Refrigerated FluMist FDA-Approved for Ages 5-49

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A new formulation of intranasal influenza live virus vaccine that can be stored in a standard refrigerator, rather than kept frozen, has been approved by the Food and Drug Administration.

The new formulation of the trivalent vaccine, FluMist, is approved for healthy children and adults aged 5-49 years, and it will be available for the 2007-2008 flu season, according to a statement from the vaccine's manufacturer, MedImmune Inc. The company is seeking FDA approval of the refrigerated vaccine for use in children aged 12-59 months (1-5 years).

“This is a useful advance because the vaccine can be stored more easily and implemented better,” Dr. Sarah Long, chief of the infectious diseases section at St. Christopher's Hospital for Children, Philadelphia, said in an interview.

But the new formulation's effect on physician practices will not necessarily be substantial at this time, added Dr. Long, who is also a member of the American Academy of Pediatrics' Red Book Committee.

“It will be very useful if it is approved for [younger] children,” she noted.

The refrigerated formulation of FluMist will likely be appealing because of its ease of use, but the major factors driving influenza vaccination rates in primary care offices will continue to be cost (including reimbursement), vaccine supply and distribution, efficacy, and safety concerns, Dr. Jonathan Temte, of the University of Wisconsin, Madison, said in an interview.

“FluMist appears to have had better supply and distribution characteristics than the other influenza vaccines of late, but it is hampered by a higher price,” said Dr. Temte, who also serves as American Academy of Family Physicians' liaison to the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices.

That said, data have shown good efficacy for FluMist even in years when the vaccine was not well matched to the flu virus, he added.

Compared with injectable vaccine, FluMist provides better, longer lasting immunity and better cross-protection from year to year as the flu virus drifts, said Dr. Michael Pichichero, a private practice pediatrician and professor of microbiology and immunology at the University of Rochester (N.Y.). But the biggest drawback is cost. “Refrigeration is a minor advance in my opinion. If it were the same cost, it would be a no-brainer,” he said.

Should universal influenza vaccination be recommended, the new FluMist formulation would theoretically make that goal more feasible. Most people are not willing to line up for an injection each year. At the same time, the refrigerated formulation broadens the potential for flu immunizations to be offered in locations outside of the physician's office, such as schools or clinics. But the caveat is that FluMist of either formulation can be given only to persons who are otherwise healthy, Dr. Long said.

The high cost will continue to be a major impediment to FluMist's utilization, although the new formulation would help to ensure a steadier vaccine supply if universal vaccination is advised, Dr. Temte added.

The original FluMist, which is also manufactured by MedImmune, has been available in a frozen formulation since its FDA approval in 2003.

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A new formulation of intranasal influenza live virus vaccine that can be stored in a standard refrigerator, rather than kept frozen, has been approved by the Food and Drug Administration.

The new formulation of the trivalent vaccine, FluMist, is approved for healthy children and adults aged 5-49 years, and it will be available for the 2007-2008 flu season, according to a statement from the vaccine's manufacturer, MedImmune Inc. The company is seeking FDA approval of the refrigerated vaccine for use in children aged 12-59 months (1-5 years).

“This is a useful advance because the vaccine can be stored more easily and implemented better,” Dr. Sarah Long, chief of the infectious diseases section at St. Christopher's Hospital for Children, Philadelphia, said in an interview.

But the new formulation's effect on physician practices will not necessarily be substantial at this time, added Dr. Long, who is also a member of the American Academy of Pediatrics' Red Book Committee.

“It will be very useful if it is approved for [younger] children,” she noted.

The refrigerated formulation of FluMist will likely be appealing because of its ease of use, but the major factors driving influenza vaccination rates in primary care offices will continue to be cost (including reimbursement), vaccine supply and distribution, efficacy, and safety concerns, Dr. Jonathan Temte, of the University of Wisconsin, Madison, said in an interview.

“FluMist appears to have had better supply and distribution characteristics than the other influenza vaccines of late, but it is hampered by a higher price,” said Dr. Temte, who also serves as American Academy of Family Physicians' liaison to the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices.

That said, data have shown good efficacy for FluMist even in years when the vaccine was not well matched to the flu virus, he added.

Compared with injectable vaccine, FluMist provides better, longer lasting immunity and better cross-protection from year to year as the flu virus drifts, said Dr. Michael Pichichero, a private practice pediatrician and professor of microbiology and immunology at the University of Rochester (N.Y.). But the biggest drawback is cost. “Refrigeration is a minor advance in my opinion. If it were the same cost, it would be a no-brainer,” he said.

Should universal influenza vaccination be recommended, the new FluMist formulation would theoretically make that goal more feasible. Most people are not willing to line up for an injection each year. At the same time, the refrigerated formulation broadens the potential for flu immunizations to be offered in locations outside of the physician's office, such as schools or clinics. But the caveat is that FluMist of either formulation can be given only to persons who are otherwise healthy, Dr. Long said.

The high cost will continue to be a major impediment to FluMist's utilization, although the new formulation would help to ensure a steadier vaccine supply if universal vaccination is advised, Dr. Temte added.

The original FluMist, which is also manufactured by MedImmune, has been available in a frozen formulation since its FDA approval in 2003.

A new formulation of intranasal influenza live virus vaccine that can be stored in a standard refrigerator, rather than kept frozen, has been approved by the Food and Drug Administration.

The new formulation of the trivalent vaccine, FluMist, is approved for healthy children and adults aged 5-49 years, and it will be available for the 2007-2008 flu season, according to a statement from the vaccine's manufacturer, MedImmune Inc. The company is seeking FDA approval of the refrigerated vaccine for use in children aged 12-59 months (1-5 years).

“This is a useful advance because the vaccine can be stored more easily and implemented better,” Dr. Sarah Long, chief of the infectious diseases section at St. Christopher's Hospital for Children, Philadelphia, said in an interview.

But the new formulation's effect on physician practices will not necessarily be substantial at this time, added Dr. Long, who is also a member of the American Academy of Pediatrics' Red Book Committee.

“It will be very useful if it is approved for [younger] children,” she noted.

The refrigerated formulation of FluMist will likely be appealing because of its ease of use, but the major factors driving influenza vaccination rates in primary care offices will continue to be cost (including reimbursement), vaccine supply and distribution, efficacy, and safety concerns, Dr. Jonathan Temte, of the University of Wisconsin, Madison, said in an interview.

“FluMist appears to have had better supply and distribution characteristics than the other influenza vaccines of late, but it is hampered by a higher price,” said Dr. Temte, who also serves as American Academy of Family Physicians' liaison to the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices.

That said, data have shown good efficacy for FluMist even in years when the vaccine was not well matched to the flu virus, he added.

Compared with injectable vaccine, FluMist provides better, longer lasting immunity and better cross-protection from year to year as the flu virus drifts, said Dr. Michael Pichichero, a private practice pediatrician and professor of microbiology and immunology at the University of Rochester (N.Y.). But the biggest drawback is cost. “Refrigeration is a minor advance in my opinion. If it were the same cost, it would be a no-brainer,” he said.

Should universal influenza vaccination be recommended, the new FluMist formulation would theoretically make that goal more feasible. Most people are not willing to line up for an injection each year. At the same time, the refrigerated formulation broadens the potential for flu immunizations to be offered in locations outside of the physician's office, such as schools or clinics. But the caveat is that FluMist of either formulation can be given only to persons who are otherwise healthy, Dr. Long said.

The high cost will continue to be a major impediment to FluMist's utilization, although the new formulation would help to ensure a steadier vaccine supply if universal vaccination is advised, Dr. Temte added.

The original FluMist, which is also manufactured by MedImmune, has been available in a frozen formulation since its FDA approval in 2003.

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Selection of Devices to Implant May be Aided by Patch Testing

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Selection of Devices to Implant May be Aided by Patch Testing

WASHINGTON — Presurgical patch testing may prompt surgeons to change devices to prevent allergic reactions in patients, Kurtis Reed said at the annual meeting of the American Contact Dermatitis Society.

To evaluate the clinical impact of a positive patch test before and after surgery, Mr. Reed, a third-year medical student at Mayo Medical School, Rochester, Minn., and his colleagues reviewed data from 22 patients who were patch tested before receiving an orthopedic device or pacemaker and 22 patients who were referred for patch testing after receiving their devices.

Five of the 22 patients who were tested prior to surgery tested positive to at least one component of the prospective device. In four of the five cases, the surgeon changed the device. In the fifth case, the surgeon proceeded as planned because the odds of an adverse reaction were low, and that patient has reported no complications, Mr. Reed said.

