Mary Ann Moon

An inexpensive telephone intervention raised the rate of annual colorectal cancer screening using fecal occult blood testing to 82% in an underserved population at particular risk for poor health, according to a report published online June 16 in JAMA Internal Medicine.

In this clinical trial, 450 people aged 51-75 years (mean age, 60 years) treated at four Chicago community clinics were randomly assigned to either usual care or an intervention in which they were given take-home fecal immunochemical test (FIT) kits and followed by automated telephone or text message to encourage adherence. Most of the study participants were Hispanic (approximately 90%) and impoverished (91%); more than 75% of them were uninsured, said Dr. David W. Baker of the department of medicine, Northwestern University, Chicago, and his associates.

A total of 82.2% of the intervention group completed the FIT within 6 months – an annual screening rate that has been shown to reduce colorectal cancer mortality – compared with only 37.3% of the usual-care group. The median time to completion of the FIT was 13 days in the intervention group, compared with 83 days in the usual-care group. The estimated cost of the intervention was less than $35 per patient, the investigators said (JAMA Intern. Med. 2014 June 16 [doi:10.1001/jamainternmed.2014.2352]).

"Our study suggests that it is possible to achieve high annual FOBT adherence rates even among highly vulnerable populations," they said.

It is hoped that this strategy will reduce ethnic and socioeconomic disparities in colorectal cancer mortality, Dr. Baker and his associates added.

This study was funded by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

An inexpensive telephone intervention raised the rate of annual colorectal cancer screening using fecal occult blood testing to 82% in an underserved population at particular risk for poor health, according to a report published online June 16 in JAMA Internal Medicine.

In this clinical trial, 450 people aged 51-75 years (mean age, 60 years) treated at four Chicago community clinics were randomly assigned to either usual care or an intervention in which they were given take-home fecal immunochemical test (FIT) kits and followed by automated telephone or text message to encourage adherence. Most of the study participants were Hispanic (approximately 90%) and impoverished (91%); more than 75% of them were uninsured, said Dr. David W. Baker of the department of medicine, Northwestern University, Chicago, and his associates.

A total of 82.2% of the intervention group completed the FIT within 6 months – an annual screening rate that has been shown to reduce colorectal cancer mortality – compared with only 37.3% of the usual-care group. The median time to completion of the FIT was 13 days in the intervention group, compared with 83 days in the usual-care group. The estimated cost of the intervention was less than $35 per patient, the investigators said (JAMA Intern. Med. 2014 June 16 [doi:10.1001/jamainternmed.2014.2352]).

"Our study suggests that it is possible to achieve high annual FOBT adherence rates even among highly vulnerable populations," they said.

It is hoped that this strategy will reduce ethnic and socioeconomic disparities in colorectal cancer mortality, Dr. Baker and his associates added.

This study was funded by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

An inexpensive telephone intervention raised the rate of annual colorectal cancer screening using fecal occult blood testing to 82% in an underserved population at particular risk for poor health, according to a report published online June 16 in JAMA Internal Medicine.

In this clinical trial, 450 people aged 51-75 years (mean age, 60 years) treated at four Chicago community clinics were randomly assigned to either usual care or an intervention in which they were given take-home fecal immunochemical test (FIT) kits and followed by automated telephone or text message to encourage adherence. Most of the study participants were Hispanic (approximately 90%) and impoverished (91%); more than 75% of them were uninsured, said Dr. David W. Baker of the department of medicine, Northwestern University, Chicago, and his associates.

A total of 82.2% of the intervention group completed the FIT within 6 months – an annual screening rate that has been shown to reduce colorectal cancer mortality – compared with only 37.3% of the usual-care group. The median time to completion of the FIT was 13 days in the intervention group, compared with 83 days in the usual-care group. The estimated cost of the intervention was less than $35 per patient, the investigators said (JAMA Intern. Med. 2014 June 16 [doi:10.1001/jamainternmed.2014.2352]).

"Our study suggests that it is possible to achieve high annual FOBT adherence rates even among highly vulnerable populations," they said.

It is hoped that this strategy will reduce ethnic and socioeconomic disparities in colorectal cancer mortality, Dr. Baker and his associates added.

This study was funded by the Agency for Healthcare Research and Quality. No financial conflicts of interest were reported.

"Actionable" oncogenic drivers – genetic mutations that are critical to the development and maintenance of a cancer and that are susceptible to targeted therapy – were identified in 64% of tumor samples from 733 patients with lung adenocarcinoma in a proof-of-concept study aimed at determining the frequency of such mutations that was reported in JAMA.

The researchers used multiplexed genetic testing to screen tumor samples for 10 possible oncogenic drivers simultaneously. In some cases, the results allowed clinicians to individually tailor cancer treatment, and patients who received this targeted therapy showed longer survival times than those who received conventional therapy.

Thus, this study established that it is feasible to incorporate genomic testing into clinical care for treatment stratification, and that multiplex testing is useful for guiding treatment in the majority of patients with lung adenocarcinoma, said Dr. Mark G. Kris, FCCP, of Memorial Sloan Kettering Cancer Center, New York, and his associates.

Since this study wasn’t designed to assess patient survival, further randomized trials are needed to definitively determine whether selecting therapy based on this method of identifying oncogenic drivers improves survival in the real-world setting, the researchers noted.

The study involved patients with stage IV or recurrent lung adenocarcinoma treated at 14 medical centers across the country during a 3-year period. Each site performed multiplex genotyping on tumor samples using one of three available methods, to search for any of 10 oncogenic drivers: mutations in the EGFR gene (which are known to respond to tyrosine kinase inhibitors such as gefitinib and erlotinib), the ALK gene (known to respond to crizotinib), and the KRAS, NRAS, BRAF, ERBB2 (formerly known as HER-2), PIK3CA, MEK1, and AKT1 genes, as well as amplification of the met protooncogene (MET).

These participants’ treating physicians decided whether or not to recommend a targeted therapy to patients found to have tumors harboring one of these oncogenic drivers.

A total of 1,007 patients had at least one gene assessed for oncogenic drivers, and 733 patients were fully genotyped. The main reason why full genotyping couldn’t be done in all the study subjects was that insufficient tissue had been obtained in some tumor samples. (When this trial began in 2009, tumor sampling was done only to establish a diagnosis. Since then, genotyping has become an essential step in choosing therapy, so larger tissue samples are now obtained routinely.)

Of the 733 specimens tested for all 10 onocogenic drivers, 466 (64%) were found to harbor them; 442 specimens had 1 oncogenic driver and 24 had 2 of them. KRAS mutations were the most frequent, found in 25% of tumors; sensitizing EGFR mutations were found in 17%, other EGFR mutations in 4%, and ALK rearrangements in 8%. Each of the other mutations were found in less than 1%-3% of tumors, Dr. Kris and his associates said (JAMA 2014 May 20 [doi:10.1001/jama.2014.3741]).

A total of 260 of these patients received targeted therapy directed at the oncogenic driver(s) found in their tumors, and their median survival was 3.5 years. In contrast, 318 patients who were found to have at least one oncogenic driver did not receive targeted therapy, and their median survival was 2.4 years. And the 360 patients with no oncogenic driver identified in their tumors had a median survival of 2.1 years.

"Actionable" oncogenic drivers – genetic mutations that are critical to the development and maintenance of a cancer and that are susceptible to targeted therapy – were identified in 64% of tumor samples from 733 patients with lung adenocarcinoma in a proof-of-concept study aimed at determining the frequency of such mutations that was reported in JAMA.

The researchers used multiplexed genetic testing to screen tumor samples for 10 possible oncogenic drivers simultaneously. In some cases, the results allowed clinicians to individually tailor cancer treatment, and patients who received this targeted therapy showed longer survival times than those who received conventional therapy.

Thus, this study established that it is feasible to incorporate genomic testing into clinical care for treatment stratification, and that multiplex testing is useful for guiding treatment in the majority of patients with lung adenocarcinoma, said Dr. Mark G. Kris, FCCP, of Memorial Sloan Kettering Cancer Center, New York, and his associates.

Since this study wasn’t designed to assess patient survival, further randomized trials are needed to definitively determine whether selecting therapy based on this method of identifying oncogenic drivers improves survival in the real-world setting, the researchers noted.

The study involved patients with stage IV or recurrent lung adenocarcinoma treated at 14 medical centers across the country during a 3-year period. Each site performed multiplex genotyping on tumor samples using one of three available methods, to search for any of 10 oncogenic drivers: mutations in the EGFR gene (which are known to respond to tyrosine kinase inhibitors such as gefitinib and erlotinib), the ALK gene (known to respond to crizotinib), and the KRAS, NRAS, BRAF, ERBB2 (formerly known as HER-2), PIK3CA, MEK1, and AKT1 genes, as well as amplification of the met protooncogene (MET).

These participants’ treating physicians decided whether or not to recommend a targeted therapy to patients found to have tumors harboring one of these oncogenic drivers.

A total of 1,007 patients had at least one gene assessed for oncogenic drivers, and 733 patients were fully genotyped. The main reason why full genotyping couldn’t be done in all the study subjects was that insufficient tissue had been obtained in some tumor samples. (When this trial began in 2009, tumor sampling was done only to establish a diagnosis. Since then, genotyping has become an essential step in choosing therapy, so larger tissue samples are now obtained routinely.)

