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Bar soaps may be better than body washes for contact dermatitis patients
SAN FRANCISCO – Chronic contact dermatitis often is tied to hidden allergens found in shampoos, soaps, and body washes, according to Cory Dunnick, MD.“A lot of patients who get referred to my patch test clinic will have chronic dermatitis that isn’t responding to treatment or is worsening despite treatment, or they present with a pattern that is suggestive of contact dermatitis,” she said in an interview.
There is also a common perception that liquid body washes are better than bar soaps because they may be more moisturizing, but the results of a recently published study suggest otherwise, Dr. Dunnick of the department of dermatology at the University of Colorado at Denver, Aurora, said at the annual meeting of the Pacific Dermatologic Association.
Dr. Dunnick was one of the investigators in a study that compared ingredients in the top-selling 50 bar soaps and 50 body washes on Amazon.com to determine if there was a difference with respect to allergen content. They obtained the ingredients list for all the products and compared them with the American Contact Dermatitis Society Core Allergen Series. Counter to the common belief, results of the study indicated that liquid soaps were likely the worse choice for sensitive patients: They contained far more preservative and surfactant allergens than bar soaps, and there was no difference in fragrance content between the two classes (Dermatitis. 2017 May 23. doi: 10.1097/DER.0000000000000289).
Of the 50 liquid soaps, 44 had one or more preservative allergens, compared with none of the bar soaps (P less than .001), and 34 had at least one surfactant allergen, compared with seven of the bar soaps (P less than .001). Forty-eight body washes had fragrance, as did 47 of the bar soaps.
The most common allergens in body washes were methylisothiazolinone (19 of 50), quaternium-15 (16), sodium benzoate (15), methylchloroisothiazolinone/methylisothiazolinone (12), DMDM hydantoin (10), and phenoxyethanol (9). None of these allergens appeared in any of the bar soaps.
“If you have a patient who you suspect has a contact allergy to a preservative or surfactant ingredient, then you can recommend perhaps switching to a bar soap, maybe one that is fragrance free,” advised Dr. Dunnick.
The most common allergen they found in body washes, methylisothiazolinone (MI), is becoming an increasing concern, she said. It has been around for many years but became more prevalent when the Food and Drug Administration decided in 2005 to allow higher concentrations of MI to be used in skin care products. “It’s a pretty strong sensitizer. As a result, we’re seeing a lot more allergy,” she noted.
This soap/body-wash allergen study sends a clear message to dermatologists to individualize recommendations, she said. “A lot of dermatologists recommend what they think are mild soaps, but they don’t necessarily think about what contact allergens might be in those soaps, so maybe they need to make more specific recommendations. They might recommend Dove soap,” but there are different Dove soaps, she pointed out.
A bigger challenge is finding a shampoo for sensitive patients. Almost all contain fragrances, and MI is an ingredient in many shampoos as well. Dr. Dunnick has found the DHS brand, which is fragrance free, to be helpful in some cases, and the Nonscents brand, also fragrance free, is sometimes recommended as safe.
But, in the end, recommendations must be individualized for the patient’s specific allergies, and that requires a thorough work-up. “You don’t know what they are unless you do the patch test,” she said.
Dr. Dunnick reported having no relevant financial disclosures.
SAN FRANCISCO – Chronic contact dermatitis often is tied to hidden allergens found in shampoos, soaps, and body washes, according to Cory Dunnick, MD.“A lot of patients who get referred to my patch test clinic will have chronic dermatitis that isn’t responding to treatment or is worsening despite treatment, or they present with a pattern that is suggestive of contact dermatitis,” she said in an interview.
There is also a common perception that liquid body washes are better than bar soaps because they may be more moisturizing, but the results of a recently published study suggest otherwise, Dr. Dunnick of the department of dermatology at the University of Colorado at Denver, Aurora, said at the annual meeting of the Pacific Dermatologic Association.
Dr. Dunnick was one of the investigators in a study that compared ingredients in the top-selling 50 bar soaps and 50 body washes on Amazon.com to determine if there was a difference with respect to allergen content. They obtained the ingredients list for all the products and compared them with the American Contact Dermatitis Society Core Allergen Series. Counter to the common belief, results of the study indicated that liquid soaps were likely the worse choice for sensitive patients: They contained far more preservative and surfactant allergens than bar soaps, and there was no difference in fragrance content between the two classes (Dermatitis. 2017 May 23. doi: 10.1097/DER.0000000000000289).
Of the 50 liquid soaps, 44 had one or more preservative allergens, compared with none of the bar soaps (P less than .001), and 34 had at least one surfactant allergen, compared with seven of the bar soaps (P less than .001). Forty-eight body washes had fragrance, as did 47 of the bar soaps.
The most common allergens in body washes were methylisothiazolinone (19 of 50), quaternium-15 (16), sodium benzoate (15), methylchloroisothiazolinone/methylisothiazolinone (12), DMDM hydantoin (10), and phenoxyethanol (9). None of these allergens appeared in any of the bar soaps.
“If you have a patient who you suspect has a contact allergy to a preservative or surfactant ingredient, then you can recommend perhaps switching to a bar soap, maybe one that is fragrance free,” advised Dr. Dunnick.
The most common allergen they found in body washes, methylisothiazolinone (MI), is becoming an increasing concern, she said. It has been around for many years but became more prevalent when the Food and Drug Administration decided in 2005 to allow higher concentrations of MI to be used in skin care products. “It’s a pretty strong sensitizer. As a result, we’re seeing a lot more allergy,” she noted.
This soap/body-wash allergen study sends a clear message to dermatologists to individualize recommendations, she said. “A lot of dermatologists recommend what they think are mild soaps, but they don’t necessarily think about what contact allergens might be in those soaps, so maybe they need to make more specific recommendations. They might recommend Dove soap,” but there are different Dove soaps, she pointed out.
A bigger challenge is finding a shampoo for sensitive patients. Almost all contain fragrances, and MI is an ingredient in many shampoos as well. Dr. Dunnick has found the DHS brand, which is fragrance free, to be helpful in some cases, and the Nonscents brand, also fragrance free, is sometimes recommended as safe.
But, in the end, recommendations must be individualized for the patient’s specific allergies, and that requires a thorough work-up. “You don’t know what they are unless you do the patch test,” she said.
Dr. Dunnick reported having no relevant financial disclosures.
SAN FRANCISCO – Chronic contact dermatitis often is tied to hidden allergens found in shampoos, soaps, and body washes, according to Cory Dunnick, MD.“A lot of patients who get referred to my patch test clinic will have chronic dermatitis that isn’t responding to treatment or is worsening despite treatment, or they present with a pattern that is suggestive of contact dermatitis,” she said in an interview.
There is also a common perception that liquid body washes are better than bar soaps because they may be more moisturizing, but the results of a recently published study suggest otherwise, Dr. Dunnick of the department of dermatology at the University of Colorado at Denver, Aurora, said at the annual meeting of the Pacific Dermatologic Association.
Dr. Dunnick was one of the investigators in a study that compared ingredients in the top-selling 50 bar soaps and 50 body washes on Amazon.com to determine if there was a difference with respect to allergen content. They obtained the ingredients list for all the products and compared them with the American Contact Dermatitis Society Core Allergen Series. Counter to the common belief, results of the study indicated that liquid soaps were likely the worse choice for sensitive patients: They contained far more preservative and surfactant allergens than bar soaps, and there was no difference in fragrance content between the two classes (Dermatitis. 2017 May 23. doi: 10.1097/DER.0000000000000289).
Of the 50 liquid soaps, 44 had one or more preservative allergens, compared with none of the bar soaps (P less than .001), and 34 had at least one surfactant allergen, compared with seven of the bar soaps (P less than .001). Forty-eight body washes had fragrance, as did 47 of the bar soaps.
The most common allergens in body washes were methylisothiazolinone (19 of 50), quaternium-15 (16), sodium benzoate (15), methylchloroisothiazolinone/methylisothiazolinone (12), DMDM hydantoin (10), and phenoxyethanol (9). None of these allergens appeared in any of the bar soaps.
“If you have a patient who you suspect has a contact allergy to a preservative or surfactant ingredient, then you can recommend perhaps switching to a bar soap, maybe one that is fragrance free,” advised Dr. Dunnick.
The most common allergen they found in body washes, methylisothiazolinone (MI), is becoming an increasing concern, she said. It has been around for many years but became more prevalent when the Food and Drug Administration decided in 2005 to allow higher concentrations of MI to be used in skin care products. “It’s a pretty strong sensitizer. As a result, we’re seeing a lot more allergy,” she noted.
This soap/body-wash allergen study sends a clear message to dermatologists to individualize recommendations, she said. “A lot of dermatologists recommend what they think are mild soaps, but they don’t necessarily think about what contact allergens might be in those soaps, so maybe they need to make more specific recommendations. They might recommend Dove soap,” but there are different Dove soaps, she pointed out.
A bigger challenge is finding a shampoo for sensitive patients. Almost all contain fragrances, and MI is an ingredient in many shampoos as well. Dr. Dunnick has found the DHS brand, which is fragrance free, to be helpful in some cases, and the Nonscents brand, also fragrance free, is sometimes recommended as safe.
But, in the end, recommendations must be individualized for the patient’s specific allergies, and that requires a thorough work-up. “You don’t know what they are unless you do the patch test,” she said.
Dr. Dunnick reported having no relevant financial disclosures.
AT PDA 2017
Diagnosing high-risk keratinocyte carcinomas in the dermatology clinic
SAN FRANCISCO – Patients with high-risk keratinocyte carcinomas sometimes present with neurologic symptoms mimicking Bell’s palsy or trigeminal neuralgia, making the diagnosis of these perineural tumors challenging, Siegrid Yu, MD, said at the annual meeting of the Pacific Dermatologic Association.
Eventually, skin manifestations can land them in a dermatologist’s office. “There is a high incidence of delayed diagnosis and misdiagnosis, which affects the outcome of these patients,” said Dr. Yu of the department of dermatology, University of California, San Francisco.
She presented several cases illustrating the central role that dermatologists can play in the diagnosis and management of high-risk keratinocyte carcinomas. “All of these patients were seen by various doctors, sometimes multiple times, without a diagnosis,” she said.
