.47; CI 95% 0.46-0.48); SGLT2i + GLP-1Ra (HR, 0.25; CI 95% 0.24-0.26).

Admissions rate: respectively HR: 0.73 (0.72-0.74); 0.69 (0.68-0.69); 0.60 (0.59-0.61).

Myocardial infarction rate: respectively HR: 0.75 (0.72-0.78); 0.70 (0.68-0.73); 0.63 (0.60-0.66).

A complementary sub-analysis also revealed a more significant reduction in all-cause mortality in the event of exposure to the combination of two antidiabetic drugs versus SGLT2i alone (HR, 0.53 [0.50-0.55]) and GLP-1Ra as monotherapy (HR, 0.56 [0.54-0.59]).

This real-world retrospective cohort study involves a large sample size: more than 400,000 patients with T2D treated with new oral antidiabetic drugs and as many control patients. It suggests that SGLT2 inhibitors and GLP-1R agonists have a significant effect on overall mortality, as well as on the risk of myocardial infarction and the admissions rate. Yes, it is retrospective, but its findings are in line with those from the most recent and conclusive randomized trials that suggest a cardio- and nephroprotective effect, at least with regard to SGLT2 inhibitors.

This article was translated from JIM and a version appeared on Medscape.com.

Cardiovascular disease is the most common cause of death in people living with type 2 diabetes (T2D). It is true that patient prognoses have improved with the use of metformin and by addressing cardiovascular risk factors. But the new oral antidiabetic drugs, SGLT2 (sodium glucose cotransporter-2) inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1Ra) offer fresh therapeutic approaches. Several recent controlled studies and meta-analyses have demonstrated the possibility of a cardioprotective and nephroprotective effect, even in patients without diabetes, especially with regard to SGLT2 inhibitors.

A cohort of more than 2 million patients with T2D

What about in the real world, far away from the ideal conditions of randomized trials? Could combining SGLT2 inhibitors with GLP-1R agonists be even more effective?

These are the questions answered by a large retrospective cohort study in which 2.2 million patients with T2D receiving insulin were initially enrolled and monitored at 85 specialist centers spread throughout three countries (Denmark, the United Kingdom, and the United States).

Three groups were formed from this cohort according to whether they received monotherapy or combination treatments: SGLT2i (n = 143,600), GLP-1Ra (n = 186,841), and SGLT2i + GLP-1Ra (n = 108,5040). A control group received none of these treatments.

Propensity score matching took into account the following relevant variables: age, sex, ischemic heart disease, hypertension, chronic kidney disease, heart failure, and glycated hemoglobin. The data was analyzed using the Cox’s proportional hazards model, with follow-up at 5 years.
 

Real-world benefits – Even better when combined

The inter-group comparison suggests that oral antidiabetic agents are effective when taking into account three major events:

All-cause mortality: SGLT2i (hazard ratio, 0.49; confidence interval 95% 0.48-0.50); GLP-1Ra (HR, 0.47; CI 95% 0.46-0.48); SGLT2i + GLP-1Ra (HR, 0.25; CI 95% 0.24-0.26).

Admissions rate: respectively HR: 0.73 (0.72-0.74); 0.69 (0.68-0.69); 0.60 (0.59-0.61).

Myocardial infarction rate: respectively HR: 0.75 (0.72-0.78); 0.70 (0.68-0.73); 0.63 (0.60-0.66).

A complementary sub-analysis also revealed a more significant reduction in all-cause mortality in the event of exposure to the combination of two antidiabetic drugs versus SGLT2i alone (HR, 0.53 [0.50-0.55]) and GLP-1Ra as monotherapy (HR, 0.56 [0.54-0.59]).

This real-world retrospective cohort study involves a large sample size: more than 400,000 patients with T2D treated with new oral antidiabetic drugs and as many control patients. It suggests that SGLT2 inhibitors and GLP-1R agonists have a significant effect on overall mortality, as well as on the risk of myocardial infarction and the admissions rate. Yes, it is retrospective, but its findings are in line with those from the most recent and conclusive randomized trials that suggest a cardio- and nephroprotective effect, at least with regard to SGLT2 inhibitors.

This article was translated from JIM and a version appeared on Medscape.com.

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Pharmacist-based strategy places more patients on statins

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Visit-based strategy has more modest effect

– In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

 

 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

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Visit-based strategy has more modest effect

Visit-based strategy has more modest effect

– In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

 

 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

– In two studies run in parallel fashion to test different strategies, one that employed automatic referral to a pharmacist appeared to be superior to one using alerts from the electronic health record (EHR) in increasing the number of at-risk patients receiving a prescription for statins.

When outcomes were compared across these related studies, the pharmacist referrals had a greater positive impact on statin prescriptions while also increasing the proportion of patients on an appropriate statin dose, reported Alexander C. Faranoff, MD, assistant professor of cardiovascular medicine at Penn Medicine, Philadelphia.

The parallel studies were part of the SUPER LIPID program, created to generate evidence-based strategies for increasing the proportion of at-risk patients on statins. Dr. Faranoff said current data show that at least 50% of patients indicated for high-intensity statins in the United States are not taking them.

The two studies were presented together in a late breaking presentation at the American Heart Association scientific sessions.
 

EHR algorithm identifies statin candidates

The candidates for statin therapy were identified through an EHR algorithm for both studies. Both compared the impact of the intervention against a baseline period of usual care, although the study of EHR alerts also randomized physicians to provide usual care for 3 months or 6 months prior to intervention.

Dr. Faranoff described these interventions as non–visit related and visit related.

In the study of the non–visit-related strategy, referrals were generated by EHR and sent directly to the pharmacist. Upon receipt, the pharmacist verified the order was appropriate and called the patient directly to discuss starting therapy. Patients agreeing to start a statin were provided with a prescription and followed by the pharmacist.

In the study of the patient-visit approach, physicians seeing EHR-identified candidates received interruptive pop-up alerts during patient encounters. The physicians were randomized to provide usual care for 3 or 6 months before they began receiving alerts. The alerts recommended referral to a pharmacist.

During usual care in the non–visit-related study, only 15.2% of the 975 candidates for statins received a prescription. During the intervention period, the rate climbed to 31.6%. Statistically, the intervention more than doubled the odds ratio (OR) of receiving a statin prescription relative to usual care (OR 2.22; 95% confidence interval [CI] 1.47-3.37).

In addition, the proportion of patients receiving an appropriate dose of statins climbed from 7.7% in the period of usual care to 24.8% in the intervention period (OR 6.79; 95% CI 4.00-11.53).
 

Visit-based study also randomized

In the study evaluating a visit-based intervention, 16 physicians were randomized to deliver usual care for 3 or 6 months. Of physicians randomized to 3 months, 970 candidates for statins were treated during the 6-month intervention period. The physicians randomized to usual care for 6 months treated 672 candidates for statins during a 3-month intervention period,

More than 3,000 alerts were sent to both groups of physicians over the intervention period. Only 165 (4.6%) were associated with a prescription.

For the group randomized to 3 months of usual care, the proportion of candidates for statins who received a prescription rose from 14.9% during the period of usual care to 17.6% in the first 3 months of intervention and then fell slightly to 15.5% in the second 3 months.

For the group randomized to usual care for 6 months, the proportion of candidates for statins who received a prescription rose from about 11% during the period of usual care to 14.6%. Combining data from both arms, the small gain in prescriptions was significant but modest (OR 1.43; 95% CI 1.02-2.00).

In addition, the visit-based EHR notifications failed to yield a significant gain in the proportion of patients on an appropriate statin dose. During the intervention period, this proportion was only about 9% of patients treated by either of the two groups of randomized physicians,

The SUPER LIPID program involved 11 internal medicine and family medicine clinics in rural Pennsylvania. In the visit-based intervention, 16 primary care physicians (PCPs) were randomized. In the asynchronous intervention, 10 primary care practices participated. The EHR identified a total of 1,950 candidates for a statin.

Although the gain in statin prescriptions was disappointing for the visit-based intervention, the strategy of using the EHR to refer statin-eligible patients to pharmacists “could be an effective adjunct to visit-based clinical interactions in increasing statin prescribing for high-risk patients,” Dr. Faranoff maintained.
 

 

 

Overcoming clinical inertia a challenge

The greater efficacy of a pharmacist-based approach did not surprise the AHA-invited discussant, Benjamin M. Scirica, MD, associate professor of medicine at Harvard Medical School, Boston.

Pointing out that the pharmacist-based strategy of increasing statin prescriptions is more complicated and more costly, he said, “You get what you pay for.” In his opinion, simple solutions are unlikely ever to be effective due to the complex reasons for clinical inertia. Overall, he thinks a multifaceted approach to placing more patients who need statins on therapy is essential.

“Implementation science is hard,” Dr. Scirica said. Even though the referral-to-a-pharmacist approach ended up putting more patients on statins and putting them on an appropriate dose, he said even this more effective strategy “is still not getting to the majority of patients.”

This does not mean that this approach is without merit or should not be one of many strategies employed, but Dr. Scirica said “there is so much more to be done,” and that it should be employed along with other initiatives.