Of the 733 specimens tested for all 10 onocogenic drivers, 466 (64%) were found to harbor them; 442 specimens had 1 oncogenic driver and 24 had 2 of them. KRAS mutations were the most frequent, found in 25% of tumors; sensitizing EGFR mutations were found in 17%, other EGFR mutations in 4%, and ALK rearrangements in 8%. Each of the other mutations were found in less than 1%-3% of tumors, Dr. Kris and his associates said (JAMA 2014 May 20 [doi:10.1001/jama.2014.3741]).

A total of 260 of these patients received targeted therapy directed at the oncogenic driver(s) found in their tumors, and their median survival was 3.5 years. In contrast, 318 patients who were found to have at least one oncogenic driver did not receive targeted therapy, and their median survival was 2.4 years. And the 360 patients with no oncogenic driver identified in their tumors had a median survival of 2.1 years.

"Actionable" oncogenic drivers – genetic mutations that are critical to the development and maintenance of a cancer and that are susceptible to targeted therapy – were identified in 64% of tumor samples from 733 patients with lung adenocarcinoma in a proof-of-concept study aimed at determining the frequency of such mutations that was reported in JAMA.

The researchers used multiplexed genetic testing to screen tumor samples for 10 possible oncogenic drivers simultaneously. In some cases, the results allowed clinicians to individually tailor cancer treatment, and patients who received this targeted therapy showed longer survival times than those who received conventional therapy.

Thus, this study established that it is feasible to incorporate genomic testing into clinical care for treatment stratification, and that multiplex testing is useful for guiding treatment in the majority of patients with lung adenocarcinoma, said Dr. Mark G. Kris, FCCP, of Memorial Sloan Kettering Cancer Center, New York, and his associates.

Since this study wasn’t designed to assess patient survival, further randomized trials are needed to definitively determine whether selecting therapy based on this method of identifying oncogenic drivers improves survival in the real-world setting, the researchers noted.

The study involved patients with stage IV or recurrent lung adenocarcinoma treated at 14 medical centers across the country during a 3-year period. Each site performed multiplex genotyping on tumor samples using one of three available methods, to search for any of 10 oncogenic drivers: mutations in the EGFR gene (which are known to respond to tyrosine kinase inhibitors such as gefitinib and erlotinib), the ALK gene (known to respond to crizotinib), and the KRAS, NRAS, BRAF, ERBB2 (formerly known as HER-2), PIK3CA, MEK1, and AKT1 genes, as well as amplification of the met protooncogene (MET).

These participants’ treating physicians decided whether or not to recommend a targeted therapy to patients found to have tumors harboring one of these oncogenic drivers.

A total of 1,007 patients had at least one gene assessed for oncogenic drivers, and 733 patients were fully genotyped. The main reason why full genotyping couldn’t be done in all the study subjects was that insufficient tissue had been obtained in some tumor samples. (When this trial began in 2009, tumor sampling was done only to establish a diagnosis. Since then, genotyping has become an essential step in choosing therapy, so larger tissue samples are now obtained routinely.)

Of the 733 specimens tested for all 10 onocogenic drivers, 466 (64%) were found to harbor them; 442 specimens had 1 oncogenic driver and 24 had 2 of them. KRAS mutations were the most frequent, found in 25% of tumors; sensitizing EGFR mutations were found in 17%, other EGFR mutations in 4%, and ALK rearrangements in 8%. Each of the other mutations were found in less than 1%-3% of tumors, Dr. Kris and his associates said (JAMA 2014 May 20 [doi:10.1001/jama.2014.3741]).

A total of 260 of these patients received targeted therapy directed at the oncogenic driver(s) found in their tumors, and their median survival was 3.5 years. In contrast, 318 patients who were found to have at least one oncogenic driver did not receive targeted therapy, and their median survival was 2.4 years. And the 360 patients with no oncogenic driver identified in their tumors had a median survival of 2.1 years.

The use of continuous positive airway pressure modestly reduced blood pressure in two separate studies involving obese patients who had moderate to severe obstructive sleep apnea, according to reports published online June 11 in the New England Journal of Medicine.

In contrast, neither the use of supplemental oxygen in one study nor a weight loss of approximately 7 kg in the other study had a beneficial effect on blood pressure.

In the first study, investigators compared the effects of CPAP against those of nocturnal supplemental oxygen on several markers of cardiovascular risk, including blood pressure. The multicenter study involved cardiology patients aged 45-75 years who either had established coronary heart disease or multiple cardiovascular risk factors, and who also were found to have obstructive sleep apnea when screened for the disorder.

The 318 patients were randomly assigned in equal numbers to receive CPAP plus education in healthy lifestyle and sleep practices, nocturnal supplemental oxygen delivered via cannula plus lifestyle and sleep education, or lifestyle and sleep education alone (the control group) for 12 weeks, said Dr. Daniel J. Gottlieb, of the Veterans Affairs Boston Healthcare System, and his associates.

The mean body mass index was 33.0 kg/m² in the CPAP group, 34.7 kg/m² in the supplemental oxygen group, and 33.7 kg/m² in the education group. Average apnea-hypopnea index scores for the three groups were 25.4, 24.0, and 25.5 events per hour, respectively

At the end of the study, 24-hour mean arterial blood pressure was significantly lower among patients in the CPAP group (87.8 mm Hg) than with oxygen (90.2 mm Hg) or education alone (89.0 mm Hg), a "modest" difference in magnitude that nevertheless has been associated with "a meaningful reduction in cardiovascular risk," the investigators noted.

That benefit was seen even though those patients’ blood pressure was already well controlled by antihypertensive medications and even though their adherence to CPAP was only "average," said Dr. Gottleib, who is also at Brigham and Women’s Hospital and Harvard Medical School, Boston, and his colleagues.

In contrast, mean arterial blood pressure was not significantly different between patients who received supplemental oxygen and the control group, even though the supplemental oxygen did reduce nocturnal hypoxemia and adherence to oxygen therapy was much better than that for CPAP. A further analysis adjusting for potential confounders such as patient age, sex, race, body mass index, and type of antihypertensive medication had no appreciable effect on the results.

"This study offers no support for the common but largely untested clinical practice of providing supplemental oxygen as salvage therapy in patients with obstructive sleep apnea for whom CPAP is problematic," Dr. Gottlieb and his associates reported (N. Engl. J. Med. 2014;370:2276-85 [doi: 10.1056/NEJMoa1306766]).

In the second study, researchers compared the effects of 24 weeks of CPAP alone, weight loss alone, or CPAP plus weight loss in obese adults who had moderate to severe obstructive sleep apnea and elevated C-reactive protein levels. A total of 181 patients underwent randomization, but only 136 completed the study: 48 in the CPAP group, 42 in the weight-loss group, and 46 in the combined-intervention group, said Dr. Julio A. Chirinos, of the Philadelphia Veterans Affairs Medical Center and the University of Pennsylvania, and his associates.

At the conclusion of the intervention, weight loss was similar between the weight-loss–only group (6.8 kg) and the combined-intervention group (7.0 kg), while there was no change in the CPAP-only group.

The study’s primary endpoint was improvement in C-reactive protein levels. There was no significant difference among the three study groups for this outcome. However, the secondary outcome of significantly decreased systolic blood pressure was achieved with the combined intervention (–14.1 mm Hg), compared with weight loss alone (–6.8 mm Hg) or CPAP alone (–3.0 mm Hg).

The combined therapy also improved insulin resistance and serum triglyceride levels, Dr. Chirinos and his associates said (N. Engl. J. Med. 2014;370:2265-75 [doi: 10.1056/NEJMoa1306187]).

"Our study shows that a weight-loss intervention is effective as a central component of the strategies used to improve the cardiovascular risk-factor profile in patients with obesity and obstructive sleep apnea," they added.

Dr. Gottlieb’s study was supported by the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Research Resources. Philips Respironics donated the equipment used in the study. Dr. Gottlieb reported ties to Philips Respironics and ResMed Corporation, and his associates reported ties to numerous industry sources.

Dr. Chirinos’s study also was supported by the NHLBI. ResMed provided CPAP equipment at no cost but had no role in study design, data accrual or analysis, or manuscript preparation. Dr. Chirinos reported no financial conflicts of interest; his associates reported ties to Boehringer Ingelheim, ConAgra Foods, Novo Nordisk, Nutrisystem, Orexigen, Tate and Lyle, United Health Group, and Weight Watchers.

The use of continuous positive airway pressure modestly reduced blood pressure in two separate studies involving obese patients who had moderate to severe obstructive sleep apnea, according to reports published online June 11 in the New England Journal of Medicine.

In contrast, neither the use of supplemental oxygen in one study nor a weight loss of approximately 7 kg in the other study had a beneficial effect on blood pressure.

In the first study, investigators compared the effects of CPAP against those of nocturnal supplemental oxygen on several markers of cardiovascular risk, including blood pressure. The multicenter study involved cardiology patients aged 45-75 years who either had established coronary heart disease or multiple cardiovascular risk factors, and who also were found to have obstructive sleep apnea when screened for the disorder.

The 318 patients were randomly assigned in equal numbers to receive CPAP plus education in healthy lifestyle and sleep practices, nocturnal supplemental oxygen delivered via cannula plus lifestyle and sleep education, or lifestyle and sleep education alone (the control group) for 12 weeks, said Dr. Daniel J. Gottlieb, of the Veterans Affairs Boston Healthcare System, and his associates.