Perineural invasion occurs in 2.6%-6% of squamous cell carcinoma (SCC) cases and 2% of basal cell carcinoma (BCC) cases. “Perineural invasion presenting with neurologic symptoms is not that common, which is part of why I think it’s easy to misdiagnose these patients,” said Dr. Yu, director of the Mohs Micrographic Surgery and Cutaneous Oncology Fellowship at the UCSF Dermatologic Surgery and Laser Center. In many cases, patients were diagnosed as having Bell’s palsy or trigeminal neuralgia for years before being diagnosed with skin cancer.
Common features of perineural invasion cases include midface location of the tumor, male gender, tumor size larger than 2 cm, recurrence, and poor histologic differentiation. Symptoms often include formication, pain, numbness, and facial weakness. Diagnosis is often delayed by 6 months to 2 years.
One case she described involved a 57-year-old immunosuppressed man who had previously undergone Mohs micrographic surgery for a primary SCC of the nasal sidewall. He experienced delayed numbness and pain of the upper lip and cheek near the surgical site 1 year later. There was no sign of cutaneous recurrence, and MRIs of the head and neck were normal. Examinations by dermatologists, neurologists, and otorhinolaryngologists yielded no diagnosis.
Two years after his initial surgery, the patient developed thickening of the scar from the Mohs surgery, without any overlying skin change. A punch biopsy showed only scar tissue, but a deeper incisional biopsy revealed a recurrence of the SCC. A second head/neck MRI, using a perineural protocol, showed abnormal enhancement at the V2 branch of the trigeminal nerve leading to the foramen rotundum. The patient underwent intensity-modulated radiation, which relies on computer-modeling to deliver doses to the precise location of the tumor. An MRI 2 months later showed a reduction in tumor size and radiographic resolution of trigeminal nerve involvement.
Another case involved a 75-year-old man with progressive right facial droop, who had experienced neurologic symptoms on the right side of his face, including numbness, tingling, oculomotor dysfunction, and radiating pain. He had been diagnosed with shingles on the right side of his face more than 20 years previously, but there was no history of postherpetic neuralgia. He also had hypertension and hypothyroidism, and had been prescribed levothyroxine, amlodipine, losartan, and gabapentin.
He had been evaluated by primary care, dermatology, and ophthalmology with no diagnosis. He then sequentially sought the opinion of four neurologists, and underwent lumbar puncture, serologic evaluation, head CT, and MRI with no findings that correlated with his symptoms. The patient’s neurological symptoms improved transiently with prednisone, and his pain improved slightly with gabapentin.
Finally, a skin biopsy of an ill-defined firmness in the right temple revealed infiltrative SCC. A repeat MRI, this time with perineural protocol, showed perineural spread along the trigeminal nerve, with involvement of the V2 and V3 branches, and possibly the V1 branch.
In another case, complete hemifacial palsy due to perineural spread of SCC was overlooked as having been related to the patient’s history of stroke. However, upon further questioning, the facial palsy involved all branches of the facial nerve, while the patient’s residual stroke symptoms of expressive aphasia and dysphagia were improving. “If you think about head and neck anatomy, an upper motor neuron lesion would not lead to complete facial nerve palsy. It could lead to palsy of the lower two-thirds of the face, sparing the temporal nerve due to cross innervation of the forehead. Only a lower motor neuron can result in progressive palsy of all branches of the facial nerve,” Dr. Yu said. In this case, the facial palsy was due to a large SCC of the external auditory canal.
Dr. Yu highlighted several considerations to keep in mind when examining these patients, including vigilance around prior skin cancer surgeries in cases with neurologic symptoms, the potential need for repeated imaging along with communication with the radiologist regarding suspicion of perineural spread, consideration of anatomy during the clinical exam, and correlation of clinical exam, histopathology, and radiographic findings.
When it comes to imaging, MRI is the most sensitive technique, she noted. It can show increase in nerve diameter, destruction of the nerve-blood barrier, obliteration of the fat below a foramen, nerve enhancement, and denervation atrophy.
Dr. Yu reported having no financial disclosures.
SAN FRANCISCO – Patients with high-risk keratinocyte carcinomas sometimes present with neurologic symptoms mimicking Bell’s palsy or trigeminal neuralgia, making the diagnosis of these perineural tumors challenging, Siegrid Yu, MD, said at the annual meeting of the Pacific Dermatologic Association.
Eventually, skin manifestations can land them in a dermatologist’s office. “There is a high incidence of delayed diagnosis and misdiagnosis, which affects the outcome of these patients,” said Dr. Yu of the department of dermatology, University of California, San Francisco.
She presented several cases illustrating the central role that dermatologists can play in the diagnosis and management of high-risk keratinocyte carcinomas. “All of these patients were seen by various doctors, sometimes multiple times, without a diagnosis,” she said.
Perineural invasion occurs in 2.6%-6% of squamous cell carcinoma (SCC) cases and 2% of basal cell carcinoma (BCC) cases. “Perineural invasion presenting with neurologic symptoms is not that common, which is part of why I think it’s easy to misdiagnose these patients,” said Dr. Yu, director of the Mohs Micrographic Surgery and Cutaneous Oncology Fellowship at the UCSF Dermatologic Surgery and Laser Center. In many cases, patients were diagnosed as having Bell’s palsy or trigeminal neuralgia for years before being diagnosed with skin cancer.
Common features of perineural invasion cases include midface location of the tumor, male gender, tumor size larger than 2 cm, recurrence, and poor histologic differentiation. Symptoms often include formication, pain, numbness, and facial weakness. Diagnosis is often delayed by 6 months to 2 years.
One case she described involved a 57-year-old immunosuppressed man who had previously undergone Mohs micrographic surgery for a primary SCC of the nasal sidewall. He experienced delayed numbness and pain of the upper lip and cheek near the surgical site 1 year later. There was no sign of cutaneous recurrence, and MRIs of the head and neck were normal. Examinations by dermatologists, neurologists, and otorhinolaryngologists yielded no diagnosis.
Two years after his initial surgery, the patient developed thickening of the scar from the Mohs surgery, without any overlying skin change. A punch biopsy showed only scar tissue, but a deeper incisional biopsy revealed a recurrence of the SCC. A second head/neck MRI, using a perineural protocol, showed abnormal enhancement at the V2 branch of the trigeminal nerve leading to the foramen rotundum. The patient underwent intensity-modulated radiation, which relies on computer-modeling to deliver doses to the precise location of the tumor. An MRI 2 months later showed a reduction in tumor size and radiographic resolution of trigeminal nerve involvement.
Another case involved a 75-year-old man with progressive right facial droop, who had experienced neurologic symptoms on the right side of his face, including numbness, tingling, oculomotor dysfunction, and radiating pain. He had been diagnosed with shingles on the right side of his face more than 20 years previously, but there was no history of postherpetic neuralgia. He also had hypertension and hypothyroidism, and had been prescribed levothyroxine, amlodipine, losartan, and gabapentin.
He had been evaluated by primary care, dermatology, and ophthalmology with no diagnosis. He then sequentially sought the opinion of four neurologists, and underwent lumbar puncture, serologic evaluation, head CT, and MRI with no findings that correlated with his symptoms. The patient’s neurological symptoms improved transiently with prednisone, and his pain improved slightly with gabapentin.
Finally, a skin biopsy of an ill-defined firmness in the right temple revealed infiltrative SCC. A repeat MRI, this time with perineural protocol, showed perineural spread along the trigeminal nerve, with involvement of the V2 and V3 branches, and possibly the V1 branch.
In another case, complete hemifacial palsy due to perineural spread of SCC was overlooked as having been related to the patient’s history of stroke. However, upon further questioning, the facial palsy involved all branches of the facial nerve, while the patient’s residual stroke symptoms of expressive aphasia and dysphagia were improving. “If you think about head and neck anatomy, an upper motor neuron lesion would not lead to complete facial nerve palsy. It could lead to palsy of the lower two-thirds of the face, sparing the temporal nerve due to cross innervation of the forehead. Only a lower motor neuron can result in progressive palsy of all branches of the facial nerve,” Dr. Yu said. In this case, the facial palsy was due to a large SCC of the external auditory canal.
Dr. Yu highlighted several considerations to keep in mind when examining these patients, including vigilance around prior skin cancer surgeries in cases with neurologic symptoms, the potential need for repeated imaging along with communication with the radiologist regarding suspicion of perineural spread, consideration of anatomy during the clinical exam, and correlation of clinical exam, histopathology, and radiographic findings.
When it comes to imaging, MRI is the most sensitive technique, she noted. It can show increase in nerve diameter, destruction of the nerve-blood barrier, obliteration of the fat below a foramen, nerve enhancement, and denervation atrophy.
Dr. Yu reported having no financial disclosures.
SAN FRANCISCO – Patients with high-risk keratinocyte carcinomas sometimes present with neurologic symptoms mimicking Bell’s palsy or trigeminal neuralgia, making the diagnosis of these perineural tumors challenging, Siegrid Yu, MD, said at the annual meeting of the Pacific Dermatologic Association.
Eventually, skin manifestations can land them in a dermatologist’s office. “There is a high incidence of delayed diagnosis and misdiagnosis, which affects the outcome of these patients,” said Dr. Yu of the department of dermatology, University of California, San Francisco.
She presented several cases illustrating the central role that dermatologists can play in the diagnosis and management of high-risk keratinocyte carcinomas. “All of these patients were seen by various doctors, sometimes multiple times, without a diagnosis,” she said.
Perineural invasion occurs in 2.6%-6% of squamous cell carcinoma (SCC) cases and 2% of basal cell carcinoma (BCC) cases. “Perineural invasion presenting with neurologic symptoms is not that common, which is part of why I think it’s easy to misdiagnose these patients,” said Dr. Yu, director of the Mohs Micrographic Surgery and Cutaneous Oncology Fellowship at the UCSF Dermatologic Surgery and Laser Center. In many cases, patients were diagnosed as having Bell’s palsy or trigeminal neuralgia for years before being diagnosed with skin cancer.
Common features of perineural invasion cases include midface location of the tumor, male gender, tumor size larger than 2 cm, recurrence, and poor histologic differentiation. Symptoms often include formication, pain, numbness, and facial weakness. Diagnosis is often delayed by 6 months to 2 years.
One case she described involved a 57-year-old immunosuppressed man who had previously undergone Mohs micrographic surgery for a primary SCC of the nasal sidewall. He experienced delayed numbness and pain of the upper lip and cheek near the surgical site 1 year later. There was no sign of cutaneous recurrence, and MRIs of the head and neck were normal. Examinations by dermatologists, neurologists, and otorhinolaryngologists yielded no diagnosis.
