Doug Brunk

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

Last updated in 2006, the statement released last month is meant to serve as a guide for clinicians regarding the diagnosis, prevention, and treatment of postmenopausal osteoporosis. The statement can be accessed at www.menopause.org/aboutmeno/consensus.aspx

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations––not a lot of which are absolutely new––but it summarizes [the evidence] extremely well and deals with all the issues.”

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, who was a member of the 2008–2009 NAMS Board of Trustees and as such reviewed the position statement, said that FRAX was included in the statement because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; bone mineral density values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800–1,000 IU/day of vitamin D₃, up from the recommended dosage of 400–600 IU/day contained in the 2006 statement.

As for choosing a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

The development of this position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US.

Dr. Utian disclosed that he is a consultant or a member of the advisory board for Bionovo, Depomed, Duramed, Eli Lilly, KV Pharmaceuticals, Merck & Co., Novartis, Orcas Therapeutics, and QuatRx. Dr. Harris disclosed that he is a consultant or a member of the speakers bureau for Amgen, GlaxoSmithKline, Eli Lilly, Merck, Novartis, Procter & Gamble, Roche, Sanofi-Aventis, and Wyeth.

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

Last updated in 2006, the statement released last month is meant to serve as a guide for clinicians regarding the diagnosis, prevention, and treatment of postmenopausal osteoporosis. The statement can be accessed at www.menopause.org/aboutmeno/consensus.aspx

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations––not a lot of which are absolutely new––but it summarizes [the evidence] extremely well and deals with all the issues.”

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, who was a member of the 2008–2009 NAMS Board of Trustees and as such reviewed the position statement, said that FRAX was included in the statement because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; bone mineral density values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800–1,000 IU/day of vitamin D₃, up from the recommended dosage of 400–600 IU/day contained in the 2006 statement.

As for choosing a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

The development of this position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US.

Dr. Utian disclosed that he is a consultant or a member of the advisory board for Bionovo, Depomed, Duramed, Eli Lilly, KV Pharmaceuticals, Merck & Co., Novartis, Orcas Therapeutics, and QuatRx. Dr. Harris disclosed that he is a consultant or a member of the speakers bureau for Amgen, GlaxoSmithKline, Eli Lilly, Merck, Novartis, Procter & Gamble, Roche, Sanofi-Aventis, and Wyeth.

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

Last updated in 2006, the statement released last month is meant to serve as a guide for clinicians regarding the diagnosis, prevention, and treatment of postmenopausal osteoporosis. The statement can be accessed at www.menopause.org/aboutmeno/consensus.aspx

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations––not a lot of which are absolutely new––but it summarizes [the evidence] extremely well and deals with all the issues.”

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, who was a member of the 2008–2009 NAMS Board of Trustees and as such reviewed the position statement, said that FRAX was included in the statement because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; bone mineral density values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800–1,000 IU/day of vitamin D₃, up from the recommended dosage of 400–600 IU/day contained in the 2006 statement.

As for choosing a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

The development of this position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US.

Dr. Utian disclosed that he is a consultant or a member of the advisory board for Bionovo, Depomed, Duramed, Eli Lilly, KV Pharmaceuticals, Merck & Co., Novartis, Orcas Therapeutics, and QuatRx. Dr. Harris disclosed that he is a consultant or a member of the speakers bureau for Amgen, GlaxoSmithKline, Eli Lilly, Merck, Novartis, Procter & Gamble, Roche, Sanofi-Aventis, and Wyeth.

SAN FRANCISCO — A newly approved cream containing 5% acyclovir and 1% hydrocortisone prevented ulcerated lesions in patients with recurrent herpes simplex labialis, compared with both topical acyclovir and placebo, a large multicenter study showed.

The product, ME-609 (brand name not yet determined), is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten lesion healing time.

“This is the first product to prevent the development of cold sores,” Dr. Spotswood L. Spruance said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. “Other products have been shown to reduce the duration of the disease, but this has been shown to block the development of ulcers and blisters.”

ME-609 is not yet available in the United States because Medivir, the Swedish company that developed the agent, has not yet partnered with a company to distribute and market it. ME-609 should be available in the United States this year.

For the study, researchers led by Dr. Christopher M. Hull of the department of dermatology at the University of Utah, Salt Lake City, randomized 1,443 patients aged 18 years and older with at least three episodes of herpes simplex labialis to one of three treatment groups: ME-609 vehicle containing 5% acyclovir and 1% hydrocortisone (601 patients), acyclovir alone in ME-609 vehicle (610), or placebo (232). The patients were instructed to start treatment at home five times daily for 5 days at the earliest sign or symptom of their next recurrence of herpes simplex labialis, and to keep a diary of symptoms.

The mean age of patients was 44 years, and 28% were male.

The researchers collected safety and efficacy data from patient diaries and from daily clinical visits. The primary study end point was prevention of ulcerative lesions, defined as abortive episodes that did not progress beyond the papule stage.

Secondary end points included episode duration to loss of hard crust, lesion healing time to normal skin, maximum lesion area, and cumulative lesion area.

Dr. Spruance, of the division of infectious diseases at the University of Utah, reported that at the end of treatment, the proportion of patients with nonulcerative recurrences was 42% in the ME-609 group, compared with 35% for acyclovir and 26% for placebo.

Among patients who developed an ulcerative lesion despite treatment, the duration of lesions was reduced by ME-609 to a similar extent as acyclovir alone (5.7 days vs. 5.9 days, respectively); both were significantly shorter than placebo (6.5 days), he said at the meeting, which was sponsored by the American Society for Microbiology.

Lesion healing time was reduced by ME-609 to a similar extent as acyclovir alone (9.6 days vs. 9.9 days, respectively), with both significantly shorter than placebo (11 days).

Maximum lesion area was smallest in the ME-609 group, Dr. Spruance reported, but the differences compared with the other groups did not reach statistical significance. The cumulative lesion area, however, was reduced by half in the ME-609 group, compared with the placebo group, and the differences in cumulative lesion area between ME-609 and the other two groups were statistically significant. The frequency and nature of adverse events was similar between the groups.

Disclosures: Medivir funded the study. Dr. Spruance disclosed that he is a paid consultant for the company.

ME-609 'has been shown to block the development of ulcers and blisters.'

Source DR. SPRUANCE

SAN FRANCISCO — A newly approved cream containing 5% acyclovir and 1% hydrocortisone prevented ulcerated lesions in patients with recurrent herpes simplex labialis, compared with both topical acyclovir and placebo, a large multicenter study showed.

The product, ME-609 (brand name not yet determined), is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten lesion healing time.