The mean body mass index was 33.0 kg/m² in the CPAP group, 34.7 kg/m² in the supplemental oxygen group, and 33.7 kg/m² in the education group. Average apnea-hypopnea index scores for the three groups were 25.4, 24.0, and 25.5 events per hour, respectively

At the end of the study, 24-hour mean arterial blood pressure was significantly lower among patients in the CPAP group (87.8 mm Hg) than with oxygen (90.2 mm Hg) or education alone (89.0 mm Hg), a "modest" difference in magnitude that nevertheless has been associated with "a meaningful reduction in cardiovascular risk," the investigators noted.

That benefit was seen even though those patients’ blood pressure was already well controlled by antihypertensive medications and even though their adherence to CPAP was only "average," said Dr. Gottleib, who is also at Brigham and Women’s Hospital and Harvard Medical School, Boston, and his colleagues.

In contrast, mean arterial blood pressure was not significantly different between patients who received supplemental oxygen and the control group, even though the supplemental oxygen did reduce nocturnal hypoxemia and adherence to oxygen therapy was much better than that for CPAP. A further analysis adjusting for potential confounders such as patient age, sex, race, body mass index, and type of antihypertensive medication had no appreciable effect on the results.

"This study offers no support for the common but largely untested clinical practice of providing supplemental oxygen as salvage therapy in patients with obstructive sleep apnea for whom CPAP is problematic," Dr. Gottlieb and his associates reported (N. Engl. J. Med. 2014;370:2276-85 [doi: 10.1056/NEJMoa1306766]).

In the second study, researchers compared the effects of 24 weeks of CPAP alone, weight loss alone, or CPAP plus weight loss in obese adults who had moderate to severe obstructive sleep apnea and elevated C-reactive protein levels. A total of 181 patients underwent randomization, but only 136 completed the study: 48 in the CPAP group, 42 in the weight-loss group, and 46 in the combined-intervention group, said Dr. Julio A. Chirinos, of the Philadelphia Veterans Affairs Medical Center and the University of Pennsylvania, and his associates.

At the conclusion of the intervention, weight loss was similar between the weight-loss–only group (6.8 kg) and the combined-intervention group (7.0 kg), while there was no change in the CPAP-only group.

The study’s primary endpoint was improvement in C-reactive protein levels. There was no significant difference among the three study groups for this outcome. However, the secondary outcome of significantly decreased systolic blood pressure was achieved with the combined intervention (–14.1 mm Hg), compared with weight loss alone (–6.8 mm Hg) or CPAP alone (–3.0 mm Hg).

The combined therapy also improved insulin resistance and serum triglyceride levels, Dr. Chirinos and his associates said (N. Engl. J. Med. 2014;370:2265-75 [doi: 10.1056/NEJMoa1306187]).

"Our study shows that a weight-loss intervention is effective as a central component of the strategies used to improve the cardiovascular risk-factor profile in patients with obesity and obstructive sleep apnea," they added.

Dr. Gottlieb’s study was supported by the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Research Resources. Philips Respironics donated the equipment used in the study. Dr. Gottlieb reported ties to Philips Respironics and ResMed Corporation, and his associates reported ties to numerous industry sources.

Dr. Chirinos’s study also was supported by the NHLBI. ResMed provided CPAP equipment at no cost but had no role in study design, data accrual or analysis, or manuscript preparation. Dr. Chirinos reported no financial conflicts of interest; his associates reported ties to Boehringer Ingelheim, ConAgra Foods, Novo Nordisk, Nutrisystem, Orexigen, Tate and Lyle, United Health Group, and Weight Watchers.

The use of continuous positive airway pressure modestly reduced blood pressure in two separate studies involving obese patients who had moderate to severe obstructive sleep apnea, according to reports published online June 11 in the New England Journal of Medicine.

In contrast, neither the use of supplemental oxygen in one study nor a weight loss of approximately 7 kg in the other study had a beneficial effect on blood pressure.

In the first study, investigators compared the effects of CPAP against those of nocturnal supplemental oxygen on several markers of cardiovascular risk, including blood pressure. The multicenter study involved cardiology patients aged 45-75 years who either had established coronary heart disease or multiple cardiovascular risk factors, and who also were found to have obstructive sleep apnea when screened for the disorder.

The 318 patients were randomly assigned in equal numbers to receive CPAP plus education in healthy lifestyle and sleep practices, nocturnal supplemental oxygen delivered via cannula plus lifestyle and sleep education, or lifestyle and sleep education alone (the control group) for 12 weeks, said Dr. Daniel J. Gottlieb, of the Veterans Affairs Boston Healthcare System, and his associates.

The mean body mass index was 33.0 kg/m² in the CPAP group, 34.7 kg/m² in the supplemental oxygen group, and 33.7 kg/m² in the education group. Average apnea-hypopnea index scores for the three groups were 25.4, 24.0, and 25.5 events per hour, respectively

At the end of the study, 24-hour mean arterial blood pressure was significantly lower among patients in the CPAP group (87.8 mm Hg) than with oxygen (90.2 mm Hg) or education alone (89.0 mm Hg), a "modest" difference in magnitude that nevertheless has been associated with "a meaningful reduction in cardiovascular risk," the investigators noted.

That benefit was seen even though those patients’ blood pressure was already well controlled by antihypertensive medications and even though their adherence to CPAP was only "average," said Dr. Gottleib, who is also at Brigham and Women’s Hospital and Harvard Medical School, Boston, and his colleagues.

In contrast, mean arterial blood pressure was not significantly different between patients who received supplemental oxygen and the control group, even though the supplemental oxygen did reduce nocturnal hypoxemia and adherence to oxygen therapy was much better than that for CPAP. A further analysis adjusting for potential confounders such as patient age, sex, race, body mass index, and type of antihypertensive medication had no appreciable effect on the results.

"This study offers no support for the common but largely untested clinical practice of providing supplemental oxygen as salvage therapy in patients with obstructive sleep apnea for whom CPAP is problematic," Dr. Gottlieb and his associates reported (N. Engl. J. Med. 2014;370:2276-85 [doi: 10.1056/NEJMoa1306766]).

In the second study, researchers compared the effects of 24 weeks of CPAP alone, weight loss alone, or CPAP plus weight loss in obese adults who had moderate to severe obstructive sleep apnea and elevated C-reactive protein levels. A total of 181 patients underwent randomization, but only 136 completed the study: 48 in the CPAP group, 42 in the weight-loss group, and 46 in the combined-intervention group, said Dr. Julio A. Chirinos, of the Philadelphia Veterans Affairs Medical Center and the University of Pennsylvania, and his associates.

At the conclusion of the intervention, weight loss was similar between the weight-loss–only group (6.8 kg) and the combined-intervention group (7.0 kg), while there was no change in the CPAP-only group.

The study’s primary endpoint was improvement in C-reactive protein levels. There was no significant difference among the three study groups for this outcome. However, the secondary outcome of significantly decreased systolic blood pressure was achieved with the combined intervention (–14.1 mm Hg), compared with weight loss alone (–6.8 mm Hg) or CPAP alone (–3.0 mm Hg).

The combined therapy also improved insulin resistance and serum triglyceride levels, Dr. Chirinos and his associates said (N. Engl. J. Med. 2014;370:2265-75 [doi: 10.1056/NEJMoa1306187]).

"Our study shows that a weight-loss intervention is effective as a central component of the strategies used to improve the cardiovascular risk-factor profile in patients with obesity and obstructive sleep apnea," they added.

Dr. Gottlieb’s study was supported by the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Research Resources. Philips Respironics donated the equipment used in the study. Dr. Gottlieb reported ties to Philips Respironics and ResMed Corporation, and his associates reported ties to numerous industry sources.

Dr. Chirinos’s study also was supported by the NHLBI. ResMed provided CPAP equipment at no cost but had no role in study design, data accrual or analysis, or manuscript preparation. Dr. Chirinos reported no financial conflicts of interest; his associates reported ties to Boehringer Ingelheim, ConAgra Foods, Novo Nordisk, Nutrisystem, Orexigen, Tate and Lyle, United Health Group, and Weight Watchers.

Among patients receiving metformin for type 2 diabetes, adding insulin rather than a sulfonylurea is associated with an increased risk of cardiovascular events and all-cause mortality, according to a report published online June 11 in JAMA.

This finding calls into question the recommendation that insulin is equivalent to sulfonylureas as an add-on agent when metformin alone fails to reduce hemoglobin A_1c, said Dr. Christianne L. Roumie of the Veterans Health Administration–Tennessee Valley Heathcare System Geriatric Research Education Clinical Center, Nashville, and her associates.

At present, there is no consensus as to which add-on medication is preferred: insulin (long acting, premixed, or fast acting), sulfonylureas (glyburide, glipizide, or glimepiride), thiazolidinediones, glucagon-like peptide-1 receptor agonists, or dipeptidyl peptidase 4 inhibitors. The investigators performed this comparative study expecting that intensifying therapy with insulin rather than sulfonylureas would improve cardiovascular outcomes because of insulin’s superiority in achieving glycemic control.

They assessed 42,938 patients who began taking metformin alone during 2001-2008 and were followed for a median of 50 months. A total of 2,948 added on insulin therapy and 39,990 added on a sulfonylurea. The rate of the primary composite outcome – acute MI or stroke hospitalization or death from any cause – was 42.7 events per 1,000 person-years with insulin, compared with 32.8 events per 1,000 person-years with sulfonylureas. The adjusted hazard ratio was 1.30, Dr. Roumie and her colleagues reported (JAMA 2014;311:2288-96).