The surgeon proceeded as planned in 16 of the 17 patients whose patch tests were negative. The device was changed in one case based on the patient's allergy history, he said.

By contrast, the clinical value of patch testing was unclear in patients who were referred following surgery. Reasons for referral included 13 cases of unexplained rash at the device site, 8 cases of chronic joint pain, and 1 case of joint loosening.

Only 1 of the 22 patients (one of the cases of unexplained rash) tested positive to an orthopedic device component, but the device could not be confirmed as the source of the rash, Mr. Reed noted.

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WASHINGTON — Presurgical patch testing may prompt surgeons to change devices to prevent allergic reactions in patients, Kurtis Reed said at the annual meeting of the American Contact Dermatitis Society.

To evaluate the clinical impact of a positive patch test before and after surgery, Mr. Reed, a third-year medical student at Mayo Medical School, Rochester, Minn., and his colleagues reviewed data from 22 patients who were patch tested before receiving an orthopedic device or pacemaker and 22 patients who were referred for patch testing after receiving their devices.

Five of the 22 patients who were tested prior to surgery tested positive to at least one component of the prospective device. In four of the five cases, the surgeon changed the device. In the fifth case, the surgeon proceeded as planned because the odds of an adverse reaction were low, and that patient has reported no complications, Mr. Reed said.

The surgeon proceeded as planned in 16 of the 17 patients whose patch tests were negative. The device was changed in one case based on the patient's allergy history, he said.

By contrast, the clinical value of patch testing was unclear in patients who were referred following surgery. Reasons for referral included 13 cases of unexplained rash at the device site, 8 cases of chronic joint pain, and 1 case of joint loosening.

Only 1 of the 22 patients (one of the cases of unexplained rash) tested positive to an orthopedic device component, but the device could not be confirmed as the source of the rash, Mr. Reed noted.

WASHINGTON — Presurgical patch testing may prompt surgeons to change devices to prevent allergic reactions in patients, Kurtis Reed said at the annual meeting of the American Contact Dermatitis Society.

To evaluate the clinical impact of a positive patch test before and after surgery, Mr. Reed, a third-year medical student at Mayo Medical School, Rochester, Minn., and his colleagues reviewed data from 22 patients who were patch tested before receiving an orthopedic device or pacemaker and 22 patients who were referred for patch testing after receiving their devices.

Five of the 22 patients who were tested prior to surgery tested positive to at least one component of the prospective device. In four of the five cases, the surgeon changed the device. In the fifth case, the surgeon proceeded as planned because the odds of an adverse reaction were low, and that patient has reported no complications, Mr. Reed said.

The surgeon proceeded as planned in 16 of the 17 patients whose patch tests were negative. The device was changed in one case based on the patient's allergy history, he said.

By contrast, the clinical value of patch testing was unclear in patients who were referred following surgery. Reasons for referral included 13 cases of unexplained rash at the device site, 8 cases of chronic joint pain, and 1 case of joint loosening.

Only 1 of the 22 patients (one of the cases of unexplained rash) tested positive to an orthopedic device component, but the device could not be confirmed as the source of the rash, Mr. Reed noted.

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Endometrial Ablation Effective for Uterine Bleeding

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Endometrial Ablation Effective for Uterine Bleeding

LAS VEGAS — Endometrial ablation as a treatment for dysfunctional uterine bleeding achieves symptom relief comparable in the short term to a hysterectomy, with less morbidity, Dr. Malcolm G. Munro reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

Data were collected from 237 women aged 18 years and older who were randomized to either endometrial ablation (EA) or hysterectomy as part of the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB), the largest trial to date to compare the two procedures in terms of patient satisfaction and complications.

“Chronic dysfunctional uterine bleeding is commonly an indication for hysterectomy,” noted Dr. Munro of the University of California, Los Angeles, and Kaiser Permanente Southern California.

Patient reports of symptom relief were similar in the EA and hysterectomy groups at 12 months and 2 years after the procedures, according to results from the multicenter trial. The hysterectomy rate for EA patients due to a return of symptoms was 30% at 4 years and seemed equivalent for those who underwent traditional resectoscopic EA and for those who underwent balloon EA, Dr. Munro said.

None of the 119 women who had EA needed readmission or surgery for significant complications within 42 days of the procedure, compared with 3 of 118 women who had hysterectomies.

In addition, there were more intraoperative and early postoperative complications in the hysterectomy patients compared with the EA patients. Complications in the hysterectomy group included two cystotomies, seven hematomas or seromas, and four wound infections, compared with one hematoma in an EA patient.

Although EA is not an option for women who wish to become pregnant or are undecided about it, patients who aren't concerned with preserving fertility may consider EA to improve their dysfunctional uterine bleeding and avoid the potential complications of a hysterectomy.

“The primary outcome was a 12-month assessment of the impact of surgery on the woman's assessment of her problem,” said Dr. Munro. The researchers also looked at specific symptoms including bleeding, pain, and fatigue, as well as quality of life.

All the patients reported dysfunctional uterine bleeding that had lasted at least 6 months. They had failed to respond to medical therapy, and they were willing to undergo a procedure that would remove their fertility. Dysfunctional uterine bleeding was defined as abnormal uterine bleeding during the reproductive years that could not be linked to uterine abnormalities such as submucosal myomas and polyps; the investigators excluded women with these abnormalities from the trial.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy, depending on whether the hysterectomy was abdominal, vaginal, or laparoscopic. Patient reports of satisfaction with their assigned procedures were not significantly different between the groups at any follow-up visit, although, as expected, EA patients were more likely to have continued menstruation while the hysterectomy patients had amenorrhea.

“Endometrial ablation is devoid of incisions, and is compatible with an individual's returning to work or virtually all other activities of daily living within a day or so of the procedure,” Dr. Munro said in an interview.

In general, both hysterectomy and endometrial ablation were effective at resolving the bleeding problems. But the differences in pain, risk, and a delayed return to activity associated with each procedure also are associated with direct and indirect costs, and Dr. Munro and his colleagues plan to evaluate those data.

The STOP-DUB study, funded by the Agency for Healthcare Research and Quality, involved more than 30 treatment centers in the United States and Canada.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy. DR. MUNRO

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LAS VEGAS — Endometrial ablation as a treatment for dysfunctional uterine bleeding achieves symptom relief comparable in the short term to a hysterectomy, with less morbidity, Dr. Malcolm G. Munro reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

Data were collected from 237 women aged 18 years and older who were randomized to either endometrial ablation (EA) or hysterectomy as part of the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB), the largest trial to date to compare the two procedures in terms of patient satisfaction and complications.

“Chronic dysfunctional uterine bleeding is commonly an indication for hysterectomy,” noted Dr. Munro of the University of California, Los Angeles, and Kaiser Permanente Southern California.

Patient reports of symptom relief were similar in the EA and hysterectomy groups at 12 months and 2 years after the procedures, according to results from the multicenter trial. The hysterectomy rate for EA patients due to a return of symptoms was 30% at 4 years and seemed equivalent for those who underwent traditional resectoscopic EA and for those who underwent balloon EA, Dr. Munro said.

None of the 119 women who had EA needed readmission or surgery for significant complications within 42 days of the procedure, compared with 3 of 118 women who had hysterectomies.

In addition, there were more intraoperative and early postoperative complications in the hysterectomy patients compared with the EA patients. Complications in the hysterectomy group included two cystotomies, seven hematomas or seromas, and four wound infections, compared with one hematoma in an EA patient.

Although EA is not an option for women who wish to become pregnant or are undecided about it, patients who aren't concerned with preserving fertility may consider EA to improve their dysfunctional uterine bleeding and avoid the potential complications of a hysterectomy.

“The primary outcome was a 12-month assessment of the impact of surgery on the woman's assessment of her problem,” said Dr. Munro. The researchers also looked at specific symptoms including bleeding, pain, and fatigue, as well as quality of life.

All the patients reported dysfunctional uterine bleeding that had lasted at least 6 months. They had failed to respond to medical therapy, and they were willing to undergo a procedure that would remove their fertility. Dysfunctional uterine bleeding was defined as abnormal uterine bleeding during the reproductive years that could not be linked to uterine abnormalities such as submucosal myomas and polyps; the investigators excluded women with these abnormalities from the trial.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy, depending on whether the hysterectomy was abdominal, vaginal, or laparoscopic. Patient reports of satisfaction with their assigned procedures were not significantly different between the groups at any follow-up visit, although, as expected, EA patients were more likely to have continued menstruation while the hysterectomy patients had amenorrhea.