“This is the first product to prevent the development of cold sores,” Dr. Spotswood L. Spruance said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. “Other products have been shown to reduce the duration of the disease, but this has been shown to block the development of ulcers and blisters.”

ME-609 is not yet available in the United States because Medivir, the Swedish company that developed the agent, has not yet partnered with a company to distribute and market it. ME-609 should be available in the United States this year.

For the study, researchers led by Dr. Christopher M. Hull of the department of dermatology at the University of Utah, Salt Lake City, randomized 1,443 patients aged 18 years and older with at least three episodes of herpes simplex labialis to one of three treatment groups: ME-609 vehicle containing 5% acyclovir and 1% hydrocortisone (601 patients), acyclovir alone in ME-609 vehicle (610), or placebo (232). The patients were instructed to start treatment at home five times daily for 5 days at the earliest sign or symptom of their next recurrence of herpes simplex labialis, and to keep a diary of symptoms.

The mean age of patients was 44 years, and 28% were male.

The researchers collected safety and efficacy data from patient diaries and from daily clinical visits. The primary study end point was prevention of ulcerative lesions, defined as abortive episodes that did not progress beyond the papule stage.

Secondary end points included episode duration to loss of hard crust, lesion healing time to normal skin, maximum lesion area, and cumulative lesion area.

Dr. Spruance, of the division of infectious diseases at the University of Utah, reported that at the end of treatment, the proportion of patients with nonulcerative recurrences was 42% in the ME-609 group, compared with 35% for acyclovir and 26% for placebo.

Among patients who developed an ulcerative lesion despite treatment, the duration of lesions was reduced by ME-609 to a similar extent as acyclovir alone (5.7 days vs. 5.9 days, respectively); both were significantly shorter than placebo (6.5 days), he said at the meeting, which was sponsored by the American Society for Microbiology.

Lesion healing time was reduced by ME-609 to a similar extent as acyclovir alone (9.6 days vs. 9.9 days, respectively), with both significantly shorter than placebo (11 days).

Maximum lesion area was smallest in the ME-609 group, Dr. Spruance reported, but the differences compared with the other groups did not reach statistical significance. The cumulative lesion area, however, was reduced by half in the ME-609 group, compared with the placebo group, and the differences in cumulative lesion area between ME-609 and the other two groups were statistically significant. The frequency and nature of adverse events was similar between the groups.

Disclosures: Medivir funded the study. Dr. Spruance disclosed that he is a paid consultant for the company.

ME-609 'has been shown to block the development of ulcers and blisters.'

Source DR. SPRUANCE

SAN FRANCISCO — A newly approved cream containing 5% acyclovir and 1% hydrocortisone prevented ulcerated lesions in patients with recurrent herpes simplex labialis, compared with both topical acyclovir and placebo, a large multicenter study showed.

The product, ME-609 (brand name not yet determined), is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten lesion healing time.

“This is the first product to prevent the development of cold sores,” Dr. Spotswood L. Spruance said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. “Other products have been shown to reduce the duration of the disease, but this has been shown to block the development of ulcers and blisters.”

ME-609 is not yet available in the United States because Medivir, the Swedish company that developed the agent, has not yet partnered with a company to distribute and market it. ME-609 should be available in the United States this year.

For the study, researchers led by Dr. Christopher M. Hull of the department of dermatology at the University of Utah, Salt Lake City, randomized 1,443 patients aged 18 years and older with at least three episodes of herpes simplex labialis to one of three treatment groups: ME-609 vehicle containing 5% acyclovir and 1% hydrocortisone (601 patients), acyclovir alone in ME-609 vehicle (610), or placebo (232). The patients were instructed to start treatment at home five times daily for 5 days at the earliest sign or symptom of their next recurrence of herpes simplex labialis, and to keep a diary of symptoms.

The mean age of patients was 44 years, and 28% were male.

The researchers collected safety and efficacy data from patient diaries and from daily clinical visits. The primary study end point was prevention of ulcerative lesions, defined as abortive episodes that did not progress beyond the papule stage.

Secondary end points included episode duration to loss of hard crust, lesion healing time to normal skin, maximum lesion area, and cumulative lesion area.

Dr. Spruance, of the division of infectious diseases at the University of Utah, reported that at the end of treatment, the proportion of patients with nonulcerative recurrences was 42% in the ME-609 group, compared with 35% for acyclovir and 26% for placebo.

Among patients who developed an ulcerative lesion despite treatment, the duration of lesions was reduced by ME-609 to a similar extent as acyclovir alone (5.7 days vs. 5.9 days, respectively); both were significantly shorter than placebo (6.5 days), he said at the meeting, which was sponsored by the American Society for Microbiology.

Lesion healing time was reduced by ME-609 to a similar extent as acyclovir alone (9.6 days vs. 9.9 days, respectively), with both significantly shorter than placebo (11 days).

Maximum lesion area was smallest in the ME-609 group, Dr. Spruance reported, but the differences compared with the other groups did not reach statistical significance. The cumulative lesion area, however, was reduced by half in the ME-609 group, compared with the placebo group, and the differences in cumulative lesion area between ME-609 and the other two groups were statistically significant. The frequency and nature of adverse events was similar between the groups.

Disclosures: Medivir funded the study. Dr. Spruance disclosed that he is a paid consultant for the company.

ME-609 'has been shown to block the development of ulcers and blisters.'

Source DR. SPRUANCE

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations—not a lot of which are absolutely new—but it summarizes [the evidence] extremely well and deals with all the issues.”

The 2010 edition of the NAMS statement, which was last updated in 2006, is available for free at www.menopause.org/aboutmeno/consensus.aspx

The statement recommends the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture. FRAX integrates the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful,” Dr. Steven T. Harris, a member of the editorial board that updated the position statement, said in an interview.

Dr. Utian, who reviewed the position statement as a member of the 2008-2009 NAMS board of trustees, said that FRAX was endorsed because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

The statement says drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture, bone mineral density consistent with osteoporosis (a T score of −2.5 or lower), or a T score from −1.0 to −2.5 plus a 10-year FRAX risk of at least 20% for a major osteoporotic fracture (hip, shoulder, wrist, and spine) or of at least 3% for a hip fracture.

Another new recommendation calls for postmenopausal women to obtain 800-1,000 IU/day of vitamin D₃, up from 400-600 IU/day in the 2006 statement. “Even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency,” said Dr. Harris of the University of California, San Francisco.

As for choice of osteoporosis therapy, the statement notes that no head-to-head trials have compared the effectiveness of medications in reducing fracture risk. Approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain.”

The statement notes that calcitonin “is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its [bone mineral density] effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause.”