These findings remained robust in a sensitivity analysis and in subgroup analyses that stratified patients by CVD history and age. They are consistent with the results of two recent large clinical trials and several observational studies, all of which found no advantage of add-on insulin over add-on sulfonylureas and some of which reported increased cardiovascular risks with insulin, the investigators said.

This study was funded by the Agency for Healthcare Research and Quality, a Veterans Affairs Clinical Science Research and Development grant, and the Center for Diabetes Translation Research. Dr. Roumie and her associates reported no potential financial conflicts of interest.

Among patients receiving metformin for type 2 diabetes, adding insulin rather than a sulfonylurea is associated with an increased risk of cardiovascular events and all-cause mortality, according to a report published online June 11 in JAMA.

This finding calls into question the recommendation that insulin is equivalent to sulfonylureas as an add-on agent when metformin alone fails to reduce hemoglobin A_1c, said Dr. Christianne L. Roumie of the Veterans Health Administration–Tennessee Valley Heathcare System Geriatric Research Education Clinical Center, Nashville, and her associates.

At present, there is no consensus as to which add-on medication is preferred: insulin (long acting, premixed, or fast acting), sulfonylureas (glyburide, glipizide, or glimepiride), thiazolidinediones, glucagon-like peptide-1 receptor agonists, or dipeptidyl peptidase 4 inhibitors. The investigators performed this comparative study expecting that intensifying therapy with insulin rather than sulfonylureas would improve cardiovascular outcomes because of insulin’s superiority in achieving glycemic control.

They assessed 42,938 patients who began taking metformin alone during 2001-2008 and were followed for a median of 50 months. A total of 2,948 added on insulin therapy and 39,990 added on a sulfonylurea. The rate of the primary composite outcome – acute MI or stroke hospitalization or death from any cause – was 42.7 events per 1,000 person-years with insulin, compared with 32.8 events per 1,000 person-years with sulfonylureas. The adjusted hazard ratio was 1.30, Dr. Roumie and her colleagues reported (JAMA 2014;311:2288-96).

These findings remained robust in a sensitivity analysis and in subgroup analyses that stratified patients by CVD history and age. They are consistent with the results of two recent large clinical trials and several observational studies, all of which found no advantage of add-on insulin over add-on sulfonylureas and some of which reported increased cardiovascular risks with insulin, the investigators said.

This study was funded by the Agency for Healthcare Research and Quality, a Veterans Affairs Clinical Science Research and Development grant, and the Center for Diabetes Translation Research. Dr. Roumie and her associates reported no potential financial conflicts of interest.

Among patients receiving metformin for type 2 diabetes, adding insulin rather than a sulfonylurea is associated with an increased risk of cardiovascular events and all-cause mortality, according to a report published online June 11 in JAMA.

This finding calls into question the recommendation that insulin is equivalent to sulfonylureas as an add-on agent when metformin alone fails to reduce hemoglobin A_1c, said Dr. Christianne L. Roumie of the Veterans Health Administration–Tennessee Valley Heathcare System Geriatric Research Education Clinical Center, Nashville, and her associates.

At present, there is no consensus as to which add-on medication is preferred: insulin (long acting, premixed, or fast acting), sulfonylureas (glyburide, glipizide, or glimepiride), thiazolidinediones, glucagon-like peptide-1 receptor agonists, or dipeptidyl peptidase 4 inhibitors. The investigators performed this comparative study expecting that intensifying therapy with insulin rather than sulfonylureas would improve cardiovascular outcomes because of insulin’s superiority in achieving glycemic control.

They assessed 42,938 patients who began taking metformin alone during 2001-2008 and were followed for a median of 50 months. A total of 2,948 added on insulin therapy and 39,990 added on a sulfonylurea. The rate of the primary composite outcome – acute MI or stroke hospitalization or death from any cause – was 42.7 events per 1,000 person-years with insulin, compared with 32.8 events per 1,000 person-years with sulfonylureas. The adjusted hazard ratio was 1.30, Dr. Roumie and her colleagues reported (JAMA 2014;311:2288-96).

These findings remained robust in a sensitivity analysis and in subgroup analyses that stratified patients by CVD history and age. They are consistent with the results of two recent large clinical trials and several observational studies, all of which found no advantage of add-on insulin over add-on sulfonylureas and some of which reported increased cardiovascular risks with insulin, the investigators said.

This study was funded by the Agency for Healthcare Research and Quality, a Veterans Affairs Clinical Science Research and Development grant, and the Center for Diabetes Translation Research. Dr. Roumie and her associates reported no potential financial conflicts of interest.

For adults with type 2 diabetes, the out-of-pocket cost of each insulin prescription and refill nearly doubled during a 10-year period, rising from $19 to $36, according to a research letter to the editor published online June 11 in JAMA.

Using information from the Optum Labs Data Warehouse, an administrative claims database of privately insured patients throughout the United States, investigators calculated the proportion of 123,486 adults with type 2 diabetes who purchased every type of insulin each year from 2000 through 2010.

© crazydiva/Thinkstock

"We found a large increase in the prevalent use of insulin analogs," said Dr. Kasia J. Lipska, an endocrinologist in the department of internal medicine, Yale University, New Haven, and her associates.

In 2000, only 18.9% of these patients filled (and refilled) prescriptions for insulin analogs. By 2010, that proportion had risen to 91.5%. Correspondingly, out-of-pocket expenditures for insulin therapy increased from $19 to $36. However, the rate of severe hypoglycemic events in insulin users did not decline significantly in that time, going from 21.1 to 17.7 events per 1000 person-years. "The clinical value of this change is unclear," they noted (JAMA 2014;311:2331-3).

For adults with type 2 diabetes, the out-of-pocket cost of each insulin prescription and refill nearly doubled during a 10-year period, rising from $19 to $36, according to a research letter to the editor published online June 11 in JAMA.

Using information from the Optum Labs Data Warehouse, an administrative claims database of privately insured patients throughout the United States, investigators calculated the proportion of 123,486 adults with type 2 diabetes who purchased every type of insulin each year from 2000 through 2010.

© crazydiva/Thinkstock

"We found a large increase in the prevalent use of insulin analogs," said Dr. Kasia J. Lipska, an endocrinologist in the department of internal medicine, Yale University, New Haven, and her associates.

In 2000, only 18.9% of these patients filled (and refilled) prescriptions for insulin analogs. By 2010, that proportion had risen to 91.5%. Correspondingly, out-of-pocket expenditures for insulin therapy increased from $19 to $36. However, the rate of severe hypoglycemic events in insulin users did not decline significantly in that time, going from 21.1 to 17.7 events per 1000 person-years. "The clinical value of this change is unclear," they noted (JAMA 2014;311:2331-3).

For adults with type 2 diabetes, the out-of-pocket cost of each insulin prescription and refill nearly doubled during a 10-year period, rising from $19 to $36, according to a research letter to the editor published online June 11 in JAMA.

Using information from the Optum Labs Data Warehouse, an administrative claims database of privately insured patients throughout the United States, investigators calculated the proportion of 123,486 adults with type 2 diabetes who purchased every type of insulin each year from 2000 through 2010.

© crazydiva/Thinkstock

"We found a large increase in the prevalent use of insulin analogs," said Dr. Kasia J. Lipska, an endocrinologist in the department of internal medicine, Yale University, New Haven, and her associates.

In 2000, only 18.9% of these patients filled (and refilled) prescriptions for insulin analogs. By 2010, that proportion had risen to 91.5%. Correspondingly, out-of-pocket expenditures for insulin therapy increased from $19 to $36. However, the rate of severe hypoglycemic events in insulin users did not decline significantly in that time, going from 21.1 to 17.7 events per 1000 person-years. "The clinical value of this change is unclear," they noted (JAMA 2014;311:2331-3).

The economic cost of autism spectrum disorders was found to be considerable in a study assessing the housing, medical and nonmedical health services, and educational expenses associated with the disorder in the United States and the United Kingdom, according to researchers.

The report was published online June 9 in JAMA Pediatrics.

Ariane V.S. Buescher of the London School of Economics and Political Science and her associates reviewed what they called "robust evidence from well-conducted studies" in the literature and from administrative sources such as the Centers for Disease Control and Prevention to calculate the costs of autism spectrum disorders to families and to society according to patient age (preschool, school-age, secondary-school-age, and adult) and functional status (the presence or absence of intellectual disability). They calculated inpatient, outpatient, emergency, physician, other health professional, pharmacy, and out-of-pocket health care costs, as well as the costs of special education, child care, special programs, after-school care, day care, summer school, weekend programs, respite care, and transportation to all of the above.

The precise prevalence of concomitant intellectual disability is not known, but it is estimated to be 40%-60% in both places. In a statistical model assuming a prevalence of 40%, the national cost of supporting autistic children was found to be $61 billion per year in the United States and 3.1 billion pounds per year in the United Kingdom, while the national cost of supporting autistic adults was found to be $175 billion per year in the United States and 29 billion pounds per year in the United Kingdom. In a model assuming a prevalence of concomitant intellectual disability of 60%, these costs were found to be $66 billion, 3.4 billion pounds, $196 billion, and 29 billion pounds, respectively.

Among autistic children, the highest costs were attributed to special education and to the lost productivity of their parents. Among autistic adults, the highest costs were attributed to special housing; direct medical costs, which were much higher than those for autistic children; and to lost productivity of the impaired individual himself or herself.