Two years after his initial surgery, the patient developed thickening of the scar from the Mohs surgery, without any overlying skin change. A punch biopsy showed only scar tissue, but a deeper incisional biopsy revealed a recurrence of the SCC. A second head/neck MRI, using a perineural protocol, showed abnormal enhancement at the V2 branch of the trigeminal nerve leading to the foramen rotundum. The patient underwent intensity-modulated radiation, which relies on computer-modeling to deliver doses to the precise location of the tumor. An MRI 2 months later showed a reduction in tumor size and radiographic resolution of trigeminal nerve involvement.
Another case involved a 75-year-old man with progressive right facial droop, who had experienced neurologic symptoms on the right side of his face, including numbness, tingling, oculomotor dysfunction, and radiating pain. He had been diagnosed with shingles on the right side of his face more than 20 years previously, but there was no history of postherpetic neuralgia. He also had hypertension and hypothyroidism, and had been prescribed levothyroxine, amlodipine, losartan, and gabapentin.
He had been evaluated by primary care, dermatology, and ophthalmology with no diagnosis. He then sequentially sought the opinion of four neurologists, and underwent lumbar puncture, serologic evaluation, head CT, and MRI with no findings that correlated with his symptoms. The patient’s neurological symptoms improved transiently with prednisone, and his pain improved slightly with gabapentin.
Finally, a skin biopsy of an ill-defined firmness in the right temple revealed infiltrative SCC. A repeat MRI, this time with perineural protocol, showed perineural spread along the trigeminal nerve, with involvement of the V2 and V3 branches, and possibly the V1 branch.
In another case, complete hemifacial palsy due to perineural spread of SCC was overlooked as having been related to the patient’s history of stroke. However, upon further questioning, the facial palsy involved all branches of the facial nerve, while the patient’s residual stroke symptoms of expressive aphasia and dysphagia were improving. “If you think about head and neck anatomy, an upper motor neuron lesion would not lead to complete facial nerve palsy. It could lead to palsy of the lower two-thirds of the face, sparing the temporal nerve due to cross innervation of the forehead. Only a lower motor neuron can result in progressive palsy of all branches of the facial nerve,” Dr. Yu said. In this case, the facial palsy was due to a large SCC of the external auditory canal.
Dr. Yu highlighted several considerations to keep in mind when examining these patients, including vigilance around prior skin cancer surgeries in cases with neurologic symptoms, the potential need for repeated imaging along with communication with the radiologist regarding suspicion of perineural spread, consideration of anatomy during the clinical exam, and correlation of clinical exam, histopathology, and radiographic findings.
When it comes to imaging, MRI is the most sensitive technique, she noted. It can show increase in nerve diameter, destruction of the nerve-blood barrier, obliteration of the fat below a foramen, nerve enhancement, and denervation atrophy.
Dr. Yu reported having no financial disclosures.
AT PDA 2017
Reduced fracture risk maintained in abaloparatide extension study
denver – Sequential treatment with abaloparatide and alendronate was associated with reduced vertebral and non-vertebral fractures compared to placebo and alendronate among high-risk women with osteoporosis in a 3.5 year extension study of the ACTIVE trial.
The ACTIVExtend trial included 558 women in the abaloparatide group and 581 women in the placebo group of the original ACTIVE study (NCT01343004). In that double-blind trial, 2,463 postmenopausal women with osteoporosis were randomized to receive daily injections of abaloparatide (80 µg) or placebo, or open-label teriparatide (20 µg). After 18 months of treatment, patients in the placebo and abaloparatide groups were switched to alendronate 70 mg weekly for two years, Henry Bone, MD, director of the Michigan Bone and Mineral Clinic in Detroit, said at the annual meeting of the American Society for Bone and Mineral Research.
The abaloparatide-alendronate group had a 34% relative risk reduction for all clinical fractures compared to the placebo-alendronate group (P = .045). For major osteoporotic fractures, the abaloparatide-alendronate group had a 50% relative risk reduction compared to the placebo-alendronate group (P = .011).
Among women who had no new vertebral fractures during the first 18 months of the ACTIVE study, 2 women in the abaloparatide-alendronate group and 13 in the placebo-alendronate group had new vertebral fractures during ACTIVExtend.
Adverse events were similar in both arms of the study. There were no cases of atypical femur fracture or osteonecrosis of the jaw.The anabolic agent abaloparatide was approved by the Food and Drug Administration in April for the treatment of osteoporosis in women at high risk of fracture. Sequential treatment with the anti-resorptive agent alendronate aims to preserve the bone density gains from abaloparatide, as previous research has shown that improvements with anabolic agents can be lost once the drug is stopped.
denver – Sequential treatment with abaloparatide and alendronate was associated with reduced vertebral and non-vertebral fractures compared to placebo and alendronate among high-risk women with osteoporosis in a 3.5 year extension study of the ACTIVE trial.
The ACTIVExtend trial included 558 women in the abaloparatide group and 581 women in the placebo group of the original ACTIVE study (NCT01343004). In that double-blind trial, 2,463 postmenopausal women with osteoporosis were randomized to receive daily injections of abaloparatide (80 µg) or placebo, or open-label teriparatide (20 µg). After 18 months of treatment, patients in the placebo and abaloparatide groups were switched to alendronate 70 mg weekly for two years, Henry Bone, MD, director of the Michigan Bone and Mineral Clinic in Detroit, said at the annual meeting of the American Society for Bone and Mineral Research.
The abaloparatide-alendronate group had a 34% relative risk reduction for all clinical fractures compared to the placebo-alendronate group (P = .045). For major osteoporotic fractures, the abaloparatide-alendronate group had a 50% relative risk reduction compared to the placebo-alendronate group (P = .011).
Among women who had no new vertebral fractures during the first 18 months of the ACTIVE study, 2 women in the abaloparatide-alendronate group and 13 in the placebo-alendronate group had new vertebral fractures during ACTIVExtend.
Adverse events were similar in both arms of the study. There were no cases of atypical femur fracture or osteonecrosis of the jaw.The anabolic agent abaloparatide was approved by the Food and Drug Administration in April for the treatment of osteoporosis in women at high risk of fracture. Sequential treatment with the anti-resorptive agent alendronate aims to preserve the bone density gains from abaloparatide, as previous research has shown that improvements with anabolic agents can be lost once the drug is stopped.
denver – Sequential treatment with abaloparatide and alendronate was associated with reduced vertebral and non-vertebral fractures compared to placebo and alendronate among high-risk women with osteoporosis in a 3.5 year extension study of the ACTIVE trial.
The ACTIVExtend trial included 558 women in the abaloparatide group and 581 women in the placebo group of the original ACTIVE study (NCT01343004). In that double-blind trial, 2,463 postmenopausal women with osteoporosis were randomized to receive daily injections of abaloparatide (80 µg) or placebo, or open-label teriparatide (20 µg). After 18 months of treatment, patients in the placebo and abaloparatide groups were switched to alendronate 70 mg weekly for two years, Henry Bone, MD, director of the Michigan Bone and Mineral Clinic in Detroit, said at the annual meeting of the American Society for Bone and Mineral Research.
The abaloparatide-alendronate group had a 34% relative risk reduction for all clinical fractures compared to the placebo-alendronate group (P = .045). For major osteoporotic fractures, the abaloparatide-alendronate group had a 50% relative risk reduction compared to the placebo-alendronate group (P = .011).
Among women who had no new vertebral fractures during the first 18 months of the ACTIVE study, 2 women in the abaloparatide-alendronate group and 13 in the placebo-alendronate group had new vertebral fractures during ACTIVExtend.
Adverse events were similar in both arms of the study. There were no cases of atypical femur fracture or osteonecrosis of the jaw.The anabolic agent abaloparatide was approved by the Food and Drug Administration in April for the treatment of osteoporosis in women at high risk of fracture. Sequential treatment with the anti-resorptive agent alendronate aims to preserve the bone density gains from abaloparatide, as previous research has shown that improvements with anabolic agents can be lost once the drug is stopped.
REPORTING FROM ASBMR 2017
Key clinical point: The reduced fracture risk seen after 18 months of abaloparatide therapy persisted at 43 months with follow up alendronate therapy, and was superior to the results seen in women who received placebo for 18 months followed by alendronate.
Major finding: 0.9% of women who started on abaloparatide experienced at least 1 new vertebral fracture, compared to 5.6% of those who started on placebo.
Data source: The ACTIVExtend trial included 558 women in the abaloparatide group and 581 women in the placebo group.
Disclosures: The study was funded by Radius Health, the maker of abaloparatide. Dr. Bone is a consultant and investigator for Radius Health and Amgen.
Study finds low risk for jaw osteonecrosis with denosumab for postmenopausal osteoporosis
AT ASBMR
DENVER – Osteonecrosis of the jaw (ONJ) was a rare adverse event in women taking denosumab for postmenopausal osteoporosis, with a 0.7% rate for women who reported an invasive oral procedure or event while taking the drug and a 0.05% rate for women who did not have such procedures, Nelson Watts, MD, reported at the annual meeting of the American Society of Bone and Mineral Research.
The finding comes from a new analysis of a 7-year extension study of denosumab use in 4,550 women who participated in the 3-year, double-blind, phase 3 FREEDOM trial (NCT00089791) that compared denosumab 60 mg and placebo every 6 months. Those who missed 1 dose or fewer and completed visits through year 3 of the initial study were eligible to continue in the 7-year, open-label extension study. Those who had received placebo in the initial trial were crossed over to denosumab for the extension study.
Extension study participants were instructed to chronicle invasive oral procedures and events that had occurred in the initial trial and completed an oral event questionnaire once every 6 months of the extension trial.
All surveys were completed by 3,591 (79%) of the extension study participants, and 45.1% reported at least one invasive oral procedure or event during that time. The frequency of events was similar for the crossover and long-term denosumab groups; these events included scaling or root planing (29.1% and 28.5%), tooth extraction (25.1% and 24.6%), dental implant (5.8% and 6.0%), natural tooth loss (4.2% and 4.0%), and jaw surgery (0.9% and 0.9%). ONJ occurred at a rate of 5.2 cases per 10,000 patient-years of denosumab use, said Nelson Watts, MD, director of osteoporosis and bone health services at Mercy Health Services in Cincinnati, Ohio.