Dr. Utian said that “we have a number of valuable therapies. Most of them are bone sparing, but gradually we're beginning to see the development of bone-developing therapies. Currently, prevention is a lot more effective than attempts at cure.”

Disclosures: The development of the position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.

'Currently, prevention is a lot more effective than attempts at cure.'

Source DR. UTIAN

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations—not a lot of which are absolutely new—but it summarizes [the evidence] extremely well and deals with all the issues.”

The 2010 edition of the NAMS statement, which was last updated in 2006, is available for free at www.menopause.org/aboutmeno/consensus.aspx

The statement recommends the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture. FRAX integrates the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful,” Dr. Steven T. Harris, a member of the editorial board that updated the position statement, said in an interview.

Dr. Utian, who reviewed the position statement as a member of the 2008-2009 NAMS board of trustees, said that FRAX was endorsed because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

The statement says drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture, bone mineral density consistent with osteoporosis (a T score of −2.5 or lower), or a T score from −1.0 to −2.5 plus a 10-year FRAX risk of at least 20% for a major osteoporotic fracture (hip, shoulder, wrist, and spine) or of at least 3% for a hip fracture.

Another new recommendation calls for postmenopausal women to obtain 800-1,000 IU/day of vitamin D₃, up from 400-600 IU/day in the 2006 statement. “Even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency,” said Dr. Harris of the University of California, San Francisco.

As for choice of osteoporosis therapy, the statement notes that no head-to-head trials have compared the effectiveness of medications in reducing fracture risk. Approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain.”

The statement notes that calcitonin “is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its [bone mineral density] effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause.”

Dr. Utian said that “we have a number of valuable therapies. Most of them are bone sparing, but gradually we're beginning to see the development of bone-developing therapies. Currently, prevention is a lot more effective than attempts at cure.”

Disclosures: The development of the position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.

'Currently, prevention is a lot more effective than attempts at cure.'

Source DR. UTIAN

The North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women includes the FRAX tool to calculate the risk of major osteoporotic fracture and recommends increasing vitamin D₃ intake.

“It's the most current and practice-oriented, evidence-based statement that's out at the moment,” Dr. Wulf H. Utian, honorary founding president and executive director emeritus of NAMS, said in an interview. “It's taken all of the current evidence into account and has come out with some key recommendations—not a lot of which are absolutely new—but it summarizes [the evidence] extremely well and deals with all the issues.”

The 2010 edition of the NAMS statement, which was last updated in 2006, is available for free at www.menopause.org/aboutmeno/consensus.aspx

The statement recommends the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture. FRAX integrates the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck.

“It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful,” Dr. Steven T. Harris, a member of the editorial board that updated the position statement, said in an interview.

Dr. Utian, who reviewed the position statement as a member of the 2008-2009 NAMS board of trustees, said that FRAX was endorsed because clinicians have come to realize “some of the limitations of DXA [dual-energy x-ray absorptiometry] and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

The statement says drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture, bone mineral density consistent with osteoporosis (a T score of −2.5 or lower), or a T score from −1.0 to −2.5 plus a 10-year FRAX risk of at least 20% for a major osteoporotic fracture (hip, shoulder, wrist, and spine) or of at least 3% for a hip fracture.

Another new recommendation calls for postmenopausal women to obtain 800-1,000 IU/day of vitamin D₃, up from 400-600 IU/day in the 2006 statement. “Even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency,” said Dr. Harris of the University of California, San Francisco.

As for choice of osteoporosis therapy, the statement notes that no head-to-head trials have compared the effectiveness of medications in reducing fracture risk. Approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain.”

The statement notes that calcitonin “is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its [bone mineral density] effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause.”

Dr. Utian said that “we have a number of valuable therapies. Most of them are bone sparing, but gradually we're beginning to see the development of bone-developing therapies. Currently, prevention is a lot more effective than attempts at cure.”

Disclosures: The development of the position statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.

'Currently, prevention is a lot more effective than attempts at cure.'

Source DR. UTIAN

SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

SAN DIEGO — Data on the estimated incidence of melanoma in the United States in 2010 from the National Cancer Institute's Surveillance, Epidemiology and End Results program will not be available until later this year, but Dr. Darrell S. Rigel does not expect the news to be good.

"Melanoma rates are rising significantly in the United States and in other parts of the world," he said at a melanoma update sponsored by the Scripps Clinic.

"Whatever criteria you use, it's clear that we're seeing more melanomas than we've seen in the past, and we'll probably continue to do so in the next 5-10 years."

According to the most recent SEER data, in 2009 there were 68,720 newly diagnosed cases of invasive melanoma and 53,120 cases of in situ melanoma. Dr. Rigel and his associates at the New York University Interdisciplinary Melanoma Cooperative Group estimate that the projected lifetime risk of invasive melanoma was 1:58 in 2009, up from 1:65 in 2004.

"Should that rate of increase continue, the risk will be about 1:50 by the year 2015," said Dr. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center. "We've been pretty close on these projections over the last few years. One in 50 is a lot. That's 2% of the population."

Factor in the incidence of in situ melanoma, and the risk of any American getting any kind of melanoma jumps to 1:30, which would be 121,840 total cases in 2009.

"It's a significant problem," he said.

Nine years ago, researchers who analyzed the melanoma incidence rates in the United States from 1960-1997 forecasted a subsequent growing incidence of melanoma. They concluded that the increase in melanoma incidence is real - "not due to improved diagnosis," Dr. Rigel said - and predicted that the incidence would continue to rise for the next decade or more (J. Natl. Cancer Inst. 2001;93:67-83).

Results from studies published in the past decade suggest that the incidence of melanoma is also rising in other parts of the world. In Finland, for example, the incidence of melanoma increased from 1.5 cases to 12.8 cases per 100,000 men between 1953 and 2003, and from 1.8 cases to 10.4 cases per 100,000 women during the same time period (Int. J. Cancer 2006;119:380-4).

In central Greece, the incidence increased from 1.4 cases to 5.2 cases per 100,000 people between 1988 and 1998 (Int. J. Tissue React. 2005;27:173-9). Melanomas were most frequently located on the head and neck, extremities, and trunk.

In Columbia, the incidence of melanoma increased from 2.7 cases to 13 cases per 100,000 people between 2003 and 2005 (Rev. Salud Pública 2007;9:595-601).

Dr. Rigel emphasized that results from the best available studies in the medical literature suggest that the rising incidence of melanoma cannot be explained by increased surveillance, awareness, or by changing histologic criteria. However, while the number of melanoma deaths continues to rise, 5-year survival rates are improving - from 86% between 1985 and 1989 to 92% between 1995 and 2002 (Cancer J. Clin. 2007;57:43-66).