Faranoff reports no potential conflicts of interest. Dr. Scirica reports financial relationships with AbbVie, Aktiia, AstraZeneca, Better Therapeutics, Boehringer-Ingelheim, Eisai, GlaxoSmithKline, Hanmi, Lexicon, Merck, Novartis, Novo Nordisk, Pfizer, and Sanofi.

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Does laughter offer better blood glucose control?

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People with diabetes who have a positive sense of humor appear to have better diabetes control, according to a series of studies that also show patients can be successfully taught to have a more positive and light-hearted approach.

David S. Greene, PhD, associate professor in the department of rehabilitation and human services at the University of Northern Colorado, Greeley, has pioneered research into the field, one previously overlooked when it comes to diabetes management.

This news organization caught up with Dr. Greene to ask about his research along with the implications for diabetes care and for patient well-being.
 

Question: What prompted you to research the link between humor and diabetes control?

Answer: I was diagnosed with type 1 diabetes in 1966 and consequently have lived with, and studied, various aspects of diabetes for the past 57 years.

For a time, I maintained a small private practice counseling people with diabetes. There I noticed, anecdotally, that my clients’ ability to laugh at, and see the humor in, their diabetes correlated with their emotional adjustment to living with their condition.

While I could find research confirming the physical and psychological benefits of humor in general, I was unable to find any research specifically relating to humor and diabetes.

My new research agenda was born.
 

Q: What did your research reveal?

A: My first study, published in 2020, found that people living with diabetes displayed the same level of both types of positive, or affiliative and self-enhancing, humor as the norm group used in developing the Humor Styles Questionnaire.

This was a surprising finding given that individuals with diabetes are dealing with a life-altering, chronic illness, with higher rates of depression and anxiety. Moreover, positive humor scores are known to be negatively correlated with depression and anxiety.

While levels of aggressive humor were not altered in my study, people with diabetes did have higher levels of self-defeating humor in my study, which is correlated with psychiatric and somatic concerns, and symptomatology, and so is to be expected.

My second study, published in 2021, examined whether there was a difference between people with diabetes who had an hemoglobin A1c level of 6.99% or less versus those with levels of at least 7% on four disparate types of humor. 

The A1c of 6.99% or less group scored significantly higher for both affiliative humor and self-enhancing humor. This implies that better diabetes control is associated with positive humor. This was expected, as was the finding that negative humor was not associated with better control.

On the other hand, there was no significant difference between participants on either type of negative humor, whether aggressive or self-defeating.

Finally, my third study, published in 2023 [with coauthor Nancy D. King, PhD], found that offering humor training to people with type 1 diabetes can strengthen both their affiliative and self-enhancing sense of humor, while leaving their aggressive or self-defeating humor unaffected.
 

Q: What is ‘positive humor,’ and why do you think it is associated with diabetes control?

A: Both affiliative and self-enhancing humor enhance a person’s sense of self and their relationships with others.

Affiliative humor has been shown to be positively correlated with self-esteem, psychological well-being, social intimacy, and emotional stability. It is also negatively correlated with depression and anxiety.

Self-enhancing humor involves the ability to maintain a humorous outlook on life and to use humor to regulate emotions and as a coping strategy. Like affiliative humor, it is correlated with cheerfulness, self-esteem, optimism, psychological well-being, and life satisfaction. It is negatively related to depression and anxiety.

The preponderance of literature suggests positive humor specifically is associated with buffering many of the risk factors and complications associated with diabetes.
 

 

 

Q: What could underlie the associations between humor and diabetes control?

A: Unfortunately, none of my studies have been able to determine cause and effect, although the most recent one came the closest.

While not reaching statistical significance, the mean reduction in A1c levels from 7.12% at baseline to 6.75% at the post–humor training assessment may very well imply a practical and psychological significance to patients.

I believe, with a larger sample size, significance will be achieved, and that the relationship between positive humor and diabetes control will be shown to be bidirectional, with positive humor improving diabetes control, and improved control improving positive humor.

I hypothesize this will also bring psychological and physiological benefits. After all, humor has already been associated with reduced blood glucose levels, reduced microvascular complications, improved heart health, reduced blood pressure, decreased levels of depression and anxiety.

Humor also helps us deal with stress and trauma, so a cause-and-effect relationship makes sense.
 

Q: Can a positive sense of humor be taught?

A: Absolutely. There is evidence that humor can be developed and strengthened. Paul McGhee, PhD, developed a seven-step humor training program that has been effective in elevating measures of humor across a number of studies.

Others have successfully developed their own protocols, and of course my third study demonstrated a significant increase in both affiliative and self-enhancing humor with training.
 

Q: Do you think humor training could be incorporated into diabetes care?

A: Humor training programs are easily accessible, incur low to no cost, and are easy to implement. Furthermore, once a person is trained, access to ongoing humor is free, readily available, and fun.

Several diabetes educators have also reported that humor can promote connections, encourage and support diabetes management, galvanize effectiveness, and increase an audience’s attention during education programs.

A version of this article appeared on Medscape.com.

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People with diabetes who have a positive sense of humor appear to have better diabetes control, according to a series of studies that also show patients can be successfully taught to have a more positive and light-hearted approach.

David S. Greene, PhD, associate professor in the department of rehabilitation and human services at the University of Northern Colorado, Greeley, has pioneered research into the field, one previously overlooked when it comes to diabetes management.

This news organization caught up with Dr. Greene to ask about his research along with the implications for diabetes care and for patient well-being.
 

Question: What prompted you to research the link between humor and diabetes control?

Answer: I was diagnosed with type 1 diabetes in 1966 and consequently have lived with, and studied, various aspects of diabetes for the past 57 years.

For a time, I maintained a small private practice counseling people with diabetes. There I noticed, anecdotally, that my clients’ ability to laugh at, and see the humor in, their diabetes correlated with their emotional adjustment to living with their condition.

While I could find research confirming the physical and psychological benefits of humor in general, I was unable to find any research specifically relating to humor and diabetes.

My new research agenda was born.
 

Q: What did your research reveal?

A: My first study, published in 2020, found that people living with diabetes displayed the same level of both types of positive, or affiliative and self-enhancing, humor as the norm group used in developing the Humor Styles Questionnaire.

This was a surprising finding given that individuals with diabetes are dealing with a life-altering, chronic illness, with higher rates of depression and anxiety. Moreover, positive humor scores are known to be negatively correlated with depression and anxiety.

While levels of aggressive humor were not altered in my study, people with diabetes did have higher levels of self-defeating humor in my study, which is correlated with psychiatric and somatic concerns, and symptomatology, and so is to be expected.

My second study, published in 2021, examined whether there was a difference between people with diabetes who had an hemoglobin A1c level of 6.99% or less versus those with levels of at least 7% on four disparate types of humor. 

The A1c of 6.99% or less group scored significantly higher for both affiliative humor and self-enhancing humor. This implies that better diabetes control is associated with positive humor. This was expected, as was the finding that negative humor was not associated with better control.

On the other hand, there was no significant difference between participants on either type of negative humor, whether aggressive or self-defeating.

Finally, my third study, published in 2023 [with coauthor Nancy D. King, PhD], found that offering humor training to people with type 1 diabetes can strengthen both their affiliative and self-enhancing sense of humor, while leaving their aggressive or self-defeating humor unaffected.
 

Q: What is ‘positive humor,’ and why do you think it is associated with diabetes control?

A: Both affiliative and self-enhancing humor enhance a person’s sense of self and their relationships with others.

Affiliative humor has been shown to be positively correlated with self-esteem, psychological well-being, social intimacy, and emotional stability. It is also negatively correlated with depression and anxiety.

Self-enhancing humor involves the ability to maintain a humorous outlook on life and to use humor to regulate emotions and as a coping strategy. Like affiliative humor, it is correlated with cheerfulness, self-esteem, optimism, psychological well-being, and life satisfaction. It is negatively related to depression and anxiety.

The preponderance of literature suggests positive humor specifically is associated with buffering many of the risk factors and complications associated with diabetes.
 

 

 

Q: What could underlie the associations between humor and diabetes control?

A: Unfortunately, none of my studies have been able to determine cause and effect, although the most recent one came the closest.

While not reaching statistical significance, the mean reduction in A1c levels from 7.12% at baseline to 6.75% at the post–humor training assessment may very well imply a practical and psychological significance to patients.

I believe, with a larger sample size, significance will be achieved, and that the relationship between positive humor and diabetes control will be shown to be bidirectional, with positive humor improving diabetes control, and improved control improving positive humor.

I hypothesize this will also bring psychological and physiological benefits. After all, humor has already been associated with reduced blood glucose levels, reduced microvascular complications, improved heart health, reduced blood pressure, decreased levels of depression and anxiety.

Humor also helps us deal with stress and trauma, so a cause-and-effect relationship makes sense.
 

Q: Can a positive sense of humor be taught?

A: Absolutely. There is evidence that humor can be developed and strengthened. Paul McGhee, PhD, developed a seven-step humor training program that has been effective in elevating measures of humor across a number of studies.

Others have successfully developed their own protocols, and of course my third study demonstrated a significant increase in both affiliative and self-enhancing humor with training.
 

Q: Do you think humor training could be incorporated into diabetes care?

