Patrice Wendling

CHICAGO — Routine use of renin angiotensin system blockers is indicated in patients with chronic kidney disease as part of a strategy to reduce cardiovascular and renal events, Dr. Matthew Weir said at the annual meeting of the American Society of Hypertension.

Patients with chronic kidney disease benefit as much as, if not more than, the general population benefits from the antihypertensive and antiproteinuric effects of renin angiotensin system (RAS) blockade because they are at increased risk for cardiovascular disease.

Decreased glomerular filtration rate (GFR), a specific indication of chronic kidney disease, has consistently been found to be an independent risk factor for cardiovascular disease outcomes and all-cause mortality.

Growing evidence, including a well-designed trial from China (N. Engl. J. Med. 2006;354:131–40), also suggests that the sicker the kidney, the greater the risk-reduction benefit with RAS blockade.

But there is anxiety about using ACE inhibitors or angiotensin II receptor blockers (ARBs) in patients with higher serum creatinine levels or reduced GFR because of concern that those levels will rise, Dr. Weir, director of the nephrology division, University of Maryland, Baltimore, said.

Because RAS blockers are designed to reduce glomerular capillary pressure, there will be a functional increase in serum creatinine or a decrease in estimated GFR. That increase or decrease can average 15%–30%, depending on the volume status of the patient, renal artery anatomy, and other cotherapies the patient is receiving. The functional change in GFR results in a long-term anatomic advantage, because the reduced capillary pressure results in less injury to the glomerular structure, Dr. Weir said.

In addition, fluctuations in serum creatinine and potassium are predictable, and discontinuation of RAS blockade is almost always avoidable.

If creatinine increases by more than 30%, Dr. Weir suggests evaluating the patient's use of diuretics and volume status, and ruling out concomitant use of NSAIDs. If the first two points are unlikely causes, then clinically significant renal artery stenosis should be ruled out.

If serum potassium increases by more than 0.5 mEq/L, then rule out eating too much fruit or other foods that are high in potassium; rule out concomitant use of NSAIDs, salt substitutes, and potassium-sparing diuretics such as triamterene, spironolactone, and eplerenone; and consider type 4 renal tubular acidosis.

Hyperkalemia has been reported in some ARB trials, but medication was discontinued in only a small percentage of patients. Hyperkalemia is unusual, Dr. Weir asserted, because the kidney develops homeostatic mechanisms mediated by an increase in sodium potassium adenosinetriphosphatase activity in the renal tubular epithelial cells of the cortical collecting duct. Only type 4 renal tubular acidosis, NSAIDs, or hypoaldosteronism limit this homeostatic effect, he added.

Other clinical pearls included:

▸ Adjusting the dose of RAS blocker based on estimated GFR and known excretory routes.

▸ Monitoring the patient's weight daily, especially if there is a change in the RAS blocker or diuretic dose.

▸ More frequently assessing serum potassium and creatinine levels with dose changes or diuretic changes, or with gastrointestinal illness.

▸ Stopping the RAS blocker and checking electrolytes if there is any clinical concern about dehydration.

CHICAGO — Routine use of renin angiotensin system blockers is indicated in patients with chronic kidney disease as part of a strategy to reduce cardiovascular and renal events, Dr. Matthew Weir said at the annual meeting of the American Society of Hypertension.

Patients with chronic kidney disease benefit as much as, if not more than, the general population benefits from the antihypertensive and antiproteinuric effects of renin angiotensin system (RAS) blockade because they are at increased risk for cardiovascular disease.

Decreased glomerular filtration rate (GFR), a specific indication of chronic kidney disease, has consistently been found to be an independent risk factor for cardiovascular disease outcomes and all-cause mortality.

Growing evidence, including a well-designed trial from China (N. Engl. J. Med. 2006;354:131–40), also suggests that the sicker the kidney, the greater the risk-reduction benefit with RAS blockade.

But there is anxiety about using ACE inhibitors or angiotensin II receptor blockers (ARBs) in patients with higher serum creatinine levels or reduced GFR because of concern that those levels will rise, Dr. Weir, director of the nephrology division, University of Maryland, Baltimore, said.

Because RAS blockers are designed to reduce glomerular capillary pressure, there will be a functional increase in serum creatinine or a decrease in estimated GFR. That increase or decrease can average 15%–30%, depending on the volume status of the patient, renal artery anatomy, and other cotherapies the patient is receiving. The functional change in GFR results in a long-term anatomic advantage, because the reduced capillary pressure results in less injury to the glomerular structure, Dr. Weir said.

In addition, fluctuations in serum creatinine and potassium are predictable, and discontinuation of RAS blockade is almost always avoidable.

If creatinine increases by more than 30%, Dr. Weir suggests evaluating the patient's use of diuretics and volume status, and ruling out concomitant use of NSAIDs. If the first two points are unlikely causes, then clinically significant renal artery stenosis should be ruled out.

If serum potassium increases by more than 0.5 mEq/L, then rule out eating too much fruit or other foods that are high in potassium; rule out concomitant use of NSAIDs, salt substitutes, and potassium-sparing diuretics such as triamterene, spironolactone, and eplerenone; and consider type 4 renal tubular acidosis.

Hyperkalemia has been reported in some ARB trials, but medication was discontinued in only a small percentage of patients. Hyperkalemia is unusual, Dr. Weir asserted, because the kidney develops homeostatic mechanisms mediated by an increase in sodium potassium adenosinetriphosphatase activity in the renal tubular epithelial cells of the cortical collecting duct. Only type 4 renal tubular acidosis, NSAIDs, or hypoaldosteronism limit this homeostatic effect, he added.

Other clinical pearls included:

▸ Adjusting the dose of RAS blocker based on estimated GFR and known excretory routes.

▸ Monitoring the patient's weight daily, especially if there is a change in the RAS blocker or diuretic dose.

▸ More frequently assessing serum potassium and creatinine levels with dose changes or diuretic changes, or with gastrointestinal illness.

▸ Stopping the RAS blocker and checking electrolytes if there is any clinical concern about dehydration.

CHICAGO — Routine use of renin angiotensin system blockers is indicated in patients with chronic kidney disease as part of a strategy to reduce cardiovascular and renal events, Dr. Matthew Weir said at the annual meeting of the American Society of Hypertension.

Patients with chronic kidney disease benefit as much as, if not more than, the general population benefits from the antihypertensive and antiproteinuric effects of renin angiotensin system (RAS) blockade because they are at increased risk for cardiovascular disease.

Decreased glomerular filtration rate (GFR), a specific indication of chronic kidney disease, has consistently been found to be an independent risk factor for cardiovascular disease outcomes and all-cause mortality.

Growing evidence, including a well-designed trial from China (N. Engl. J. Med. 2006;354:131–40), also suggests that the sicker the kidney, the greater the risk-reduction benefit with RAS blockade.

But there is anxiety about using ACE inhibitors or angiotensin II receptor blockers (ARBs) in patients with higher serum creatinine levels or reduced GFR because of concern that those levels will rise, Dr. Weir, director of the nephrology division, University of Maryland, Baltimore, said.

Because RAS blockers are designed to reduce glomerular capillary pressure, there will be a functional increase in serum creatinine or a decrease in estimated GFR. That increase or decrease can average 15%–30%, depending on the volume status of the patient, renal artery anatomy, and other cotherapies the patient is receiving. The functional change in GFR results in a long-term anatomic advantage, because the reduced capillary pressure results in less injury to the glomerular structure, Dr. Weir said.

In addition, fluctuations in serum creatinine and potassium are predictable, and discontinuation of RAS blockade is almost always avoidable.

If creatinine increases by more than 30%, Dr. Weir suggests evaluating the patient's use of diuretics and volume status, and ruling out concomitant use of NSAIDs. If the first two points are unlikely causes, then clinically significant renal artery stenosis should be ruled out.