In the United States and the United Kingdom, the discovery of these substantial and wide-ranging economic effects "should energize a search for actions that make better use of available resources," Ms. Buescher and her associates noted (JAMA Pediatr. 2014 June 9 [doi:10.1001/jamapediatrics.2014.210]).

Specifically, the unexpectedly high cost to families from employment disruption should be addressed, perhaps through workplace policies specific to parents of autistic children. And the excessive cost of residential housing for autistic adults should be reconsidered; perhaps more cost-effective community-living programs should be explored, the investigators said.

Ms. Buescher and her associates noted that the cost estimates in the study came from a range of sources. Because some costs were not available in the literature, those numbers were based on "expert judgment," they wrote. "Nevertheless, by highlighting the scale of economic effect, the relative scale of different cost contributors, and patterns throughout life, such studies can stimulate and support policy and practice discussion."

This study was funded by Autism Speaks. Ms. Buescher and her associates reported no financial conflicts of interest.

The economic cost of autism spectrum disorders was found to be considerable in a study assessing the housing, medical and nonmedical health services, and educational expenses associated with the disorder in the United States and the United Kingdom, according to researchers.

The report was published online June 9 in JAMA Pediatrics.

Ariane V.S. Buescher of the London School of Economics and Political Science and her associates reviewed what they called "robust evidence from well-conducted studies" in the literature and from administrative sources such as the Centers for Disease Control and Prevention to calculate the costs of autism spectrum disorders to families and to society according to patient age (preschool, school-age, secondary-school-age, and adult) and functional status (the presence or absence of intellectual disability). They calculated inpatient, outpatient, emergency, physician, other health professional, pharmacy, and out-of-pocket health care costs, as well as the costs of special education, child care, special programs, after-school care, day care, summer school, weekend programs, respite care, and transportation to all of the above.

The precise prevalence of concomitant intellectual disability is not known, but it is estimated to be 40%-60% in both places. In a statistical model assuming a prevalence of 40%, the national cost of supporting autistic children was found to be $61 billion per year in the United States and 3.1 billion pounds per year in the United Kingdom, while the national cost of supporting autistic adults was found to be $175 billion per year in the United States and 29 billion pounds per year in the United Kingdom. In a model assuming a prevalence of concomitant intellectual disability of 60%, these costs were found to be $66 billion, 3.4 billion pounds, $196 billion, and 29 billion pounds, respectively.

Among autistic children, the highest costs were attributed to special education and to the lost productivity of their parents. Among autistic adults, the highest costs were attributed to special housing; direct medical costs, which were much higher than those for autistic children; and to lost productivity of the impaired individual himself or herself.

In the United States and the United Kingdom, the discovery of these substantial and wide-ranging economic effects "should energize a search for actions that make better use of available resources," Ms. Buescher and her associates noted (JAMA Pediatr. 2014 June 9 [doi:10.1001/jamapediatrics.2014.210]).

Specifically, the unexpectedly high cost to families from employment disruption should be addressed, perhaps through workplace policies specific to parents of autistic children. And the excessive cost of residential housing for autistic adults should be reconsidered; perhaps more cost-effective community-living programs should be explored, the investigators said.

Ms. Buescher and her associates noted that the cost estimates in the study came from a range of sources. Because some costs were not available in the literature, those numbers were based on "expert judgment," they wrote. "Nevertheless, by highlighting the scale of economic effect, the relative scale of different cost contributors, and patterns throughout life, such studies can stimulate and support policy and practice discussion."

This study was funded by Autism Speaks. Ms. Buescher and her associates reported no financial conflicts of interest.

The economic cost of autism spectrum disorders was found to be considerable in a study assessing the housing, medical and nonmedical health services, and educational expenses associated with the disorder in the United States and the United Kingdom, according to researchers.

The report was published online June 9 in JAMA Pediatrics.

Ariane V.S. Buescher of the London School of Economics and Political Science and her associates reviewed what they called "robust evidence from well-conducted studies" in the literature and from administrative sources such as the Centers for Disease Control and Prevention to calculate the costs of autism spectrum disorders to families and to society according to patient age (preschool, school-age, secondary-school-age, and adult) and functional status (the presence or absence of intellectual disability). They calculated inpatient, outpatient, emergency, physician, other health professional, pharmacy, and out-of-pocket health care costs, as well as the costs of special education, child care, special programs, after-school care, day care, summer school, weekend programs, respite care, and transportation to all of the above.

The precise prevalence of concomitant intellectual disability is not known, but it is estimated to be 40%-60% in both places. In a statistical model assuming a prevalence of 40%, the national cost of supporting autistic children was found to be $61 billion per year in the United States and 3.1 billion pounds per year in the United Kingdom, while the national cost of supporting autistic adults was found to be $175 billion per year in the United States and 29 billion pounds per year in the United Kingdom. In a model assuming a prevalence of concomitant intellectual disability of 60%, these costs were found to be $66 billion, 3.4 billion pounds, $196 billion, and 29 billion pounds, respectively.

Among autistic children, the highest costs were attributed to special education and to the lost productivity of their parents. Among autistic adults, the highest costs were attributed to special housing; direct medical costs, which were much higher than those for autistic children; and to lost productivity of the impaired individual himself or herself.

In the United States and the United Kingdom, the discovery of these substantial and wide-ranging economic effects "should energize a search for actions that make better use of available resources," Ms. Buescher and her associates noted (JAMA Pediatr. 2014 June 9 [doi:10.1001/jamapediatrics.2014.210]).

Specifically, the unexpectedly high cost to families from employment disruption should be addressed, perhaps through workplace policies specific to parents of autistic children. And the excessive cost of residential housing for autistic adults should be reconsidered; perhaps more cost-effective community-living programs should be explored, the investigators said.

Ms. Buescher and her associates noted that the cost estimates in the study came from a range of sources. Because some costs were not available in the literature, those numbers were based on "expert judgment," they wrote. "Nevertheless, by highlighting the scale of economic effect, the relative scale of different cost contributors, and patterns throughout life, such studies can stimulate and support policy and practice discussion."

This study was funded by Autism Speaks. Ms. Buescher and her associates reported no financial conflicts of interest.

Initiating statin therapy in older men was associated with a modest but significant drop in physical activity, according findings from a large, observational study published online June 9 in JAMA Internal Medicine.

In addition, older men who used statins showed lower activity levels and higher levels of sedentariness than did nonusers, for as long as they took the drugs. Although results of an observational study such as theirs cannot prove causality, it is likely that the statins’ well-known adverse effects of inducing muscle pain, myopathy, and muscular fatigue account for these differences, said David S.H. Lee, Pharm.D., Ph.D., of Oregon State University/Oregon Health and Science University, Portland, and his associates.

© Dave/Fotolia.com

To assess the relationship between statin use and physical activity, the investigators analyzed data from the MrOS (Osteoporotic Fractures in Men Study), an observational study of healthy aging involving men aged 65 years and older who resided in six geographic regions across the United States and were followed at intervals for roughly 7 years.

Dr. Lee and his colleagues performed both a cross-sectional analysis involving 4,137 of the participants (mean age, 73 years) and a longitudinal analysis involving 3,039 of them. About 24% were statin users at baseline, 48% never used statins throughout the study period, and the remainder began using statins during the study. Activity level was measured subjectively, using the PASE (Physical Activity Scale for the Elderly), and objectively, using an accelerometer.

Men who began using statins during the study showed a modest but significant decline of about 10% in physical activity, compared with those who never took statins.

After the data were adjusted to account for possible confounders between users and nonusers such as medical history, body mass index, and smoking status, it was found that statin users engaged in 9.6% fewer minutes of moderate physical activity and 9.0% fewer minutes of vigorous activity per day than nonusers did. They also engaged in sedentary behavior for 1% more minutes per day than men who didn’t use statins. This equates to a mean decrease of approximately 151 minutes/week of walking and 37.8 minutes/week of more vigorous exercise, and an increase of 21.8 hours/week in sedentariness, for the statin users (JAMA Intern. Med. 2014 June 9 [doi:10.1001/jamainternmed.2014.2266]).

Given these findings and the fact that the literature does not support the benefit of statin therapy in older adults, clinicians and patients should carefully weigh the drugs’ potential harms and benefits, Dr. Lee and his associates said.

This study was funded by the Medical Research Foundation of Oregon; the MrOS study was supported by the National Institutes of Health. Dr. Lee and his associates reported no potential financial conflicts of interest.

Initiating statin therapy in older men was associated with a modest but significant drop in physical activity, according findings from a large, observational study published online June 9 in JAMA Internal Medicine.

In addition, older men who used statins showed lower activity levels and higher levels of sedentariness than did nonusers, for as long as they took the drugs. Although results of an observational study such as theirs cannot prove causality, it is likely that the statins’ well-known adverse effects of inducing muscle pain, myopathy, and muscular fatigue account for these differences, said David S.H. Lee, Pharm.D., Ph.D., of Oregon State University/Oregon Health and Science University, Portland, and his associates.

© Dave/Fotolia.com

To assess the relationship between statin use and physical activity, the investigators analyzed data from the MrOS (Osteoporotic Fractures in Men Study), an observational study of healthy aging involving men aged 65 years and older who resided in six geographic regions across the United States and were followed at intervals for roughly 7 years.

Dr. Lee and his colleagues performed both a cross-sectional analysis involving 4,137 of the participants (mean age, 73 years) and a longitudinal analysis involving 3,039 of them. About 24% were statin users at baseline, 48% never used statins throughout the study period, and the remainder began using statins during the study. Activity level was measured subjectively, using the PASE (Physical Activity Scale for the Elderly), and objectively, using an accelerometer.