"That seems incongruous," Dr. Rigel said. "The only way that can be happening mathematically is that the incidence has to be rising even faster. That's a compelling reason to explain why the rising incidence is real. According to the World Health Organization, melanoma is rising faster than any other cancer worldwide, on a percentage basis."

He went on to note that the current incidence of melanoma is probably underreported because data from SEER are collected primarily from hospitals.
"The biopsy may be done in an outpatient setting," he explained. "It may go to an outpatient lab; it may be re-excised, and then it may go back to the same lab. It may never hit a hospital. That's why melanoma probably is significantly undercounted."

According to the American Cancer Society, melanoma kills one American citizen per hour. "Some people pooh-pooh skin cancer," Dr. Rigel said. "It's the most common cancer in women aged 25-29, and it's the number one cancer killer in women aged 30-35. There are some subsets of the population that are particularly hurt by this disease."

Dr. Rigel disclosed that he receives grants and advising and consulting fees from a number of pharmaceutical companies, including Neutrogena, Johnson & Johnson, Procter & Gamble, and Beiersdorf.

SAN DIEGO — Data on the estimated incidence of melanoma in the United States in 2010 from the National Cancer Institute's Surveillance, Epidemiology and End Results program will not be available until later this year, but Dr. Darrell S. Rigel does not expect the news to be good.

"Melanoma rates are rising significantly in the United States and in other parts of the world," he said at a melanoma update sponsored by the Scripps Clinic.

"Whatever criteria you use, it's clear that we're seeing more melanomas than we've seen in the past, and we'll probably continue to do so in the next 5-10 years."

According to the most recent SEER data, in 2009 there were 68,720 newly diagnosed cases of invasive melanoma and 53,120 cases of in situ melanoma. Dr. Rigel and his associates at the New York University Interdisciplinary Melanoma Cooperative Group estimate that the projected lifetime risk of invasive melanoma was 1:58 in 2009, up from 1:65 in 2004.

"Should that rate of increase continue, the risk will be about 1:50 by the year 2015," said Dr. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center. "We've been pretty close on these projections over the last few years. One in 50 is a lot. That's 2% of the population."

Factor in the incidence of in situ melanoma, and the risk of any American getting any kind of melanoma jumps to 1:30, which would be 121,840 total cases in 2009.

"It's a significant problem," he said.

Nine years ago, researchers who analyzed the melanoma incidence rates in the United States from 1960-1997 forecasted a subsequent growing incidence of melanoma. They concluded that the increase in melanoma incidence is real - "not due to improved diagnosis," Dr. Rigel said - and predicted that the incidence would continue to rise for the next decade or more (J. Natl. Cancer Inst. 2001;93:67-83).

Results from studies published in the past decade suggest that the incidence of melanoma is also rising in other parts of the world. In Finland, for example, the incidence of melanoma increased from 1.5 cases to 12.8 cases per 100,000 men between 1953 and 2003, and from 1.8 cases to 10.4 cases per 100,000 women during the same time period (Int. J. Cancer 2006;119:380-4).

In central Greece, the incidence increased from 1.4 cases to 5.2 cases per 100,000 people between 1988 and 1998 (Int. J. Tissue React. 2005;27:173-9). Melanomas were most frequently located on the head and neck, extremities, and trunk.

In Columbia, the incidence of melanoma increased from 2.7 cases to 13 cases per 100,000 people between 2003 and 2005 (Rev. Salud Pública 2007;9:595-601).

Dr. Rigel emphasized that results from the best available studies in the medical literature suggest that the rising incidence of melanoma cannot be explained by increased surveillance, awareness, or by changing histologic criteria. However, while the number of melanoma deaths continues to rise, 5-year survival rates are improving - from 86% between 1985 and 1989 to 92% between 1995 and 2002 (Cancer J. Clin. 2007;57:43-66).

"That seems incongruous," Dr. Rigel said. "The only way that can be happening mathematically is that the incidence has to be rising even faster. That's a compelling reason to explain why the rising incidence is real. According to the World Health Organization, melanoma is rising faster than any other cancer worldwide, on a percentage basis."

He went on to note that the current incidence of melanoma is probably underreported because data from SEER are collected primarily from hospitals.
"The biopsy may be done in an outpatient setting," he explained. "It may go to an outpatient lab; it may be re-excised, and then it may go back to the same lab. It may never hit a hospital. That's why melanoma probably is significantly undercounted."

According to the American Cancer Society, melanoma kills one American citizen per hour. "Some people pooh-pooh skin cancer," Dr. Rigel said. "It's the most common cancer in women aged 25-29, and it's the number one cancer killer in women aged 30-35. There are some subsets of the population that are particularly hurt by this disease."

Dr. Rigel disclosed that he receives grants and advising and consulting fees from a number of pharmaceutical companies, including Neutrogena, Johnson & Johnson, Procter & Gamble, and Beiersdorf.

SAN DIEGO — Data on the estimated incidence of melanoma in the United States in 2010 from the National Cancer Institute's Surveillance, Epidemiology and End Results program will not be available until later this year, but Dr. Darrell S. Rigel does not expect the news to be good.

"Melanoma rates are rising significantly in the United States and in other parts of the world," he said at a melanoma update sponsored by the Scripps Clinic.

"Whatever criteria you use, it's clear that we're seeing more melanomas than we've seen in the past, and we'll probably continue to do so in the next 5-10 years."

According to the most recent SEER data, in 2009 there were 68,720 newly diagnosed cases of invasive melanoma and 53,120 cases of in situ melanoma. Dr. Rigel and his associates at the New York University Interdisciplinary Melanoma Cooperative Group estimate that the projected lifetime risk of invasive melanoma was 1:58 in 2009, up from 1:65 in 2004.

"Should that rate of increase continue, the risk will be about 1:50 by the year 2015," said Dr. Rigel, who is a professor of dermatology and dermatologic surgery at New York University Medical Center. "We've been pretty close on these projections over the last few years. One in 50 is a lot. That's 2% of the population."

Factor in the incidence of in situ melanoma, and the risk of any American getting any kind of melanoma jumps to 1:30, which would be 121,840 total cases in 2009.

"It's a significant problem," he said.

Nine years ago, researchers who analyzed the melanoma incidence rates in the United States from 1960-1997 forecasted a subsequent growing incidence of melanoma. They concluded that the increase in melanoma incidence is real - "not due to improved diagnosis," Dr. Rigel said - and predicted that the incidence would continue to rise for the next decade or more (J. Natl. Cancer Inst. 2001;93:67-83).