“Endometrial ablation is devoid of incisions, and is compatible with an individual's returning to work or virtually all other activities of daily living within a day or so of the procedure,” Dr. Munro said in an interview.

In general, both hysterectomy and endometrial ablation were effective at resolving the bleeding problems. But the differences in pain, risk, and a delayed return to activity associated with each procedure also are associated with direct and indirect costs, and Dr. Munro and his colleagues plan to evaluate those data.

The STOP-DUB study, funded by the Agency for Healthcare Research and Quality, involved more than 30 treatment centers in the United States and Canada.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy. DR. MUNRO

LAS VEGAS — Endometrial ablation as a treatment for dysfunctional uterine bleeding achieves symptom relief comparable in the short term to a hysterectomy, with less morbidity, Dr. Malcolm G. Munro reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

Data were collected from 237 women aged 18 years and older who were randomized to either endometrial ablation (EA) or hysterectomy as part of the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB), the largest trial to date to compare the two procedures in terms of patient satisfaction and complications.

“Chronic dysfunctional uterine bleeding is commonly an indication for hysterectomy,” noted Dr. Munro of the University of California, Los Angeles, and Kaiser Permanente Southern California.

Patient reports of symptom relief were similar in the EA and hysterectomy groups at 12 months and 2 years after the procedures, according to results from the multicenter trial. The hysterectomy rate for EA patients due to a return of symptoms was 30% at 4 years and seemed equivalent for those who underwent traditional resectoscopic EA and for those who underwent balloon EA, Dr. Munro said.

None of the 119 women who had EA needed readmission or surgery for significant complications within 42 days of the procedure, compared with 3 of 118 women who had hysterectomies.

In addition, there were more intraoperative and early postoperative complications in the hysterectomy patients compared with the EA patients. Complications in the hysterectomy group included two cystotomies, seven hematomas or seromas, and four wound infections, compared with one hematoma in an EA patient.

Although EA is not an option for women who wish to become pregnant or are undecided about it, patients who aren't concerned with preserving fertility may consider EA to improve their dysfunctional uterine bleeding and avoid the potential complications of a hysterectomy.

“The primary outcome was a 12-month assessment of the impact of surgery on the woman's assessment of her problem,” said Dr. Munro. The researchers also looked at specific symptoms including bleeding, pain, and fatigue, as well as quality of life.

All the patients reported dysfunctional uterine bleeding that had lasted at least 6 months. They had failed to respond to medical therapy, and they were willing to undergo a procedure that would remove their fertility. Dysfunctional uterine bleeding was defined as abnormal uterine bleeding during the reproductive years that could not be linked to uterine abnormalities such as submucosal myomas and polyps; the investigators excluded women with these abnormalities from the trial.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy, depending on whether the hysterectomy was abdominal, vaginal, or laparoscopic. Patient reports of satisfaction with their assigned procedures were not significantly different between the groups at any follow-up visit, although, as expected, EA patients were more likely to have continued menstruation while the hysterectomy patients had amenorrhea.

“Endometrial ablation is devoid of incisions, and is compatible with an individual's returning to work or virtually all other activities of daily living within a day or so of the procedure,” Dr. Munro said in an interview.

In general, both hysterectomy and endometrial ablation were effective at resolving the bleeding problems. But the differences in pain, risk, and a delayed return to activity associated with each procedure also are associated with direct and indirect costs, and Dr. Munro and his colleagues plan to evaluate those data.

The STOP-DUB study, funded by the Agency for Healthcare Research and Quality, involved more than 30 treatment centers in the United States and Canada.

EA patients had an average hospital stay of less than 1 day vs. an average of 1–3 days for hysterectomy. DR. MUNRO

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Melasma, Undertreated in Men, Clears With Topical Solution

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GRAND CAYMAN, CAYMAN ISLANDS — A topical solution containing 2% mequinol and 0.01% tretinoin can noticeably improve facial melasma in men, based on results from a small study presented at the Caribbean Dermatology Symposium.

Male melasma is undertreated, in part because many men are ashamed to seek help given the condition's association with women and pregnancy, said Dr. Jon Keeling, a dermatology resident at Wellington Regional Medical Center in West Palm Beach, Fla.

“There are no previous reports of using mequinol in the treatment of melasma in women or men,” he said. Dr. Keeling presented the data on behalf of Dr. Marta I. Rendon, who conducted the study at her private dermatology practice in Boca Raton, Fla.

Five healthy men aged 30–45 years with at least a 1-year history of melasma were instructed to apply a 2% mequinol/0.01% tretinoin solution nightly for 12 weeks along with a 6% zinc oxide sunscreen with SPF 30 each day. All of the patients had failed at least one previous treatment for melasma.

After 12 weeks, four of the five patients' faces were cleared, based on physician assessment, patient self-assessment, and evaluations of standardized photos taken at 2, 4, 8, 12, and 16 weeks after baseline.

The fifth patient had partial clearance after 12 weeks, Dr. Keeling said.

All patients showed some improvement after 4 weeks and the maximum improvement after 12 weeks of treatment. Their skin remained clear 16 weeks after the start of the study.

Overall, the medication was well tolerated; one patient reported mild stinging when he applied the solution.

“It is important to note the psychosocial impact of melasma for men,” said Dr. Keeling, adding that the number of men seeking treatment for skin pigment problems is rapidly growing.

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GRAND CAYMAN, CAYMAN ISLANDS — A topical solution containing 2% mequinol and 0.01% tretinoin can noticeably improve facial melasma in men, based on results from a small study presented at the Caribbean Dermatology Symposium.

Male melasma is undertreated, in part because many men are ashamed to seek help given the condition's association with women and pregnancy, said Dr. Jon Keeling, a dermatology resident at Wellington Regional Medical Center in West Palm Beach, Fla.

“There are no previous reports of using mequinol in the treatment of melasma in women or men,” he said. Dr. Keeling presented the data on behalf of Dr. Marta I. Rendon, who conducted the study at her private dermatology practice in Boca Raton, Fla.

Five healthy men aged 30–45 years with at least a 1-year history of melasma were instructed to apply a 2% mequinol/0.01% tretinoin solution nightly for 12 weeks along with a 6% zinc oxide sunscreen with SPF 30 each day. All of the patients had failed at least one previous treatment for melasma.

After 12 weeks, four of the five patients' faces were cleared, based on physician assessment, patient self-assessment, and evaluations of standardized photos taken at 2, 4, 8, 12, and 16 weeks after baseline.

The fifth patient had partial clearance after 12 weeks, Dr. Keeling said.

All patients showed some improvement after 4 weeks and the maximum improvement after 12 weeks of treatment. Their skin remained clear 16 weeks after the start of the study.

Overall, the medication was well tolerated; one patient reported mild stinging when he applied the solution.

“It is important to note the psychosocial impact of melasma for men,” said Dr. Keeling, adding that the number of men seeking treatment for skin pigment problems is rapidly growing.

GRAND CAYMAN, CAYMAN ISLANDS — A topical solution containing 2% mequinol and 0.01% tretinoin can noticeably improve facial melasma in men, based on results from a small study presented at the Caribbean Dermatology Symposium.

Male melasma is undertreated, in part because many men are ashamed to seek help given the condition's association with women and pregnancy, said Dr. Jon Keeling, a dermatology resident at Wellington Regional Medical Center in West Palm Beach, Fla.

“There are no previous reports of using mequinol in the treatment of melasma in women or men,” he said. Dr. Keeling presented the data on behalf of Dr. Marta I. Rendon, who conducted the study at her private dermatology practice in Boca Raton, Fla.

Five healthy men aged 30–45 years with at least a 1-year history of melasma were instructed to apply a 2% mequinol/0.01% tretinoin solution nightly for 12 weeks along with a 6% zinc oxide sunscreen with SPF 30 each day. All of the patients had failed at least one previous treatment for melasma.

After 12 weeks, four of the five patients' faces were cleared, based on physician assessment, patient self-assessment, and evaluations of standardized photos taken at 2, 4, 8, 12, and 16 weeks after baseline.

The fifth patient had partial clearance after 12 weeks, Dr. Keeling said.

All patients showed some improvement after 4 weeks and the maximum improvement after 12 weeks of treatment. Their skin remained clear 16 weeks after the start of the study.

Overall, the medication was well tolerated; one patient reported mild stinging when he applied the solution.

“It is important to note the psychosocial impact of melasma for men,” said Dr. Keeling, adding that the number of men seeking treatment for skin pigment problems is rapidly growing.

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Consider Prognosis in HIV With Comorbidities : Clinicians need to decide which comorbidities are worth worrying about in the HIV-positive population.