A: Humor training programs are easily accessible, incur low to no cost, and are easy to implement. Furthermore, once a person is trained, access to ongoing humor is free, readily available, and fun.

Several diabetes educators have also reported that humor can promote connections, encourage and support diabetes management, galvanize effectiveness, and increase an audience’s attention during education programs.

A version of this article appeared on Medscape.com.

People with diabetes who have a positive sense of humor appear to have better diabetes control, according to a series of studies that also show patients can be successfully taught to have a more positive and light-hearted approach.

David S. Greene, PhD, associate professor in the department of rehabilitation and human services at the University of Northern Colorado, Greeley, has pioneered research into the field, one previously overlooked when it comes to diabetes management.

This news organization caught up with Dr. Greene to ask about his research along with the implications for diabetes care and for patient well-being.
 

Question: What prompted you to research the link between humor and diabetes control?

Answer: I was diagnosed with type 1 diabetes in 1966 and consequently have lived with, and studied, various aspects of diabetes for the past 57 years.

For a time, I maintained a small private practice counseling people with diabetes. There I noticed, anecdotally, that my clients’ ability to laugh at, and see the humor in, their diabetes correlated with their emotional adjustment to living with their condition.

While I could find research confirming the physical and psychological benefits of humor in general, I was unable to find any research specifically relating to humor and diabetes.

My new research agenda was born.
 

Q: What did your research reveal?

A: My first study, published in 2020, found that people living with diabetes displayed the same level of both types of positive, or affiliative and self-enhancing, humor as the norm group used in developing the Humor Styles Questionnaire.

This was a surprising finding given that individuals with diabetes are dealing with a life-altering, chronic illness, with higher rates of depression and anxiety. Moreover, positive humor scores are known to be negatively correlated with depression and anxiety.

While levels of aggressive humor were not altered in my study, people with diabetes did have higher levels of self-defeating humor in my study, which is correlated with psychiatric and somatic concerns, and symptomatology, and so is to be expected.

My second study, published in 2021, examined whether there was a difference between people with diabetes who had an hemoglobin A1c level of 6.99% or less versus those with levels of at least 7% on four disparate types of humor. 

The A1c of 6.99% or less group scored significantly higher for both affiliative humor and self-enhancing humor. This implies that better diabetes control is associated with positive humor. This was expected, as was the finding that negative humor was not associated with better control.

On the other hand, there was no significant difference between participants on either type of negative humor, whether aggressive or self-defeating.

Finally, my third study, published in 2023 [with coauthor Nancy D. King, PhD], found that offering humor training to people with type 1 diabetes can strengthen both their affiliative and self-enhancing sense of humor, while leaving their aggressive or self-defeating humor unaffected.
 

Q: What is ‘positive humor,’ and why do you think it is associated with diabetes control?

A: Both affiliative and self-enhancing humor enhance a person’s sense of self and their relationships with others.

Affiliative humor has been shown to be positively correlated with self-esteem, psychological well-being, social intimacy, and emotional stability. It is also negatively correlated with depression and anxiety.

Self-enhancing humor involves the ability to maintain a humorous outlook on life and to use humor to regulate emotions and as a coping strategy. Like affiliative humor, it is correlated with cheerfulness, self-esteem, optimism, psychological well-being, and life satisfaction. It is negatively related to depression and anxiety.

The preponderance of literature suggests positive humor specifically is associated with buffering many of the risk factors and complications associated with diabetes.
 

 

 

Q: What could underlie the associations between humor and diabetes control?

A: Unfortunately, none of my studies have been able to determine cause and effect, although the most recent one came the closest.

While not reaching statistical significance, the mean reduction in A1c levels from 7.12% at baseline to 6.75% at the post–humor training assessment may very well imply a practical and psychological significance to patients.

I believe, with a larger sample size, significance will be achieved, and that the relationship between positive humor and diabetes control will be shown to be bidirectional, with positive humor improving diabetes control, and improved control improving positive humor.

I hypothesize this will also bring psychological and physiological benefits. After all, humor has already been associated with reduced blood glucose levels, reduced microvascular complications, improved heart health, reduced blood pressure, decreased levels of depression and anxiety.

Humor also helps us deal with stress and trauma, so a cause-and-effect relationship makes sense.
 

Q: Can a positive sense of humor be taught?

A: Absolutely. There is evidence that humor can be developed and strengthened. Paul McGhee, PhD, developed a seven-step humor training program that has been effective in elevating measures of humor across a number of studies.

Others have successfully developed their own protocols, and of course my third study demonstrated a significant increase in both affiliative and self-enhancing humor with training.
 

Q: Do you think humor training could be incorporated into diabetes care?

A: Humor training programs are easily accessible, incur low to no cost, and are easy to implement. Furthermore, once a person is trained, access to ongoing humor is free, readily available, and fun.

Several diabetes educators have also reported that humor can promote connections, encourage and support diabetes management, galvanize effectiveness, and increase an audience’s attention during education programs.

A version of this article appeared on Medscape.com.

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Low-salt diet cut BP by 6 mm Hg in 1 week: CARDIA-SSBP

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People who followed a low-salt diet for just a week experienced a reduction in systolic blood pressure of about 6 mm Hg, in a new study.

The CARDIA-SSBP trial involved 213 individuals aged 50-75 years, including those with and those without hypertension, and showed that the decline in blood pressure brought about by a low-salt diet was independent of hypertension status and antihypertensive medication use. It was also generally consistent across subgroups and did not result in excess adverse events.

“The blood pressure reduction we see here is meaningful, and comparable to that produced by one antihypertensive medication,” lead investigator Deepak Gupta, MD, Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.

Dr. Gupta presented the CARDIA-SSBP study on Nov. 11 at the American Heart Association scientific sessions, held in Philadelphia. The study was published online in JAMA. The exact menus used in the study are available in a supplement to the JAMA paper.

“In order to live a healthy lifestyle, understanding what we eat has important health effects. Raised blood pressure contributes to one out of every eight deaths worldwide,” Dr. Gupta noted. “If people want to lower their blood pressure, attention to dietary sodium is one part of that. If individuals can stick with a low sodium diet, they may be able to stop taking one of their antihypertensive medications, and those who are normotensive will be less likely to develop hypertension.”

Commentators said the study had significant implications for public health, but they pointed out that maintaining a low-sodium diet over the long term is challenging, given the high salt content of generally available foods.

Dr. Gupta noted that the study did use commercially available products in the low-sodium diets and the menus are available for people to follow, making it more accessible than some diets used in previous studies.

“What may also be attractive to people is that you don’t have to wait for months to see an effect. If you start to consume a low-sodium diet, you can see results on blood pressure rapidly, within a week,” he said.

The diet in this study brought about a large reduction in dietary sodium, but Dr. Gupta says any reduction in dietary sodium is likely to be beneficial.

“If you go to the level that we got to, you could expect to see a reduction of around 6 mm Hg. But it’s like walking – you don’t necessarily need to get to 10,000 steps every day. Any amount of walking or physical activity is of benefit. The same is probably true for salt: Any reduction that you can make is probably of benefit.”

For the study, participants had their blood pressure measured by 24-hour ambulatory monitoring while on their usual diets. They were then randomly assigned to either a high-sodium diet or a low-sodium diet for 1 week. Participants then crossed over to the opposite diet for 1 week, with blood pressure measured over a 24-hour period on the last day of each diet.

As assessed by 24-hour urine excretion, the usual diet of participants was found to already be high in sodium (median, 4.45 g/d). This increased to a median of 5.00 g/d when on the high-sodium diet in the study and decreased to 1.27 g/d while on the low-sodium diet.

Results found participants had a median systolic blood pressure of 125 mm Hg on their usual diets. This was raised to 126 mm Hg on the high-sodium diet and lowered to 119 mm Hg on the low-sodium diet.

The researchers also reported that 75% of individuals showed a blood pressure reduction on the low-sodium diet and are thus defined as “salt-sensitive.” This is a higher percentage than found in previous studies.

“Of those that didn’t show a blood pressure reduction with a low-sodium diet in this study, it appears that they may not have been so adherent to the diet as those who did show a blood pressure reduction,” Dr. Gupta said.

He noted that hypertension is the most common chronic disease condition worldwide, with about 1.3 billion people affected, and although it has been known for some time that dietary sodium affects blood pressure, there have been some gaps in previous studies.

For example, many studies have excluded individuals who were already taking antihypertensive medications and people with diabetes, and they have generally not included many older individuals. The current study found that all of these groups showed significant blood pressure reductions by reducing dietary sodium.
 

 

 

Large effect in people with diabetes

Subgroup analysis largely showed consistent results across the population, regardless of age, sex, race, and body mass index and whether participants were taking antihypertensive medication or not, but there were a couple of exceptions. Individuals with higher blood pressure at baseline seemed to have a greater effect of lowering dietary sodium, although those who were normotensive at baseline still showed significant blood pressure reduction, Dr. Gupta reported.

The researchers found a particularly large reduction in blood pressure from lowering sodium intake in people with diabetes, who made up about 21% of the overall cohort. Their average reduction in systolic blood pressure between the high and low sodium diet was close to 17 mm Hg rather than the 7-8 mm Hg in the whole cohort.

Dr. Gupta said that the results are applicable to most of the population.