If serum potassium increases by more than 0.5 mEq/L, then rule out eating too much fruit or other foods that are high in potassium; rule out concomitant use of NSAIDs, salt substitutes, and potassium-sparing diuretics such as triamterene, spironolactone, and eplerenone; and consider type 4 renal tubular acidosis.

Hyperkalemia has been reported in some ARB trials, but medication was discontinued in only a small percentage of patients. Hyperkalemia is unusual, Dr. Weir asserted, because the kidney develops homeostatic mechanisms mediated by an increase in sodium potassium adenosinetriphosphatase activity in the renal tubular epithelial cells of the cortical collecting duct. Only type 4 renal tubular acidosis, NSAIDs, or hypoaldosteronism limit this homeostatic effect, he added.

Other clinical pearls included:

▸ Adjusting the dose of RAS blocker based on estimated GFR and known excretory routes.

▸ Monitoring the patient's weight daily, especially if there is a change in the RAS blocker or diuretic dose.

▸ More frequently assessing serum potassium and creatinine levels with dose changes or diuretic changes, or with gastrointestinal illness.

▸ Stopping the RAS blocker and checking electrolytes if there is any clinical concern about dehydration.

CHICAGO — Health care professionals are trying a new tack to better engage diabetes patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

Roughly 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years. The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians, nurses, and pharmacists. The five Conversation Maps will be provided free to those who go through the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that is used as a framework by the facilitator to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct.

“It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on,” he added.

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A_1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, he explained.

The wide range of subjects addressed by the maps is particularly attractive to patient advocate Michael Weiss, past chair of the ADA board and member of the ADA content team, who said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works.

“This is the validation that patients have a seat at the table,” Mr. Weiss told reporters. “To my knowledge, this is the only educational product developed by physicians and patients working together, and I think that says a lot about the project.”

U.S. Diabetes Conversation Maps depict symbolic images that can help groups explore a variety of diabetes-related issues. Healthy Interactions Inc.

CHICAGO — Health care professionals are trying a new tack to better engage diabetes patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

Roughly 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years. The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians, nurses, and pharmacists. The five Conversation Maps will be provided free to those who go through the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that is used as a framework by the facilitator to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct.

“It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on,” he added.

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A_1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, he explained.

The wide range of subjects addressed by the maps is particularly attractive to patient advocate Michael Weiss, past chair of the ADA board and member of the ADA content team, who said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works.

“This is the validation that patients have a seat at the table,” Mr. Weiss told reporters. “To my knowledge, this is the only educational product developed by physicians and patients working together, and I think that says a lot about the project.”

U.S. Diabetes Conversation Maps depict symbolic images that can help groups explore a variety of diabetes-related issues. Healthy Interactions Inc.

CHICAGO — Health care professionals are trying a new tack to better engage diabetes patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

Roughly 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years. The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians, nurses, and pharmacists. The five Conversation Maps will be provided free to those who go through the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that is used as a framework by the facilitator to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct.

“It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on,” he added.

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A_1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, he explained.

The wide range of subjects addressed by the maps is particularly attractive to patient advocate Michael Weiss, past chair of the ADA board and member of the ADA content team, who said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works.

“This is the validation that patients have a seat at the table,” Mr. Weiss told reporters. “To my knowledge, this is the only educational product developed by physicians and patients working together, and I think that says a lot about the project.”

U.S. Diabetes Conversation Maps depict symbolic images that can help groups explore a variety of diabetes-related issues. Healthy Interactions Inc.

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in BP control, because BP reductions were comparable in patients taking either angiotension II receptor blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said in a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect than did those on losartan. This is important to clinicians, because it suggests that telmisartan has done something independent of controlling BP to change the natural history or biology of the disease. “The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of end-stage renal disease, although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as BP > 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, ACE inhibitors, and direct vasodilators.

At admission, the average BP was 143/80 mm Hg in both groups; the mean urinary protein to creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine level was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in the morning spot urinary protein to creatinine ratio—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Adverse events were not different between groups, said Dr. Bakris, who disclosed that he is a consultant and speaker for, and has received research support from, the study sponsor Boehringer Ingelheim.

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in BP control, because BP reductions were comparable in patients taking either angiotension II receptor blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said in a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect than did those on losartan. This is important to clinicians, because it suggests that telmisartan has done something independent of controlling BP to change the natural history or biology of the disease. “The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of end-stage renal disease, although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as BP > 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, ACE inhibitors, and direct vasodilators.

At admission, the average BP was 143/80 mm Hg in both groups; the mean urinary protein to creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine level was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in the morning spot urinary protein to creatinine ratio—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Adverse events were not different between groups, said Dr. Bakris, who disclosed that he is a consultant and speaker for, and has received research support from, the study sponsor Boehringer Ingelheim.

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in BP control, because BP reductions were comparable in patients taking either angiotension II receptor blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said in a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect than did those on losartan. This is important to clinicians, because it suggests that telmisartan has done something independent of controlling BP to change the natural history or biology of the disease. “The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of end-stage renal disease, although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as BP > 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, ACE inhibitors, and direct vasodilators.

At admission, the average BP was 143/80 mm Hg in both groups; the mean urinary protein to creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine level was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in the morning spot urinary protein to creatinine ratio—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Adverse events were not different between groups, said Dr. Bakris, who disclosed that he is a consultant and speaker for, and has received research support from, the study sponsor Boehringer Ingelheim.

CHICAGO — Monovalent acellular pertussis vaccine given at birth and 1 month results in immunogenicity in infants by 2 months of age, according to data presented in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The finding is important because most cases of severe pertussis disease occur in infants less than 4 months of age, before they are fully vaccinated. The currently recommended vaccination schedule for U.S. children aged 0–6 years calls for diphtheria, tetanus, and acellular pertussis (DTaP) vaccinations at 2, 4, and 6 months of age.

Two doses of acellular pertussis are thought to be crucial for protection, but are typically delayed until at least 6 weeks of age because of concerns that the newborns' immature immune systems may not recognize the vaccine and respond by making antibodies, and that maternal antibodies may interfere with vaccine efficacy, lead investigator Dr. Nicolas Wood told reporters at a press briefing at the conference, which was sponsored by the American Society for Microbiology.

“We think it's an important study because we were able to show that the early doses at birth and 1 month could get you higher antibody at a time [when] if you do get pertussis infection you are more likely to get severe disease,” said Dr. Wood, a pediatrician and clinical fellow at the Children's Hospital at Westmead, New South Wales, Australia.

Dr. Wood and his associates at the Women's and Children's Hospital, in Adelaide, Australia, examined the immunogenicity of birth and 1-month acellular pertussis (Pa) vaccination in a cohort of 76 children. Serology and pertussis vaccine were provided by GlaxoSmithKline. Each dose contained pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, and pertactin 8 mcg. The children were divided into three groups. (See accompanying chart for vaccination schedules.)

At 2 months of age, infants who received pertussis vaccine at birth and 1 month had significantly higher antibody levels against pertussis toxin and pertactin (an antigenic protein in most pertussis vaccines) than infants who received pertussis just at birth or who did not receive any pertussis before 2 months of age.

The infants were followed for 4, 6, and 8 months, and at all time points, the infants who received pertussis vaccine at birth and 1 month had higher antibody levels against pertussis toxin and pertactin than infants on the other two schedules.

The difference in antipertussis response was significant at 2, 4, and 6 months for group 1 vs. groups 2 and 3 (P < .05), and at 2 and 4 months for group 2 versus group 3 (P < .05).

“By the end we were able to show that giving the early doses had given them earlier antibody protection, and by the time they'd finished the schedule, the antibodies were equivalent to those [in] babies [who] started later,” Dr. Wood said. “So it didn't result in the suppression of the immune system, which was of one of our concerns.”