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Consider Prognosis in HIV With Comorbidities : Clinicians need to decide which comorbidities are worth worrying about in the HIV-positive population.

WASHINGTON — More HIV patients are living long enough to die of non-HIV causes, and clinicians who treat these patients will need to juggle the management of HIV with the management of other medical conditions, said Dr. Amy C. Justice at the Ryan White CARE Act meeting on HIV treatment.

“It's not appropriate to take guidelines for patients who don't have HIV and blindly apply them to people with a very different prognosis,” said Dr. Justice, of the West Haven Veteran's Affairs Medical Center and Yale University, both in New Haven, Conn.

Adapting guidelines intended for general populations to HIV patients remains a challenge, Dr. Justice acknowledged. Patients with HIV are a special population that is more likely to drink heavily, smoke, have viral hepatitis, and have some type of mental illness. In addition, many HIV patients are poor and have few resources, she said.

However, the same demographic factors—including age, race, and sex—that influence the development of comorbidities in the general population also apply to HIV patients.

The bottom line is that clinicians need to decide which comorbidities are worth worrying about in the HIV-positive population. Dr. Justice advises clinicians to consider three questions:

▸ What is the prognosis? Will the HIV patient live long enough to benefit from treatment for a comorbid condition?

▸ What is the impact on the patient and his or her community? Is the condition prevalent and harmful?

▸ What is the benefit of intervention? Even if a condition is prevalent and harmful (such as diabetes), treating it may not improve the patient's outcome.

Although antiviral therapy has extended the life expectancy of HIV patients, data have shown that the survival rate drops with age. Based on census data and a computer simulation developed at Yale University, more HIV patients are likely to die from non-HIV causes than from HIV in the future.

“The older you are, the more likely you are to die a non-AIDS-related death because you have increasing rates of comorbid illness as you get older,” Dr. Justice explained. If the mean age at HIV diagnosis remains 38 years, the mean age at death will likely approach 58 years before long, she added.

Hepatitis C, hypertension, diabetes, and chronic obstructive pulmonary disease are the most common comorbidities among HIV patients, with prevalences of 34%, 32%, 13%, and 12%, respectively, according to data from the Veterans Aging Cohort 3 Site Study (VACS3).

The study, conducted by Dr. Justice and her colleagues, involved a review of the records of more than 800 HIV-positive patients seen at veterans' hospitals between June 1999 and July 2000 (Med. Care 2006;44:S52–60).

“Theoretically, HIV itself may alter the association between the condition and the outcome,” Dr. Justice said. For example, HIV may make diabetes worse. The stress of fighting the virus may affect the body's blood glucose levels, in the same way that active bacterial infections do. Comorbidities also have an impact on survival rates in HIV patients through their effects on antiviral therapy adherence, she said.

For example, substance use may not only reduce adherence to HIV treatment, but it may also exacerbate comorbid conditions.

Alcohol is the substance most commonly used by HIV patients, Dr. Justice said. Data from multiple studies have shown that 60%-75% of patients with HIV infection drink alcohol, 40%–50% use tobacco, and 30% use other drugs such as marijuana, cocaine, and heroin.

“The level of alcohol use that may be harmful in HIV patients may be substantially lower than the level that is harmful in non-HIV patients,” Dr. Justice noted. Alcohol use by HIV patients makes the treatment of hepatitis C and other illnesses more difficult. “And it certainly increases the possibility of risky sex and poor adherence to medication,” she said.

Also, the detrimental effects of smoking may be exacerbated in HIV patients; studies suggest that HIV patients who smoke are at increased risk for emphysema, lung cancer, pneumonia, heart disease, and stroke. Additional data from the VACS study (J. Gen. Intern. Med. 2005;20:1142–5) indicated that mortality in HIV patients was more than twice as high among current smokers as in patients who had never smoked (5.4 vs. 2.5 deaths per 100 person-years).

One way to apply primary care guidelines to HIV patients is to consider the “payoff time,” Dr. Justice said. The payoff time is the estimated number of years of a patient's life during which the benefits of treating a comorbid condition outweigh the short-term harms.

Thus the value of screening procedures such as colonoscopy depends on the life expectancy related to a comorbid disease as well as HIV. For example, if a 50-year-old HIV-positive man is likely to die from HIV before treatment for colon cancer, if found, would reduce his risk of death from colon cancer, it may not be worth putting him through the discomfort and risk of a colonoscopy, Dr. Justice suggested.

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WASHINGTON — More HIV patients are living long enough to die of non-HIV causes, and clinicians who treat these patients will need to juggle the management of HIV with the management of other medical conditions, said Dr. Amy C. Justice at the Ryan White CARE Act meeting on HIV treatment.

“It's not appropriate to take guidelines for patients who don't have HIV and blindly apply them to people with a very different prognosis,” said Dr. Justice, of the West Haven Veteran's Affairs Medical Center and Yale University, both in New Haven, Conn.

Adapting guidelines intended for general populations to HIV patients remains a challenge, Dr. Justice acknowledged. Patients with HIV are a special population that is more likely to drink heavily, smoke, have viral hepatitis, and have some type of mental illness. In addition, many HIV patients are poor and have few resources, she said.

However, the same demographic factors—including age, race, and sex—that influence the development of comorbidities in the general population also apply to HIV patients.

The bottom line is that clinicians need to decide which comorbidities are worth worrying about in the HIV-positive population. Dr. Justice advises clinicians to consider three questions:

▸ What is the prognosis? Will the HIV patient live long enough to benefit from treatment for a comorbid condition?

▸ What is the impact on the patient and his or her community? Is the condition prevalent and harmful?

▸ What is the benefit of intervention? Even if a condition is prevalent and harmful (such as diabetes), treating it may not improve the patient's outcome.

Although antiviral therapy has extended the life expectancy of HIV patients, data have shown that the survival rate drops with age. Based on census data and a computer simulation developed at Yale University, more HIV patients are likely to die from non-HIV causes than from HIV in the future.

“The older you are, the more likely you are to die a non-AIDS-related death because you have increasing rates of comorbid illness as you get older,” Dr. Justice explained. If the mean age at HIV diagnosis remains 38 years, the mean age at death will likely approach 58 years before long, she added.

Hepatitis C, hypertension, diabetes, and chronic obstructive pulmonary disease are the most common comorbidities among HIV patients, with prevalences of 34%, 32%, 13%, and 12%, respectively, according to data from the Veterans Aging Cohort 3 Site Study (VACS3).

The study, conducted by Dr. Justice and her colleagues, involved a review of the records of more than 800 HIV-positive patients seen at veterans' hospitals between June 1999 and July 2000 (Med. Care 2006;44:S52–60).

“Theoretically, HIV itself may alter the association between the condition and the outcome,” Dr. Justice said. For example, HIV may make diabetes worse. The stress of fighting the virus may affect the body's blood glucose levels, in the same way that active bacterial infections do. Comorbidities also have an impact on survival rates in HIV patients through their effects on antiviral therapy adherence, she said.

For example, substance use may not only reduce adherence to HIV treatment, but it may also exacerbate comorbid conditions.

Alcohol is the substance most commonly used by HIV patients, Dr. Justice said. Data from multiple studies have shown that 60%-75% of patients with HIV infection drink alcohol, 40%–50% use tobacco, and 30% use other drugs such as marijuana, cocaine, and heroin.

“The level of alcohol use that may be harmful in HIV patients may be substantially lower than the level that is harmful in non-HIV patients,” Dr. Justice noted. Alcohol use by HIV patients makes the treatment of hepatitis C and other illnesses more difficult. “And it certainly increases the possibility of risky sex and poor adherence to medication,” she said.

Also, the detrimental effects of smoking may be exacerbated in HIV patients; studies suggest that HIV patients who smoke are at increased risk for emphysema, lung cancer, pneumonia, heart disease, and stroke. Additional data from the VACS study (J. Gen. Intern. Med. 2005;20:1142–5) indicated that mortality in HIV patients was more than twice as high among current smokers as in patients who had never smoked (5.4 vs. 2.5 deaths per 100 person-years).

One way to apply primary care guidelines to HIV patients is to consider the “payoff time,” Dr. Justice said. The payoff time is the estimated number of years of a patient's life during which the benefits of treating a comorbid condition outweigh the short-term harms.

Thus the value of screening procedures such as colonoscopy depends on the life expectancy related to a comorbid disease as well as HIV. For example, if a 50-year-old HIV-positive man is likely to die from HIV before treatment for colon cancer, if found, would reduce his risk of death from colon cancer, it may not be worth putting him through the discomfort and risk of a colonoscopy, Dr. Justice suggested.