“The people who will be most motivated to follow a low-sodium diet are those with hypertension. But even in normotensive individuals, there is likely to be benefit.”

To help people follow a low-sodium diet, Dr. Gupta says education campaigns are needed “to show people that they can do it and make it work.” But there are bigger structural issues that need to be addressed at policy and governmental levels.

“Most of our food available in grocery stores and restaurants is high in salt. We now have a preponderance of evidence showing us that we need to change what’s available in the food supply,” he said. “There is a push going on for this now, and the U.S. has introduced some guidelines for the food industry on sodium content of foods. These are voluntary at this point, but it’s a start.”
 

Difficult to maintain long term

Commenting on the study, Paul Whelton, MD, chair in global public health at Tulane University, New Orleans, noted that sodium reduction is known to reduce blood pressure, with greater sodium reductions giving greater blood pressure decreases, and that some people are more sensitive to the effects of sodium than others.

He described CARDIA-SSBP as a “well-done study.”

“They managed to get a very low sodium intake and a large difference between the two groups, which translated into a big reduction in systolic blood pressure,” Dr. Whelton said. “However, the problem with these sorts of trials where the diets are provided to the participants is that although they show proof of concept, it is difficult to generalize because we can’t normally provide patients with their meals. In this type of ‘feeding’ study, we find it difficult to maintain people on their behavioral intervention over the long term.”

Dr. Whelton said that he was more excited about this trial knowing that the food given was commercially available. “That makes it more practical, but you still have to be quite motivated to follow a diet like this. Buying low-sodium products in the supermarket does require quite a lot of work to read the labels, and sometimes the low-sodium foods are specialty products and are more expensive.”

He pointed out that older people in higher socioeconomic classes are more likely to attempt this and do better from behavioral interventions in general. “Unfortunately, people who don’t do well from behavioral interventions like this are those from lower socioeconomic groups, who are ones at most at risk for cardiovascular disease.”

Dr. Whelton noted that the food industry has been reluctant to lower sodium content because high-salt foods sell better. “Unfortunately, foods high in saturated fat and salt taste good to most people. We are generally attuned to a high salt intake. But when people have been following a low-salt diet for a while, they generally don’t like high-salt foods anymore. They become attuned to lower-sodium diet,” he added.
 

 

 

New U.S. sodium reduction guidelines

Discussant of the CARDIA-SSBP study at the AHA meeting, Cheryl Anderson, MD, University of California, San Diego, said that the findings were important and consistent with prior studies.

“These studies have global implications because salt is ubiquitous in the food supply in much of the world,” she noted, adding that, “Americans consume almost 50% more sodium than recommended, and there has been a persistent lack of adherence to healthy diet recommendations for reductions in salt, sugar, and fats.”

Dr. Anderson pointed out that in 2021, the Food and Drug Administration issued guidance for voluntary sodium reduction, which uses a gradual approach, with targets to reach a population goal of 3,000 mg/d of sodium by 2023 and 2,300 mg/d by 2031.

“These targets apply to 150 categories of food that are sales-weighted to focus on dominant sellers in each category. They apply to food manufacturers, restaurants and food service operations,” she concluded. “These targets serve as a basis for continued dialogue. The research community eagerly awaits the review of population-based data to help refine this approach and goals.”

This study was supported by grants from the National Heart, Lung, and Blood Institute, the National Institutes of Health, the American Heart Association, and the National Center for Advancing Translational Sciences. The authors report no disclosures.

A version of this article appeared on Medscape.com.

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People who followed a low-salt diet for just a week experienced a reduction in systolic blood pressure of about 6 mm Hg, in a new study.

The CARDIA-SSBP trial involved 213 individuals aged 50-75 years, including those with and those without hypertension, and showed that the decline in blood pressure brought about by a low-salt diet was independent of hypertension status and antihypertensive medication use. It was also generally consistent across subgroups and did not result in excess adverse events.

“The blood pressure reduction we see here is meaningful, and comparable to that produced by one antihypertensive medication,” lead investigator Deepak Gupta, MD, Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.

Dr. Gupta presented the CARDIA-SSBP study on Nov. 11 at the American Heart Association scientific sessions, held in Philadelphia. The study was published online in JAMA. The exact menus used in the study are available in a supplement to the JAMA paper.

“In order to live a healthy lifestyle, understanding what we eat has important health effects. Raised blood pressure contributes to one out of every eight deaths worldwide,” Dr. Gupta noted. “If people want to lower their blood pressure, attention to dietary sodium is one part of that. If individuals can stick with a low sodium diet, they may be able to stop taking one of their antihypertensive medications, and those who are normotensive will be less likely to develop hypertension.”

Commentators said the study had significant implications for public health, but they pointed out that maintaining a low-sodium diet over the long term is challenging, given the high salt content of generally available foods.

Dr. Gupta noted that the study did use commercially available products in the low-sodium diets and the menus are available for people to follow, making it more accessible than some diets used in previous studies.

“What may also be attractive to people is that you don’t have to wait for months to see an effect. If you start to consume a low-sodium diet, you can see results on blood pressure rapidly, within a week,” he said.

The diet in this study brought about a large reduction in dietary sodium, but Dr. Gupta says any reduction in dietary sodium is likely to be beneficial.

“If you go to the level that we got to, you could expect to see a reduction of around 6 mm Hg. But it’s like walking – you don’t necessarily need to get to 10,000 steps every day. Any amount of walking or physical activity is of benefit. The same is probably true for salt: Any reduction that you can make is probably of benefit.”

For the study, participants had their blood pressure measured by 24-hour ambulatory monitoring while on their usual diets. They were then randomly assigned to either a high-sodium diet or a low-sodium diet for 1 week. Participants then crossed over to the opposite diet for 1 week, with blood pressure measured over a 24-hour period on the last day of each diet.

As assessed by 24-hour urine excretion, the usual diet of participants was found to already be high in sodium (median, 4.45 g/d). This increased to a median of 5.00 g/d when on the high-sodium diet in the study and decreased to 1.27 g/d while on the low-sodium diet.

Results found participants had a median systolic blood pressure of 125 mm Hg on their usual diets. This was raised to 126 mm Hg on the high-sodium diet and lowered to 119 mm Hg on the low-sodium diet.

The researchers also reported that 75% of individuals showed a blood pressure reduction on the low-sodium diet and are thus defined as “salt-sensitive.” This is a higher percentage than found in previous studies.

“Of those that didn’t show a blood pressure reduction with a low-sodium diet in this study, it appears that they may not have been so adherent to the diet as those who did show a blood pressure reduction,” Dr. Gupta said.

He noted that hypertension is the most common chronic disease condition worldwide, with about 1.3 billion people affected, and although it has been known for some time that dietary sodium affects blood pressure, there have been some gaps in previous studies.

For example, many studies have excluded individuals who were already taking antihypertensive medications and people with diabetes, and they have generally not included many older individuals. The current study found that all of these groups showed significant blood pressure reductions by reducing dietary sodium.
 

 

 

Large effect in people with diabetes

Subgroup analysis largely showed consistent results across the population, regardless of age, sex, race, and body mass index and whether participants were taking antihypertensive medication or not, but there were a couple of exceptions. Individuals with higher blood pressure at baseline seemed to have a greater effect of lowering dietary sodium, although those who were normotensive at baseline still showed significant blood pressure reduction, Dr. Gupta reported.

The researchers found a particularly large reduction in blood pressure from lowering sodium intake in people with diabetes, who made up about 21% of the overall cohort. Their average reduction in systolic blood pressure between the high and low sodium diet was close to 17 mm Hg rather than the 7-8 mm Hg in the whole cohort.

Dr. Gupta said that the results are applicable to most of the population.

“The people who will be most motivated to follow a low-sodium diet are those with hypertension. But even in normotensive individuals, there is likely to be benefit.”

To help people follow a low-sodium diet, Dr. Gupta says education campaigns are needed “to show people that they can do it and make it work.” But there are bigger structural issues that need to be addressed at policy and governmental levels.

“Most of our food available in grocery stores and restaurants is high in salt. We now have a preponderance of evidence showing us that we need to change what’s available in the food supply,” he said. “There is a push going on for this now, and the U.S. has introduced some guidelines for the food industry on sodium content of foods. These are voluntary at this point, but it’s a start.”
 

Difficult to maintain long term

Commenting on the study, Paul Whelton, MD, chair in global public health at Tulane University, New Orleans, noted that sodium reduction is known to reduce blood pressure, with greater sodium reductions giving greater blood pressure decreases, and that some people are more sensitive to the effects of sodium than others.

He described CARDIA-SSBP as a “well-done study.”

“They managed to get a very low sodium intake and a large difference between the two groups, which translated into a big reduction in systolic blood pressure,” Dr. Whelton said. “However, the problem with these sorts of trials where the diets are provided to the participants is that although they show proof of concept, it is difficult to generalize because we can’t normally provide patients with their meals. In this type of ‘feeding’ study, we find it difficult to maintain people on their behavioral intervention over the long term.”

Dr. Whelton said that he was more excited about this trial knowing that the food given was commercially available. “That makes it more practical, but you still have to be quite motivated to follow a diet like this. Buying low-sodium products in the supermarket does require quite a lot of work to read the labels, and sometimes the low-sodium foods are specialty products and are more expensive.”