Of the 12 ONJ cases identified in the study, 11 occurred in women who reported an invasive oral procedure or event. This translated to a 0.7% risk of ONJ in women who reported an invasive oral procedure or event (11 in 1,621) and a 0.05% risk in women who did not (1 in 1,970).
The most common inciting event for ONJ appeared to be dental extractions, often of two or three teeth. The next most common dental issue associated with ONJ seemed to be poorly-fitted dentures.
ONJ resolved with treatment in 10 of 12 cases; one case was ongoing at the end of the study and one had an unknown outcome because the subject had withdrawn from the study. “With effective dental therapy, healing is the most likely outcome,” said Dr. Watts.
In clinical trials, ONJ occurred at a rate between 1 and 10 per 10,000 patient-years. A report in 2003, however, described severe ONJ in 36 cancer patients who received bisphosphonates (https://www.ncbi.nlm.nih.gov/pubmed/12966493).
The denosumab doses that cancer patients receive can be 10 to 12 times higher than the typical dose given to a postmenopausal woman being treated for osteoporosis.
“I can’t tell you how many phone calls I get from patients who are worried somehow or worried in situations created by their dentists that whatever procedure they’re going to have is going to end horribly,” Dr. Watts said. “In some cases dentists are telling my patients to either stop the drug that I’m giving them or to wait to get the next dose, and there’s absolutely nothing to support that.”
The study was funded by Amgen, the maker of denosumab (Prolia). Dr. Watts has received research support from Shire and has consulted for Abbvie, Amgen, and Radius. He is on the speakers’ bureau for Amgen, Radius, and Shire.
rhnews@frontlinemedcom.com
AT ASBMR
DENVER – Osteonecrosis of the jaw (ONJ) was a rare adverse event in women taking denosumab for postmenopausal osteoporosis, with a 0.7% rate for women who reported an invasive oral procedure or event while taking the drug and a 0.05% rate for women who did not have such procedures, Nelson Watts, MD, reported at the annual meeting of the American Society of Bone and Mineral Research.
The finding comes from a new analysis of a 7-year extension study of denosumab use in 4,550 women who participated in the 3-year, double-blind, phase 3 FREEDOM trial (NCT00089791) that compared denosumab 60 mg and placebo every 6 months. Those who missed 1 dose or fewer and completed visits through year 3 of the initial study were eligible to continue in the 7-year, open-label extension study. Those who had received placebo in the initial trial were crossed over to denosumab for the extension study.
Extension study participants were instructed to chronicle invasive oral procedures and events that had occurred in the initial trial and completed an oral event questionnaire once every 6 months of the extension trial.
All surveys were completed by 3,591 (79%) of the extension study participants, and 45.1% reported at least one invasive oral procedure or event during that time. The frequency of events was similar for the crossover and long-term denosumab groups; these events included scaling or root planing (29.1% and 28.5%), tooth extraction (25.1% and 24.6%), dental implant (5.8% and 6.0%), natural tooth loss (4.2% and 4.0%), and jaw surgery (0.9% and 0.9%). ONJ occurred at a rate of 5.2 cases per 10,000 patient-years of denosumab use, said Nelson Watts, MD, director of osteoporosis and bone health services at Mercy Health Services in Cincinnati, Ohio.
Of the 12 ONJ cases identified in the study, 11 occurred in women who reported an invasive oral procedure or event. This translated to a 0.7% risk of ONJ in women who reported an invasive oral procedure or event (11 in 1,621) and a 0.05% risk in women who did not (1 in 1,970).
The most common inciting event for ONJ appeared to be dental extractions, often of two or three teeth. The next most common dental issue associated with ONJ seemed to be poorly-fitted dentures.
ONJ resolved with treatment in 10 of 12 cases; one case was ongoing at the end of the study and one had an unknown outcome because the subject had withdrawn from the study. “With effective dental therapy, healing is the most likely outcome,” said Dr. Watts.
In clinical trials, ONJ occurred at a rate between 1 and 10 per 10,000 patient-years. A report in 2003, however, described severe ONJ in 36 cancer patients who received bisphosphonates (https://www.ncbi.nlm.nih.gov/pubmed/12966493).
The denosumab doses that cancer patients receive can be 10 to 12 times higher than the typical dose given to a postmenopausal woman being treated for osteoporosis.
“I can’t tell you how many phone calls I get from patients who are worried somehow or worried in situations created by their dentists that whatever procedure they’re going to have is going to end horribly,” Dr. Watts said. “In some cases dentists are telling my patients to either stop the drug that I’m giving them or to wait to get the next dose, and there’s absolutely nothing to support that.”
The study was funded by Amgen, the maker of denosumab (Prolia). Dr. Watts has received research support from Shire and has consulted for Abbvie, Amgen, and Radius. He is on the speakers’ bureau for Amgen, Radius, and Shire.
rhnews@frontlinemedcom.com
AT ASBMR
DENVER – Osteonecrosis of the jaw (ONJ) was a rare adverse event in women taking denosumab for postmenopausal osteoporosis, with a 0.7% rate for women who reported an invasive oral procedure or event while taking the drug and a 0.05% rate for women who did not have such procedures, Nelson Watts, MD, reported at the annual meeting of the American Society of Bone and Mineral Research.
The finding comes from a new analysis of a 7-year extension study of denosumab use in 4,550 women who participated in the 3-year, double-blind, phase 3 FREEDOM trial (NCT00089791) that compared denosumab 60 mg and placebo every 6 months. Those who missed 1 dose or fewer and completed visits through year 3 of the initial study were eligible to continue in the 7-year, open-label extension study. Those who had received placebo in the initial trial were crossed over to denosumab for the extension study.
Extension study participants were instructed to chronicle invasive oral procedures and events that had occurred in the initial trial and completed an oral event questionnaire once every 6 months of the extension trial.
All surveys were completed by 3,591 (79%) of the extension study participants, and 45.1% reported at least one invasive oral procedure or event during that time. The frequency of events was similar for the crossover and long-term denosumab groups; these events included scaling or root planing (29.1% and 28.5%), tooth extraction (25.1% and 24.6%), dental implant (5.8% and 6.0%), natural tooth loss (4.2% and 4.0%), and jaw surgery (0.9% and 0.9%). ONJ occurred at a rate of 5.2 cases per 10,000 patient-years of denosumab use, said Nelson Watts, MD, director of osteoporosis and bone health services at Mercy Health Services in Cincinnati, Ohio.
Of the 12 ONJ cases identified in the study, 11 occurred in women who reported an invasive oral procedure or event. This translated to a 0.7% risk of ONJ in women who reported an invasive oral procedure or event (11 in 1,621) and a 0.05% risk in women who did not (1 in 1,970).
The most common inciting event for ONJ appeared to be dental extractions, often of two or three teeth. The next most common dental issue associated with ONJ seemed to be poorly-fitted dentures.
ONJ resolved with treatment in 10 of 12 cases; one case was ongoing at the end of the study and one had an unknown outcome because the subject had withdrawn from the study. “With effective dental therapy, healing is the most likely outcome,” said Dr. Watts.
In clinical trials, ONJ occurred at a rate between 1 and 10 per 10,000 patient-years. A report in 2003, however, described severe ONJ in 36 cancer patients who received bisphosphonates (https://www.ncbi.nlm.nih.gov/pubmed/12966493).
The denosumab doses that cancer patients receive can be 10 to 12 times higher than the typical dose given to a postmenopausal woman being treated for osteoporosis.
“I can’t tell you how many phone calls I get from patients who are worried somehow or worried in situations created by their dentists that whatever procedure they’re going to have is going to end horribly,” Dr. Watts said. “In some cases dentists are telling my patients to either stop the drug that I’m giving them or to wait to get the next dose, and there’s absolutely nothing to support that.”
The study was funded by Amgen, the maker of denosumab (Prolia). Dr. Watts has received research support from Shire and has consulted for Abbvie, Amgen, and Radius. He is on the speakers’ bureau for Amgen, Radius, and Shire.
rhnews@frontlinemedcom.com
Allopurinol extension trial backs treat-to-target approach in gout
In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.
The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.
Dr. Stamp did emphasize the need to monitor liver and kidney function, as well as for rashes.
Allopurinol is approved at doses as high as 800 mg/day in the United States, and 900 mg/day in Europe, but most physicians rarely exceed 300 mg/day for fear of side effects. Existing guidelines and recommendations offer different opinions. The European League Against Rheumatism (EULAR) recommends switching to another urate-lowering therapy if the maximum dose adjusted to creatinine clearance (CrCl) isn’t effective, while the American College of Rheumatology recommends gradual dose escalation (DE) beyond CrCl-based doses, even in patients with chronic kidney disease.
The earlier study included 183 patients who had failed to achieve serum urate target levels at CrCl dose, which is intended to avoid allopurinol hypersensitivity syndrome and other potential adverse events. The short-term study results favored the DE approach. At 1 year, there was no difference in adverse events between the 93 control subjects and the 90 DE subjects. The DE group experienced an average serum urate reduction of 1.5 mg/dL, compared with 0.35 mg/dL in the control group (P less than .001). Overall, 32% of controls and 69% of the dose escalation group had achieved serum urate of 6.0 mg/dL or less.
In the extension study, subjects in the control group were switched to a strategy of dose escalation (control/DE), while the patients in the original treatment group remained at their existing allopurinol doses (DE/DE). Those who switched had a mean reduction in serum urate of 1.1 mg/dL, compared with an increase of 0.1 mg/dL in the DE/DE group (P less than .001).
From baseline to month 24, the control/DE group experienced a change in serum urate from 7.13 mg/dL to 5.7 mg/dL, while the DE/DE group experienced a change from 7.18 mg/dL to 5.4 mg/dL.
Both groups had a significant reduction in gout flares, but there was no difference in flare reduction between the two groups at 24 months.
Of those with a tophus at baseline, 6 (16%) of 37 of the control/DE group and 4 (13%) of 31 of the DE/DE group had complete resolution of all tophi between months 12 and 24. Measurable tophi completely resolved between baseline and 24 months in the same percentage of patients (29%) in each group. Tophus size decline significantly overall in both groups together, and there was no difference between the randomized groups.
In the control/DE group, there were 38 serious adverse events in 14 patients, compared with 33 serious adverse events in 22 patients in the DE/DE group. None of the serious adverse events were believed to be related to allopurinol. There were four deaths in the control/DE group and three in the DE/DE group between months 12 and 24, but none of the deaths were believed to be related to allopurinol.