Among the 75 evaluated children, there were no serious adverse reactions. One child was exposed to pertussis, which resulted in a mild case. Because there was only one exposure, Dr. Wood said no conclusions could be made about how protective the early schedule is against disease. Unlike hepatitis B, there is no specific antibody level cutoff point at which protection can be guaranteed.

Larger trials are needed to consider the combination of pertussis with hepatitis B vaccine at birth and different schedules, said Dr. Wood, who received research support from the Financial Markets Foundation for Children in Australia.

Dr. Claire Anne Siegrist of the Centre of Vaccinology and the Neonatal Immunology, University of Geneva, said in an interview that the findings confirm results reported previously by her and her colleagues. “What all of our studies have shown is that you can give the first dose of pertussis at birth and already have a significant immune response much earlier than if you wait until the age of 2 months, which is the regular timing,” she said.

Further studies are needed to define the best dosing schedule, she said, and to entice vaccine manufacturers to create a monovalent acellular pertussis vaccine, which currently is not commercially available.

A third study, reported by Dr. Natasha Halasa at the Interscience Conference on Antimicrobial Agents and Chemotherapy in 2005, supports the use of a monovalent pertussis vaccine, as antibody suppression was demonstrated when pertussis was given in combination with diphtheria. “One of the theories with the diphtheria added with it is that there may be some intolerance early on that is interfering with the antigen presentation with pertussis,” Dr. Halasa of Vanderbilt Children's Hospital, Nashville, Tenn., said in an interview.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Monovalent acellular pertussis vaccine given at birth and 1 month results in immunogenicity in infants by 2 months of age, according to data presented in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The finding is important because most cases of severe pertussis disease occur in infants less than 4 months of age, before they are fully vaccinated. The currently recommended vaccination schedule for U.S. children aged 0–6 years calls for diphtheria, tetanus, and acellular pertussis (DTaP) vaccinations at 2, 4, and 6 months of age.

Two doses of acellular pertussis are thought to be crucial for protection, but are typically delayed until at least 6 weeks of age because of concerns that the newborns' immature immune systems may not recognize the vaccine and respond by making antibodies, and that maternal antibodies may interfere with vaccine efficacy, lead investigator Dr. Nicolas Wood told reporters at a press briefing at the conference, which was sponsored by the American Society for Microbiology.

“We think it's an important study because we were able to show that the early doses at birth and 1 month could get you higher antibody at a time [when] if you do get pertussis infection you are more likely to get severe disease,” said Dr. Wood, a pediatrician and clinical fellow at the Children's Hospital at Westmead, New South Wales, Australia.

Dr. Wood and his associates at the Women's and Children's Hospital, in Adelaide, Australia, examined the immunogenicity of birth and 1-month acellular pertussis (Pa) vaccination in a cohort of 76 children. Serology and pertussis vaccine were provided by GlaxoSmithKline. Each dose contained pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, and pertactin 8 mcg. The children were divided into three groups. (See accompanying chart for vaccination schedules.)

At 2 months of age, infants who received pertussis vaccine at birth and 1 month had significantly higher antibody levels against pertussis toxin and pertactin (an antigenic protein in most pertussis vaccines) than infants who received pertussis just at birth or who did not receive any pertussis before 2 months of age.

The infants were followed for 4, 6, and 8 months, and at all time points, the infants who received pertussis vaccine at birth and 1 month had higher antibody levels against pertussis toxin and pertactin than infants on the other two schedules.

The difference in antipertussis response was significant at 2, 4, and 6 months for group 1 vs. groups 2 and 3 (P < .05), and at 2 and 4 months for group 2 versus group 3 (P < .05).

“By the end we were able to show that giving the early doses had given them earlier antibody protection, and by the time they'd finished the schedule, the antibodies were equivalent to those [in] babies [who] started later,” Dr. Wood said. “So it didn't result in the suppression of the immune system, which was of one of our concerns.”

Among the 75 evaluated children, there were no serious adverse reactions. One child was exposed to pertussis, which resulted in a mild case. Because there was only one exposure, Dr. Wood said no conclusions could be made about how protective the early schedule is against disease. Unlike hepatitis B, there is no specific antibody level cutoff point at which protection can be guaranteed.

Larger trials are needed to consider the combination of pertussis with hepatitis B vaccine at birth and different schedules, said Dr. Wood, who received research support from the Financial Markets Foundation for Children in Australia.

Dr. Claire Anne Siegrist of the Centre of Vaccinology and the Neonatal Immunology, University of Geneva, said in an interview that the findings confirm results reported previously by her and her colleagues. “What all of our studies have shown is that you can give the first dose of pertussis at birth and already have a significant immune response much earlier than if you wait until the age of 2 months, which is the regular timing,” she said.

Further studies are needed to define the best dosing schedule, she said, and to entice vaccine manufacturers to create a monovalent acellular pertussis vaccine, which currently is not commercially available.

A third study, reported by Dr. Natasha Halasa at the Interscience Conference on Antimicrobial Agents and Chemotherapy in 2005, supports the use of a monovalent pertussis vaccine, as antibody suppression was demonstrated when pertussis was given in combination with diphtheria. “One of the theories with the diphtheria added with it is that there may be some intolerance early on that is interfering with the antigen presentation with pertussis,” Dr. Halasa of Vanderbilt Children's Hospital, Nashville, Tenn., said in an interview.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Monovalent acellular pertussis vaccine given at birth and 1 month results in immunogenicity in infants by 2 months of age, according to data presented in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The finding is important because most cases of severe pertussis disease occur in infants less than 4 months of age, before they are fully vaccinated. The currently recommended vaccination schedule for U.S. children aged 0–6 years calls for diphtheria, tetanus, and acellular pertussis (DTaP) vaccinations at 2, 4, and 6 months of age.

Two doses of acellular pertussis are thought to be crucial for protection, but are typically delayed until at least 6 weeks of age because of concerns that the newborns' immature immune systems may not recognize the vaccine and respond by making antibodies, and that maternal antibodies may interfere with vaccine efficacy, lead investigator Dr. Nicolas Wood told reporters at a press briefing at the conference, which was sponsored by the American Society for Microbiology.

“We think it's an important study because we were able to show that the early doses at birth and 1 month could get you higher antibody at a time [when] if you do get pertussis infection you are more likely to get severe disease,” said Dr. Wood, a pediatrician and clinical fellow at the Children's Hospital at Westmead, New South Wales, Australia.

Dr. Wood and his associates at the Women's and Children's Hospital, in Adelaide, Australia, examined the immunogenicity of birth and 1-month acellular pertussis (Pa) vaccination in a cohort of 76 children. Serology and pertussis vaccine were provided by GlaxoSmithKline. Each dose contained pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, and pertactin 8 mcg. The children were divided into three groups. (See accompanying chart for vaccination schedules.)

At 2 months of age, infants who received pertussis vaccine at birth and 1 month had significantly higher antibody levels against pertussis toxin and pertactin (an antigenic protein in most pertussis vaccines) than infants who received pertussis just at birth or who did not receive any pertussis before 2 months of age.

The infants were followed for 4, 6, and 8 months, and at all time points, the infants who received pertussis vaccine at birth and 1 month had higher antibody levels against pertussis toxin and pertactin than infants on the other two schedules.

The difference in antipertussis response was significant at 2, 4, and 6 months for group 1 vs. groups 2 and 3 (P < .05), and at 2 and 4 months for group 2 versus group 3 (P < .05).

“By the end we were able to show that giving the early doses had given them earlier antibody protection, and by the time they'd finished the schedule, the antibodies were equivalent to those [in] babies [who] started later,” Dr. Wood said. “So it didn't result in the suppression of the immune system, which was of one of our concerns.”