He pointed out that older people in higher socioeconomic classes are more likely to attempt this and do better from behavioral interventions in general. “Unfortunately, people who don’t do well from behavioral interventions like this are those from lower socioeconomic groups, who are ones at most at risk for cardiovascular disease.”

Dr. Whelton noted that the food industry has been reluctant to lower sodium content because high-salt foods sell better. “Unfortunately, foods high in saturated fat and salt taste good to most people. We are generally attuned to a high salt intake. But when people have been following a low-salt diet for a while, they generally don’t like high-salt foods anymore. They become attuned to lower-sodium diet,” he added.
 

 

 

New U.S. sodium reduction guidelines

Discussant of the CARDIA-SSBP study at the AHA meeting, Cheryl Anderson, MD, University of California, San Diego, said that the findings were important and consistent with prior studies.

“These studies have global implications because salt is ubiquitous in the food supply in much of the world,” she noted, adding that, “Americans consume almost 50% more sodium than recommended, and there has been a persistent lack of adherence to healthy diet recommendations for reductions in salt, sugar, and fats.”

Dr. Anderson pointed out that in 2021, the Food and Drug Administration issued guidance for voluntary sodium reduction, which uses a gradual approach, with targets to reach a population goal of 3,000 mg/d of sodium by 2023 and 2,300 mg/d by 2031.

“These targets apply to 150 categories of food that are sales-weighted to focus on dominant sellers in each category. They apply to food manufacturers, restaurants and food service operations,” she concluded. “These targets serve as a basis for continued dialogue. The research community eagerly awaits the review of population-based data to help refine this approach and goals.”

This study was supported by grants from the National Heart, Lung, and Blood Institute, the National Institutes of Health, the American Heart Association, and the National Center for Advancing Translational Sciences. The authors report no disclosures.

A version of this article appeared on Medscape.com.

People who followed a low-salt diet for just a week experienced a reduction in systolic blood pressure of about 6 mm Hg, in a new study.

The CARDIA-SSBP trial involved 213 individuals aged 50-75 years, including those with and those without hypertension, and showed that the decline in blood pressure brought about by a low-salt diet was independent of hypertension status and antihypertensive medication use. It was also generally consistent across subgroups and did not result in excess adverse events.

“The blood pressure reduction we see here is meaningful, and comparable to that produced by one antihypertensive medication,” lead investigator Deepak Gupta, MD, Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.

Dr. Gupta presented the CARDIA-SSBP study on Nov. 11 at the American Heart Association scientific sessions, held in Philadelphia. The study was published online in JAMA. The exact menus used in the study are available in a supplement to the JAMA paper.

“In order to live a healthy lifestyle, understanding what we eat has important health effects. Raised blood pressure contributes to one out of every eight deaths worldwide,” Dr. Gupta noted. “If people want to lower their blood pressure, attention to dietary sodium is one part of that. If individuals can stick with a low sodium diet, they may be able to stop taking one of their antihypertensive medications, and those who are normotensive will be less likely to develop hypertension.”

Commentators said the study had significant implications for public health, but they pointed out that maintaining a low-sodium diet over the long term is challenging, given the high salt content of generally available foods.

Dr. Gupta noted that the study did use commercially available products in the low-sodium diets and the menus are available for people to follow, making it more accessible than some diets used in previous studies.

“What may also be attractive to people is that you don’t have to wait for months to see an effect. If you start to consume a low-sodium diet, you can see results on blood pressure rapidly, within a week,” he said.

The diet in this study brought about a large reduction in dietary sodium, but Dr. Gupta says any reduction in dietary sodium is likely to be beneficial.

“If you go to the level that we got to, you could expect to see a reduction of around 6 mm Hg. But it’s like walking – you don’t necessarily need to get to 10,000 steps every day. Any amount of walking or physical activity is of benefit. The same is probably true for salt: Any reduction that you can make is probably of benefit.”

For the study, participants had their blood pressure measured by 24-hour ambulatory monitoring while on their usual diets. They were then randomly assigned to either a high-sodium diet or a low-sodium diet for 1 week. Participants then crossed over to the opposite diet for 1 week, with blood pressure measured over a 24-hour period on the last day of each diet.

As assessed by 24-hour urine excretion, the usual diet of participants was found to already be high in sodium (median, 4.45 g/d). This increased to a median of 5.00 g/d when on the high-sodium diet in the study and decreased to 1.27 g/d while on the low-sodium diet.

Results found participants had a median systolic blood pressure of 125 mm Hg on their usual diets. This was raised to 126 mm Hg on the high-sodium diet and lowered to 119 mm Hg on the low-sodium diet.

The researchers also reported that 75% of individuals showed a blood pressure reduction on the low-sodium diet and are thus defined as “salt-sensitive.” This is a higher percentage than found in previous studies.

“Of those that didn’t show a blood pressure reduction with a low-sodium diet in this study, it appears that they may not have been so adherent to the diet as those who did show a blood pressure reduction,” Dr. Gupta said.

He noted that hypertension is the most common chronic disease condition worldwide, with about 1.3 billion people affected, and although it has been known for some time that dietary sodium affects blood pressure, there have been some gaps in previous studies.

For example, many studies have excluded individuals who were already taking antihypertensive medications and people with diabetes, and they have generally not included many older individuals. The current study found that all of these groups showed significant blood pressure reductions by reducing dietary sodium.
 

 

 

Large effect in people with diabetes

Subgroup analysis largely showed consistent results across the population, regardless of age, sex, race, and body mass index and whether participants were taking antihypertensive medication or not, but there were a couple of exceptions. Individuals with higher blood pressure at baseline seemed to have a greater effect of lowering dietary sodium, although those who were normotensive at baseline still showed significant blood pressure reduction, Dr. Gupta reported.

The researchers found a particularly large reduction in blood pressure from lowering sodium intake in people with diabetes, who made up about 21% of the overall cohort. Their average reduction in systolic blood pressure between the high and low sodium diet was close to 17 mm Hg rather than the 7-8 mm Hg in the whole cohort.

Dr. Gupta said that the results are applicable to most of the population.

“The people who will be most motivated to follow a low-sodium diet are those with hypertension. But even in normotensive individuals, there is likely to be benefit.”

To help people follow a low-sodium diet, Dr. Gupta says education campaigns are needed “to show people that they can do it and make it work.” But there are bigger structural issues that need to be addressed at policy and governmental levels.

“Most of our food available in grocery stores and restaurants is high in salt. We now have a preponderance of evidence showing us that we need to change what’s available in the food supply,” he said. “There is a push going on for this now, and the U.S. has introduced some guidelines for the food industry on sodium content of foods. These are voluntary at this point, but it’s a start.”
 

Difficult to maintain long term

Commenting on the study, Paul Whelton, MD, chair in global public health at Tulane University, New Orleans, noted that sodium reduction is known to reduce blood pressure, with greater sodium reductions giving greater blood pressure decreases, and that some people are more sensitive to the effects of sodium than others.

He described CARDIA-SSBP as a “well-done study.”

“They managed to get a very low sodium intake and a large difference between the two groups, which translated into a big reduction in systolic blood pressure,” Dr. Whelton said. “However, the problem with these sorts of trials where the diets are provided to the participants is that although they show proof of concept, it is difficult to generalize because we can’t normally provide patients with their meals. In this type of ‘feeding’ study, we find it difficult to maintain people on their behavioral intervention over the long term.”

Dr. Whelton said that he was more excited about this trial knowing that the food given was commercially available. “That makes it more practical, but you still have to be quite motivated to follow a diet like this. Buying low-sodium products in the supermarket does require quite a lot of work to read the labels, and sometimes the low-sodium foods are specialty products and are more expensive.”

He pointed out that older people in higher socioeconomic classes are more likely to attempt this and do better from behavioral interventions in general. “Unfortunately, people who don’t do well from behavioral interventions like this are those from lower socioeconomic groups, who are ones at most at risk for cardiovascular disease.”

Dr. Whelton noted that the food industry has been reluctant to lower sodium content because high-salt foods sell better. “Unfortunately, foods high in saturated fat and salt taste good to most people. We are generally attuned to a high salt intake. But when people have been following a low-salt diet for a while, they generally don’t like high-salt foods anymore. They become attuned to lower-sodium diet,” he added.
 

 

 

New U.S. sodium reduction guidelines

Discussant of the CARDIA-SSBP study at the AHA meeting, Cheryl Anderson, MD, University of California, San Diego, said that the findings were important and consistent with prior studies.

“These studies have global implications because salt is ubiquitous in the food supply in much of the world,” she noted, adding that, “Americans consume almost 50% more sodium than recommended, and there has been a persistent lack of adherence to healthy diet recommendations for reductions in salt, sugar, and fats.”

Dr. Anderson pointed out that in 2021, the Food and Drug Administration issued guidance for voluntary sodium reduction, which uses a gradual approach, with targets to reach a population goal of 3,000 mg/d of sodium by 2023 and 2,300 mg/d by 2031.