Men who began using statins during the study showed a modest but significant decline of about 10% in physical activity, compared with those who never took statins.

After the data were adjusted to account for possible confounders between users and nonusers such as medical history, body mass index, and smoking status, it was found that statin users engaged in 9.6% fewer minutes of moderate physical activity and 9.0% fewer minutes of vigorous activity per day than nonusers did. They also engaged in sedentary behavior for 1% more minutes per day than men who didn’t use statins. This equates to a mean decrease of approximately 151 minutes/week of walking and 37.8 minutes/week of more vigorous exercise, and an increase of 21.8 hours/week in sedentariness, for the statin users (JAMA Intern. Med. 2014 June 9 [doi:10.1001/jamainternmed.2014.2266]).

Given these findings and the fact that the literature does not support the benefit of statin therapy in older adults, clinicians and patients should carefully weigh the drugs’ potential harms and benefits, Dr. Lee and his associates said.

This study was funded by the Medical Research Foundation of Oregon; the MrOS study was supported by the National Institutes of Health. Dr. Lee and his associates reported no potential financial conflicts of interest.

Initiating statin therapy in older men was associated with a modest but significant drop in physical activity, according findings from a large, observational study published online June 9 in JAMA Internal Medicine.

In addition, older men who used statins showed lower activity levels and higher levels of sedentariness than did nonusers, for as long as they took the drugs. Although results of an observational study such as theirs cannot prove causality, it is likely that the statins’ well-known adverse effects of inducing muscle pain, myopathy, and muscular fatigue account for these differences, said David S.H. Lee, Pharm.D., Ph.D., of Oregon State University/Oregon Health and Science University, Portland, and his associates.

© Dave/Fotolia.com

To assess the relationship between statin use and physical activity, the investigators analyzed data from the MrOS (Osteoporotic Fractures in Men Study), an observational study of healthy aging involving men aged 65 years and older who resided in six geographic regions across the United States and were followed at intervals for roughly 7 years.

Dr. Lee and his colleagues performed both a cross-sectional analysis involving 4,137 of the participants (mean age, 73 years) and a longitudinal analysis involving 3,039 of them. About 24% were statin users at baseline, 48% never used statins throughout the study period, and the remainder began using statins during the study. Activity level was measured subjectively, using the PASE (Physical Activity Scale for the Elderly), and objectively, using an accelerometer.

Men who began using statins during the study showed a modest but significant decline of about 10% in physical activity, compared with those who never took statins.

After the data were adjusted to account for possible confounders between users and nonusers such as medical history, body mass index, and smoking status, it was found that statin users engaged in 9.6% fewer minutes of moderate physical activity and 9.0% fewer minutes of vigorous activity per day than nonusers did. They also engaged in sedentary behavior for 1% more minutes per day than men who didn’t use statins. This equates to a mean decrease of approximately 151 minutes/week of walking and 37.8 minutes/week of more vigorous exercise, and an increase of 21.8 hours/week in sedentariness, for the statin users (JAMA Intern. Med. 2014 June 9 [doi:10.1001/jamainternmed.2014.2266]).

Given these findings and the fact that the literature does not support the benefit of statin therapy in older adults, clinicians and patients should carefully weigh the drugs’ potential harms and benefits, Dr. Lee and his associates said.

This study was funded by the Medical Research Foundation of Oregon; the MrOS study was supported by the National Institutes of Health. Dr. Lee and his associates reported no potential financial conflicts of interest.

The demographics of heroin users have shifted profoundly in recent years, according to a retrospective analysis involving more than 2,700 people.

Heroin has migrated out of young minority populations in lower-class city neighborhoods, and users are now far more likely to be white, middle-class men and women in their late 20s living in suburban, small-town, or rural areas, wrote Theodore J. Cicero, Ph.D., of the department of psychiatry, Washington University, St. Louis (JAMA Psychiatry 2014 May 28 [doi:10.1001/jamapsychiatry.2014.366]).

©Remains/Thinkstock

Noting the paucity of systematic studies of the demographics of today’s heroin users, Dr. Cicero and his colleagues analyzed data from the ongoing Survey of Key Informants’ Patients (SKIP) program, in which 150 publicly and privately funded treatment centers (the key informants) recruit patients/clients to complete anonymous surveys about their substance use. The surveys cover all 48 contiguous states.

Dr. Cicero and his colleagues reviewed the survey responses of 2,797 self-reported heroin users entering treatment in 2010-2013. Most (86.4%) said they used heroin at least once a day, and many (66%) said they had concurrently abused prescription opioids during the preceding month.

Three-fourths of the respondents who began heroin use during the past decade said they had begun by abusing a prescription opioid, usually OxyContin. In contrast, about 80% of those who began using heroin in the 1960s and 1970s said they initiated their drug use with heroin itself. Fifty years ago, the average age at first use of heroin was 16 years; now it is 23 years.

A subset of 54 respondents who agreed to more detailed online interviews explained why they progressed from prescription opioids to heroin. A total of 98% said they considered the "high" from heroin to be superior to that from prescription opioids, and 94% said that heroin was far less expensive and far easier to obtain. In addition, one-third of this subgroup said that inhalation or injection is easier with heroin because it doesn’t require extraction, as prescription opioids do.

Nevertheless, if the cost, availability, and ease of use of the two agents were comparable, half of the 54 respondents said they would switch back to prescription opioids, which they described as offering a "cleaner" high and averting the legal problems associated with heroin, the investigators said.

Nearly 83% of the respondents who began heroin use in the 1960s or 1970s were men. In contrast, those who began heroin use during the past decade were approximately equally divided between men and women. Similarly, most who began using heroin in the 1960s and 1970s were nonwhite, while 90% of those who began use more recently were white.

It is important to note that this study population was not randomly selected and might not be representative of all current heroin users. These study subjects were entering treatment and had Internet access that enabled them to participate, so factors such as financial status, education level, family support, and court pressure affected their participation, Dr. Cicero and his associates said.

The SKIP database is supported by the Denver Health and Hospital Authority, which is funded by fees from 14 pharmaceutical firms. Dr. Cicero and his associates reported no financial conflicts of interest

The demographics of heroin users have shifted profoundly in recent years, according to a retrospective analysis involving more than 2,700 people.

Heroin has migrated out of young minority populations in lower-class city neighborhoods, and users are now far more likely to be white, middle-class men and women in their late 20s living in suburban, small-town, or rural areas, wrote Theodore J. Cicero, Ph.D., of the department of psychiatry, Washington University, St. Louis (JAMA Psychiatry 2014 May 28 [doi:10.1001/jamapsychiatry.2014.366]).

©Remains/Thinkstock

Noting the paucity of systematic studies of the demographics of today’s heroin users, Dr. Cicero and his colleagues analyzed data from the ongoing Survey of Key Informants’ Patients (SKIP) program, in which 150 publicly and privately funded treatment centers (the key informants) recruit patients/clients to complete anonymous surveys about their substance use. The surveys cover all 48 contiguous states.

Dr. Cicero and his colleagues reviewed the survey responses of 2,797 self-reported heroin users entering treatment in 2010-2013. Most (86.4%) said they used heroin at least once a day, and many (66%) said they had concurrently abused prescription opioids during the preceding month.

Three-fourths of the respondents who began heroin use during the past decade said they had begun by abusing a prescription opioid, usually OxyContin. In contrast, about 80% of those who began using heroin in the 1960s and 1970s said they initiated their drug use with heroin itself. Fifty years ago, the average age at first use of heroin was 16 years; now it is 23 years.

A subset of 54 respondents who agreed to more detailed online interviews explained why they progressed from prescription opioids to heroin. A total of 98% said they considered the "high" from heroin to be superior to that from prescription opioids, and 94% said that heroin was far less expensive and far easier to obtain. In addition, one-third of this subgroup said that inhalation or injection is easier with heroin because it doesn’t require extraction, as prescription opioids do.

Nevertheless, if the cost, availability, and ease of use of the two agents were comparable, half of the 54 respondents said they would switch back to prescription opioids, which they described as offering a "cleaner" high and averting the legal problems associated with heroin, the investigators said.

Nearly 83% of the respondents who began heroin use in the 1960s or 1970s were men. In contrast, those who began heroin use during the past decade were approximately equally divided between men and women. Similarly, most who began using heroin in the 1960s and 1970s were nonwhite, while 90% of those who began use more recently were white.

It is important to note that this study population was not randomly selected and might not be representative of all current heroin users. These study subjects were entering treatment and had Internet access that enabled them to participate, so factors such as financial status, education level, family support, and court pressure affected their participation, Dr. Cicero and his associates said.

The SKIP database is supported by the Denver Health and Hospital Authority, which is funded by fees from 14 pharmaceutical firms. Dr. Cicero and his associates reported no financial conflicts of interest

The demographics of heroin users have shifted profoundly in recent years, according to a retrospective analysis involving more than 2,700 people.

Heroin has migrated out of young minority populations in lower-class city neighborhoods, and users are now far more likely to be white, middle-class men and women in their late 20s living in suburban, small-town, or rural areas, wrote Theodore J. Cicero, Ph.D., of the department of psychiatry, Washington University, St. Louis (JAMA Psychiatry 2014 May 28 [doi:10.1001/jamapsychiatry.2014.366]).