Among the 75 evaluated children, there were no serious adverse reactions. One child was exposed to pertussis, which resulted in a mild case. Because there was only one exposure, Dr. Wood said no conclusions could be made about how protective the early schedule is against disease. Unlike hepatitis B, there is no specific antibody level cutoff point at which protection can be guaranteed.

Larger trials are needed to consider the combination of pertussis with hepatitis B vaccine at birth and different schedules, said Dr. Wood, who received research support from the Financial Markets Foundation for Children in Australia.

Dr. Claire Anne Siegrist of the Centre of Vaccinology and the Neonatal Immunology, University of Geneva, said in an interview that the findings confirm results reported previously by her and her colleagues. “What all of our studies have shown is that you can give the first dose of pertussis at birth and already have a significant immune response much earlier than if you wait until the age of 2 months, which is the regular timing,” she said.

Further studies are needed to define the best dosing schedule, she said, and to entice vaccine manufacturers to create a monovalent acellular pertussis vaccine, which currently is not commercially available.

A third study, reported by Dr. Natasha Halasa at the Interscience Conference on Antimicrobial Agents and Chemotherapy in 2005, supports the use of a monovalent pertussis vaccine, as antibody suppression was demonstrated when pertussis was given in combination with diphtheria. “One of the theories with the diphtheria added with it is that there may be some intolerance early on that is interfering with the antigen presentation with pertussis,” Dr. Halasa of Vanderbilt Children's Hospital, Nashville, Tenn., said in an interview.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Oral tinidazole, single-dose clindamycin vaginal cream, and lactobacillus-containing products are among the newer therapies for the treatment of bacterial vaginosis, Dr. Paul Nyirjesy said at a conference on vulvovaginal diseases.

Many of the therapies have emerged since the Centers for Disease Control and Prevention's treatment guidelines for bacterial vaginosis (BV) were issued in 2006. Bacterial vaginosis is among the most common vaginal diseases, occurring in about 10% of American women of reproductive age.

Oral tinidazole was approved in the United States in May 2007 for the treatment of BV. A recently published randomized controlled study in 235 women with BV found no significant difference in cure rates when tinidazole was administered as 1 g daily for 5 days or 2 g daily for 2 days. (Obstet. Gynecol. 2007;110:302–9).

Using the Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% of those using the 5-day regimen were cured, compared with the 5.7% who received placebo, said Dr. Nyirjesy, an investigator for the study. Both tinidazole regimens were superior to placebo.

The CDC's recommended oral therapy for BV is metronidazole 500 mg, twice a day for 7 days, with clindamycin 300 mg, twice a day for 7 days listed as an alternative. Although metronidazole can cause GI complaints in up to 52% of patients, it remains the cheapest therapy for BV, said Dr. Nyirjesy, professor of obstetrics and gynecology and medicine at Drexel University College of Medicine, in Philadelphia. Oral metronidazole 2 g as a single dose was dropped as an alternative oral therapy in the 2006 guidelines because it is inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation, said Dr. Nyirjesy, who has received support from Mission Pharmacal and KV Pharmaceuticals/Ther-RX, which respectively manufacture tinidazole and single-dose clindamycin cream. In a study of 251 women with BV, clinical cure rates were not significantly different between single-dose clindamycin (Clindesse) and clindamycin 7-day (Cleocin) vaginal creams (88% vs. 83%, respectively; Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV because the goal of treatment is to reestablish naturally occurring lactobacillus flora in the vagina depleted by BV and to decrease the presence of other species, such as Mobiluncus and G. vaginalis. But study findings have been mixed, and Dr. Nyirjesy suggested individualizing BV therapy based on a range of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference. He noted that most of the lactobacillus products are not available in the U.S.

The debate about which antibiotic is better has been further complicated by emerging evidence that not all BV is the same. For example, research has shown that, compared with other pregnant women, women with BV who have Mobiluncus morphotypes on Gram stain are more likely to be symptomatic, have higher numbers of clue cells and positive “whiff” tests, and have vaginal immune and hydrolytic enzyme profiles, all of which are associated with a greater risk of preterm birth, Dr. Nyirjesy said.

A recent study led by Dr. Nyirjesy (Sex. Transm. Dis. 2007;34:197–202) found that significantly more patients on single-dose 2% clindamycin cream cleared Mobiluncus morphotypes than patients on multiple doses of 0.75 metronidazole gel (97.5% vs. 80%, respectively).

Among women with Mobiluncus at baseline, clinical cure rates were significantly higher in those who received clindamycin (57.5% vs. 27%), but were not significantly different between treatment groups in women with no Mobiluncus at baseline (61% vs. 53%). He stressed that this was a retrospective study from pooled data, and that marketing efforts not withstanding, it was a preliminary paper that calls for further investigation.

Some audience members asked whether they should identify species on wet mount for all their BV patients.

“Absolutely not,” said Dr. Nyirjesy. “Not all bacterial vaginosis is the same, and there may be different responses to antibiotics in women with BV.”

CHICAGO — Oral tinidazole, single-dose clindamycin vaginal cream, and lactobacillus-containing products are among the newer therapies for the treatment of bacterial vaginosis, Dr. Paul Nyirjesy said at a conference on vulvovaginal diseases.

Many of the therapies have emerged since the Centers for Disease Control and Prevention's treatment guidelines for bacterial vaginosis (BV) were issued in 2006. Bacterial vaginosis is among the most common vaginal diseases, occurring in about 10% of American women of reproductive age.

Oral tinidazole was approved in the United States in May 2007 for the treatment of BV. A recently published randomized controlled study in 235 women with BV found no significant difference in cure rates when tinidazole was administered as 1 g daily for 5 days or 2 g daily for 2 days. (Obstet. Gynecol. 2007;110:302–9).

Using the Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% of those using the 5-day regimen were cured, compared with the 5.7% who received placebo, said Dr. Nyirjesy, an investigator for the study. Both tinidazole regimens were superior to placebo.

The CDC's recommended oral therapy for BV is metronidazole 500 mg, twice a day for 7 days, with clindamycin 300 mg, twice a day for 7 days listed as an alternative. Although metronidazole can cause GI complaints in up to 52% of patients, it remains the cheapest therapy for BV, said Dr. Nyirjesy, professor of obstetrics and gynecology and medicine at Drexel University College of Medicine, in Philadelphia. Oral metronidazole 2 g as a single dose was dropped as an alternative oral therapy in the 2006 guidelines because it is inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation, said Dr. Nyirjesy, who has received support from Mission Pharmacal and KV Pharmaceuticals/Ther-RX, which respectively manufacture tinidazole and single-dose clindamycin cream. In a study of 251 women with BV, clinical cure rates were not significantly different between single-dose clindamycin (Clindesse) and clindamycin 7-day (Cleocin) vaginal creams (88% vs. 83%, respectively; Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV because the goal of treatment is to reestablish naturally occurring lactobacillus flora in the vagina depleted by BV and to decrease the presence of other species, such as Mobiluncus and G. vaginalis. But study findings have been mixed, and Dr. Nyirjesy suggested individualizing BV therapy based on a range of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference. He noted that most of the lactobacillus products are not available in the U.S.

The debate about which antibiotic is better has been further complicated by emerging evidence that not all BV is the same. For example, research has shown that, compared with other pregnant women, women with BV who have Mobiluncus morphotypes on Gram stain are more likely to be symptomatic, have higher numbers of clue cells and positive “whiff” tests, and have vaginal immune and hydrolytic enzyme profiles, all of which are associated with a greater risk of preterm birth, Dr. Nyirjesy said.

A recent study led by Dr. Nyirjesy (Sex. Transm. Dis. 2007;34:197–202) found that significantly more patients on single-dose 2% clindamycin cream cleared Mobiluncus morphotypes than patients on multiple doses of 0.75 metronidazole gel (97.5% vs. 80%, respectively).