“These targets apply to 150 categories of food that are sales-weighted to focus on dominant sellers in each category. They apply to food manufacturers, restaurants and food service operations,” she concluded. “These targets serve as a basis for continued dialogue. The research community eagerly awaits the review of population-based data to help refine this approach and goals.”

This study was supported by grants from the National Heart, Lung, and Blood Institute, the National Institutes of Health, the American Heart Association, and the National Center for Advancing Translational Sciences. The authors report no disclosures.

A version of this article appeared on Medscape.com.

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Life in the woods

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I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA
No caption needed

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.



Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente
Dr. Jeffrey Benabio

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

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I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA
No caption needed

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.



Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente
Dr. Jeffrey Benabio

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

 

I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA
No caption needed

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.



Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente
Dr. Jeffrey Benabio

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

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People with diabetes have a higher risk of colon cancer: Study

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People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

A version of this article first appeared on WebMD.com.

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People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

A version of this article first appeared on WebMD.com.

People with diabetes had a 47% increased risk of getting colorectal cancer, compared with people without diabetes, according to results of a large new study. Getting a colonoscopy dramatically reduced the risk, the results showed.

The findings, published in JAMA Network Open, suggest that colonoscopies are particularly important for people with diabetes. People diagnosed with diabetes within the past 5 years have the greatest colorectal cancer risk, the study found, suggesting screening should be part of a person’s health care after they’re diagnosed with diabetes.

Researchers analyzed data for 54,597 people who contributed at least 2 years of health data as part of a study that recruited people from 12 Southeastern states between 2002 and 2009. The people self-reported their diabetes status, and although researchers tried to only include people with type 2 diabetes, it’s possible that some people in the study had type 1 diabetes. The average age of those in the study was 51 years old; 64% were women; more than half of them had an income of less than $15,000 per year; and 66% of them were African American. 

Among the people in the study who had diabetes, the risk of having colorectal cancer was not strongly impacted by their race or ethnicity, gender, weight, or income level, the study showed.

While race didn’t predict whether people with diabetes would get colorectal cancer, the findings are particularly important because most of the people in the study were African American. Diabetes and colorectal cancer disproportionately affect African American people, the authors noted. Medical research studies often struggle to recruit people of color, resulting in a lack of data to help guide health care priorities and decision-making.

The study also provided important guidance for people newly diagnosed with diabetes. People who were diagnosed with diabetes within the past 5 years were at a particularly increased risk of getting colorectal cancer, compared to people who had been diagnosed for 5-10 years.

The authors concluded that increased referrals for colonoscopies among people with diabetes, particularly among those newly diagnosed, could greatly reduce the impact of colorectal cancer. Current guidelines suggest most people should begin colorectal cancer screenings at age 45, according to the Centers for Disease Control and Prevention.

The study was supported by the National Cancer Institute and the University of Wisconsin, Madison. The study authors reported no relevant conflicts of interest.

A version of this article first appeared on WebMD.com.

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FTC considers proposals on mergers and noncompete clauses

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Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

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Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

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GLP-1s don’t appear to worsen diabetic retinopathy

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– A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

  • No retinopathy or background retinopathy (71.8%).
  • Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
  • Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

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– A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

  • No retinopathy or background retinopathy (71.8%).
  • Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
  • Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

– A large observational registry study of almost 100,000 eyes has found that the diabetes drug semaglutide, a GLP-1 agonist recently approved for weight loss, does not worsen the progression of potentially vision-threatening diabetic retinopathy in the long term in patients taking the drug. However, the researchers said, the findings do not obviate the need for providers to have a conversation about the potential risks to vision posed by the drug.

“In patients that have either no or early or relatively nonadvanced diabetic retinopathy, the absolute risk of having a worsening in their retinopathy is variable,” Zeeshan Haq, MD, a retina specialist at Retinal Consultants of Minnesota, told this news organization. Dr. Hag presented the findings Nov. 3 at the annual meeting of the American Academy of Ophthalmology.

“Based on this preliminary evidence and what we know so far, it suggests that there is a risk of worsening, but it’s quite low for most patients, and so a conversation needs to be had between anyone considering prescribing the drug, such as a general practitioner or a nurse practitioner, and that patient’s optometrist or comprehensive ophthalmologist or retina specialist.”
 

Methodology and results

Dr. Haq reported on a retrospective case series of 96,462 eyes from the Intelligent Research in Sight (IRIS) registry. Patients had type 2 diabetes and began taking injectable semaglutide between January 2013 and December 2021.

The study evaluated eyes with three levels of retinopathy:

  • No retinopathy or background retinopathy (71.8%).
  • Mild or moderate nonproliferative diabetic retinopathy (NPDR) (18.4%).
  • Severe NPDR or proliferative diabetic retinopathy (PDR) (9.8%).

In eyes with no or background retinopathy, 1.3%, 1.2%, 1.6%, and 2.2% experienced a worsening in status of the condition at 3, 6, 12, and 24 months, respectively.

In eyes with mild or moderate NPDR, 2.4%, 3%, 3.4%, and 3.5% showed worsening retinopathy at the respective time intervals.

Improvement of retinopathy rather than worsening was evaluated in the eyes with severe NPDR or PDR. At 3, 6, 12, and 24 months, improvement was observed in 40%, 37.8%, 47.7%, and 58.7% of these eyes, respectively.

Most patients were aged 51-75 years (77.2%), female (55.0%), and White (63.8%).

The study found low rates of the following complications across the same time intervals: vitreous hemorrhage (from 0.1% to 0.15%); traction retinal detachment (0.02% to 0.05%); and neovascular glaucoma (0.03% to –0.04%), Dr. Haq reported.

Dr. Haq noted that understanding the possible consequences that semaglutide has on vision is important as the drug becomes more widely available for both diabetes and weight control. The Centers for Disease Control and Prevention reports that 37.3 million people in the United States have diabetes; 28.7 million cases have been diagnosed, and 8.5 million are undiagnosed.
 

Clinical implications

“Any patient in the United States with diabetes has to undergo screening for diabetic eye disease, and so they’re usually plugged into the eye-care system,” Dr. Haq said. “But if they’re going to be starting this drug and they don’t have any existing diabetic retinopathy, the discussion should be had between their doctor and the eye-care provider, and if they do have a history of DR, an evaluation with the eye-care provider should probably happen upon starting the drug.”

Vaidehi Dedania, MD, a retina specialist at NYU Langone Health in New York, said the findings underscore the importance of counseling patients who are taking semaglutide about potential vision outcomes.

“We know that when patients get rapid control of their diabetes, their diabetic retinopathy can worsen in the short term, although it always ends up doing better in long term anyway,” Dr. Dedania said in an interview. “We always educate our patients that if they get control of the diabetes to not feel discouraged if their diabetic retinopathy worsens despite getting good control, because we know in the long run it always get better.”

The new findings, however, may have masked some worsening of retinopathy because of how the researchers categorized the condition. “It’s hard to assess changes within a designation because they’re so broad,” Dr. Dedania said.

She also noted potential limitations with the IRIS database itself. “The data collected from it are not always as complete as you might need for the purpose of understanding this, so that’s a limitation,” she said. While the high number of patients is a strength of the study, she added, “I still think the limitations are pretty significant.”

Dr. Haq has disclosed no relevant financial relationships. Dr. Dedania has relationships with Genentech/Roche and Regeneron Pharmaceuticals.

A version of this article first appeared on Medscape.com.

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Older adults with type 2 diabetes find weight loss, deprescribing benefits in GLP-1 agonists, small study suggests

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Glucagon-like peptide 1 (GLP-1) agonists may help clinicians manage uncontrolled type 2 diabetes in some older patients without the need for additional glucose-controlling medications, according to a study presented Nov. 8 at the annual meeting of the Gerontological Society of America.

The study analyzed charts of 30 adults aged 65-84 years who were seen in clinic from January 2022 to February 2023 and were started on GLP-1 or GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonists. Participants had uncontrolled type 2 diabetes with initial A1c levels ranging from 9.6% to 12.6% and a body mass index between 27 and 48.2. The patients also received education about their conditions as well as counseling on diet and lifestyle modifications.

All participants experienced a reduction in A1c to a range of 5.8% to 7.7%, and a moderate reduction in BMI to between 23 and 39.8 within the year.

“The reduction in BMI that we saw in our patients even though they were still in the category of obesity produces a substantial benefit in the management [of type 2 diabetes],” because weight loss helps to control the condition, said Anna Pendrey, MD, assistant professor of clinical family medicine and geriatrics at Indiana University, Indianapolis, and sole author of the study.

In some cases, the addition of a GLP-1 agonist or GLP-1/GIP agonist allowed for clinicians to deprescribe other medications such as insulin and sulfonylureas, which can cause hypoglycemia in older adults, Dr. Pendrey said.

Approximately 11% of U.S. adults have type 2 diabetes, a percentage that is likely to grow given the prevalence of childhood obesity, according to the Centers for Disease Control and Prevention. Dr. Pendrey highlighted the increased incidence of newly diagnosed diabetes in individuals aged 65-79 years.

Previous studies have shown that GLP-1 agonists have the potential to aid in weight reduction, glucose control, and the prevention of major adverse cardiovascular events in these patients.