“It is common that people don’t respond to allopurinol at doses based on kidney function and then the dose is not increased. This should give prescribers more confidence to increase the dose,” Dr. Stamp said.
The Health Research Council of New Zealand funded the study. Dr. Stamp has received grants from Ardea Biosciences. One coauthor reported receiving grants and personal fees from AstraZeneca and Ardea Biosciences; personal fees from Takeda, Teijin, and Menarini; grants from Fonterra; and personal fees from Pfizer, Crealta, and Cymabay.
In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.
The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.
Dr. Stamp did emphasize the need to monitor liver and kidney function, as well as for rashes.
Allopurinol is approved at doses as high as 800 mg/day in the United States, and 900 mg/day in Europe, but most physicians rarely exceed 300 mg/day for fear of side effects. Existing guidelines and recommendations offer different opinions. The European League Against Rheumatism (EULAR) recommends switching to another urate-lowering therapy if the maximum dose adjusted to creatinine clearance (CrCl) isn’t effective, while the American College of Rheumatology recommends gradual dose escalation (DE) beyond CrCl-based doses, even in patients with chronic kidney disease.
The earlier study included 183 patients who had failed to achieve serum urate target levels at CrCl dose, which is intended to avoid allopurinol hypersensitivity syndrome and other potential adverse events. The short-term study results favored the DE approach. At 1 year, there was no difference in adverse events between the 93 control subjects and the 90 DE subjects. The DE group experienced an average serum urate reduction of 1.5 mg/dL, compared with 0.35 mg/dL in the control group (P less than .001). Overall, 32% of controls and 69% of the dose escalation group had achieved serum urate of 6.0 mg/dL or less.
In the extension study, subjects in the control group were switched to a strategy of dose escalation (control/DE), while the patients in the original treatment group remained at their existing allopurinol doses (DE/DE). Those who switched had a mean reduction in serum urate of 1.1 mg/dL, compared with an increase of 0.1 mg/dL in the DE/DE group (P less than .001).
From baseline to month 24, the control/DE group experienced a change in serum urate from 7.13 mg/dL to 5.7 mg/dL, while the DE/DE group experienced a change from 7.18 mg/dL to 5.4 mg/dL.
Both groups had a significant reduction in gout flares, but there was no difference in flare reduction between the two groups at 24 months.
Of those with a tophus at baseline, 6 (16%) of 37 of the control/DE group and 4 (13%) of 31 of the DE/DE group had complete resolution of all tophi between months 12 and 24. Measurable tophi completely resolved between baseline and 24 months in the same percentage of patients (29%) in each group. Tophus size decline significantly overall in both groups together, and there was no difference between the randomized groups.
In the control/DE group, there were 38 serious adverse events in 14 patients, compared with 33 serious adverse events in 22 patients in the DE/DE group. None of the serious adverse events were believed to be related to allopurinol. There were four deaths in the control/DE group and three in the DE/DE group between months 12 and 24, but none of the deaths were believed to be related to allopurinol.
“It is common that people don’t respond to allopurinol at doses based on kidney function and then the dose is not increased. This should give prescribers more confidence to increase the dose,” Dr. Stamp said.
The Health Research Council of New Zealand funded the study. Dr. Stamp has received grants from Ardea Biosciences. One coauthor reported receiving grants and personal fees from AstraZeneca and Ardea Biosciences; personal fees from Takeda, Teijin, and Menarini; grants from Fonterra; and personal fees from Pfizer, Crealta, and Cymabay.
In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.
The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.
Dr. Stamp did emphasize the need to monitor liver and kidney function, as well as for rashes.
Allopurinol is approved at doses as high as 800 mg/day in the United States, and 900 mg/day in Europe, but most physicians rarely exceed 300 mg/day for fear of side effects. Existing guidelines and recommendations offer different opinions. The European League Against Rheumatism (EULAR) recommends switching to another urate-lowering therapy if the maximum dose adjusted to creatinine clearance (CrCl) isn’t effective, while the American College of Rheumatology recommends gradual dose escalation (DE) beyond CrCl-based doses, even in patients with chronic kidney disease.
The earlier study included 183 patients who had failed to achieve serum urate target levels at CrCl dose, which is intended to avoid allopurinol hypersensitivity syndrome and other potential adverse events. The short-term study results favored the DE approach. At 1 year, there was no difference in adverse events between the 93 control subjects and the 90 DE subjects. The DE group experienced an average serum urate reduction of 1.5 mg/dL, compared with 0.35 mg/dL in the control group (P less than .001). Overall, 32% of controls and 69% of the dose escalation group had achieved serum urate of 6.0 mg/dL or less.
In the extension study, subjects in the control group were switched to a strategy of dose escalation (control/DE), while the patients in the original treatment group remained at their existing allopurinol doses (DE/DE). Those who switched had a mean reduction in serum urate of 1.1 mg/dL, compared with an increase of 0.1 mg/dL in the DE/DE group (P less than .001).
From baseline to month 24, the control/DE group experienced a change in serum urate from 7.13 mg/dL to 5.7 mg/dL, while the DE/DE group experienced a change from 7.18 mg/dL to 5.4 mg/dL.
Both groups had a significant reduction in gout flares, but there was no difference in flare reduction between the two groups at 24 months.
Of those with a tophus at baseline, 6 (16%) of 37 of the control/DE group and 4 (13%) of 31 of the DE/DE group had complete resolution of all tophi between months 12 and 24. Measurable tophi completely resolved between baseline and 24 months in the same percentage of patients (29%) in each group. Tophus size decline significantly overall in both groups together, and there was no difference between the randomized groups.
In the control/DE group, there were 38 serious adverse events in 14 patients, compared with 33 serious adverse events in 22 patients in the DE/DE group. None of the serious adverse events were believed to be related to allopurinol. There were four deaths in the control/DE group and three in the DE/DE group between months 12 and 24, but none of the deaths were believed to be related to allopurinol.
“It is common that people don’t respond to allopurinol at doses based on kidney function and then the dose is not increased. This should give prescribers more confidence to increase the dose,” Dr. Stamp said.
The Health Research Council of New Zealand funded the study. Dr. Stamp has received grants from Ardea Biosciences. One coauthor reported receiving grants and personal fees from AstraZeneca and Ardea Biosciences; personal fees from Takeda, Teijin, and Menarini; grants from Fonterra; and personal fees from Pfizer, Crealta, and Cymabay.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: An extension study showed continued safety and efficacy of heightened allopurinol doses using a dose-escalation approach.
Major finding: A treat-to-target dosing strategy had a safety profile similar to that of a maximum dose adjusted to creatinine clearance.
Data source: Open-label extension study (n = 183).
Disclosures: The Health Research Council of New Zealand funded the study. Dr. Stamp has received grants from Ardea Biosciences. One coauthor reported receiving grants and personal fees from AstraZeneca and Ardea Biosciences; personal fees from Takeda, Teijin, and Menarini; grants from Fonterra; and personal fees from Pfizer, Crealta, and Cymabay.
In T1 diabetes, CABG seems better than PCI
In patients with type 1 diabetes in need of multivessel revascularization, coronary artery bypass graft (CABG) may be a better choice than percutaneous coronary intervention (PCI), according to results from a new comparative study presented at the annual congress of the European Society of Cardiology by Martin J. Holzmann, PhD, of the Karolinska Institute, Stockholm.
The two procedures had similar mortality rates, but PCI patients fared worse with respect to mortality due to myocardial infarction and several cardiovascular outcomes.
Previous studies had also suggested better outcomes with CABG than with PCI, but they lumped together patients with type 1 and type 2 diabetes, while the current study focused only on patients with type 1 diabetes.
The study included patients in Sweden with type 1 diabetes who underwent CABG (683 patients) or PCI (1,863 patients) between 1995 and 2013. During follow-up, 44.6% of patients in the PCI group died, compared with 53.3% in the CABG group. After adjustment for between-group differences, however, there was no significant difference in mortality risk between the two groups.
However, assessments of cause-specific mortality told a different story. Subjects in the PCI group had a greater risk of death from coronary artery disease (hazard ratio, 1.45; 95% confidence interval, 1.21-1.74).
Subjects in the PCI group were also more likely to suffer myocardial infarction (HR, 1.47; 95% CI, 1.21-1.77) and were more than five times more likely to undergo repeat vascularization (adjusted HR, 5.64; 95% CI, 4.67-6.82). The CABG group had a higher 30-day stroke risk (1.9% vs. 0.8%), but there was no difference in long-term risk.
The two groups had similar risks of hospitalization for heart failure.
The researchers noted a large difference between the two groups with respect to risk during the first year of follow-up, which suggests that some patients underwent PCI because they were too ill to undergo CABG. This limitation is also suggested by the greater proportion of previous stroke, heart failure, active cancer, and end-stage renal disease in the PCI group. The researchers adjusted for these differences, but it remains possible that there were residual confounders.
No source of funding was disclosed. One of the authors has received consultancy honoraria from Actelion and Pfizer. Dr. Domanski and Dr. Farkouh report no relevant financial relationships.
In patients with aggressive multivessel CAD and stable symptoms associated with diabetes or high SYNTAX score, the mechanisms of benefit of PCI and CABG are different, and this difference likely explains the superior results of CABG.
Better stents alone cannot change the superiority of CABG, compared with PCI for patients with aggressive CAD (diabetes or high SYNTAX score), because PCI addresses only a small portion of the coronary anatomy. This does not diminish the importance of continuing advances in stent technology, but rather, it puts into appropriate perspective what can be expected from these advances.
The findings of this important study help to better inform practice, and should influence decision-making for revascularization in patients with T1DM.
These remarks were taken from an editorial by Michael J. Domanski, MD, and Michael E. Farkouh, MD (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.07.781). Dr. Domanski is with the Peter Munk Cardiac Centre, Toronto, and the Heart and Stroke Richard Lewar Centre, University of Toronto. Dr. Farokouh is the director of clinical trials at the Peter Munk Cardiac Centre, University of Toronto.
In patients with aggressive multivessel CAD and stable symptoms associated with diabetes or high SYNTAX score, the mechanisms of benefit of PCI and CABG are different, and this difference likely explains the superior results of CABG.
Better stents alone cannot change the superiority of CABG, compared with PCI for patients with aggressive CAD (diabetes or high SYNTAX score), because PCI addresses only a small portion of the coronary anatomy. This does not diminish the importance of continuing advances in stent technology, but rather, it puts into appropriate perspective what can be expected from these advances.