Results from studies published in the past decade suggest that the incidence of melanoma is also rising in other parts of the world. In Finland, for example, the incidence of melanoma increased from 1.5 cases to 12.8 cases per 100,000 men between 1953 and 2003, and from 1.8 cases to 10.4 cases per 100,000 women during the same time period (Int. J. Cancer 2006;119:380-4).

In central Greece, the incidence increased from 1.4 cases to 5.2 cases per 100,000 people between 1988 and 1998 (Int. J. Tissue React. 2005;27:173-9). Melanomas were most frequently located on the head and neck, extremities, and trunk.

In Columbia, the incidence of melanoma increased from 2.7 cases to 13 cases per 100,000 people between 2003 and 2005 (Rev. Salud Pública 2007;9:595-601).

Dr. Rigel emphasized that results from the best available studies in the medical literature suggest that the rising incidence of melanoma cannot be explained by increased surveillance, awareness, or by changing histologic criteria. However, while the number of melanoma deaths continues to rise, 5-year survival rates are improving - from 86% between 1985 and 1989 to 92% between 1995 and 2002 (Cancer J. Clin. 2007;57:43-66).

"That seems incongruous," Dr. Rigel said. "The only way that can be happening mathematically is that the incidence has to be rising even faster. That's a compelling reason to explain why the rising incidence is real. According to the World Health Organization, melanoma is rising faster than any other cancer worldwide, on a percentage basis."

He went on to note that the current incidence of melanoma is probably underreported because data from SEER are collected primarily from hospitals.
"The biopsy may be done in an outpatient setting," he explained. "It may go to an outpatient lab; it may be re-excised, and then it may go back to the same lab. It may never hit a hospital. That's why melanoma probably is significantly undercounted."

According to the American Cancer Society, melanoma kills one American citizen per hour. "Some people pooh-pooh skin cancer," Dr. Rigel said. "It's the most common cancer in women aged 25-29, and it's the number one cancer killer in women aged 30-35. There are some subsets of the population that are particularly hurt by this disease."

Dr. Rigel disclosed that he receives grants and advising and consulting fees from a number of pharmaceutical companies, including Neutrogena, Johnson & Johnson, Procter & Gamble, and Beiersdorf.

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate-to-severe psoriasis.

The findings "are generally consistent with those of previous studies," researchers led by Dr. Christopher E.M. Griffiths reported in the Jan. 14 issue of the New England Journal of Medicine. "The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance."

For this phase III study, known as the Active Comparator (CNTO 1275/Enbrel) Psoriasis Trial (ACCEPT), 903 patients with moderate-to-severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)-alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12. A secondary end point was the proportion of patients with cleared or minimal disease according to the physician's global assessment score (N. Engl. J. Med. 2010;362:1,118-28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% of those in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% of those in the etanercept arm.

As for safety, the proportion of patients who had at least one adverse event during the study was similar between groups (66% in the 45-mg ustekinumab arm, 69% of patients in the 90-mg ustekinumab arm, and 70% in the etanercept arm).

Dr. Griffith of the Manchester (England) Academic Health Science Centre and his associates wrote that the study findings "could have implications for determining the optimal approach to the treatment of psoriasis and, in particular, the need for therapeutic strategies targeting Th1 cells, Th17 cells, or both to provide optimal benefit and safety."

The study was supported by Centocor Research and Development.

The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

Dr. Andrew Blauvelt, professor of dermatology and molecular microbiology & immunology at Oregon Health and Science University, Portland, spoke about this trial in an interview. "This is the first study to directly compare two biologic agents head-to-head for the treatment of moderate-to-severe psoriasis. This kind of direct comparison has been greatly needed in the psoriasis field. Until this point, we have been assuming that ustekinumab was better than etanercept for patients with moderate-to-severe psoriasis based upon individual clinical trials. Even though people had a hunch that etanercept would not perform as well as ustekinumab, this study now provides proof of that assumption.

The overall findings are not surprising at all. The treatment response rates for both agents are similar to the numbers that have been reported in previous clinical trials of each individual agent.

It's hard to say what the direct impact of this particular clinical trial will be. In situations where insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab, without requiring prior use of etanercept.

Taking into consideration whether a patient has psoriatic arthritis or not should also be determined before making the decision between etanercept and ustekinumab, because etanercept is approved for psoriatic arthritis and ustekinumab is not.

Clinicians who provide care to patients with moderate-to-severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known about ustekinumab's long-term effects."

Dr. Blauvent is also the psoriasis research director of OHSU's Center of Excellence for Psoriasis and Psoriatic Arthritis. He is an investigator for an earlier ustekinumab trial (PHOENIX 2). He has previously acted as a scientific advisor for Amgen Wyeth and Centocor, but was not involved with ACCEPT.

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate-to-severe psoriasis.

The findings "are generally consistent with those of previous studies," researchers led by Dr. Christopher E.M. Griffiths reported in the Jan. 14 issue of the New England Journal of Medicine. "The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance."

For this phase III study, known as the Active Comparator (CNTO 1275/Enbrel) Psoriasis Trial (ACCEPT), 903 patients with moderate-to-severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)-alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12. A secondary end point was the proportion of patients with cleared or minimal disease according to the physician's global assessment score (N. Engl. J. Med. 2010;362:1,118-28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% of those in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% of those in the etanercept arm.

As for safety, the proportion of patients who had at least one adverse event during the study was similar between groups (66% in the 45-mg ustekinumab arm, 69% of patients in the 90-mg ustekinumab arm, and 70% in the etanercept arm).

Dr. Griffith of the Manchester (England) Academic Health Science Centre and his associates wrote that the study findings "could have implications for determining the optimal approach to the treatment of psoriasis and, in particular, the need for therapeutic strategies targeting Th1 cells, Th17 cells, or both to provide optimal benefit and safety."

The study was supported by Centocor Research and Development.

The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

Dr. Andrew Blauvelt, professor of dermatology and molecular microbiology & immunology at Oregon Health and Science University, Portland, spoke about this trial in an interview. "This is the first study to directly compare two biologic agents head-to-head for the treatment of moderate-to-severe psoriasis. This kind of direct comparison has been greatly needed in the psoriasis field. Until this point, we have been assuming that ustekinumab was better than etanercept for patients with moderate-to-severe psoriasis based upon individual clinical trials. Even though people had a hunch that etanercept would not perform as well as ustekinumab, this study now provides proof of that assumption.

The overall findings are not surprising at all. The treatment response rates for both agents are similar to the numbers that have been reported in previous clinical trials of each individual agent.

It's hard to say what the direct impact of this particular clinical trial will be. In situations where insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab, without requiring prior use of etanercept.