The new study is one of many post hoc analyses that mark another step forward in addressing the complex challenges associated with diabetes in older adults, according to Rodolfo Galindo, MD, director of the Comprehensive Diabetes Center at the University of Miami Health System in Florida.

“I believe this is important because unfortunately many of our older adults have both diabetes and obesity,” Dr. Galindo, who was not involved with the research, told this news organization. “You can induce remission of type 2 diabetes through weight loss that GLP-1s can cause.”

The treatment paradigm has shifted away from focusing only on lowering glucose levels as the primary means to prevent complications from diabetes, Dr. Galindo said.

Indeed, weight loss can modify diseases and prevent other complications associated with type 2 diabetes, Dr. Pendrey said.

“Weight loss and diabetes mellitus control also produces cardiovascular protection that is significant for patients with diabetes, so this group of patients in my opinion are the ones that benefit the most from GLP-1s,” she said.

Side effects of GLP-1 agonists can include nausea and vomiting, which could lead to dehydration. GLP-1s can also increase the risk for pancreatitis. For older adults, weight loss from the drug could cause sarcopenia, or loss of muscle mass, Dr. Galindo said.

“This is the reason why patients in treatment with GLP-1s have to be in close contact with their providers,” Dr. Pendrey said.

This study was independently supported. Dr. Pendrey and Dr. Galindo report no relevant conflicts.

A version of this article appeared on Medscape.com.

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Glucagon-like peptide 1 (GLP-1) agonists may help clinicians manage uncontrolled type 2 diabetes in some older patients without the need for additional glucose-controlling medications, according to a study presented Nov. 8 at the annual meeting of the Gerontological Society of America.

The study analyzed charts of 30 adults aged 65-84 years who were seen in clinic from January 2022 to February 2023 and were started on GLP-1 or GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonists. Participants had uncontrolled type 2 diabetes with initial A1c levels ranging from 9.6% to 12.6% and a body mass index between 27 and 48.2. The patients also received education about their conditions as well as counseling on diet and lifestyle modifications.

All participants experienced a reduction in A1c to a range of 5.8% to 7.7%, and a moderate reduction in BMI to between 23 and 39.8 within the year.

“The reduction in BMI that we saw in our patients even though they were still in the category of obesity produces a substantial benefit in the management [of type 2 diabetes],” because weight loss helps to control the condition, said Anna Pendrey, MD, assistant professor of clinical family medicine and geriatrics at Indiana University, Indianapolis, and sole author of the study.

In some cases, the addition of a GLP-1 agonist or GLP-1/GIP agonist allowed for clinicians to deprescribe other medications such as insulin and sulfonylureas, which can cause hypoglycemia in older adults, Dr. Pendrey said.

Approximately 11% of U.S. adults have type 2 diabetes, a percentage that is likely to grow given the prevalence of childhood obesity, according to the Centers for Disease Control and Prevention. Dr. Pendrey highlighted the increased incidence of newly diagnosed diabetes in individuals aged 65-79 years.

Previous studies have shown that GLP-1 agonists have the potential to aid in weight reduction, glucose control, and the prevention of major adverse cardiovascular events in these patients.

The new study is one of many post hoc analyses that mark another step forward in addressing the complex challenges associated with diabetes in older adults, according to Rodolfo Galindo, MD, director of the Comprehensive Diabetes Center at the University of Miami Health System in Florida.

“I believe this is important because unfortunately many of our older adults have both diabetes and obesity,” Dr. Galindo, who was not involved with the research, told this news organization. “You can induce remission of type 2 diabetes through weight loss that GLP-1s can cause.”

The treatment paradigm has shifted away from focusing only on lowering glucose levels as the primary means to prevent complications from diabetes, Dr. Galindo said.

Indeed, weight loss can modify diseases and prevent other complications associated with type 2 diabetes, Dr. Pendrey said.

“Weight loss and diabetes mellitus control also produces cardiovascular protection that is significant for patients with diabetes, so this group of patients in my opinion are the ones that benefit the most from GLP-1s,” she said.

Side effects of GLP-1 agonists can include nausea and vomiting, which could lead to dehydration. GLP-1s can also increase the risk for pancreatitis. For older adults, weight loss from the drug could cause sarcopenia, or loss of muscle mass, Dr. Galindo said.

“This is the reason why patients in treatment with GLP-1s have to be in close contact with their providers,” Dr. Pendrey said.

This study was independently supported. Dr. Pendrey and Dr. Galindo report no relevant conflicts.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 (GLP-1) agonists may help clinicians manage uncontrolled type 2 diabetes in some older patients without the need for additional glucose-controlling medications, according to a study presented Nov. 8 at the annual meeting of the Gerontological Society of America.

The study analyzed charts of 30 adults aged 65-84 years who were seen in clinic from January 2022 to February 2023 and were started on GLP-1 or GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) agonists. Participants had uncontrolled type 2 diabetes with initial A1c levels ranging from 9.6% to 12.6% and a body mass index between 27 and 48.2. The patients also received education about their conditions as well as counseling on diet and lifestyle modifications.

All participants experienced a reduction in A1c to a range of 5.8% to 7.7%, and a moderate reduction in BMI to between 23 and 39.8 within the year.

“The reduction in BMI that we saw in our patients even though they were still in the category of obesity produces a substantial benefit in the management [of type 2 diabetes],” because weight loss helps to control the condition, said Anna Pendrey, MD, assistant professor of clinical family medicine and geriatrics at Indiana University, Indianapolis, and sole author of the study.

In some cases, the addition of a GLP-1 agonist or GLP-1/GIP agonist allowed for clinicians to deprescribe other medications such as insulin and sulfonylureas, which can cause hypoglycemia in older adults, Dr. Pendrey said.

Approximately 11% of U.S. adults have type 2 diabetes, a percentage that is likely to grow given the prevalence of childhood obesity, according to the Centers for Disease Control and Prevention. Dr. Pendrey highlighted the increased incidence of newly diagnosed diabetes in individuals aged 65-79 years.

Previous studies have shown that GLP-1 agonists have the potential to aid in weight reduction, glucose control, and the prevention of major adverse cardiovascular events in these patients.

The new study is one of many post hoc analyses that mark another step forward in addressing the complex challenges associated with diabetes in older adults, according to Rodolfo Galindo, MD, director of the Comprehensive Diabetes Center at the University of Miami Health System in Florida.

“I believe this is important because unfortunately many of our older adults have both diabetes and obesity,” Dr. Galindo, who was not involved with the research, told this news organization. “You can induce remission of type 2 diabetes through weight loss that GLP-1s can cause.”

The treatment paradigm has shifted away from focusing only on lowering glucose levels as the primary means to prevent complications from diabetes, Dr. Galindo said.

Indeed, weight loss can modify diseases and prevent other complications associated with type 2 diabetes, Dr. Pendrey said.

“Weight loss and diabetes mellitus control also produces cardiovascular protection that is significant for patients with diabetes, so this group of patients in my opinion are the ones that benefit the most from GLP-1s,” she said.

Side effects of GLP-1 agonists can include nausea and vomiting, which could lead to dehydration. GLP-1s can also increase the risk for pancreatitis. For older adults, weight loss from the drug could cause sarcopenia, or loss of muscle mass, Dr. Galindo said.

“This is the reason why patients in treatment with GLP-1s have to be in close contact with their providers,” Dr. Pendrey said.

This study was independently supported. Dr. Pendrey and Dr. Galindo report no relevant conflicts.

A version of this article appeared on Medscape.com.

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Weight-loss drugs improve liver measures, too

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– With the current demand for type 2 diabetes drugs that both improve glycemic control and help patients shed large amounts of weight, liver specialists have speculated that the metabolic benefits could also extend to the liver.

Spoiler alert: they do.

In a retrospective study of patients with metabolic-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus (T2DM) who received either a sodium-glucose cotransporter 2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist, 87% of those who lost at least 3% of body weight within 8 weeks eventually experienced normalization of alanine aminotransferase (ALT) levels, reported Takamasa Ohki, MD, PhD, and colleagues from the department of gastroenterology at Mitsui Memorial Hospital in Tokyo.

“Body weight reduction within 8 weeks after administration of these agents was an independent factor [that] contributed to rapid improvement of ALT. Maintenance of body weight and T2DM after normalization of ALT was also very important,” they wrote in a scientific poster presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

The biggest losers benefit most

Dr. Ohki and colleagues evaluated the effectiveness of SGLT-2 inhibitors and GLP-1 agonists as treatment of MAFLD for patients with T2DM.

They conducted a retrospective study of 233 patients who had both conditions and who received either of the drug classes at their institution from June 2010 through December 2021; the most recent follow-up was in December 2022. The primary endpoint of the study was normalization of ALT values.

A total of 54 patients had a 3% or greater reduction in body weight within 8 weeks of beginning treatment with their respective drugs. The researchers found that for 47 of these patients (87%), ALT values normalized; the 12-, 24-, and 36-month cumulative normalization rates were 61%, 73%, and 80%, respectively.

In contrast, among the 179 patients who did not lose weight as robustly or rapidly, 137 (76.5%) demonstrated normalization of ALT, with cumulative normalization rates of 41%, 59% and 69%, respectively (P < .01).