The findings of this important study help to better inform practice, and should influence decision-making for revascularization in patients with T1DM.
These remarks were taken from an editorial by Michael J. Domanski, MD, and Michael E. Farkouh, MD (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.07.781). Dr. Domanski is with the Peter Munk Cardiac Centre, Toronto, and the Heart and Stroke Richard Lewar Centre, University of Toronto. Dr. Farokouh is the director of clinical trials at the Peter Munk Cardiac Centre, University of Toronto.
In patients with aggressive multivessel CAD and stable symptoms associated with diabetes or high SYNTAX score, the mechanisms of benefit of PCI and CABG are different, and this difference likely explains the superior results of CABG.
Better stents alone cannot change the superiority of CABG, compared with PCI for patients with aggressive CAD (diabetes or high SYNTAX score), because PCI addresses only a small portion of the coronary anatomy. This does not diminish the importance of continuing advances in stent technology, but rather, it puts into appropriate perspective what can be expected from these advances.
The findings of this important study help to better inform practice, and should influence decision-making for revascularization in patients with T1DM.
These remarks were taken from an editorial by Michael J. Domanski, MD, and Michael E. Farkouh, MD (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.07.781). Dr. Domanski is with the Peter Munk Cardiac Centre, Toronto, and the Heart and Stroke Richard Lewar Centre, University of Toronto. Dr. Farokouh is the director of clinical trials at the Peter Munk Cardiac Centre, University of Toronto.
In patients with type 1 diabetes in need of multivessel revascularization, coronary artery bypass graft (CABG) may be a better choice than percutaneous coronary intervention (PCI), according to results from a new comparative study presented at the annual congress of the European Society of Cardiology by Martin J. Holzmann, PhD, of the Karolinska Institute, Stockholm.
The two procedures had similar mortality rates, but PCI patients fared worse with respect to mortality due to myocardial infarction and several cardiovascular outcomes.
Previous studies had also suggested better outcomes with CABG than with PCI, but they lumped together patients with type 1 and type 2 diabetes, while the current study focused only on patients with type 1 diabetes.
The study included patients in Sweden with type 1 diabetes who underwent CABG (683 patients) or PCI (1,863 patients) between 1995 and 2013. During follow-up, 44.6% of patients in the PCI group died, compared with 53.3% in the CABG group. After adjustment for between-group differences, however, there was no significant difference in mortality risk between the two groups.
However, assessments of cause-specific mortality told a different story. Subjects in the PCI group had a greater risk of death from coronary artery disease (hazard ratio, 1.45; 95% confidence interval, 1.21-1.74).
Subjects in the PCI group were also more likely to suffer myocardial infarction (HR, 1.47; 95% CI, 1.21-1.77) and were more than five times more likely to undergo repeat vascularization (adjusted HR, 5.64; 95% CI, 4.67-6.82). The CABG group had a higher 30-day stroke risk (1.9% vs. 0.8%), but there was no difference in long-term risk.
The two groups had similar risks of hospitalization for heart failure.
The researchers noted a large difference between the two groups with respect to risk during the first year of follow-up, which suggests that some patients underwent PCI because they were too ill to undergo CABG. This limitation is also suggested by the greater proportion of previous stroke, heart failure, active cancer, and end-stage renal disease in the PCI group. The researchers adjusted for these differences, but it remains possible that there were residual confounders.
No source of funding was disclosed. One of the authors has received consultancy honoraria from Actelion and Pfizer. Dr. Domanski and Dr. Farkouh report no relevant financial relationships.
In patients with type 1 diabetes in need of multivessel revascularization, coronary artery bypass graft (CABG) may be a better choice than percutaneous coronary intervention (PCI), according to results from a new comparative study presented at the annual congress of the European Society of Cardiology by Martin J. Holzmann, PhD, of the Karolinska Institute, Stockholm.
The two procedures had similar mortality rates, but PCI patients fared worse with respect to mortality due to myocardial infarction and several cardiovascular outcomes.
Previous studies had also suggested better outcomes with CABG than with PCI, but they lumped together patients with type 1 and type 2 diabetes, while the current study focused only on patients with type 1 diabetes.
The study included patients in Sweden with type 1 diabetes who underwent CABG (683 patients) or PCI (1,863 patients) between 1995 and 2013. During follow-up, 44.6% of patients in the PCI group died, compared with 53.3% in the CABG group. After adjustment for between-group differences, however, there was no significant difference in mortality risk between the two groups.
However, assessments of cause-specific mortality told a different story. Subjects in the PCI group had a greater risk of death from coronary artery disease (hazard ratio, 1.45; 95% confidence interval, 1.21-1.74).
Subjects in the PCI group were also more likely to suffer myocardial infarction (HR, 1.47; 95% CI, 1.21-1.77) and were more than five times more likely to undergo repeat vascularization (adjusted HR, 5.64; 95% CI, 4.67-6.82). The CABG group had a higher 30-day stroke risk (1.9% vs. 0.8%), but there was no difference in long-term risk.
The two groups had similar risks of hospitalization for heart failure.
The researchers noted a large difference between the two groups with respect to risk during the first year of follow-up, which suggests that some patients underwent PCI because they were too ill to undergo CABG. This limitation is also suggested by the greater proportion of previous stroke, heart failure, active cancer, and end-stage renal disease in the PCI group. The researchers adjusted for these differences, but it remains possible that there were residual confounders.
No source of funding was disclosed. One of the authors has received consultancy honoraria from Actelion and Pfizer. Dr. Domanski and Dr. Farkouh report no relevant financial relationships.
FROM THE ESC CONGRESS 2017
Key clinical point: Patients undergoing PCI had worse cardiovascular outcomes than those receiving CABG.
Major finding: The PCI group had a 45% increased risk of death due to myocardial infarction.
Data source: Observational study (n = 2,546).
Disclosures: No source of funding was disclosed. One of the authors has received consultancy honoraria from Actelion and Pfizer. Dr. Domanski and Dr. Farkouh report no relevant financial relationships.
Analysis: Gabapentinoids aren’t the answer to back pain
Treating chronic lower back pain with gabapentinoids carries risks of dizziness, fatigue, and other side effects, but there is little evidence of their efficacy, according to a meta-analysis.
First-line analgesic treatment of chronic lower back pain (CLBP) often brings insufficient relief, leading to second-line treatments with gabapentinoids such as gabapentin (GB) or pregabalin (PG). These drugs are effective for neuropathic pain, but in most cases, CLBP has no clear cause.
Long-term use of gabapentinoids for CLBP has been increasing, but it could carry the risk of side effects. That prompted Harsha Shanthanna, MD, of McMaster University, Hamilton, Ont., and his colleagues to analyze existing research to determine their efficacy and potential harms in the treatment of CLBP.
The authors converted pain relief expressed in numerical rating scale or visual analog scale into a common scale of pain relief.
A meta-analysis of trials that compared GB to placebo found a small reduction in pain in the GB group (mean difference, 0.22 units; 95% confidence interval [CI], –0.51-0.07). No studies compared PG to placebo. Three studies (n = 169) compared PG to an active comparator, and the comparator yielded better improvements in pain (mean difference, 0.42 units; 95% CI, 0.20-0.64). The quality of evidence was rated very low in both PG to comparator and GB to placebo.
No deaths or hospitalizations were reported in the studies. Rates of adverse events were higher in the gabapentinoid groups than in the placebo group, including dizziness (risk ratio, 1.99, 95% CI, 1.17-3.37; number needed to harm, 7), fatigue (RR, 1.85; 95% CI, 1.12-3.05; I2 = 0; NNH, 8), difficulties with mentation (RR, 3.34; 95% CI, 1.54-7.25; NNH, 6), and visual disturbances (RR, 5.72; 95% CI, 1.94-16.91; NNH, 6). The evidence was of very low quality for dizziness and fatigue, low for difficulties with mentation, and moderate with respect to visual disturbances.
Dizziness was more common in PG groups, compared with active comparators (RR, 2.70; 95% CI, 1.25-5.83; NNH, 11), although the quality of evidence was very low.
The study included only a small number of trials, which could lead to issues with heterogeneity, the investigators cautioned.
“Our review demonstrates that there is limited evidence on the use of gabapentinoids in nonspecific CLBP, and the existing evidence in the form of RCTs does not support their use,” the authors concluded.
The study was not funded, and the authors reported having no relevant financial disclosures.
Treating chronic lower back pain with gabapentinoids carries risks of dizziness, fatigue, and other side effects, but there is little evidence of their efficacy, according to a meta-analysis.
First-line analgesic treatment of chronic lower back pain (CLBP) often brings insufficient relief, leading to second-line treatments with gabapentinoids such as gabapentin (GB) or pregabalin (PG). These drugs are effective for neuropathic pain, but in most cases, CLBP has no clear cause.
Long-term use of gabapentinoids for CLBP has been increasing, but it could carry the risk of side effects. That prompted Harsha Shanthanna, MD, of McMaster University, Hamilton, Ont., and his colleagues to analyze existing research to determine their efficacy and potential harms in the treatment of CLBP.
The authors converted pain relief expressed in numerical rating scale or visual analog scale into a common scale of pain relief.
A meta-analysis of trials that compared GB to placebo found a small reduction in pain in the GB group (mean difference, 0.22 units; 95% confidence interval [CI], –0.51-0.07). No studies compared PG to placebo. Three studies (n = 169) compared PG to an active comparator, and the comparator yielded better improvements in pain (mean difference, 0.42 units; 95% CI, 0.20-0.64). The quality of evidence was rated very low in both PG to comparator and GB to placebo.
No deaths or hospitalizations were reported in the studies. Rates of adverse events were higher in the gabapentinoid groups than in the placebo group, including dizziness (risk ratio, 1.99, 95% CI, 1.17-3.37; number needed to harm, 7), fatigue (RR, 1.85; 95% CI, 1.12-3.05; I2 = 0; NNH, 8), difficulties with mentation (RR, 3.34; 95% CI, 1.54-7.25; NNH, 6), and visual disturbances (RR, 5.72; 95% CI, 1.94-16.91; NNH, 6). The evidence was of very low quality for dizziness and fatigue, low for difficulties with mentation, and moderate with respect to visual disturbances.
Dizziness was more common in PG groups, compared with active comparators (RR, 2.70; 95% CI, 1.25-5.83; NNH, 11), although the quality of evidence was very low.