Taking into consideration whether a patient has psoriatic arthritis or not should also be determined before making the decision between etanercept and ustekinumab, because etanercept is approved for psoriatic arthritis and ustekinumab is not.

Clinicians who provide care to patients with moderate-to-severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known about ustekinumab's long-term effects."

Dr. Blauvent is also the psoriasis research director of OHSU's Center of Excellence for Psoriasis and Psoriatic Arthritis. He is an investigator for an earlier ustekinumab trial (PHOENIX 2). He has previously acted as a scientific advisor for Amgen Wyeth and Centocor, but was not involved with ACCEPT.

Ustekinumab at a dose of 45 or 90 mg at baseline and again at week 4 was more effective than a 50-mg dose of etanercept twice weekly in a 12-week randomized study of patients with moderate-to-severe psoriasis.

The findings "are generally consistent with those of previous studies," researchers led by Dr. Christopher E.M. Griffiths reported in the Jan. 14 issue of the New England Journal of Medicine. "The high level of efficacy of ustekinumab treatment that we observed was achieved with only two injections during the 12-week period, as compared with twice-weekly injections of etanercept, which may be important for improved treatment compliance."

For this phase III study, known as the Active Comparator (CNTO 1275/Enbrel) Psoriasis Trial (ACCEPT), 903 patients with moderate-to-severe arthritis were randomly assigned to one of three treatment groups: 45 mg ustekinumab at baseline and week 4 (209 patients), 90 mg of ustekinumab at baseline and week 4 (347 patients), or 50 mg etanercept twice weekly for 12 weeks (347 patients).

Ustekinumab (marketed as Stelara by Centocor Ortho Biotech Services) blocks interleukin-12 and interleukin-23 while etanercept (marketed as Enbrel by Amgen and Wyeth) blocks tumor necrosis factor (TNF)-alpha.

The primary end point was the proportion of patients who achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12. A secondary end point was the proportion of patients with cleared or minimal disease according to the physician's global assessment score (N. Engl. J. Med. 2010;362:1,118-28).

A total of 68% of patients in the 45-mg ustekinumab arm and 74% of those in the 90-mg ustekinumab arm achieved at least a 75% in the PASI score at week 12, compared with 57% of those in the etanercept arm.

Similarly, 65% of patients in the 45-mg ustekinumab arm and 71% of those in the 90-mg ustekinumab arm had cleared or minimal disease based on the physician's global assessment score, compared with 49% of those in the etanercept arm.

As for safety, the proportion of patients who had at least one adverse event during the study was similar between groups (66% in the 45-mg ustekinumab arm, 69% of patients in the 90-mg ustekinumab arm, and 70% in the etanercept arm).

Dr. Griffith of the Manchester (England) Academic Health Science Centre and his associates wrote that the study findings "could have implications for determining the optimal approach to the treatment of psoriasis and, in particular, the need for therapeutic strategies targeting Th1 cells, Th17 cells, or both to provide optimal benefit and safety."

The study was supported by Centocor Research and Development.

The investigators disclosed conflicts with a number of pharmaceutical companies, including Centocor, Amgen, and Wyeth.

Dr. Andrew Blauvelt, professor of dermatology and molecular microbiology & immunology at Oregon Health and Science University, Portland, spoke about this trial in an interview. "This is the first study to directly compare two biologic agents head-to-head for the treatment of moderate-to-severe psoriasis. This kind of direct comparison has been greatly needed in the psoriasis field. Until this point, we have been assuming that ustekinumab was better than etanercept for patients with moderate-to-severe psoriasis based upon individual clinical trials. Even though people had a hunch that etanercept would not perform as well as ustekinumab, this study now provides proof of that assumption.

The overall findings are not surprising at all. The treatment response rates for both agents are similar to the numbers that have been reported in previous clinical trials of each individual agent.

It's hard to say what the direct impact of this particular clinical trial will be. In situations where insurance companies have a tiered approval process whereby etanercept failure is a condition for ustekinumab use, this study is unlikely to change that requirement. For insurance companies that do not have a tiered approval process, this study could logically lead to treatment guidelines that support initial use of ustekinumab, without requiring prior use of etanercept.

Taking into consideration whether a patient has psoriatic arthritis or not should also be determined before making the decision between etanercept and ustekinumab, because etanercept is approved for psoriatic arthritis and ustekinumab is not.

Clinicians who provide care to patients with moderate-to-severe psoriasis have cautious optimism for ustekinumab in terms of its long-term safety profile. However, we really don't know for sure what that long-term safety profile is going to be. Accordingly, some of my colleagues will argue for the use of etanercept over ustekinumab from a safety point of view until more is known about ustekinumab's long-term effects."

Dr. Blauvent is also the psoriasis research director of OHSU's Center of Excellence for Psoriasis and Psoriatic Arthritis. He is an investigator for an earlier ustekinumab trial (PHOENIX 2). He has previously acted as a scientific advisor for Amgen Wyeth and Centocor, but was not involved with ACCEPT.

SAN DIEGO — Women who underwent bilateral oophorectomy at the time of hysterectomy reported significantly decreased levels of sexual functioning compared with women who underwent hysterectomy with ovarian conservation, results from a survey of 50 women showed.

The findings underscore the potential impact of prophylactic ovary removal on women's sexual functioning, Elizabeth Plourde, Ph.D., said in an interview during a poster session at the annual meeting of the North American Menopause Society.

“The potential for loss of ability to respond sexually is a very important consideration for women who are being advised to do prophylactic oophorectomy,” said Dr. Plourde, a psychologist in Irvine, Calif., with research interests in the biochemical and structural changes that arise from reproductive organ removal.

“They're not really being apprised of the significance,” she added.

Dr. Plourde and her associates asked 25 women who underwent hysterectomy with ovarian conservation and 25 women who underwent bilateral oophorohysterectomy to complete the Changes in Sexual Functioning Questionnaire–Female (CSFQ-F) and the Sexual Response Questionnaire–Hysterectomy (SRQ-H).

The latter measure was designed for the study to compare the changes in sexual response before and after surgery.

The mean age of the questionnaire respondents was 49 years.

Only women who had functioning ovaries, based on their responses to survey questions about menopause symptoms, were retained for the hysterectomy-only group, Dr. Plourde said.

Compared with women who underwent a hysterectomy with ovarian conservation, those who underwent bilateral oophorectomy at the time of hysterectomy had significantly lower scores in total sexual functioning and in the subscale aspects of pleasure, desire/frequency and desire/interest; the number who were orgasmic was also lower among those who had bilateral oophorectomy.

Significant interactions favoring the hysterectomy with ovarian conservation group were also detected before and after surgery in total sexual functioning scores as well as in the subscales of pleasure, desire/frequency, desire/interest, and orgasm/completion.