WASHINGTON — More HIV patients are living long enough to die of non-HIV causes, and clinicians who treat these patients will need to juggle the management of HIV with the management of other medical conditions, said Dr. Amy C. Justice at the Ryan White CARE Act meeting on HIV treatment.

“It's not appropriate to take guidelines for patients who don't have HIV and blindly apply them to people with a very different prognosis,” said Dr. Justice, of the West Haven Veteran's Affairs Medical Center and Yale University, both in New Haven, Conn.

Adapting guidelines intended for general populations to HIV patients remains a challenge, Dr. Justice acknowledged. Patients with HIV are a special population that is more likely to drink heavily, smoke, have viral hepatitis, and have some type of mental illness. In addition, many HIV patients are poor and have few resources, she said.

However, the same demographic factors—including age, race, and sex—that influence the development of comorbidities in the general population also apply to HIV patients.

The bottom line is that clinicians need to decide which comorbidities are worth worrying about in the HIV-positive population. Dr. Justice advises clinicians to consider three questions:

▸ What is the prognosis? Will the HIV patient live long enough to benefit from treatment for a comorbid condition?

▸ What is the impact on the patient and his or her community? Is the condition prevalent and harmful?

▸ What is the benefit of intervention? Even if a condition is prevalent and harmful (such as diabetes), treating it may not improve the patient's outcome.

Although antiviral therapy has extended the life expectancy of HIV patients, data have shown that the survival rate drops with age. Based on census data and a computer simulation developed at Yale University, more HIV patients are likely to die from non-HIV causes than from HIV in the future.

“The older you are, the more likely you are to die a non-AIDS-related death because you have increasing rates of comorbid illness as you get older,” Dr. Justice explained. If the mean age at HIV diagnosis remains 38 years, the mean age at death will likely approach 58 years before long, she added.

Hepatitis C, hypertension, diabetes, and chronic obstructive pulmonary disease are the most common comorbidities among HIV patients, with prevalences of 34%, 32%, 13%, and 12%, respectively, according to data from the Veterans Aging Cohort 3 Site Study (VACS3).

The study, conducted by Dr. Justice and her colleagues, involved a review of the records of more than 800 HIV-positive patients seen at veterans' hospitals between June 1999 and July 2000 (Med. Care 2006;44:S52–60).

“Theoretically, HIV itself may alter the association between the condition and the outcome,” Dr. Justice said. For example, HIV may make diabetes worse. The stress of fighting the virus may affect the body's blood glucose levels, in the same way that active bacterial infections do. Comorbidities also have an impact on survival rates in HIV patients through their effects on antiviral therapy adherence, she said.

For example, substance use may not only reduce adherence to HIV treatment, but it may also exacerbate comorbid conditions.

Alcohol is the substance most commonly used by HIV patients, Dr. Justice said. Data from multiple studies have shown that 60%-75% of patients with HIV infection drink alcohol, 40%–50% use tobacco, and 30% use other drugs such as marijuana, cocaine, and heroin.

“The level of alcohol use that may be harmful in HIV patients may be substantially lower than the level that is harmful in non-HIV patients,” Dr. Justice noted. Alcohol use by HIV patients makes the treatment of hepatitis C and other illnesses more difficult. “And it certainly increases the possibility of risky sex and poor adherence to medication,” she said.

Also, the detrimental effects of smoking may be exacerbated in HIV patients; studies suggest that HIV patients who smoke are at increased risk for emphysema, lung cancer, pneumonia, heart disease, and stroke. Additional data from the VACS study (J. Gen. Intern. Med. 2005;20:1142–5) indicated that mortality in HIV patients was more than twice as high among current smokers as in patients who had never smoked (5.4 vs. 2.5 deaths per 100 person-years).

One way to apply primary care guidelines to HIV patients is to consider the “payoff time,” Dr. Justice said. The payoff time is the estimated number of years of a patient's life during which the benefits of treating a comorbid condition outweigh the short-term harms.

Thus the value of screening procedures such as colonoscopy depends on the life expectancy related to a comorbid disease as well as HIV. For example, if a 50-year-old HIV-positive man is likely to die from HIV before treatment for colon cancer, if found, would reduce his risk of death from colon cancer, it may not be worth putting him through the discomfort and risk of a colonoscopy, Dr. Justice suggested.

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Vitamin D for Breast-Feeding Moms Benefits Infants

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CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.

“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?' “said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.

Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.

People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.

Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).

To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.

The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects. In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.

The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.

“What we found was a wonderful increase” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.

After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.

“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.

For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.

The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained. Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.

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CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.

“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?' “said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.

Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.

People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.

Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).

To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.

The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects. In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.

The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.

“What we found was a wonderful increase” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.

After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.

“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.

For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.

The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained. Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.

CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.

“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?' “said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.

Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.

People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.

Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).

To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.

The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects. In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.

The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.

“What we found was a wonderful increase” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.

After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.

“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.

For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.

The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained. Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.

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Uterine Myomas in Pregnancy Increase Risk of Complications

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LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.

Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.

To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.

Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.

Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.

“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.

Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.

Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.

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LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.

Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.

To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.

Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.

Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.

“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.

Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.

Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.

LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.

In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.

Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.

To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.

Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.

Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.

“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.

Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.

Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.

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Clinical Capsules

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Norovirus Shed Long After Symptoms

Infants younger than 6 months of age continued to shed norovirus more than a month after the onset of gastroenteritis and after their clinical symptoms had resolved, Toshio Murata, Ph.D., of the Yamagata (Japan) Prefectural Institute of Public Health, and associates reported.

To investigate the duration of shedding in infants and young children, the investigators tested fecal specimens from 71 children aged 0–3 years who were infected with norovirus. Follow-up data were available for 23 children (8 younger than 1 year, 7 aged 1 year, and 8 aged 2–3 years).

The median period of viral shedding in the 5 patients aged 6 months and younger was significantly longer than in patients older than 1 year (42 days vs. 10 days).

Although 3 of 5 patients aged 6 months and younger shed norovirus for more than 40 days, they showed no symptoms of gastroenteritis during the postrecovery period (Pediatr. Infect. Dis. J. 2007;26:46–9).

Overall, the mean duration of illness was 5 days and the median duration of norovirus shedding was 16 days. But 6 of 8 children (75%) younger than 1 year were still shedding norovirus more than 2 weeks after the onset of gastroenteritis, compared with 5 of 7 children (71.4%) aged 1 year and 2 of 8 (25%) children aged 2–3 years.

The data support the need for caution when handling the excrement of infants and young children with gastroenteritis, even after they appear to have recovered, the researchers noted.

Few Saw Need for 2nd Varicella Dose

A majority of 610 primary care physicians surveyed before the recommendation for a second dose of varicella vaccine said that the current level of breakthrough varicella disease in their practices was acceptable, Dr. Matthew Davis of the University of Michigan, Ann Arbor, and his associates reported.

Although varicella vaccination rates in the United States reached 88% by 2004, the number of reported cases has remained steady during the past 3–4 years; the effectiveness of the vaccine has been from 70% to 90%, according to recently published outbreak investigations. In 2006, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended a second dose of varicella vaccine for children.

To assess the opinions of primary care physicians about the value of a second dose, Dr. Davis and his colleagues surveyed a national sample of primary care pediatricians and family physicians between April and June 2005. The 610 surveys included 342 pediatricians and 268 family physicians (Pediatrics 2006;119:258–64).

Overall, 82% of the survey respondents said they “strongly recommend” the single-dose varicella vaccine for children aged 6 years and younger. Although 79% of respondents had reported breakthrough varicella cases in recent years, 71% of these physicians agreed that the level of breakthrough cases was acceptable.

Only 38% of respondents indicated that a second dose of the varicella vaccine was needed to control the breakthrough cases, whether they had seen such cases in their practices or not. However, 53% of respondents said they would likely recommend a second dose of varicella vaccine if it were recommended by ACIP.

Repeat Cultures Unnecessary in UTIs

Additional urine cultures are not necessary to confirm cure in children with urinary tract infections who have been treated with antibiotics, Dr. Nicolas Oreskovic and Dr. Eduardo Sembrano of Mount Sinai Hospital in New York reported.

Urine cultures are uncomfortable for patients, and they are expensive for hospitals. To determine the clinical value of repeating urine cultures after antibiotic therapy, the investigators reviewed data from 328 children younger than 18 years of age who were hospitalized with urinary tract infections (UTIs) between December 1998 and December 2004 and who underwent repeat urine cultures after 2 days of intravenous antibiotics (Pediatrics 2007;119: [Epub doi:10.1542/peds.2006–1134]).