©Remains/Thinkstock

Noting the paucity of systematic studies of the demographics of today’s heroin users, Dr. Cicero and his colleagues analyzed data from the ongoing Survey of Key Informants’ Patients (SKIP) program, in which 150 publicly and privately funded treatment centers (the key informants) recruit patients/clients to complete anonymous surveys about their substance use. The surveys cover all 48 contiguous states.

Dr. Cicero and his colleagues reviewed the survey responses of 2,797 self-reported heroin users entering treatment in 2010-2013. Most (86.4%) said they used heroin at least once a day, and many (66%) said they had concurrently abused prescription opioids during the preceding month.

Three-fourths of the respondents who began heroin use during the past decade said they had begun by abusing a prescription opioid, usually OxyContin. In contrast, about 80% of those who began using heroin in the 1960s and 1970s said they initiated their drug use with heroin itself. Fifty years ago, the average age at first use of heroin was 16 years; now it is 23 years.

A subset of 54 respondents who agreed to more detailed online interviews explained why they progressed from prescription opioids to heroin. A total of 98% said they considered the "high" from heroin to be superior to that from prescription opioids, and 94% said that heroin was far less expensive and far easier to obtain. In addition, one-third of this subgroup said that inhalation or injection is easier with heroin because it doesn’t require extraction, as prescription opioids do.

Nevertheless, if the cost, availability, and ease of use of the two agents were comparable, half of the 54 respondents said they would switch back to prescription opioids, which they described as offering a "cleaner" high and averting the legal problems associated with heroin, the investigators said.

Nearly 83% of the respondents who began heroin use in the 1960s or 1970s were men. In contrast, those who began heroin use during the past decade were approximately equally divided between men and women. Similarly, most who began using heroin in the 1960s and 1970s were nonwhite, while 90% of those who began use more recently were white.

It is important to note that this study population was not randomly selected and might not be representative of all current heroin users. These study subjects were entering treatment and had Internet access that enabled them to participate, so factors such as financial status, education level, family support, and court pressure affected their participation, Dr. Cicero and his associates said.

The SKIP database is supported by the Denver Health and Hospital Authority, which is funded by fees from 14 pharmaceutical firms. Dr. Cicero and his associates reported no financial conflicts of interest

Adjuvant endocrine therapy should be extended from 5 to 10 years in women with hormone receptor–positive breast cancer, according to an updated clinical practice guideline published online May 27 in the Journal of Clinical Oncology.

"For decades, tamoxifen taken for 5 years was the standard adjuvant endocrine treatment. More recently, patients who are postmenopausal also have been offered the option of taking an aromatase inhibitor (AI) as an alternative to tamoxifen or in sequence after tamoxifen," said Dr. Harold J. Burstein, cochair of the American Society of Clinical Oncology expert panel that wrote the update.

However, since the last update (2010) of this clinical practice guideline, emerging research from international randomized trials has demonstrated that women who continue adjuvant endocrine therapy for an additional 5 years have a modest gain in overall survival, as well as lower rates of recurrence and contralateral breast cancer, the panel noted.

Now, pre- and perimenopausal women diagnosed with hormone receptor–positive breast cancer should be offered a total of 10 years of adjuvant endocrine therapy. Which agents they should take depends on their menopausal status. Pre- and perimenopausal women can be given tamoxifen but not aromatase inhibitors; postmenopausal women can be given either agent, but the total duration of aromatase inhibitors shouldn’t exceed 5 years, Dr. Burstein and his associates said (J. Clin. Oncol. 2014 May 27 [doi:10.1200/JCO.2013.54.2258]).

"It is not known which strategy is preferred; tamoxifen and AIs have different adverse effect profiles that might reasonably inform that choice, and patient preferences based on the tolerability of these agents in individual women should be considered," the guideline states.

The known adverse effects of both treatments, which include menopausal symptoms and rare cases of endometrial cancer and thromboembolism, persist with longer duration of treatment. But no new adverse effects specific to that increased duration have been identified to date, Dr. Burstein and his associates said.

Given the importance of adjuvant endocrine therapy to patient survival and quality of life, "clinicians are encouraged to inquire diligently about treatment compliance and treatment-related adverse effects, and to pursue interventions known to mitigate adverse effects and enhance adherence," the guideline says.

The updated recommendations, along with other explanatory information, can be obtained at www.asco.org/guidelines/endocrinebreast. Patient information is available at www.cancer.net.

Adjuvant endocrine therapy should be extended from 5 to 10 years in women with hormone receptor–positive breast cancer, according to an updated clinical practice guideline published online May 27 in the Journal of Clinical Oncology.

"For decades, tamoxifen taken for 5 years was the standard adjuvant endocrine treatment. More recently, patients who are postmenopausal also have been offered the option of taking an aromatase inhibitor (AI) as an alternative to tamoxifen or in sequence after tamoxifen," said Dr. Harold J. Burstein, cochair of the American Society of Clinical Oncology expert panel that wrote the update.

However, since the last update (2010) of this clinical practice guideline, emerging research from international randomized trials has demonstrated that women who continue adjuvant endocrine therapy for an additional 5 years have a modest gain in overall survival, as well as lower rates of recurrence and contralateral breast cancer, the panel noted.

Now, pre- and perimenopausal women diagnosed with hormone receptor–positive breast cancer should be offered a total of 10 years of adjuvant endocrine therapy. Which agents they should take depends on their menopausal status. Pre- and perimenopausal women can be given tamoxifen but not aromatase inhibitors; postmenopausal women can be given either agent, but the total duration of aromatase inhibitors shouldn’t exceed 5 years, Dr. Burstein and his associates said (J. Clin. Oncol. 2014 May 27 [doi:10.1200/JCO.2013.54.2258]).

"It is not known which strategy is preferred; tamoxifen and AIs have different adverse effect profiles that might reasonably inform that choice, and patient preferences based on the tolerability of these agents in individual women should be considered," the guideline states.

The known adverse effects of both treatments, which include menopausal symptoms and rare cases of endometrial cancer and thromboembolism, persist with longer duration of treatment. But no new adverse effects specific to that increased duration have been identified to date, Dr. Burstein and his associates said.

Given the importance of adjuvant endocrine therapy to patient survival and quality of life, "clinicians are encouraged to inquire diligently about treatment compliance and treatment-related adverse effects, and to pursue interventions known to mitigate adverse effects and enhance adherence," the guideline says.

The updated recommendations, along with other explanatory information, can be obtained at www.asco.org/guidelines/endocrinebreast. Patient information is available at www.cancer.net.

Adjuvant endocrine therapy should be extended from 5 to 10 years in women with hormone receptor–positive breast cancer, according to an updated clinical practice guideline published online May 27 in the Journal of Clinical Oncology.

"For decades, tamoxifen taken for 5 years was the standard adjuvant endocrine treatment. More recently, patients who are postmenopausal also have been offered the option of taking an aromatase inhibitor (AI) as an alternative to tamoxifen or in sequence after tamoxifen," said Dr. Harold J. Burstein, cochair of the American Society of Clinical Oncology expert panel that wrote the update.

However, since the last update (2010) of this clinical practice guideline, emerging research from international randomized trials has demonstrated that women who continue adjuvant endocrine therapy for an additional 5 years have a modest gain in overall survival, as well as lower rates of recurrence and contralateral breast cancer, the panel noted.

Now, pre- and perimenopausal women diagnosed with hormone receptor–positive breast cancer should be offered a total of 10 years of adjuvant endocrine therapy. Which agents they should take depends on their menopausal status. Pre- and perimenopausal women can be given tamoxifen but not aromatase inhibitors; postmenopausal women can be given either agent, but the total duration of aromatase inhibitors shouldn’t exceed 5 years, Dr. Burstein and his associates said (J. Clin. Oncol. 2014 May 27 [doi:10.1200/JCO.2013.54.2258]).

"It is not known which strategy is preferred; tamoxifen and AIs have different adverse effect profiles that might reasonably inform that choice, and patient preferences based on the tolerability of these agents in individual women should be considered," the guideline states.

The known adverse effects of both treatments, which include menopausal symptoms and rare cases of endometrial cancer and thromboembolism, persist with longer duration of treatment. But no new adverse effects specific to that increased duration have been identified to date, Dr. Burstein and his associates said.

Given the importance of adjuvant endocrine therapy to patient survival and quality of life, "clinicians are encouraged to inquire diligently about treatment compliance and treatment-related adverse effects, and to pursue interventions known to mitigate adverse effects and enhance adherence," the guideline says.

The updated recommendations, along with other explanatory information, can be obtained at www.asco.org/guidelines/endocrinebreast. Patient information is available at www.cancer.net.

A structured physical activity program reduced the rate of major mobility disability among sedentary men and women aged 70-89 years who were at high risk for the condition, in a randomized clinical trial presented at the annual meeting of the American College of Sports Medicine in Orlando and simultaneously published online May 27 in JAMA.

Compared with a sedentary health education intervention, the physical activity program was particularly effective in the large subgroup of participants who had the lowest physical function at baseline, said Dr. Marco Pahor of the department of aging and geriatric research, University of Florida, Gainesville, and his associates in the Lifestyle Interventions and Independence for the Elderly (LIFE) trial.

©Image Source Pink/thinkstockphotos.com

"These results suggest the potential for structured physical activity as a feasible and effective intervention to reduce the burden of disability among vulnerable older persons, in spite of functional decline in later life," they noted (JAMA 2014 May 27 [doi:10.1001/jama.2014.5616]).