In multivariate analysis that controlled for age, sex, smoking, hypertension, dyslipidemia, weight reduction, and antidiabetes drug use, body weight reduction of at least 3% within 8 weeks of beginning treatment with either an SLT-2 or GLP-1 agent was associated independently with normalization of ALT, with a hazard ratio (HR) of 0.67 (P = .028).

Improvement of T2DM was an independent predictor for ALT normalization (HR, 0.64; P = .015).

Other factors contributing to ALT normalization included use of sulfonylurea (HR, 0.63; P < .01) and insulin (HR, 0.54; P < .01).

In all, 103 of the 184 patients with initial normalization of ALT values experienced a recurrence of ALT elevation during follow-up. In multivariate analysis, body weight gain and exacerbation of T2DM were independent factors for ALT reexacerbation (HR, 0.52 and 0.48, respectively; P < .01 for both comparisons).
 

Duration of effect uncertain

Philip A. Newsome, PhD, FRCPE, professor of experimental hepatology and honorary consultant hepatologist at the University of Birmingham, England, who was not involved in the study, has conducted research into the metabolic effects of SGLT-2 inhibitors and GLP-1 agonists. In an interview, he said that both drug classes are likely to have positive near-term effects on metabolic dysfunction–associated steatohepatitis (MASH, formerly NASH) through their effects on glucose control and reduction in associated comorbidities.

“The unknown question,” he added, is what will happen in the long term. “I think there are some uncertainties around what proportion of patients will essentially be downstaged or downgraded such that they don’t develop any other problem; I suspect that will be the case in very many patients. However, I suspect there will also be a large proportion that end up requiring additional therapy above and beyond weight loss,” said Dr. Newsome.

The investigators did not report a funding source for the study. Dr. Ohki and colleagues have disclosed no relevant financial relationships. Dr. Newsome has consulted on behalf of his institution with Novo Nordisk, BMS, Gilead, Pfizer, Poxel, and Intercept and has received a grant from Pharmaxis and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

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– With the current demand for type 2 diabetes drugs that both improve glycemic control and help patients shed large amounts of weight, liver specialists have speculated that the metabolic benefits could also extend to the liver.

Spoiler alert: they do.

In a retrospective study of patients with metabolic-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus (T2DM) who received either a sodium-glucose cotransporter 2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist, 87% of those who lost at least 3% of body weight within 8 weeks eventually experienced normalization of alanine aminotransferase (ALT) levels, reported Takamasa Ohki, MD, PhD, and colleagues from the department of gastroenterology at Mitsui Memorial Hospital in Tokyo.

“Body weight reduction within 8 weeks after administration of these agents was an independent factor [that] contributed to rapid improvement of ALT. Maintenance of body weight and T2DM after normalization of ALT was also very important,” they wrote in a scientific poster presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

The biggest losers benefit most

Dr. Ohki and colleagues evaluated the effectiveness of SGLT-2 inhibitors and GLP-1 agonists as treatment of MAFLD for patients with T2DM.

They conducted a retrospective study of 233 patients who had both conditions and who received either of the drug classes at their institution from June 2010 through December 2021; the most recent follow-up was in December 2022. The primary endpoint of the study was normalization of ALT values.

A total of 54 patients had a 3% or greater reduction in body weight within 8 weeks of beginning treatment with their respective drugs. The researchers found that for 47 of these patients (87%), ALT values normalized; the 12-, 24-, and 36-month cumulative normalization rates were 61%, 73%, and 80%, respectively.

In contrast, among the 179 patients who did not lose weight as robustly or rapidly, 137 (76.5%) demonstrated normalization of ALT, with cumulative normalization rates of 41%, 59% and 69%, respectively (P < .01).

In multivariate analysis that controlled for age, sex, smoking, hypertension, dyslipidemia, weight reduction, and antidiabetes drug use, body weight reduction of at least 3% within 8 weeks of beginning treatment with either an SLT-2 or GLP-1 agent was associated independently with normalization of ALT, with a hazard ratio (HR) of 0.67 (P = .028).

Improvement of T2DM was an independent predictor for ALT normalization (HR, 0.64; P = .015).

Other factors contributing to ALT normalization included use of sulfonylurea (HR, 0.63; P < .01) and insulin (HR, 0.54; P < .01).

In all, 103 of the 184 patients with initial normalization of ALT values experienced a recurrence of ALT elevation during follow-up. In multivariate analysis, body weight gain and exacerbation of T2DM were independent factors for ALT reexacerbation (HR, 0.52 and 0.48, respectively; P < .01 for both comparisons).
 

Duration of effect uncertain

Philip A. Newsome, PhD, FRCPE, professor of experimental hepatology and honorary consultant hepatologist at the University of Birmingham, England, who was not involved in the study, has conducted research into the metabolic effects of SGLT-2 inhibitors and GLP-1 agonists. In an interview, he said that both drug classes are likely to have positive near-term effects on metabolic dysfunction–associated steatohepatitis (MASH, formerly NASH) through their effects on glucose control and reduction in associated comorbidities.

“The unknown question,” he added, is what will happen in the long term. “I think there are some uncertainties around what proportion of patients will essentially be downstaged or downgraded such that they don’t develop any other problem; I suspect that will be the case in very many patients. However, I suspect there will also be a large proportion that end up requiring additional therapy above and beyond weight loss,” said Dr. Newsome.

The investigators did not report a funding source for the study. Dr. Ohki and colleagues have disclosed no relevant financial relationships. Dr. Newsome has consulted on behalf of his institution with Novo Nordisk, BMS, Gilead, Pfizer, Poxel, and Intercept and has received a grant from Pharmaxis and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

– With the current demand for type 2 diabetes drugs that both improve glycemic control and help patients shed large amounts of weight, liver specialists have speculated that the metabolic benefits could also extend to the liver.

Spoiler alert: they do.

In a retrospective study of patients with metabolic-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus (T2DM) who received either a sodium-glucose cotransporter 2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist, 87% of those who lost at least 3% of body weight within 8 weeks eventually experienced normalization of alanine aminotransferase (ALT) levels, reported Takamasa Ohki, MD, PhD, and colleagues from the department of gastroenterology at Mitsui Memorial Hospital in Tokyo.

“Body weight reduction within 8 weeks after administration of these agents was an independent factor [that] contributed to rapid improvement of ALT. Maintenance of body weight and T2DM after normalization of ALT was also very important,” they wrote in a scientific poster presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

The biggest losers benefit most

Dr. Ohki and colleagues evaluated the effectiveness of SGLT-2 inhibitors and GLP-1 agonists as treatment of MAFLD for patients with T2DM.

They conducted a retrospective study of 233 patients who had both conditions and who received either of the drug classes at their institution from June 2010 through December 2021; the most recent follow-up was in December 2022. The primary endpoint of the study was normalization of ALT values.

A total of 54 patients had a 3% or greater reduction in body weight within 8 weeks of beginning treatment with their respective drugs. The researchers found that for 47 of these patients (87%), ALT values normalized; the 12-, 24-, and 36-month cumulative normalization rates were 61%, 73%, and 80%, respectively.

In contrast, among the 179 patients who did not lose weight as robustly or rapidly, 137 (76.5%) demonstrated normalization of ALT, with cumulative normalization rates of 41%, 59% and 69%, respectively (P < .01).

In multivariate analysis that controlled for age, sex, smoking, hypertension, dyslipidemia, weight reduction, and antidiabetes drug use, body weight reduction of at least 3% within 8 weeks of beginning treatment with either an SLT-2 or GLP-1 agent was associated independently with normalization of ALT, with a hazard ratio (HR) of 0.67 (P = .028).

Improvement of T2DM was an independent predictor for ALT normalization (HR, 0.64; P = .015).

Other factors contributing to ALT normalization included use of sulfonylurea (HR, 0.63; P < .01) and insulin (HR, 0.54; P < .01).

In all, 103 of the 184 patients with initial normalization of ALT values experienced a recurrence of ALT elevation during follow-up. In multivariate analysis, body weight gain and exacerbation of T2DM were independent factors for ALT reexacerbation (HR, 0.52 and 0.48, respectively; P < .01 for both comparisons).
 

Duration of effect uncertain

Philip A. Newsome, PhD, FRCPE, professor of experimental hepatology and honorary consultant hepatologist at the University of Birmingham, England, who was not involved in the study, has conducted research into the metabolic effects of SGLT-2 inhibitors and GLP-1 agonists. In an interview, he said that both drug classes are likely to have positive near-term effects on metabolic dysfunction–associated steatohepatitis (MASH, formerly NASH) through their effects on glucose control and reduction in associated comorbidities.

“The unknown question,” he added, is what will happen in the long term. “I think there are some uncertainties around what proportion of patients will essentially be downstaged or downgraded such that they don’t develop any other problem; I suspect that will be the case in very many patients. However, I suspect there will also be a large proportion that end up requiring additional therapy above and beyond weight loss,” said Dr. Newsome.

The investigators did not report a funding source for the study. Dr. Ohki and colleagues have disclosed no relevant financial relationships. Dr. Newsome has consulted on behalf of his institution with Novo Nordisk, BMS, Gilead, Pfizer, Poxel, and Intercept and has received a grant from Pharmaxis and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

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