The study included only a small number of trials, which could lead to issues with heterogeneity, the investigators cautioned.
“Our review demonstrates that there is limited evidence on the use of gabapentinoids in nonspecific CLBP, and the existing evidence in the form of RCTs does not support their use,” the authors concluded.
The study was not funded, and the authors reported having no relevant financial disclosures.
Treating chronic lower back pain with gabapentinoids carries risks of dizziness, fatigue, and other side effects, but there is little evidence of their efficacy, according to a meta-analysis.
First-line analgesic treatment of chronic lower back pain (CLBP) often brings insufficient relief, leading to second-line treatments with gabapentinoids such as gabapentin (GB) or pregabalin (PG). These drugs are effective for neuropathic pain, but in most cases, CLBP has no clear cause.
Long-term use of gabapentinoids for CLBP has been increasing, but it could carry the risk of side effects. That prompted Harsha Shanthanna, MD, of McMaster University, Hamilton, Ont., and his colleagues to analyze existing research to determine their efficacy and potential harms in the treatment of CLBP.
The authors converted pain relief expressed in numerical rating scale or visual analog scale into a common scale of pain relief.
A meta-analysis of trials that compared GB to placebo found a small reduction in pain in the GB group (mean difference, 0.22 units; 95% confidence interval [CI], –0.51-0.07). No studies compared PG to placebo. Three studies (n = 169) compared PG to an active comparator, and the comparator yielded better improvements in pain (mean difference, 0.42 units; 95% CI, 0.20-0.64). The quality of evidence was rated very low in both PG to comparator and GB to placebo.
No deaths or hospitalizations were reported in the studies. Rates of adverse events were higher in the gabapentinoid groups than in the placebo group, including dizziness (risk ratio, 1.99, 95% CI, 1.17-3.37; number needed to harm, 7), fatigue (RR, 1.85; 95% CI, 1.12-3.05; I2 = 0; NNH, 8), difficulties with mentation (RR, 3.34; 95% CI, 1.54-7.25; NNH, 6), and visual disturbances (RR, 5.72; 95% CI, 1.94-16.91; NNH, 6). The evidence was of very low quality for dizziness and fatigue, low for difficulties with mentation, and moderate with respect to visual disturbances.
Dizziness was more common in PG groups, compared with active comparators (RR, 2.70; 95% CI, 1.25-5.83; NNH, 11), although the quality of evidence was very low.
The study included only a small number of trials, which could lead to issues with heterogeneity, the investigators cautioned.
“Our review demonstrates that there is limited evidence on the use of gabapentinoids in nonspecific CLBP, and the existing evidence in the form of RCTs does not support their use,” the authors concluded.
The study was not funded, and the authors reported having no relevant financial disclosures.
FROM PLOS MEDICINE
Key clinical point: Gabapentins were little better than placebo for chronic lower back pain, but they posed risks of dizziness and other effects.
Major finding: A meta-analysis of trials that compared gabapentin to placebo found a small reduction in pain in the gabapentin group, but rates of adverse events were higher in the gabapentinoid groups.
Data source: A meta-analysis of 14 randomized, controlled trials.
Disclosures: The study was not funded, and the authors reported having no relevant financial disclosures.
California study indicates increased melanoma incidence is real
A new analysis in non-Hispanic whites suggests that rising melanoma rates are real, not attributable to increased levels of detection, and that the burden of the disease could rise significantly in the coming years.
The incidence of melanoma in light-skinned individuals has been rising worldwide in recent years, but it remains unclear whether that trend is due to an increase in the disease, or better screening and diagnosis. The new results are drawn from California, and track incidence and stage at diagnosis of melanoma across different socioeconomic status (SES) groups. Across all groups, the researchers found increases not only in incidence, but also in advanced disease.
“Our findings support a true real rise in incidence of melanoma across all thicknesses and stages, and not just thinner, more indolent tumors that may be due to increased screening or diagnosis,” lead researcher Susan Swetter, MD, said in an interview. The study was published online in the Journal of Investigative Dermatology (J Invest Dermatol. 2017 Jul 20. pii: S0022-202X(17)31867-5. doi: 10.1016/j.jid.2017.06.024).
Overall, the incidence rose 25% in men from 1998-2002 to 2008-2012 (an average annual age-adjusted incidence of 34.7 to 43.5 per 100,000 person-years), and by 21% in women between those two time periods (from 21.7 to 26.2 per 100,000). Melanoma incidence rate ratios (IRR) increased across all SES classes: by 27% among men in the highest SES neighborhoods, and by 12% among men in the lowest SES neighborhoods. For women, the rates increased by 28% and 13% respectively.
The highest increases in the incidence of regional and distant disease occurred in the lowest SES neighborhoods, nearly doubling in men (distant disease IRR, 1.87; 95% CI, 1.39-2.53; regional disease IRR, 1.93; 95% CI, 1.51-2.47). Women in these neighborhoods also experienced a significant increase in regional disease (IRR, 1.44; 95% CI, 1.00-2.08), but not distant disease.
Incidence of diagnosis with the thickest tumors (greater than 4 mm) rose significantly in most neighborhood SES quartiles, with the exception of the men in the lowest SES quartiles, who had a lower increase that was of borderline significance.
The results solidify the evidence that melanoma incidence is truly increasing, but they also have public health implications. The rising incidence of more advanced disease suggests a heightening health care burden from melanoma in the coming years, but also points to strategies for prevention, according to Dr. Swetter. “It’s important that we focus not only on primary prevention. We need methods to enhance early detection, especially in areas where there is lower access to dermatologists and even primary care providers, who can assist in this effort,” she said.
The Stanford Cancer Institute funded the study. Dr. Swetter reported having no financial disclosures.
A new analysis in non-Hispanic whites suggests that rising melanoma rates are real, not attributable to increased levels of detection, and that the burden of the disease could rise significantly in the coming years.
The incidence of melanoma in light-skinned individuals has been rising worldwide in recent years, but it remains unclear whether that trend is due to an increase in the disease, or better screening and diagnosis. The new results are drawn from California, and track incidence and stage at diagnosis of melanoma across different socioeconomic status (SES) groups. Across all groups, the researchers found increases not only in incidence, but also in advanced disease.
“Our findings support a true real rise in incidence of melanoma across all thicknesses and stages, and not just thinner, more indolent tumors that may be due to increased screening or diagnosis,” lead researcher Susan Swetter, MD, said in an interview. The study was published online in the Journal of Investigative Dermatology (J Invest Dermatol. 2017 Jul 20. pii: S0022-202X(17)31867-5. doi: 10.1016/j.jid.2017.06.024).
Overall, the incidence rose 25% in men from 1998-2002 to 2008-2012 (an average annual age-adjusted incidence of 34.7 to 43.5 per 100,000 person-years), and by 21% in women between those two time periods (from 21.7 to 26.2 per 100,000). Melanoma incidence rate ratios (IRR) increased across all SES classes: by 27% among men in the highest SES neighborhoods, and by 12% among men in the lowest SES neighborhoods. For women, the rates increased by 28% and 13% respectively.
The highest increases in the incidence of regional and distant disease occurred in the lowest SES neighborhoods, nearly doubling in men (distant disease IRR, 1.87; 95% CI, 1.39-2.53; regional disease IRR, 1.93; 95% CI, 1.51-2.47). Women in these neighborhoods also experienced a significant increase in regional disease (IRR, 1.44; 95% CI, 1.00-2.08), but not distant disease.
Incidence of diagnosis with the thickest tumors (greater than 4 mm) rose significantly in most neighborhood SES quartiles, with the exception of the men in the lowest SES quartiles, who had a lower increase that was of borderline significance.
The results solidify the evidence that melanoma incidence is truly increasing, but they also have public health implications. The rising incidence of more advanced disease suggests a heightening health care burden from melanoma in the coming years, but also points to strategies for prevention, according to Dr. Swetter. “It’s important that we focus not only on primary prevention. We need methods to enhance early detection, especially in areas where there is lower access to dermatologists and even primary care providers, who can assist in this effort,” she said.
The Stanford Cancer Institute funded the study. Dr. Swetter reported having no financial disclosures.
A new analysis in non-Hispanic whites suggests that rising melanoma rates are real, not attributable to increased levels of detection, and that the burden of the disease could rise significantly in the coming years.
The incidence of melanoma in light-skinned individuals has been rising worldwide in recent years, but it remains unclear whether that trend is due to an increase in the disease, or better screening and diagnosis. The new results are drawn from California, and track incidence and stage at diagnosis of melanoma across different socioeconomic status (SES) groups. Across all groups, the researchers found increases not only in incidence, but also in advanced disease.
“Our findings support a true real rise in incidence of melanoma across all thicknesses and stages, and not just thinner, more indolent tumors that may be due to increased screening or diagnosis,” lead researcher Susan Swetter, MD, said in an interview. The study was published online in the Journal of Investigative Dermatology (J Invest Dermatol. 2017 Jul 20. pii: S0022-202X(17)31867-5. doi: 10.1016/j.jid.2017.06.024).
Overall, the incidence rose 25% in men from 1998-2002 to 2008-2012 (an average annual age-adjusted incidence of 34.7 to 43.5 per 100,000 person-years), and by 21% in women between those two time periods (from 21.7 to 26.2 per 100,000). Melanoma incidence rate ratios (IRR) increased across all SES classes: by 27% among men in the highest SES neighborhoods, and by 12% among men in the lowest SES neighborhoods. For women, the rates increased by 28% and 13% respectively.
The highest increases in the incidence of regional and distant disease occurred in the lowest SES neighborhoods, nearly doubling in men (distant disease IRR, 1.87; 95% CI, 1.39-2.53; regional disease IRR, 1.93; 95% CI, 1.51-2.47). Women in these neighborhoods also experienced a significant increase in regional disease (IRR, 1.44; 95% CI, 1.00-2.08), but not distant disease.
Incidence of diagnosis with the thickest tumors (greater than 4 mm) rose significantly in most neighborhood SES quartiles, with the exception of the men in the lowest SES quartiles, who had a lower increase that was of borderline significance.
The results solidify the evidence that melanoma incidence is truly increasing, but they also have public health implications. The rising incidence of more advanced disease suggests a heightening health care burden from melanoma in the coming years, but also points to strategies for prevention, according to Dr. Swetter. “It’s important that we focus not only on primary prevention. We need methods to enhance early detection, especially in areas where there is lower access to dermatologists and even primary care providers, who can assist in this effort,” she said.