In what they described as the largest and longest lasting randomized trial of physical activity in older persons, Dr. Pahor and his associates assessed 1,635 participants of diverse ethnic/racial backgrounds residing in rural, urban, and suburban communities. These study subjects (mean age, 78.9 years) were followed at geriatric health facilities at eight medical centers across the country.

They were deemed to be at high risk for mobility disability – losing the ability to walk 400 meters within 15 minutes without sitting, leaning, or the assistance of a walker or another person – based on functional limitations determined by the Short Physical Performance Battery (SPPB). This is considered an excellent proxy for impaired mobility in the community, the investigators said, and maintaining such mobility is central to retaining independence and a good quality of life.

The study participants were randomly assigned to receive either a structured physical activity intervention (818 people) or a health education intervention (817 people) and followed at 6-month intervals for at least 2 years.

The activity intervention involved two visits per week to the medical center, plus home-based activity three-four times per week. The goal was to walk for at least 30 minutes daily at moderate intensity and to perform 10 minutes of lower-extremity strength training with ankle weights, 10 minutes of balance training, and large muscle–group flexibility exercises daily.

The education program involved weekly workshops for 26 weeks, followed by monthly workshops thereafter, in which a health educator spoke about topics related to "successful aging," such as negotiating the health care system, travelling safely, obtaining preventive services and screenings, finding reliable health information, and nutrition. This intervention included 5-10 minutes of seated, gentle, upper-extremity stretching or flexibility exercises at each meeting.

The primary outcome was developing mobility disability – losing the ability to walk 400 meters within 15 minutes at their usual pace, without overexerting and without assistance, at the 2-year follow-up visit. This occurred in 30.1% of the activity group, which was significantly lower than the 35.5% rate in the education group, Dr. Pahor and his associates said.

A subgroup comprising 44.7% of the entire study population had the lowest physical function at baseline, reflected in scores of less than eight on the SPPB. They derived "considerable benefit" from the activity intervention and showed the largest reduction in the rate of impaired mobility, with a hazard ratio of 0.81.

People in the activity group had the same number of hospitalizations as those in the education group, as well as the same mortality. However, the mortality data in this study are considered inconclusive, the researchers said, because there were very few deaths overall.

The LIFE study was supported by the National Institutes of Health, the National Institute on Aging, the National Heart, Lung, and Blood Institute, the Claude D. Pepper Older Americans Independence Centers, the National Center for Research Resources, the Boston Rehabilitation Outcomes Center, the Department of Veterans Affairs, and the Department of Agriculture. Dr. Pahor reported no financial conflicts of interest; his associates reported ties to numerous industry sources.

A structured physical activity program reduced the rate of major mobility disability among sedentary men and women aged 70-89 years who were at high risk for the condition, in a randomized clinical trial presented at the annual meeting of the American College of Sports Medicine in Orlando and simultaneously published online May 27 in JAMA.

Compared with a sedentary health education intervention, the physical activity program was particularly effective in the large subgroup of participants who had the lowest physical function at baseline, said Dr. Marco Pahor of the department of aging and geriatric research, University of Florida, Gainesville, and his associates in the Lifestyle Interventions and Independence for the Elderly (LIFE) trial.

©Image Source Pink/thinkstockphotos.com

"These results suggest the potential for structured physical activity as a feasible and effective intervention to reduce the burden of disability among vulnerable older persons, in spite of functional decline in later life," they noted (JAMA 2014 May 27 [doi:10.1001/jama.2014.5616]).

In what they described as the largest and longest lasting randomized trial of physical activity in older persons, Dr. Pahor and his associates assessed 1,635 participants of diverse ethnic/racial backgrounds residing in rural, urban, and suburban communities. These study subjects (mean age, 78.9 years) were followed at geriatric health facilities at eight medical centers across the country.

They were deemed to be at high risk for mobility disability – losing the ability to walk 400 meters within 15 minutes without sitting, leaning, or the assistance of a walker or another person – based on functional limitations determined by the Short Physical Performance Battery (SPPB). This is considered an excellent proxy for impaired mobility in the community, the investigators said, and maintaining such mobility is central to retaining independence and a good quality of life.

The study participants were randomly assigned to receive either a structured physical activity intervention (818 people) or a health education intervention (817 people) and followed at 6-month intervals for at least 2 years.

The activity intervention involved two visits per week to the medical center, plus home-based activity three-four times per week. The goal was to walk for at least 30 minutes daily at moderate intensity and to perform 10 minutes of lower-extremity strength training with ankle weights, 10 minutes of balance training, and large muscle–group flexibility exercises daily.

The education program involved weekly workshops for 26 weeks, followed by monthly workshops thereafter, in which a health educator spoke about topics related to "successful aging," such as negotiating the health care system, travelling safely, obtaining preventive services and screenings, finding reliable health information, and nutrition. This intervention included 5-10 minutes of seated, gentle, upper-extremity stretching or flexibility exercises at each meeting.

The primary outcome was developing mobility disability – losing the ability to walk 400 meters within 15 minutes at their usual pace, without overexerting and without assistance, at the 2-year follow-up visit. This occurred in 30.1% of the activity group, which was significantly lower than the 35.5% rate in the education group, Dr. Pahor and his associates said.

A subgroup comprising 44.7% of the entire study population had the lowest physical function at baseline, reflected in scores of less than eight on the SPPB. They derived "considerable benefit" from the activity intervention and showed the largest reduction in the rate of impaired mobility, with a hazard ratio of 0.81.

People in the activity group had the same number of hospitalizations as those in the education group, as well as the same mortality. However, the mortality data in this study are considered inconclusive, the researchers said, because there were very few deaths overall.

The LIFE study was supported by the National Institutes of Health, the National Institute on Aging, the National Heart, Lung, and Blood Institute, the Claude D. Pepper Older Americans Independence Centers, the National Center for Research Resources, the Boston Rehabilitation Outcomes Center, the Department of Veterans Affairs, and the Department of Agriculture. Dr. Pahor reported no financial conflicts of interest; his associates reported ties to numerous industry sources.

A structured physical activity program reduced the rate of major mobility disability among sedentary men and women aged 70-89 years who were at high risk for the condition, in a randomized clinical trial presented at the annual meeting of the American College of Sports Medicine in Orlando and simultaneously published online May 27 in JAMA.

Compared with a sedentary health education intervention, the physical activity program was particularly effective in the large subgroup of participants who had the lowest physical function at baseline, said Dr. Marco Pahor of the department of aging and geriatric research, University of Florida, Gainesville, and his associates in the Lifestyle Interventions and Independence for the Elderly (LIFE) trial.

©Image Source Pink/thinkstockphotos.com

"These results suggest the potential for structured physical activity as a feasible and effective intervention to reduce the burden of disability among vulnerable older persons, in spite of functional decline in later life," they noted (JAMA 2014 May 27 [doi:10.1001/jama.2014.5616]).

In what they described as the largest and longest lasting randomized trial of physical activity in older persons, Dr. Pahor and his associates assessed 1,635 participants of diverse ethnic/racial backgrounds residing in rural, urban, and suburban communities. These study subjects (mean age, 78.9 years) were followed at geriatric health facilities at eight medical centers across the country.

They were deemed to be at high risk for mobility disability – losing the ability to walk 400 meters within 15 minutes without sitting, leaning, or the assistance of a walker or another person – based on functional limitations determined by the Short Physical Performance Battery (SPPB). This is considered an excellent proxy for impaired mobility in the community, the investigators said, and maintaining such mobility is central to retaining independence and a good quality of life.

The study participants were randomly assigned to receive either a structured physical activity intervention (818 people) or a health education intervention (817 people) and followed at 6-month intervals for at least 2 years.

The activity intervention involved two visits per week to the medical center, plus home-based activity three-four times per week. The goal was to walk for at least 30 minutes daily at moderate intensity and to perform 10 minutes of lower-extremity strength training with ankle weights, 10 minutes of balance training, and large muscle–group flexibility exercises daily.

The education program involved weekly workshops for 26 weeks, followed by monthly workshops thereafter, in which a health educator spoke about topics related to "successful aging," such as negotiating the health care system, travelling safely, obtaining preventive services and screenings, finding reliable health information, and nutrition. This intervention included 5-10 minutes of seated, gentle, upper-extremity stretching or flexibility exercises at each meeting.

The primary outcome was developing mobility disability – losing the ability to walk 400 meters within 15 minutes at their usual pace, without overexerting and without assistance, at the 2-year follow-up visit. This occurred in 30.1% of the activity group, which was significantly lower than the 35.5% rate in the education group, Dr. Pahor and his associates said.

A subgroup comprising 44.7% of the entire study population had the lowest physical function at baseline, reflected in scores of less than eight on the SPPB. They derived "considerable benefit" from the activity intervention and showed the largest reduction in the rate of impaired mobility, with a hazard ratio of 0.81.

People in the activity group had the same number of hospitalizations as those in the education group, as well as the same mortality. However, the mortality data in this study are considered inconclusive, the researchers said, because there were very few deaths overall.

The LIFE study was supported by the National Institutes of Health, the National Institute on Aging, the National Heart, Lung, and Blood Institute, the Claude D. Pepper Older Americans Independence Centers, the National Center for Research Resources, the Boston Rehabilitation Outcomes Center, the Department of Veterans Affairs, and the Department of Agriculture. Dr. Pahor reported no financial conflicts of interest; his associates reported ties to numerous industry sources.