“I redid all of the calculations to make sure that they were right, because the degree of significance between the two groups surprised me,” Dr. Plourde commented.

There were no statistically significant differences between the two groups of women in the rating of the importance of sex before and after surgery.

“The complexity and multifaceted nature of the human sexual response is demonstrated by the fact that not all the women who had their ovaries removed lost their interest in sex or ability to respond sexually, and not all of the women who retained their ovaries maintained their sexual functioning,” Dr. Plourde and her associates indicated in their poster.

“These conflicting results indicate there are other factors that influence sexual functioning and need further research,” Dr. Plourde noted.

She acknowledged that the small sample size was a limitation of the study.

Dr. Plourde disclosed no conflicts of interest.

To see an interview with Dr. Plourde, go to www.youtube.com/user/ClinicalEndoNews

Women are 'not really being apprised of the significance' before undergoing oophorectomy.

Source DR. PLOURDE

SAN DIEGO — Women who underwent bilateral oophorectomy at the time of hysterectomy reported significantly decreased levels of sexual functioning compared with women who underwent hysterectomy with ovarian conservation, results from a survey of 50 women showed.

The findings underscore the potential impact of prophylactic ovary removal on women's sexual functioning, Elizabeth Plourde, Ph.D., said in an interview during a poster session at the annual meeting of the North American Menopause Society.

“The potential for loss of ability to respond sexually is a very important consideration for women who are being advised to do prophylactic oophorectomy,” said Dr. Plourde, a psychologist in Irvine, Calif., with research interests in the biochemical and structural changes that arise from reproductive organ removal.

“They're not really being apprised of the significance,” she added.

Dr. Plourde and her associates asked 25 women who underwent hysterectomy with ovarian conservation and 25 women who underwent bilateral oophorohysterectomy to complete the Changes in Sexual Functioning Questionnaire–Female (CSFQ-F) and the Sexual Response Questionnaire–Hysterectomy (SRQ-H).

The latter measure was designed for the study to compare the changes in sexual response before and after surgery.

The mean age of the questionnaire respondents was 49 years.

Only women who had functioning ovaries, based on their responses to survey questions about menopause symptoms, were retained for the hysterectomy-only group, Dr. Plourde said.

Compared with women who underwent a hysterectomy with ovarian conservation, those who underwent bilateral oophorectomy at the time of hysterectomy had significantly lower scores in total sexual functioning and in the subscale aspects of pleasure, desire/frequency and desire/interest; the number who were orgasmic was also lower among those who had bilateral oophorectomy.

Significant interactions favoring the hysterectomy with ovarian conservation group were also detected before and after surgery in total sexual functioning scores as well as in the subscales of pleasure, desire/frequency, desire/interest, and orgasm/completion.

“I redid all of the calculations to make sure that they were right, because the degree of significance between the two groups surprised me,” Dr. Plourde commented.

There were no statistically significant differences between the two groups of women in the rating of the importance of sex before and after surgery.

“The complexity and multifaceted nature of the human sexual response is demonstrated by the fact that not all the women who had their ovaries removed lost their interest in sex or ability to respond sexually, and not all of the women who retained their ovaries maintained their sexual functioning,” Dr. Plourde and her associates indicated in their poster.

“These conflicting results indicate there are other factors that influence sexual functioning and need further research,” Dr. Plourde noted.

She acknowledged that the small sample size was a limitation of the study.

Dr. Plourde disclosed no conflicts of interest.

To see an interview with Dr. Plourde, go to www.youtube.com/user/ClinicalEndoNews

Women are 'not really being apprised of the significance' before undergoing oophorectomy.

Source DR. PLOURDE

SAN DIEGO — Women who underwent bilateral oophorectomy at the time of hysterectomy reported significantly decreased levels of sexual functioning compared with women who underwent hysterectomy with ovarian conservation, results from a survey of 50 women showed.

The findings underscore the potential impact of prophylactic ovary removal on women's sexual functioning, Elizabeth Plourde, Ph.D., said in an interview during a poster session at the annual meeting of the North American Menopause Society.

“The potential for loss of ability to respond sexually is a very important consideration for women who are being advised to do prophylactic oophorectomy,” said Dr. Plourde, a psychologist in Irvine, Calif., with research interests in the biochemical and structural changes that arise from reproductive organ removal.

“They're not really being apprised of the significance,” she added.

Dr. Plourde and her associates asked 25 women who underwent hysterectomy with ovarian conservation and 25 women who underwent bilateral oophorohysterectomy to complete the Changes in Sexual Functioning Questionnaire–Female (CSFQ-F) and the Sexual Response Questionnaire–Hysterectomy (SRQ-H).

The latter measure was designed for the study to compare the changes in sexual response before and after surgery.

The mean age of the questionnaire respondents was 49 years.

Only women who had functioning ovaries, based on their responses to survey questions about menopause symptoms, were retained for the hysterectomy-only group, Dr. Plourde said.

Compared with women who underwent a hysterectomy with ovarian conservation, those who underwent bilateral oophorectomy at the time of hysterectomy had significantly lower scores in total sexual functioning and in the subscale aspects of pleasure, desire/frequency and desire/interest; the number who were orgasmic was also lower among those who had bilateral oophorectomy.

Significant interactions favoring the hysterectomy with ovarian conservation group were also detected before and after surgery in total sexual functioning scores as well as in the subscales of pleasure, desire/frequency, desire/interest, and orgasm/completion.

“I redid all of the calculations to make sure that they were right, because the degree of significance between the two groups surprised me,” Dr. Plourde commented.

There were no statistically significant differences between the two groups of women in the rating of the importance of sex before and after surgery.

“The complexity and multifaceted nature of the human sexual response is demonstrated by the fact that not all the women who had their ovaries removed lost their interest in sex or ability to respond sexually, and not all of the women who retained their ovaries maintained their sexual functioning,” Dr. Plourde and her associates indicated in their poster.

“These conflicting results indicate there are other factors that influence sexual functioning and need further research,” Dr. Plourde noted.

She acknowledged that the small sample size was a limitation of the study.

Dr. Plourde disclosed no conflicts of interest.

To see an interview with Dr. Plourde, go to www.youtube.com/user/ClinicalEndoNews

Women are 'not really being apprised of the significance' before undergoing oophorectomy.

Source DR. PLOURDE

Disclosures: Dr. Alghonaim said he had no financial conflicts of interest.

SAN DIEGO — Although pregnant women with chronic kidney disease face an elevated risk of adverse maternal and fetal outcomes, most are able to deliver a surviving newborn, according to results from a multicenter study.