Only one patient (0.3%) had a positive repeat urine culture—a 7-month-old boy who was diagnosed with a UTI and bronchiolitis. The child was allergic to amoxicillin and received trimethoprim-sulfamethoxazole. His admission culture showed Escherichia coli, but this information was not known immediately. He was subsequently treated with cefaclor, and a follow-up culture 2 days later was negative.

A repeat urine culture may be appropriate in children who do not show clinical improvement after 48 hours of antimicrobial therapy, but many pediatricians routinely reculture UTI patients after 2 days to obtain a “proof of bacteriologic cure.”

The study was limited by its retrospective nature, but the results support findings from previous studies suggesting that routine reculturing of children with UTIs who have been treated with antibiotics is unnecessary, the researchers wrote.

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Norovirus Shed Long After Symptoms

Infants younger than 6 months of age continued to shed norovirus more than a month after the onset of gastroenteritis and after their clinical symptoms had resolved, Toshio Murata, Ph.D., of the Yamagata (Japan) Prefectural Institute of Public Health, and associates reported.

To investigate the duration of shedding in infants and young children, the investigators tested fecal specimens from 71 children aged 0–3 years who were infected with norovirus. Follow-up data were available for 23 children (8 younger than 1 year, 7 aged 1 year, and 8 aged 2–3 years).

The median period of viral shedding in the 5 patients aged 6 months and younger was significantly longer than in patients older than 1 year (42 days vs. 10 days).

Although 3 of 5 patients aged 6 months and younger shed norovirus for more than 40 days, they showed no symptoms of gastroenteritis during the postrecovery period (Pediatr. Infect. Dis. J. 2007;26:46–9).

Overall, the mean duration of illness was 5 days and the median duration of norovirus shedding was 16 days. But 6 of 8 children (75%) younger than 1 year were still shedding norovirus more than 2 weeks after the onset of gastroenteritis, compared with 5 of 7 children (71.4%) aged 1 year and 2 of 8 (25%) children aged 2–3 years.

The data support the need for caution when handling the excrement of infants and young children with gastroenteritis, even after they appear to have recovered, the researchers noted.

Few Saw Need for 2nd Varicella Dose

A majority of 610 primary care physicians surveyed before the recommendation for a second dose of varicella vaccine said that the current level of breakthrough varicella disease in their practices was acceptable, Dr. Matthew Davis of the University of Michigan, Ann Arbor, and his associates reported.

Although varicella vaccination rates in the United States reached 88% by 2004, the number of reported cases has remained steady during the past 3–4 years; the effectiveness of the vaccine has been from 70% to 90%, according to recently published outbreak investigations. In 2006, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended a second dose of varicella vaccine for children.

To assess the opinions of primary care physicians about the value of a second dose, Dr. Davis and his colleagues surveyed a national sample of primary care pediatricians and family physicians between April and June 2005. The 610 surveys included 342 pediatricians and 268 family physicians (Pediatrics 2006;119:258–64).

Overall, 82% of the survey respondents said they “strongly recommend” the single-dose varicella vaccine for children aged 6 years and younger. Although 79% of respondents had reported breakthrough varicella cases in recent years, 71% of these physicians agreed that the level of breakthrough cases was acceptable.

Only 38% of respondents indicated that a second dose of the varicella vaccine was needed to control the breakthrough cases, whether they had seen such cases in their practices or not. However, 53% of respondents said they would likely recommend a second dose of varicella vaccine if it were recommended by ACIP.

Repeat Cultures Unnecessary in UTIs

Additional urine cultures are not necessary to confirm cure in children with urinary tract infections who have been treated with antibiotics, Dr. Nicolas Oreskovic and Dr. Eduardo Sembrano of Mount Sinai Hospital in New York reported.

Urine cultures are uncomfortable for patients, and they are expensive for hospitals. To determine the clinical value of repeating urine cultures after antibiotic therapy, the investigators reviewed data from 328 children younger than 18 years of age who were hospitalized with urinary tract infections (UTIs) between December 1998 and December 2004 and who underwent repeat urine cultures after 2 days of intravenous antibiotics (Pediatrics 2007;119: [Epub doi:10.1542/peds.2006–1134]).

Only one patient (0.3%) had a positive repeat urine culture—a 7-month-old boy who was diagnosed with a UTI and bronchiolitis. The child was allergic to amoxicillin and received trimethoprim-sulfamethoxazole. His admission culture showed Escherichia coli, but this information was not known immediately. He was subsequently treated with cefaclor, and a follow-up culture 2 days later was negative.

A repeat urine culture may be appropriate in children who do not show clinical improvement after 48 hours of antimicrobial therapy, but many pediatricians routinely reculture UTI patients after 2 days to obtain a “proof of bacteriologic cure.”

The study was limited by its retrospective nature, but the results support findings from previous studies suggesting that routine reculturing of children with UTIs who have been treated with antibiotics is unnecessary, the researchers wrote.

Norovirus Shed Long After Symptoms

Infants younger than 6 months of age continued to shed norovirus more than a month after the onset of gastroenteritis and after their clinical symptoms had resolved, Toshio Murata, Ph.D., of the Yamagata (Japan) Prefectural Institute of Public Health, and associates reported.

To investigate the duration of shedding in infants and young children, the investigators tested fecal specimens from 71 children aged 0–3 years who were infected with norovirus. Follow-up data were available for 23 children (8 younger than 1 year, 7 aged 1 year, and 8 aged 2–3 years).

The median period of viral shedding in the 5 patients aged 6 months and younger was significantly longer than in patients older than 1 year (42 days vs. 10 days).

Although 3 of 5 patients aged 6 months and younger shed norovirus for more than 40 days, they showed no symptoms of gastroenteritis during the postrecovery period (Pediatr. Infect. Dis. J. 2007;26:46–9).

Overall, the mean duration of illness was 5 days and the median duration of norovirus shedding was 16 days. But 6 of 8 children (75%) younger than 1 year were still shedding norovirus more than 2 weeks after the onset of gastroenteritis, compared with 5 of 7 children (71.4%) aged 1 year and 2 of 8 (25%) children aged 2–3 years.

The data support the need for caution when handling the excrement of infants and young children with gastroenteritis, even after they appear to have recovered, the researchers noted.

Few Saw Need for 2nd Varicella Dose

A majority of 610 primary care physicians surveyed before the recommendation for a second dose of varicella vaccine said that the current level of breakthrough varicella disease in their practices was acceptable, Dr. Matthew Davis of the University of Michigan, Ann Arbor, and his associates reported.

Although varicella vaccination rates in the United States reached 88% by 2004, the number of reported cases has remained steady during the past 3–4 years; the effectiveness of the vaccine has been from 70% to 90%, according to recently published outbreak investigations. In 2006, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended a second dose of varicella vaccine for children.

To assess the opinions of primary care physicians about the value of a second dose, Dr. Davis and his colleagues surveyed a national sample of primary care pediatricians and family physicians between April and June 2005. The 610 surveys included 342 pediatricians and 268 family physicians (Pediatrics 2006;119:258–64).

Overall, 82% of the survey respondents said they “strongly recommend” the single-dose varicella vaccine for children aged 6 years and younger. Although 79% of respondents had reported breakthrough varicella cases in recent years, 71% of these physicians agreed that the level of breakthrough cases was acceptable.

Only 38% of respondents indicated that a second dose of the varicella vaccine was needed to control the breakthrough cases, whether they had seen such cases in their practices or not. However, 53% of respondents said they would likely recommend a second dose of varicella vaccine if it were recommended by ACIP.

Repeat Cultures Unnecessary in UTIs

Additional urine cultures are not necessary to confirm cure in children with urinary tract infections who have been treated with antibiotics, Dr. Nicolas Oreskovic and Dr. Eduardo Sembrano of Mount Sinai Hospital in New York reported.

Urine cultures are uncomfortable for patients, and they are expensive for hospitals. To determine the clinical value of repeating urine cultures after antibiotic therapy, the investigators reviewed data from 328 children younger than 18 years of age who were hospitalized with urinary tract infections (UTIs) between December 1998 and December 2004 and who underwent repeat urine cultures after 2 days of intravenous antibiotics (Pediatrics 2007;119: [Epub doi:10.1542/peds.2006–1134]).

Only one patient (0.3%) had a positive repeat urine culture—a 7-month-old boy who was diagnosed with a UTI and bronchiolitis. The child was allergic to amoxicillin and received trimethoprim-sulfamethoxazole. His admission culture showed Escherichia coli, but this information was not known immediately. He was subsequently treated with cefaclor, and a follow-up culture 2 days later was negative.