Among women with Mobiluncus at baseline, clinical cure rates were significantly higher in those who received clindamycin (57.5% vs. 27%), but were not significantly different between treatment groups in women with no Mobiluncus at baseline (61% vs. 53%). He stressed that this was a retrospective study from pooled data, and that marketing efforts not withstanding, it was a preliminary paper that calls for further investigation.

Some audience members asked whether they should identify species on wet mount for all their BV patients.

“Absolutely not,” said Dr. Nyirjesy. “Not all bacterial vaginosis is the same, and there may be different responses to antibiotics in women with BV.”

CHICAGO — Oral tinidazole, single-dose clindamycin vaginal cream, and lactobacillus-containing products are among the newer therapies for the treatment of bacterial vaginosis, Dr. Paul Nyirjesy said at a conference on vulvovaginal diseases.

Many of the therapies have emerged since the Centers for Disease Control and Prevention's treatment guidelines for bacterial vaginosis (BV) were issued in 2006. Bacterial vaginosis is among the most common vaginal diseases, occurring in about 10% of American women of reproductive age.

Oral tinidazole was approved in the United States in May 2007 for the treatment of BV. A recently published randomized controlled study in 235 women with BV found no significant difference in cure rates when tinidazole was administered as 1 g daily for 5 days or 2 g daily for 2 days. (Obstet. Gynecol. 2007;110:302–9).

Using the Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% of those using the 5-day regimen were cured, compared with the 5.7% who received placebo, said Dr. Nyirjesy, an investigator for the study. Both tinidazole regimens were superior to placebo.

The CDC's recommended oral therapy for BV is metronidazole 500 mg, twice a day for 7 days, with clindamycin 300 mg, twice a day for 7 days listed as an alternative. Although metronidazole can cause GI complaints in up to 52% of patients, it remains the cheapest therapy for BV, said Dr. Nyirjesy, professor of obstetrics and gynecology and medicine at Drexel University College of Medicine, in Philadelphia. Oral metronidazole 2 g as a single dose was dropped as an alternative oral therapy in the 2006 guidelines because it is inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation, said Dr. Nyirjesy, who has received support from Mission Pharmacal and KV Pharmaceuticals/Ther-RX, which respectively manufacture tinidazole and single-dose clindamycin cream. In a study of 251 women with BV, clinical cure rates were not significantly different between single-dose clindamycin (Clindesse) and clindamycin 7-day (Cleocin) vaginal creams (88% vs. 83%, respectively; Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV because the goal of treatment is to reestablish naturally occurring lactobacillus flora in the vagina depleted by BV and to decrease the presence of other species, such as Mobiluncus and G. vaginalis. But study findings have been mixed, and Dr. Nyirjesy suggested individualizing BV therapy based on a range of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference. He noted that most of the lactobacillus products are not available in the U.S.

The debate about which antibiotic is better has been further complicated by emerging evidence that not all BV is the same. For example, research has shown that, compared with other pregnant women, women with BV who have Mobiluncus morphotypes on Gram stain are more likely to be symptomatic, have higher numbers of clue cells and positive “whiff” tests, and have vaginal immune and hydrolytic enzyme profiles, all of which are associated with a greater risk of preterm birth, Dr. Nyirjesy said.

A recent study led by Dr. Nyirjesy (Sex. Transm. Dis. 2007;34:197–202) found that significantly more patients on single-dose 2% clindamycin cream cleared Mobiluncus morphotypes than patients on multiple doses of 0.75 metronidazole gel (97.5% vs. 80%, respectively).

Among women with Mobiluncus at baseline, clinical cure rates were significantly higher in those who received clindamycin (57.5% vs. 27%), but were not significantly different between treatment groups in women with no Mobiluncus at baseline (61% vs. 53%). He stressed that this was a retrospective study from pooled data, and that marketing efforts not withstanding, it was a preliminary paper that calls for further investigation.

Some audience members asked whether they should identify species on wet mount for all their BV patients.

“Absolutely not,” said Dr. Nyirjesy. “Not all bacterial vaginosis is the same, and there may be different responses to antibiotics in women with BV.”

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes. Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said.

“We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar and can be acute with blistering, subacute with redness and scaling, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, Dr. Margesson said. Patients will self-treat with over-the-counter products or receive multiple medications from different providers. Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices. A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation. Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes. Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said.

“We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar and can be acute with blistering, subacute with redness and scaling, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, Dr. Margesson said. Patients will self-treat with over-the-counter products or receive multiple medications from different providers. Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices. A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation. Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes. Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said.

“We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar and can be acute with blistering, subacute with redness and scaling, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, Dr. Margesson said. Patients will self-treat with over-the-counter products or receive multiple medications from different providers. Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices. A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation. Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — A patient wants her hymen reattached as a 30-year wedding anniversary present to her husband. Would you perform the surgery?

Would your answer change if the patient was a 20-year-old woman seeking the same procedure because religious practices dictate that she be a virgin at her upcoming wedding?

It's necessary to understand what aesthetic vulvovaginal procedures are being pitched to patients, and be prepared to address the ethical issues surrounding these procedures, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Television programs, direct marketing, and the Internet are providing patients with information on a range of procedures, including revirgination, designer laser vaginoplasty, labial reduction, augmentation labioplasty, hymenoplasty, vulvar lipoplasty, and genital bleaching.

A recent Internet search revealed more than 100,000 hits for vaginal rejuvenation and over 300,000 hits for G-spot amplification/enhancement, while a Medline search revealed scarcely a mention of these topics, according to Dr. Haefner, professor of obstetrics and gynecology and codirector of the University of Michigan's Center for Vulvar Diseases, Ann Arbor.

G-spot amplification involves injecting the Gräfenberg spot with collagen in an effort to enhance sexual arousal or gratification temporarily. Anal and vaginal lightening products are sold to reverse the discoloration that comes with aging and hormonal changes in the body.

The exact procedure performed often is unclear because standard medical nomenclature is not used, notes the American College of Obstetricians and Gynecologists (ACOG), which takes up the issue in its Committee Opinion on Gynecologic Practice (Obstet. Gynecol. 2007;110:737-8).

The ACOGcommittee advises physicians to inform their patients about the lack of data supporting the efficacy of these procedures and their potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.

What sets these aesthetic procedures apart from genital mutilation, such as female circumcision, is the age of the patient and consent, Dr. Haefner said.

Still, many cases demand a full work-up, including a psychological evaluation.

She presented a case of a young patient requesting clitoral reduction that included a complete physical examination, chromosomal and endocrinologic evaluations, and a visit to a pediatric urologist.

The issue of whether the patient is symptomatic or asymptomatic can help in determining if a procedure should be undertaken.

Dr. Haefner recalled two patients who requested labial reductions, one of whom had irritation of the labia with exercise and one who had a history of urinary tract infections that may have been associated with her enlarged labia. Even with those histories, both patients received extensive counseling before the reductions were performed.

The same request becomes more vexing in an asymptomatic patient who asks for the procedure because she doesn't feel her labia are “normal.” The average inner labia is thought to be 4.5 cm in width when extended to the side, but where that definition of normal came from, Dr. Haefner admits, is anyone's guess. What some patients and their physicians find acceptable, others will feel the need to alter.

Gynecologists aren't the only clinicians who may face these ethical dilemmas. Many procedures are being advertised to both men and women. Some centers package more traditional aesthetic procedures, such as breast augmentation, together with labioplasty.

But other centers are offering packages to couples, for example, who may want the man to undergo scrotal reduction or penile enhancement at the same time that the woman undergoes labial reduction or breast augmentation, she said.

In addition to the ACOG committee's opinion on cosmetic vaginal procedures, Dr. Haefner noted, differing opinions can be obtained from the American Academy of Cosmetic Gynecologists (www.aaocg.orgwww.iscgyn.com

CHICAGO — A patient wants her hymen reattached as a 30-year wedding anniversary present to her husband. Would you perform the surgery?