The current analysis is believed to be the second largest of its kind and supports earlier findings in the medical literature, Dr. Mohammed Alghonaim said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“These women need vigilant care,” said Dr. Alghonaim of the nephrology section in the department of medicine at King Saud University, Riyadh, Saudi Arabia. “If they've had a previous pregnancy, I would not advise them to get pregnant again if they have advanced-stage chronic kidney disease because of the potential for adverse maternal and fetal outcomes.”

In a study led by his associate at the university, Dr. Abdulkareem Alsuwaida, researchers at five tertiary hospitals in the Middle East reviewed 101 pregnancies in women (mean age, 32 years) with chronic kidney disease to estimate the rate of fetal, maternal, and neonatal complications.

The mean serum preconception creatinine concentration was 81.2 μmol/L, and the mean 24-hour urine proteinuria was 1.97 g/day. A total of 21 women (21%) had renal impairment, with a mean serum creatinine of 144 μmol/L.

In 10 pregnancies (10%), levels of serum creatinine rose more than 25% from preconception levels. Overall maternal and fetal complications included cesarean section (39%), preeclampsia (23%), preterm delivery (22%, with 4% delivered at less than 30 weeks' gestation), and intrauterine growth retardation (19%). Six infants (6%) were stillborn.

“Renal impairment was the most important predictor for both maternal and fetal complications,” Dr. Alghonaim said.

'Renal impairment was the most important predictor for both maternal and fetal complications.'

Source DR. ALGHONAIM

Disclosures: Dr. Alghonaim said he had no financial conflicts of interest.

SAN DIEGO — Although pregnant women with chronic kidney disease face an elevated risk of adverse maternal and fetal outcomes, most are able to deliver a surviving newborn, according to results from a multicenter study.

The current analysis is believed to be the second largest of its kind and supports earlier findings in the medical literature, Dr. Mohammed Alghonaim said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“These women need vigilant care,” said Dr. Alghonaim of the nephrology section in the department of medicine at King Saud University, Riyadh, Saudi Arabia. “If they've had a previous pregnancy, I would not advise them to get pregnant again if they have advanced-stage chronic kidney disease because of the potential for adverse maternal and fetal outcomes.”

In a study led by his associate at the university, Dr. Abdulkareem Alsuwaida, researchers at five tertiary hospitals in the Middle East reviewed 101 pregnancies in women (mean age, 32 years) with chronic kidney disease to estimate the rate of fetal, maternal, and neonatal complications.

The mean serum preconception creatinine concentration was 81.2 μmol/L, and the mean 24-hour urine proteinuria was 1.97 g/day. A total of 21 women (21%) had renal impairment, with a mean serum creatinine of 144 μmol/L.

In 10 pregnancies (10%), levels of serum creatinine rose more than 25% from preconception levels. Overall maternal and fetal complications included cesarean section (39%), preeclampsia (23%), preterm delivery (22%, with 4% delivered at less than 30 weeks' gestation), and intrauterine growth retardation (19%). Six infants (6%) were stillborn.

“Renal impairment was the most important predictor for both maternal and fetal complications,” Dr. Alghonaim said.

'Renal impairment was the most important predictor for both maternal and fetal complications.'

Source DR. ALGHONAIM

Disclosures: Dr. Alghonaim said he had no financial conflicts of interest.

SAN DIEGO — Although pregnant women with chronic kidney disease face an elevated risk of adverse maternal and fetal outcomes, most are able to deliver a surviving newborn, according to results from a multicenter study.

The current analysis is believed to be the second largest of its kind and supports earlier findings in the medical literature, Dr. Mohammed Alghonaim said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

“These women need vigilant care,” said Dr. Alghonaim of the nephrology section in the department of medicine at King Saud University, Riyadh, Saudi Arabia. “If they've had a previous pregnancy, I would not advise them to get pregnant again if they have advanced-stage chronic kidney disease because of the potential for adverse maternal and fetal outcomes.”

In a study led by his associate at the university, Dr. Abdulkareem Alsuwaida, researchers at five tertiary hospitals in the Middle East reviewed 101 pregnancies in women (mean age, 32 years) with chronic kidney disease to estimate the rate of fetal, maternal, and neonatal complications.

The mean serum preconception creatinine concentration was 81.2 μmol/L, and the mean 24-hour urine proteinuria was 1.97 g/day. A total of 21 women (21%) had renal impairment, with a mean serum creatinine of 144 μmol/L.

In 10 pregnancies (10%), levels of serum creatinine rose more than 25% from preconception levels. Overall maternal and fetal complications included cesarean section (39%), preeclampsia (23%), preterm delivery (22%, with 4% delivered at less than 30 weeks' gestation), and intrauterine growth retardation (19%). Six infants (6%) were stillborn.

“Renal impairment was the most important predictor for both maternal and fetal complications,” Dr. Alghonaim said.

'Renal impairment was the most important predictor for both maternal and fetal complications.'

Source DR. ALGHONAIM

Disclosures: The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife.

The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression.

The University of Pittsburgh researchers classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger of the department of epidemiology at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) had at least one major depressive episode.

Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline, the epidemiologist reported.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio, 3.52) or when they were perimenopausal (OR, 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR, 3.79) or perimenopausal (OR, 2.05), she reported. Odds ratios were also significantly greater for African American women (OR, 2.10); women with a history of depression (OR, 2.97);, and women who reported stressful life events (OR, 2.90) during the study period.

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

Odds ratios were also greater for African American women, and women who reported stressful life events.

Source DR. BROMBERGER

Disclosures: The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife.

The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression.

The University of Pittsburgh researchers classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger of the department of epidemiology at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) had at least one major depressive episode.

Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline, the epidemiologist reported.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio, 3.52) or when they were perimenopausal (OR, 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR, 3.79) or perimenopausal (OR, 2.05), she reported. Odds ratios were also significantly greater for African American women (OR, 2.10); women with a history of depression (OR, 2.97);, and women who reported stressful life events (OR, 2.90) during the study period.

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

Odds ratios were also greater for African American women, and women who reported stressful life events.

Source DR. BROMBERGER

Disclosures: The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife.

The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression.

The University of Pittsburgh researchers classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger of the department of epidemiology at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) had at least one major depressive episode.

Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline, the epidemiologist reported.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio, 3.52) or when they were perimenopausal (OR, 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR, 3.79) or perimenopausal (OR, 2.05), she reported. Odds ratios were also significantly greater for African American women (OR, 2.10); women with a history of depression (OR, 2.97);, and women who reported stressful life events (OR, 2.90) during the study period.

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

Odds ratios were also greater for African American women, and women who reported stressful life events.

Source DR. BROMBERGER