A repeat urine culture may be appropriate in children who do not show clinical improvement after 48 hours of antimicrobial therapy, but many pediatricians routinely reculture UTI patients after 2 days to obtain a “proof of bacteriologic cure.”

The study was limited by its retrospective nature, but the results support findings from previous studies suggesting that routine reculturing of children with UTIs who have been treated with antibiotics is unnecessary, the researchers wrote.

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Methotrexate Trumped by Adalimumab for Psoriasis

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WHISTLER, B.C. — Adalimumab was significantly more effective against psoriasis than both methotrexate and placebo were in a double-blind, double-dummy, randomized, controlled phase III trial, Dr. Richard Langley reported at a dermatology symposium.

The study is the first head-to-head comparison of a biologic and a standard systemic treatment for psoriasis, said Dr. Langley of Dalhousie University, Halifax, N.S., who participated in the multisite study. Dr. Langley has received funding to conduct the study from Abbott Laboratories, which manufactures adalimumab.

The Comparative Study of Humira vs. Methotrexate vs. Placebo in Psoriasis Patients included 271 patients with moderate to severe psoriasis from eight European countries and Canada. The patients were randomized into three groups to receive injections of adalimumab (108 patients), methotrexate (110 patients), or placebo (53 patients). The patient demographics were similar among the three groups.

The adalimumab group received the standard dosage given for other indications: a single subcutaneous injection of 80 mg, followed by a 40-mg subcutaneous injection every other week for 16 weeks.

After 16 weeks of treatment, 79.6% of the adalimumab patients achieved a Psoriasis Area and Severity Index (PASI) score of 75, which indicates a 75% reduction in symptoms of psoriasis. This improvement was statistically significant, compared with the other patients' scores: 35.5% of the methotrexate group and 18.9% of the placebo group achieved a PASI score of 75.

In addition, 88.0% of adalimumab patients achieved a PASI score of 50, compared with 61.8% of methotrexate patients and 30.2% of placebo patients, Dr. Langley reported.

Using the Physician's Global Assessment, psoriasis was judged to be clear or minimal in 73% of the adalimumab patients, compared with 30% of the methotrexate patients and 11% of placebo patients.

The mean methotrexate dosage was approximately 15 mg/kg by week 6, but it had been increased to approximately 20 mg/kg by week 12, whereas the adalimumab dose remained consistent, Dr. Langley noted.

The nature and incidence of adverse events were similar across the three groups. One placebo patient developed a kidney stone, one case of hepatitis occurred in a methotrexate patient, and one case of pancreatitis occurred in an adalimumab patient who had a history of heavy alcohol use, he said.

Nasopharyngitis was the most common of the adverse events that occurred in more than 5% of patients. Other reported adverse events included injection site reactions, hepatic events, arthralgia, and headache.

Adalimumab is currently approved in the United States for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Abbott plans to apply for a psoriasis treatment indication for adalimumab in the United States and Europe this year, Dr. Langley said.

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WHISTLER, B.C. — Adalimumab was significantly more effective against psoriasis than both methotrexate and placebo were in a double-blind, double-dummy, randomized, controlled phase III trial, Dr. Richard Langley reported at a dermatology symposium.

The study is the first head-to-head comparison of a biologic and a standard systemic treatment for psoriasis, said Dr. Langley of Dalhousie University, Halifax, N.S., who participated in the multisite study. Dr. Langley has received funding to conduct the study from Abbott Laboratories, which manufactures adalimumab.

The Comparative Study of Humira vs. Methotrexate vs. Placebo in Psoriasis Patients included 271 patients with moderate to severe psoriasis from eight European countries and Canada. The patients were randomized into three groups to receive injections of adalimumab (108 patients), methotrexate (110 patients), or placebo (53 patients). The patient demographics were similar among the three groups.

The adalimumab group received the standard dosage given for other indications: a single subcutaneous injection of 80 mg, followed by a 40-mg subcutaneous injection every other week for 16 weeks.

After 16 weeks of treatment, 79.6% of the adalimumab patients achieved a Psoriasis Area and Severity Index (PASI) score of 75, which indicates a 75% reduction in symptoms of psoriasis. This improvement was statistically significant, compared with the other patients' scores: 35.5% of the methotrexate group and 18.9% of the placebo group achieved a PASI score of 75.

In addition, 88.0% of adalimumab patients achieved a PASI score of 50, compared with 61.8% of methotrexate patients and 30.2% of placebo patients, Dr. Langley reported.

Using the Physician's Global Assessment, psoriasis was judged to be clear or minimal in 73% of the adalimumab patients, compared with 30% of the methotrexate patients and 11% of placebo patients.

The mean methotrexate dosage was approximately 15 mg/kg by week 6, but it had been increased to approximately 20 mg/kg by week 12, whereas the adalimumab dose remained consistent, Dr. Langley noted.

The nature and incidence of adverse events were similar across the three groups. One placebo patient developed a kidney stone, one case of hepatitis occurred in a methotrexate patient, and one case of pancreatitis occurred in an adalimumab patient who had a history of heavy alcohol use, he said.

Nasopharyngitis was the most common of the adverse events that occurred in more than 5% of patients. Other reported adverse events included injection site reactions, hepatic events, arthralgia, and headache.

Adalimumab is currently approved in the United States for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Abbott plans to apply for a psoriasis treatment indication for adalimumab in the United States and Europe this year, Dr. Langley said.

ELSEVIER GLOBAL MEDICAL NEWS

WHISTLER, B.C. — Adalimumab was significantly more effective against psoriasis than both methotrexate and placebo were in a double-blind, double-dummy, randomized, controlled phase III trial, Dr. Richard Langley reported at a dermatology symposium.

The study is the first head-to-head comparison of a biologic and a standard systemic treatment for psoriasis, said Dr. Langley of Dalhousie University, Halifax, N.S., who participated in the multisite study. Dr. Langley has received funding to conduct the study from Abbott Laboratories, which manufactures adalimumab.

The Comparative Study of Humira vs. Methotrexate vs. Placebo in Psoriasis Patients included 271 patients with moderate to severe psoriasis from eight European countries and Canada. The patients were randomized into three groups to receive injections of adalimumab (108 patients), methotrexate (110 patients), or placebo (53 patients). The patient demographics were similar among the three groups.

The adalimumab group received the standard dosage given for other indications: a single subcutaneous injection of 80 mg, followed by a 40-mg subcutaneous injection every other week for 16 weeks.

After 16 weeks of treatment, 79.6% of the adalimumab patients achieved a Psoriasis Area and Severity Index (PASI) score of 75, which indicates a 75% reduction in symptoms of psoriasis. This improvement was statistically significant, compared with the other patients' scores: 35.5% of the methotrexate group and 18.9% of the placebo group achieved a PASI score of 75.

In addition, 88.0% of adalimumab patients achieved a PASI score of 50, compared with 61.8% of methotrexate patients and 30.2% of placebo patients, Dr. Langley reported.

Using the Physician's Global Assessment, psoriasis was judged to be clear or minimal in 73% of the adalimumab patients, compared with 30% of the methotrexate patients and 11% of placebo patients.

The mean methotrexate dosage was approximately 15 mg/kg by week 6, but it had been increased to approximately 20 mg/kg by week 12, whereas the adalimumab dose remained consistent, Dr. Langley noted.

The nature and incidence of adverse events were similar across the three groups. One placebo patient developed a kidney stone, one case of hepatitis occurred in a methotrexate patient, and one case of pancreatitis occurred in an adalimumab patient who had a history of heavy alcohol use, he said.

Nasopharyngitis was the most common of the adverse events that occurred in more than 5% of patients. Other reported adverse events included injection site reactions, hepatic events, arthralgia, and headache.

Adalimumab is currently approved in the United States for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Abbott plans to apply for a psoriasis treatment indication for adalimumab in the United States and Europe this year, Dr. Langley said.

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Ankle-Brachial Index Gauges Arterial Ulcer Risk, Outcomes

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OTTAWA — The ankle-brachial index, which indicates the arterial supply to the legs, can help confirm an arterial wound in suspected cases of arterial leg ulcers, Dr. Rob Miller said at the annual conference of the Canadian Association of Wound Care.

Identification of atherosclerosis is often delayed because the wounds are insidious; 50%–70% of the artery's interior must be blocked before the tissue breaks down and wounds appear, said Dr. Miller, a dermatologist at Queen Elizabeth II Hospital in Halifax, N. S.