The Stanford Cancer Institute funded the study. Dr. Swetter reported having no financial disclosures.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Increased incidences of more advanced disease suggest a rising health care burden.
Major finding: Between 1998-2002 and 2008-2012, incidence rate ratios rose by 25% in men and 21% in women.
Data source: A retrospective study of over 58,000 melanoma cases.
Disclosures: The Stanford Cancer Institute funded the study. Dr. Swetter reported having no financial disclosures.
For acute gout, corticosteroids look safer than NSAIDs
For the treatment of acute gout, corticosteroids may be as effective as nonsteroidal anti-inflammatory drugs but with fewer side effects, based on findings from a meta-analysis of six randomized, controlled trials.
“There is insufficient information to determine the comparative efficacy of corticosteroids and NSAID[s] to treat acute gout, while corticosteroids appear to have a more favorable safety profile for selected [adverse events],” Christy A. Billy, MD, of the University of Sydney and her coauthors wrote in their report published online in the Journal of Rheumatology (J Rheumatol. 2017 Aug. doi: 10.3899/jrheum.170137).
Two previous systematic reviews also suggested that corticosteroids may be therapeutically equivalent to but safer than NSAIDs, but both were based on a very small number of available studies and suffered from statistical between-trial heterogeneity.
The meta-analysis of six trials included a total of 817 patients. The trials had a mean follow-up of 15 days. Two trials were in hospitalized patients, two involved patients in the emergency department, one included outpatients, and one did not disclose the location of clinical presentation. Mean age of participants ranged from 44 years to 65.9 years, and the proportion of men ranged from 70% to 100%.
With respect to pain scores, the researchers found no significant difference between corticosteroid and NSAIDs within 7 days of treatment based on moderate-quality evidence from two randomized, controlled trials (RCTs) involving 534 patients (standardized mean difference = –0.09; 95% confidence interval, –0.26 to 0.08). There was also no difference between the two on pain after 7 or more days based on low-quality evidence from two RCTs of 506 patients (SMD = 0.32; 95% CI, –0.27 to 0.92). There was no evidence of statistical heterogeneity in the short-term trials, but there was evidence of significant heterogeneity in trials measuring treatment effects for 7 days or longer (P = .01; I2 [heterogeneity] = 85%).
Two RCTs of 173 patients gave low-quality evidence to show no difference between corticosteroids and NSAIDs in the rate of treatment response in the short term (relative risk, 1.07; 95% CI, 0.80-1.44; moderate heterogeneity, P = .15, I2 = 53%). One long-term study of the rate of treatment response provided similar results. There were also no between-group differences in joint swelling, erythema, tenderness, or activity limitations.
The investigators discovered that patients who took corticosteroids had a lower risk of indigestion in three RCTs with 526 patients (RR, 0.50; 95% CI, 0.27-0.92), nausea in three RCTs of 566 patients (RR, 0.25; 95% CI, 0.11-0.54), and vomiting in two RCTs totaling 506 patients (RR, 0.11; 95% CI, 0.02-0.56).
Patients taking corticosteroids had a higher risk of rash in two RCTs of 506 patients (RR, 4.62; 95% CI, 1.34-15.97). There was statistically significant heterogeneity in summary effects of treatment for total adverse events across all six studies (P = .04; I2 = 56%).
This meta-analysis was limited by the small number of clinical trials available for inclusion, which prevented the estimate of a number of outcomes and subgroup analyses. There was also a high risk of bias in many of the studies. Only half of the studies confirmed the diagnosis of gout by the presence of monosodium urate crystals within joint spaces. No studies reported on the effects of treatment on kidney function or injury.
The authors disclosed no source of funding or financial relationships.
For the treatment of acute gout, corticosteroids may be as effective as nonsteroidal anti-inflammatory drugs but with fewer side effects, based on findings from a meta-analysis of six randomized, controlled trials.
“There is insufficient information to determine the comparative efficacy of corticosteroids and NSAID[s] to treat acute gout, while corticosteroids appear to have a more favorable safety profile for selected [adverse events],” Christy A. Billy, MD, of the University of Sydney and her coauthors wrote in their report published online in the Journal of Rheumatology (J Rheumatol. 2017 Aug. doi: 10.3899/jrheum.170137).
Two previous systematic reviews also suggested that corticosteroids may be therapeutically equivalent to but safer than NSAIDs, but both were based on a very small number of available studies and suffered from statistical between-trial heterogeneity.
The meta-analysis of six trials included a total of 817 patients. The trials had a mean follow-up of 15 days. Two trials were in hospitalized patients, two involved patients in the emergency department, one included outpatients, and one did not disclose the location of clinical presentation. Mean age of participants ranged from 44 years to 65.9 years, and the proportion of men ranged from 70% to 100%.
With respect to pain scores, the researchers found no significant difference between corticosteroid and NSAIDs within 7 days of treatment based on moderate-quality evidence from two randomized, controlled trials (RCTs) involving 534 patients (standardized mean difference = –0.09; 95% confidence interval, –0.26 to 0.08). There was also no difference between the two on pain after 7 or more days based on low-quality evidence from two RCTs of 506 patients (SMD = 0.32; 95% CI, –0.27 to 0.92). There was no evidence of statistical heterogeneity in the short-term trials, but there was evidence of significant heterogeneity in trials measuring treatment effects for 7 days or longer (P = .01; I2 [heterogeneity] = 85%).
Two RCTs of 173 patients gave low-quality evidence to show no difference between corticosteroids and NSAIDs in the rate of treatment response in the short term (relative risk, 1.07; 95% CI, 0.80-1.44; moderate heterogeneity, P = .15, I2 = 53%). One long-term study of the rate of treatment response provided similar results. There were also no between-group differences in joint swelling, erythema, tenderness, or activity limitations.
The investigators discovered that patients who took corticosteroids had a lower risk of indigestion in three RCTs with 526 patients (RR, 0.50; 95% CI, 0.27-0.92), nausea in three RCTs of 566 patients (RR, 0.25; 95% CI, 0.11-0.54), and vomiting in two RCTs totaling 506 patients (RR, 0.11; 95% CI, 0.02-0.56).
Patients taking corticosteroids had a higher risk of rash in two RCTs of 506 patients (RR, 4.62; 95% CI, 1.34-15.97). There was statistically significant heterogeneity in summary effects of treatment for total adverse events across all six studies (P = .04; I2 = 56%).
This meta-analysis was limited by the small number of clinical trials available for inclusion, which prevented the estimate of a number of outcomes and subgroup analyses. There was also a high risk of bias in many of the studies. Only half of the studies confirmed the diagnosis of gout by the presence of monosodium urate crystals within joint spaces. No studies reported on the effects of treatment on kidney function or injury.
The authors disclosed no source of funding or financial relationships.
For the treatment of acute gout, corticosteroids may be as effective as nonsteroidal anti-inflammatory drugs but with fewer side effects, based on findings from a meta-analysis of six randomized, controlled trials.
“There is insufficient information to determine the comparative efficacy of corticosteroids and NSAID[s] to treat acute gout, while corticosteroids appear to have a more favorable safety profile for selected [adverse events],” Christy A. Billy, MD, of the University of Sydney and her coauthors wrote in their report published online in the Journal of Rheumatology (J Rheumatol. 2017 Aug. doi: 10.3899/jrheum.170137).
Two previous systematic reviews also suggested that corticosteroids may be therapeutically equivalent to but safer than NSAIDs, but both were based on a very small number of available studies and suffered from statistical between-trial heterogeneity.
The meta-analysis of six trials included a total of 817 patients. The trials had a mean follow-up of 15 days. Two trials were in hospitalized patients, two involved patients in the emergency department, one included outpatients, and one did not disclose the location of clinical presentation. Mean age of participants ranged from 44 years to 65.9 years, and the proportion of men ranged from 70% to 100%.
With respect to pain scores, the researchers found no significant difference between corticosteroid and NSAIDs within 7 days of treatment based on moderate-quality evidence from two randomized, controlled trials (RCTs) involving 534 patients (standardized mean difference = –0.09; 95% confidence interval, –0.26 to 0.08). There was also no difference between the two on pain after 7 or more days based on low-quality evidence from two RCTs of 506 patients (SMD = 0.32; 95% CI, –0.27 to 0.92). There was no evidence of statistical heterogeneity in the short-term trials, but there was evidence of significant heterogeneity in trials measuring treatment effects for 7 days or longer (P = .01; I2 [heterogeneity] = 85%).
Two RCTs of 173 patients gave low-quality evidence to show no difference between corticosteroids and NSAIDs in the rate of treatment response in the short term (relative risk, 1.07; 95% CI, 0.80-1.44; moderate heterogeneity, P = .15, I2 = 53%). One long-term study of the rate of treatment response provided similar results. There were also no between-group differences in joint swelling, erythema, tenderness, or activity limitations.
The investigators discovered that patients who took corticosteroids had a lower risk of indigestion in three RCTs with 526 patients (RR, 0.50; 95% CI, 0.27-0.92), nausea in three RCTs of 566 patients (RR, 0.25; 95% CI, 0.11-0.54), and vomiting in two RCTs totaling 506 patients (RR, 0.11; 95% CI, 0.02-0.56).
Patients taking corticosteroids had a higher risk of rash in two RCTs of 506 patients (RR, 4.62; 95% CI, 1.34-15.97). There was statistically significant heterogeneity in summary effects of treatment for total adverse events across all six studies (P = .04; I2 = 56%).
This meta-analysis was limited by the small number of clinical trials available for inclusion, which prevented the estimate of a number of outcomes and subgroup analyses. There was also a high risk of bias in many of the studies. Only half of the studies confirmed the diagnosis of gout by the presence of monosodium urate crystals within joint spaces. No studies reported on the effects of treatment on kidney function or injury.
The authors disclosed no source of funding or financial relationships.
FROM JOURNAL OF RHEUMATOLOGY
Key clinical point: Corticosteroids had a similar efficacy but a better safety profile than NSAIDs.
Major finding: Corticosteroids had efficacy similar to NSAIDs in the treatment of acute gout.
Data source: Meta-analysis of six randomized, controlled trials (n = 817).
Disclosures: The authors disclosed no source of funding or financial relationships.
AADE: New standards for diabetes self-management programs
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
FROM DIABETES CARE