Would your answer change if the patient was a 20-year-old woman seeking the same procedure because religious practices dictate that she be a virgin at her upcoming wedding?

It's necessary to understand what aesthetic vulvovaginal procedures are being pitched to patients, and be prepared to address the ethical issues surrounding these procedures, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Television programs, direct marketing, and the Internet are providing patients with information on a range of procedures, including revirgination, designer laser vaginoplasty, labial reduction, augmentation labioplasty, hymenoplasty, vulvar lipoplasty, and genital bleaching.

A recent Internet search revealed more than 100,000 hits for vaginal rejuvenation and over 300,000 hits for G-spot amplification/enhancement, while a Medline search revealed scarcely a mention of these topics, according to Dr. Haefner, professor of obstetrics and gynecology and codirector of the University of Michigan's Center for Vulvar Diseases, Ann Arbor.

G-spot amplification involves injecting the Gräfenberg spot with collagen in an effort to enhance sexual arousal or gratification temporarily. Anal and vaginal lightening products are sold to reverse the discoloration that comes with aging and hormonal changes in the body.

The exact procedure performed often is unclear because standard medical nomenclature is not used, notes the American College of Obstetricians and Gynecologists (ACOG), which takes up the issue in its Committee Opinion on Gynecologic Practice (Obstet. Gynecol. 2007;110:737-8).

The ACOGcommittee advises physicians to inform their patients about the lack of data supporting the efficacy of these procedures and their potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.

What sets these aesthetic procedures apart from genital mutilation, such as female circumcision, is the age of the patient and consent, Dr. Haefner said.

Still, many cases demand a full work-up, including a psychological evaluation.

She presented a case of a young patient requesting clitoral reduction that included a complete physical examination, chromosomal and endocrinologic evaluations, and a visit to a pediatric urologist.

The issue of whether the patient is symptomatic or asymptomatic can help in determining if a procedure should be undertaken.

Dr. Haefner recalled two patients who requested labial reductions, one of whom had irritation of the labia with exercise and one who had a history of urinary tract infections that may have been associated with her enlarged labia. Even with those histories, both patients received extensive counseling before the reductions were performed.

The same request becomes more vexing in an asymptomatic patient who asks for the procedure because she doesn't feel her labia are “normal.” The average inner labia is thought to be 4.5 cm in width when extended to the side, but where that definition of normal came from, Dr. Haefner admits, is anyone's guess. What some patients and their physicians find acceptable, others will feel the need to alter.

Gynecologists aren't the only clinicians who may face these ethical dilemmas. Many procedures are being advertised to both men and women. Some centers package more traditional aesthetic procedures, such as breast augmentation, together with labioplasty.

But other centers are offering packages to couples, for example, who may want the man to undergo scrotal reduction or penile enhancement at the same time that the woman undergoes labial reduction or breast augmentation, she said.

In addition to the ACOG committee's opinion on cosmetic vaginal procedures, Dr. Haefner noted, differing opinions can be obtained from the American Academy of Cosmetic Gynecologists (www.aaocg.orgwww.iscgyn.com

CHICAGO — A patient wants her hymen reattached as a 30-year wedding anniversary present to her husband. Would you perform the surgery?

Would your answer change if the patient was a 20-year-old woman seeking the same procedure because religious practices dictate that she be a virgin at her upcoming wedding?

It's necessary to understand what aesthetic vulvovaginal procedures are being pitched to patients, and be prepared to address the ethical issues surrounding these procedures, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Television programs, direct marketing, and the Internet are providing patients with information on a range of procedures, including revirgination, designer laser vaginoplasty, labial reduction, augmentation labioplasty, hymenoplasty, vulvar lipoplasty, and genital bleaching.

A recent Internet search revealed more than 100,000 hits for vaginal rejuvenation and over 300,000 hits for G-spot amplification/enhancement, while a Medline search revealed scarcely a mention of these topics, according to Dr. Haefner, professor of obstetrics and gynecology and codirector of the University of Michigan's Center for Vulvar Diseases, Ann Arbor.

G-spot amplification involves injecting the Gräfenberg spot with collagen in an effort to enhance sexual arousal or gratification temporarily. Anal and vaginal lightening products are sold to reverse the discoloration that comes with aging and hormonal changes in the body.

The exact procedure performed often is unclear because standard medical nomenclature is not used, notes the American College of Obstetricians and Gynecologists (ACOG), which takes up the issue in its Committee Opinion on Gynecologic Practice (Obstet. Gynecol. 2007;110:737-8).

The ACOGcommittee advises physicians to inform their patients about the lack of data supporting the efficacy of these procedures and their potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.

What sets these aesthetic procedures apart from genital mutilation, such as female circumcision, is the age of the patient and consent, Dr. Haefner said.

Still, many cases demand a full work-up, including a psychological evaluation.

She presented a case of a young patient requesting clitoral reduction that included a complete physical examination, chromosomal and endocrinologic evaluations, and a visit to a pediatric urologist.

The issue of whether the patient is symptomatic or asymptomatic can help in determining if a procedure should be undertaken.

Dr. Haefner recalled two patients who requested labial reductions, one of whom had irritation of the labia with exercise and one who had a history of urinary tract infections that may have been associated with her enlarged labia. Even with those histories, both patients received extensive counseling before the reductions were performed.

The same request becomes more vexing in an asymptomatic patient who asks for the procedure because she doesn't feel her labia are “normal.” The average inner labia is thought to be 4.5 cm in width when extended to the side, but where that definition of normal came from, Dr. Haefner admits, is anyone's guess. What some patients and their physicians find acceptable, others will feel the need to alter.

Gynecologists aren't the only clinicians who may face these ethical dilemmas. Many procedures are being advertised to both men and women. Some centers package more traditional aesthetic procedures, such as breast augmentation, together with labioplasty.

But other centers are offering packages to couples, for example, who may want the man to undergo scrotal reduction or penile enhancement at the same time that the woman undergoes labial reduction or breast augmentation, she said.

In addition to the ACOG committee's opinion on cosmetic vaginal procedures, Dr. Haefner noted, differing opinions can be obtained from the American Academy of Cosmetic Gynecologists (www.aaocg.orgwww.iscgyn.com

MILWAUKEE — Regular enemas did not reverse increased rectal compliance in children with intractable functional constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

The prospective, longitudinal barostat study of 101 patients also found that increased rectal compliance was not related to treatment failure.

Rectal compliance is an indirect measure of contraction and relaxation in the rectum. It is thought to be increased in children with constipation compared with healthy children, and to be reduced in those with irritable bowel syndrome with diarrhea.

Regarding the result that enemas did not reverse increased rectal compliance, Dr. Benninga said: “It is a provocative finding, because increased rectal compliance seems not to be an important underlying mechanism of intractable functional constipation in childhood.” Dr. Benninga works in the department of pediatric gastroenterology and nutrition at Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

The study was enthusiastically received by audience members. “Your study required a lot of work and a lot of courage,” said Dr. David R. Fleischer of the department of child health at the University of Missouri in Columbia. “It deflates a lot of the pediatric folklore that has led to iatrogenic abuse of children.”

The investigators randomized 101 children aged 8–18 years, with symptoms of functional constipation lasting for at least 2 years, to either conventional treatment with laxatives and toilet training or conventional treatment plus enemas. Patients in the latter group had three enemas per week for the first 3 months, with a reduction in the number of enemas by one per week every 3 months.

Among the 87 children who completed 12 months of treatment, there were no significant differences in clinical success between the two treatments or between children with and without abnormal rectal compliance at baseline.

Functional constipation was defined as the presence of two or more of the following criteria: defecation frequency less than three times a week, fecal incontinence at least twice a week, large-diameter stool, and fecal retention at physical examination.

The patients' mean age was 11 years, 65% were boys, 72% had large-diameter stools, and 47% had fecal impaction. Defecation frequency averaged 1.5 per week, and fecal incontinence occurred an average of seven times per week. Symptom duration averaged 7 years.