“The ankle-brachial index is the most effective and practical way to check for arterial disease,” Dr. Miller said. An ankle-brachial index (ABI) test requires measuring the blood pressure in both the ankle and the arm of the patient at rest, and dividing the ankle systolic pressure by the brachial systolic pressure. Blood pressure should be rechecked after the patient completes a 5-minute treadmill test. An ABI of 0.9 mm Hg or less after activity is predictive of arterial disease, and the ABI has a specificity of nearly 100% in identifying individuals without arterial disease, Dr. Miller noted.

Clinical features of arterial wounds include delayed capillary refill time, in which a toe takes more than 3 seconds to regain normal color after being gently squeezed, and Buerger's sign, in which the foot turns pale when elevated by 30 degrees and becomes red when lowered. Other signs are dry, scaly skin, soft tissue atrophy, and a lack of hair in the area of the ulcer.

ABI also may predict limb loss. Dr. Miller cited a recent study of 142 patients and 169 limbs in which chronic leg ulcers were treated with pressure relief, debridement, infection control, and moist healing. These patients could not be treated with revascularization surgery due to comorbidities and other risk factors (J. Vasc. Surg. 2006;44:108–14). Patients with ABI measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 6 months (28%) and 12 months of treatment (34%), compared with patients with ABIs higher than 0.5 mm Hg (10% and 15%, respectively).

The treatment strategy depends on how much fluid can pass through the arteries. If perfusion status is adequate, the wound can be debrided and dressed. If perfusion status is marginal, conservative treatment consisting of minimal, judicious debridement and dressing is indicated and should be followed with a referral to a vascular surgeon if the wound isn't healing. If perfusion status is inadequate, make a referral to a vascular surgeon, Dr. Miller advised.

Surgical revascularization is the mainstay of treatment for most arterial ulcers because pharmaceutical and medical interventions have not matched its efficacy. But not all patients are candidates for surgery, and consequently the ABI measurement can help assess which of these patients who are medically managed are more likely to need amputations.

Medical management of arterial ulcers involves treating the underlying medical problems and providing proper wound care. Strategies include lipid-lowering therapy, control of hypertension and diabetes, exercise, and topical vasodilators. Avoid excessive debridement of arterial ulcers. Instead, paint the area with a povidone-iodine mix. And don't use compression therapy, because it exacerbates ischemic disease and is contraindicated for arterial ulcers.

In one study, patients with index measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 12 months of treatment (34%), compared with patients who had index values higher than 0.5 mm Hg (15%). Courtesy Dr. Rob Miller

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OTTAWA — The ankle-brachial index, which indicates the arterial supply to the legs, can help confirm an arterial wound in suspected cases of arterial leg ulcers, Dr. Rob Miller said at the annual conference of the Canadian Association of Wound Care.

Identification of atherosclerosis is often delayed because the wounds are insidious; 50%–70% of the artery's interior must be blocked before the tissue breaks down and wounds appear, said Dr. Miller, a dermatologist at Queen Elizabeth II Hospital in Halifax, N. S.

“The ankle-brachial index is the most effective and practical way to check for arterial disease,” Dr. Miller said. An ankle-brachial index (ABI) test requires measuring the blood pressure in both the ankle and the arm of the patient at rest, and dividing the ankle systolic pressure by the brachial systolic pressure. Blood pressure should be rechecked after the patient completes a 5-minute treadmill test. An ABI of 0.9 mm Hg or less after activity is predictive of arterial disease, and the ABI has a specificity of nearly 100% in identifying individuals without arterial disease, Dr. Miller noted.

Clinical features of arterial wounds include delayed capillary refill time, in which a toe takes more than 3 seconds to regain normal color after being gently squeezed, and Buerger's sign, in which the foot turns pale when elevated by 30 degrees and becomes red when lowered. Other signs are dry, scaly skin, soft tissue atrophy, and a lack of hair in the area of the ulcer.

ABI also may predict limb loss. Dr. Miller cited a recent study of 142 patients and 169 limbs in which chronic leg ulcers were treated with pressure relief, debridement, infection control, and moist healing. These patients could not be treated with revascularization surgery due to comorbidities and other risk factors (J. Vasc. Surg. 2006;44:108–14). Patients with ABI measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 6 months (28%) and 12 months of treatment (34%), compared with patients with ABIs higher than 0.5 mm Hg (10% and 15%, respectively).

The treatment strategy depends on how much fluid can pass through the arteries. If perfusion status is adequate, the wound can be debrided and dressed. If perfusion status is marginal, conservative treatment consisting of minimal, judicious debridement and dressing is indicated and should be followed with a referral to a vascular surgeon if the wound isn't healing. If perfusion status is inadequate, make a referral to a vascular surgeon, Dr. Miller advised.

Surgical revascularization is the mainstay of treatment for most arterial ulcers because pharmaceutical and medical interventions have not matched its efficacy. But not all patients are candidates for surgery, and consequently the ABI measurement can help assess which of these patients who are medically managed are more likely to need amputations.

Medical management of arterial ulcers involves treating the underlying medical problems and providing proper wound care. Strategies include lipid-lowering therapy, control of hypertension and diabetes, exercise, and topical vasodilators. Avoid excessive debridement of arterial ulcers. Instead, paint the area with a povidone-iodine mix. And don't use compression therapy, because it exacerbates ischemic disease and is contraindicated for arterial ulcers.

In one study, patients with index measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 12 months of treatment (34%), compared with patients who had index values higher than 0.5 mm Hg (15%). Courtesy Dr. Rob Miller

OTTAWA — The ankle-brachial index, which indicates the arterial supply to the legs, can help confirm an arterial wound in suspected cases of arterial leg ulcers, Dr. Rob Miller said at the annual conference of the Canadian Association of Wound Care.

Identification of atherosclerosis is often delayed because the wounds are insidious; 50%–70% of the artery's interior must be blocked before the tissue breaks down and wounds appear, said Dr. Miller, a dermatologist at Queen Elizabeth II Hospital in Halifax, N. S.

“The ankle-brachial index is the most effective and practical way to check for arterial disease,” Dr. Miller said. An ankle-brachial index (ABI) test requires measuring the blood pressure in both the ankle and the arm of the patient at rest, and dividing the ankle systolic pressure by the brachial systolic pressure. Blood pressure should be rechecked after the patient completes a 5-minute treadmill test. An ABI of 0.9 mm Hg or less after activity is predictive of arterial disease, and the ABI has a specificity of nearly 100% in identifying individuals without arterial disease, Dr. Miller noted.

Clinical features of arterial wounds include delayed capillary refill time, in which a toe takes more than 3 seconds to regain normal color after being gently squeezed, and Buerger's sign, in which the foot turns pale when elevated by 30 degrees and becomes red when lowered. Other signs are dry, scaly skin, soft tissue atrophy, and a lack of hair in the area of the ulcer.

ABI also may predict limb loss. Dr. Miller cited a recent study of 142 patients and 169 limbs in which chronic leg ulcers were treated with pressure relief, debridement, infection control, and moist healing. These patients could not be treated with revascularization surgery due to comorbidities and other risk factors (J. Vasc. Surg. 2006;44:108–14). Patients with ABI measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 6 months (28%) and 12 months of treatment (34%), compared with patients with ABIs higher than 0.5 mm Hg (10% and 15%, respectively).

The treatment strategy depends on how much fluid can pass through the arteries. If perfusion status is adequate, the wound can be debrided and dressed. If perfusion status is marginal, conservative treatment consisting of minimal, judicious debridement and dressing is indicated and should be followed with a referral to a vascular surgeon if the wound isn't healing. If perfusion status is inadequate, make a referral to a vascular surgeon, Dr. Miller advised.

Surgical revascularization is the mainstay of treatment for most arterial ulcers because pharmaceutical and medical interventions have not matched its efficacy. But not all patients are candidates for surgery, and consequently the ABI measurement can help assess which of these patients who are medically managed are more likely to need amputations.

Medical management of arterial ulcers involves treating the underlying medical problems and providing proper wound care. Strategies include lipid-lowering therapy, control of hypertension and diabetes, exercise, and topical vasodilators. Avoid excessive debridement of arterial ulcers. Instead, paint the area with a povidone-iodine mix. And don't use compression therapy, because it exacerbates ischemic disease and is contraindicated for arterial ulcers.

In one study, patients with index measurements less than 0.5 mm Hg were significantly more likely to have a limb amputated after 12 months of treatment (34%), compared with patients who had index values higher than 0.5 mm Hg (15%). Courtesy Dr. Rob Miller

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