Assessment of rectal compliance was performed with an electronic barostat and polyethylene bag, which is thought to be more accurate than a latex balloon and manual inflations used in clinical settings, Dr. Benninga explained. The upper limit of the normal range was 20 mL/mm Hg.

Clinical success, defined as defecation at least three times per week and fecal incontinence less than once a week, was achieved in 33 children with normal rectal compliance, 34 with moderately increased compliance, and 20 with severely increased compliance, Dr. Benninga said at the meeting, which was cosponsored by the University of Wisconsin.

MILWAUKEE — Regular enemas did not reverse increased rectal compliance in children with intractable functional constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

The prospective, longitudinal barostat study of 101 patients also found that increased rectal compliance was not related to treatment failure.

Rectal compliance is an indirect measure of contraction and relaxation in the rectum. It is thought to be increased in children with constipation compared with healthy children, and to be reduced in those with irritable bowel syndrome with diarrhea.

Regarding the result that enemas did not reverse increased rectal compliance, Dr. Benninga said: “It is a provocative finding, because increased rectal compliance seems not to be an important underlying mechanism of intractable functional constipation in childhood.” Dr. Benninga works in the department of pediatric gastroenterology and nutrition at Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

The study was enthusiastically received by audience members. “Your study required a lot of work and a lot of courage,” said Dr. David R. Fleischer of the department of child health at the University of Missouri in Columbia. “It deflates a lot of the pediatric folklore that has led to iatrogenic abuse of children.”

The investigators randomized 101 children aged 8–18 years, with symptoms of functional constipation lasting for at least 2 years, to either conventional treatment with laxatives and toilet training or conventional treatment plus enemas. Patients in the latter group had three enemas per week for the first 3 months, with a reduction in the number of enemas by one per week every 3 months.

Among the 87 children who completed 12 months of treatment, there were no significant differences in clinical success between the two treatments or between children with and without abnormal rectal compliance at baseline.

Functional constipation was defined as the presence of two or more of the following criteria: defecation frequency less than three times a week, fecal incontinence at least twice a week, large-diameter stool, and fecal retention at physical examination.

The patients' mean age was 11 years, 65% were boys, 72% had large-diameter stools, and 47% had fecal impaction. Defecation frequency averaged 1.5 per week, and fecal incontinence occurred an average of seven times per week. Symptom duration averaged 7 years.

Assessment of rectal compliance was performed with an electronic barostat and polyethylene bag, which is thought to be more accurate than a latex balloon and manual inflations used in clinical settings, Dr. Benninga explained. The upper limit of the normal range was 20 mL/mm Hg.

Clinical success, defined as defecation at least three times per week and fecal incontinence less than once a week, was achieved in 33 children with normal rectal compliance, 34 with moderately increased compliance, and 20 with severely increased compliance, Dr. Benninga said at the meeting, which was cosponsored by the University of Wisconsin.

MILWAUKEE — Regular enemas did not reverse increased rectal compliance in children with intractable functional constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

The prospective, longitudinal barostat study of 101 patients also found that increased rectal compliance was not related to treatment failure.

Rectal compliance is an indirect measure of contraction and relaxation in the rectum. It is thought to be increased in children with constipation compared with healthy children, and to be reduced in those with irritable bowel syndrome with diarrhea.

Regarding the result that enemas did not reverse increased rectal compliance, Dr. Benninga said: “It is a provocative finding, because increased rectal compliance seems not to be an important underlying mechanism of intractable functional constipation in childhood.” Dr. Benninga works in the department of pediatric gastroenterology and nutrition at Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

The study was enthusiastically received by audience members. “Your study required a lot of work and a lot of courage,” said Dr. David R. Fleischer of the department of child health at the University of Missouri in Columbia. “It deflates a lot of the pediatric folklore that has led to iatrogenic abuse of children.”

The investigators randomized 101 children aged 8–18 years, with symptoms of functional constipation lasting for at least 2 years, to either conventional treatment with laxatives and toilet training or conventional treatment plus enemas. Patients in the latter group had three enemas per week for the first 3 months, with a reduction in the number of enemas by one per week every 3 months.

Among the 87 children who completed 12 months of treatment, there were no significant differences in clinical success between the two treatments or between children with and without abnormal rectal compliance at baseline.

Functional constipation was defined as the presence of two or more of the following criteria: defecation frequency less than three times a week, fecal incontinence at least twice a week, large-diameter stool, and fecal retention at physical examination.

The patients' mean age was 11 years, 65% were boys, 72% had large-diameter stools, and 47% had fecal impaction. Defecation frequency averaged 1.5 per week, and fecal incontinence occurred an average of seven times per week. Symptom duration averaged 7 years.

Assessment of rectal compliance was performed with an electronic barostat and polyethylene bag, which is thought to be more accurate than a latex balloon and manual inflations used in clinical settings, Dr. Benninga explained. The upper limit of the normal range was 20 mL/mm Hg.

Clinical success, defined as defecation at least three times per week and fecal incontinence less than once a week, was achieved in 33 children with normal rectal compliance, 34 with moderately increased compliance, and 20 with severely increased compliance, Dr. Benninga said at the meeting, which was cosponsored by the University of Wisconsin.

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes.

Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said. “We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common vulvar irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar; they can be acute with blistering, subacute with scaling and red-ness, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, said Dr. Margesson. Patients will self-treat with over-the-counter products or receive multiple medications from different providers.

Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices.

A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation.

Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes.

Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said. “We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common vulvar irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar; they can be acute with blistering, subacute with scaling and red-ness, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, said Dr. Margesson. Patients will self-treat with over-the-counter products or receive multiple medications from different providers.

Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices.

A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation.

Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — Chronic use of sanitary pads and panty liners for urinary incontinence may put patients at risk for vulvar contact dermatitis, Dr. Lynette J. Margesson said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Some women with urinary or fecal incontinence don't want to acknowledge they have the condition or are too embarrassed to wear incontinence pads, and instead opt to wear sanitary pads or panty liners to address their incontinence. The problem is that these are inadequate for urine volume, leaving the vulva wet throughout the day.

“Women don't use appropriate pads to stay dry, and we do have a real epidemic of incontinence,” said Dr. Margesson of Dartmouth Medical School, Hanover, N.H. “These patients are desperate with itch, burn, and pain.”

Elderly patients often have problems with contact dermatitis from incontinence that is complicated by obesity and reduced mobility.

Age-related loss of estrogen also increases susceptibility to irritant contact dermatitis by causing the epidermal barrier to be weakened and thinned, and less moist and viable.

The epidermal barrier also can be lost because of overzealous washing with a washcloth, sponge, or wipes.

Dr. Margesson warned the audience to be wary of patients who are convinced the vulva is “dirty,” and needs to be scrubbed.

“You can get a reaction including redness and swelling from the use of baby wipes,” Dr. Margesson said. “We're seeing a lot of patients using these.” A strong show of hands confirmed a similar experience among the audience.

Other common vulvar allergens include benzocaine (Vagisil), neomycin (Neosporin), chlorhexidine (KY jelly), preservatives, latex condoms, lanolin, and nail polish. Common vulvar irritants include douches, spermicides, and medications such as trichloroacetic acid and 5-fluorouracil.

The clinical features of irritant and allergic contact dermatitis are similar; they can be acute with blistering, subacute with scaling and red-ness, and chronic with redness and induration.

Contact dermatitis is frequently superimposed on preexisting, chronic vulvar conditions and complicates their management, said Dr. Margesson. Patients will self-treat with over-the-counter products or receive multiple medications from different providers.

Dr. Margesson has observed patients who developed burns from using benzocaine 20% 10–15 times a day, or whose condition was worsened by their use of ice packs rather than cool gel packs to cool an itchy, burning vulva.

The first step in managing contact dermatitis in the anogenital area is to stop the irritant or allergen exposure and any irritating practices.

A sitz bath, tub bath with lukewarm water only, or cool compress can be used one to three times a day for 5–10 minutes to improve barrier function and to soothe weeping, red, or hot irritated areas. Bland emollients such as petrolatum, mineral oil, or olive oil help seal in moisture.

Antibiotics should be used to treat secondary infections, and steroids to suppress inflammation.

Patients should be given specific instructions for topical steroids and shown in the office the exact site to which to apply them.

To counter the commonly held belief that more must be better, Dr. Margesson suggests the use of “toothpick” dermatology, which limits the amount of ointment or cream needed to cover the vulva to the end of a toothpick.

Finally, it's essential to review and rereview hygiene habits with the patient. “It's amazing how many people will go back to what they were doing before,” Dr. Margesson said.

CHICAGO — Bedtime dosing of valsartan is more efficient than morning dosing in controlling blood pressure and improving renal function in hypertensive patients with or without diabetes, Ramon Hermida, Ph.D., said at the annual meeting of the American Society of Hypertension.

Dr. Hermida suggests this time-dependent effect is not unique to valsartan, but may be class related for angiotensin II receptor blockers (ARBs) and should be taken into account when treating hypertensive patients.

Dr. Hermida and his colleagues randomized 204 untreated hypertensive patients to receive valsartan 160 mg/day either upon awakening or at bedtime. Blood pressure was measured at 20-minute intervals from 7:00 a.m. to 11:00 p.m., and at 30-minute intervals at night for 48 hours before and after 12 weeks of therapy. Urine was collected by the patients during the first 24 hours of BP monitoring. The patients' mean age was 52 years, and 97 had type 2 diabetes mellitus.

Bedtime dosing with valsartan was significantly more effective than morning dosing in reducing nocturnal BP in patients with or without diabetes, said Dr. Hermida, of the University of Vigo (Spain). The diurnal/nocturnal BP ratio was unchanged after taking valsartan on awakening, but significantly increased by 5.3% when taken before bedtime.

Urinary albumin excretion was significantly reduced by 23% from baseline in patients without diabetes and by 31% in those with diabetes only after bedtime administration.

This reduction was independent of the significant decrease in 24-hour or diurnal mean BP after treatment. It was highly correlated with the decrease in nocturnal BP, and mainly correlated with the increase in diurnal/nocturnal BP ratio, said Dr. Hermida, who disclosed no potential conflicts of interest.

When analyzed separately, the decrease in urinary albumin excretion associated with the increase in diurnal/nocturnal BP ratio was statistically significant for patients both with and without diabetes.

Bedtime administration of valsartan is preferred to morning dosing because it seems to improve the diurnal/nocturnal BP ratio, Dr. Hermida said.

When asked by an audience member if the time-dependent effects observed in the trial are specific to valsartan's duration of action, Dr. Hermida responded with a definitive “no.” Data from two similarly designed independent randomized trials presented at the same meeting show “the results are exactly the same” with nighttime administration of two other ARBs with completely different half-lives—telmisartan and olmesartan, he said.

“This could be a class effect that would be potentially applicable to all ARBs,” Dr. Hermida said.

CHICAGO — Bedtime dosing of valsartan is more efficient than morning dosing in controlling blood pressure and improving renal function in hypertensive patients with or without diabetes, Ramon Hermida, Ph.D., said at the annual meeting of the American Society of Hypertension.

Dr. Hermida suggests this time-dependent effect is not unique to valsartan, but may be class related for angiotensin II receptor blockers (ARBs) and should be taken into account when treating hypertensive patients.

Dr. Hermida and his colleagues randomized 204 untreated hypertensive patients to receive valsartan 160 mg/day either upon awakening or at bedtime. Blood pressure was measured at 20-minute intervals from 7:00 a.m. to 11:00 p.m., and at 30-minute intervals at night for 48 hours before and after 12 weeks of therapy. Urine was collected by the patients during the first 24 hours of BP monitoring. The patients' mean age was 52 years, and 97 had type 2 diabetes mellitus.

Bedtime dosing with valsartan was significantly more effective than morning dosing in reducing nocturnal BP in patients with or without diabetes, said Dr. Hermida, of the University of Vigo (Spain). The diurnal/nocturnal BP ratio was unchanged after taking valsartan on awakening, but significantly increased by 5.3% when taken before bedtime.

Urinary albumin excretion was significantly reduced by 23% from baseline in patients without diabetes and by 31% in those with diabetes only after bedtime administration.

This reduction was independent of the significant decrease in 24-hour or diurnal mean BP after treatment. It was highly correlated with the decrease in nocturnal BP, and mainly correlated with the increase in diurnal/nocturnal BP ratio, said Dr. Hermida, who disclosed no potential conflicts of interest.

When analyzed separately, the decrease in urinary albumin excretion associated with the increase in diurnal/nocturnal BP ratio was statistically significant for patients both with and without diabetes.

Bedtime administration of valsartan is preferred to morning dosing because it seems to improve the diurnal/nocturnal BP ratio, Dr. Hermida said.

When asked by an audience member if the time-dependent effects observed in the trial are specific to valsartan's duration of action, Dr. Hermida responded with a definitive “no.” Data from two similarly designed independent randomized trials presented at the same meeting show “the results are exactly the same” with nighttime administration of two other ARBs with completely different half-lives—telmisartan and olmesartan, he said.

“This could be a class effect that would be potentially applicable to all ARBs,” Dr. Hermida said.

CHICAGO — Bedtime dosing of valsartan is more efficient than morning dosing in controlling blood pressure and improving renal function in hypertensive patients with or without diabetes, Ramon Hermida, Ph.D., said at the annual meeting of the American Society of Hypertension.

Dr. Hermida suggests this time-dependent effect is not unique to valsartan, but may be class related for angiotensin II receptor blockers (ARBs) and should be taken into account when treating hypertensive patients.

Dr. Hermida and his colleagues randomized 204 untreated hypertensive patients to receive valsartan 160 mg/day either upon awakening or at bedtime. Blood pressure was measured at 20-minute intervals from 7:00 a.m. to 11:00 p.m., and at 30-minute intervals at night for 48 hours before and after 12 weeks of therapy. Urine was collected by the patients during the first 24 hours of BP monitoring. The patients' mean age was 52 years, and 97 had type 2 diabetes mellitus.

Bedtime dosing with valsartan was significantly more effective than morning dosing in reducing nocturnal BP in patients with or without diabetes, said Dr. Hermida, of the University of Vigo (Spain). The diurnal/nocturnal BP ratio was unchanged after taking valsartan on awakening, but significantly increased by 5.3% when taken before bedtime.

Urinary albumin excretion was significantly reduced by 23% from baseline in patients without diabetes and by 31% in those with diabetes only after bedtime administration.

This reduction was independent of the significant decrease in 24-hour or diurnal mean BP after treatment. It was highly correlated with the decrease in nocturnal BP, and mainly correlated with the increase in diurnal/nocturnal BP ratio, said Dr. Hermida, who disclosed no potential conflicts of interest.

When analyzed separately, the decrease in urinary albumin excretion associated with the increase in diurnal/nocturnal BP ratio was statistically significant for patients both with and without diabetes.

Bedtime administration of valsartan is preferred to morning dosing because it seems to improve the diurnal/nocturnal BP ratio, Dr. Hermida said.

When asked by an audience member if the time-dependent effects observed in the trial are specific to valsartan's duration of action, Dr. Hermida responded with a definitive “no.” Data from two similarly designed independent randomized trials presented at the same meeting show “the results are exactly the same” with nighttime administration of two other ARBs with completely different half-lives—telmisartan and olmesartan, he said.

“This could be a class effect that would be potentially applicable to all ARBs,” Dr. Hermida said.