Patrice Wendling

CHICAGO — The MF59-adjuvanted H5N1 influenza vaccine was as well tolerated as the widely used adjuvanted seasonal FLUAD influenza vaccine among adults in a large phase III multicenter study sponsored by Novartis Vaccines.

Local and systemic reactions occurred significantly less often with the MF59-adjuvanted H5N1 influenza vaccine than with FLUAD in adults; results were similar in the elderly.

No vaccine-related serious adverse events or deaths were reported among the 4,226 healthy participants in this study, the largest to date to assess the safety and tolerability of a prepandemic H5N1 vaccine.

“This is the first report of an antigen-sparing adjuvanted H5N1 vaccine that has an acceptable safety and reactogenicity profile in adults and the elderly, indicating that it can be used in a prepandemic setting,” Dr. Angelika Banzhoff, of Novartis Vaccines, in Marburg, Germany, and her associates reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Prepandemic vaccination has been proposed to prime the population and offer cross-protection against a range of heterovariant influenza virus strains. As of Oct. 12, 2007, 331 cases of laboratory-confirmed avian influenza have been reported to the World Health Organization, including 202 related deaths.

Participants in the study were randomized to receive two intramuscular doses, 3 weeks apart, of either the MF59-adjuvanted H5N1 influenza vaccine (7.5 mcg H5N1 influenza antigen/dose) or FLUAD (15 mcg each of A/H1N1, A/H3N2 and B antigens). Both vaccines were developed by Novartis Vaccines.

A total of 4,207 patients received dose one and were included in the safety analysis. Of these, 3,155 received the H5N1 vaccine (2,914 adults aged 60 years or younger and 241 elderly aged 61 or older) and 1,052 had FLUAD (971 adults and 81 elderly). A total of 4,143 patients also received dose two.

In all, 66% of adults who received the H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 74% who received FLUAD. Corresponding values for the week following dose two were 47% and 49%.

Most reactions were mild or moderate and short lived, with most patients reaction free by 1 week post dose, the investigators reported at the meeting sponsored by the American Society for Microbiology.

Significantly fewer patients in the H5N1 group than in the FLUAD group experienced induration (10 vs. 15), swelling (7 vs. 11), or pain (53 vs. 61) after dose one. And significantly fewer patients in the H5N1 group experienced chills (10 vs. 15), malaise (15 vs. 22), myalgia (17 vs. 25), headache (17 vs. 24), or fatigue (20 vs. 26) after dose one.

After dose two, the incidence of local and systemic reactions was similar between the two treatment groups.

Severe reactions were reported after dose one by 3% of patients in the H5N1 group versus 7% in the FLUAD group, and by 2% of patients in both groups after dose two. Thirteen adult patients reported 17 serious adverse events up to 3 weeks after dose two.

The proportion of elderly patients experiencing local or systemic reactions following dose one was generally lower than that for adult patients, and was largely similar between the two treatment groups after both doses one and two.

In all, 50% of elderly patients receiving H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 48% receiving FLUAD. Corresponding values for the week following dose two were 38% and 27%.

For both doses, most local and systemic reactions were short lived, with the exception of arthralgia, which persisted beyond 1 week in 3% of elderly patients in the H5N1 group following dose one.

Six elderly patients reported eight serious adverse events up to 3 weeks after dose two, the investigators reported.

CHICAGO — The MF59-adjuvanted H5N1 influenza vaccine was as well tolerated as the widely used adjuvanted seasonal FLUAD influenza vaccine among adults in a large phase III multicenter study sponsored by Novartis Vaccines.

Local and systemic reactions occurred significantly less often with the MF59-adjuvanted H5N1 influenza vaccine than with FLUAD in adults; results were similar in the elderly.

No vaccine-related serious adverse events or deaths were reported among the 4,226 healthy participants in this study, the largest to date to assess the safety and tolerability of a prepandemic H5N1 vaccine.

“This is the first report of an antigen-sparing adjuvanted H5N1 vaccine that has an acceptable safety and reactogenicity profile in adults and the elderly, indicating that it can be used in a prepandemic setting,” Dr. Angelika Banzhoff, of Novartis Vaccines, in Marburg, Germany, and her associates reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Prepandemic vaccination has been proposed to prime the population and offer cross-protection against a range of heterovariant influenza virus strains. As of Oct. 12, 2007, 331 cases of laboratory-confirmed avian influenza have been reported to the World Health Organization, including 202 related deaths.

Participants in the study were randomized to receive two intramuscular doses, 3 weeks apart, of either the MF59-adjuvanted H5N1 influenza vaccine (7.5 mcg H5N1 influenza antigen/dose) or FLUAD (15 mcg each of A/H1N1, A/H3N2 and B antigens). Both vaccines were developed by Novartis Vaccines.

A total of 4,207 patients received dose one and were included in the safety analysis. Of these, 3,155 received the H5N1 vaccine (2,914 adults aged 60 years or younger and 241 elderly aged 61 or older) and 1,052 had FLUAD (971 adults and 81 elderly). A total of 4,143 patients also received dose two.

In all, 66% of adults who received the H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 74% who received FLUAD. Corresponding values for the week following dose two were 47% and 49%.

Most reactions were mild or moderate and short lived, with most patients reaction free by 1 week post dose, the investigators reported at the meeting sponsored by the American Society for Microbiology.

Significantly fewer patients in the H5N1 group than in the FLUAD group experienced induration (10 vs. 15), swelling (7 vs. 11), or pain (53 vs. 61) after dose one. And significantly fewer patients in the H5N1 group experienced chills (10 vs. 15), malaise (15 vs. 22), myalgia (17 vs. 25), headache (17 vs. 24), or fatigue (20 vs. 26) after dose one.

After dose two, the incidence of local and systemic reactions was similar between the two treatment groups.

Severe reactions were reported after dose one by 3% of patients in the H5N1 group versus 7% in the FLUAD group, and by 2% of patients in both groups after dose two. Thirteen adult patients reported 17 serious adverse events up to 3 weeks after dose two.

The proportion of elderly patients experiencing local or systemic reactions following dose one was generally lower than that for adult patients, and was largely similar between the two treatment groups after both doses one and two.

In all, 50% of elderly patients receiving H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 48% receiving FLUAD. Corresponding values for the week following dose two were 38% and 27%.

For both doses, most local and systemic reactions were short lived, with the exception of arthralgia, which persisted beyond 1 week in 3% of elderly patients in the H5N1 group following dose one.

Six elderly patients reported eight serious adverse events up to 3 weeks after dose two, the investigators reported.

CHICAGO — The MF59-adjuvanted H5N1 influenza vaccine was as well tolerated as the widely used adjuvanted seasonal FLUAD influenza vaccine among adults in a large phase III multicenter study sponsored by Novartis Vaccines.

Local and systemic reactions occurred significantly less often with the MF59-adjuvanted H5N1 influenza vaccine than with FLUAD in adults; results were similar in the elderly.

No vaccine-related serious adverse events or deaths were reported among the 4,226 healthy participants in this study, the largest to date to assess the safety and tolerability of a prepandemic H5N1 vaccine.

“This is the first report of an antigen-sparing adjuvanted H5N1 vaccine that has an acceptable safety and reactogenicity profile in adults and the elderly, indicating that it can be used in a prepandemic setting,” Dr. Angelika Banzhoff, of Novartis Vaccines, in Marburg, Germany, and her associates reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

Prepandemic vaccination has been proposed to prime the population and offer cross-protection against a range of heterovariant influenza virus strains. As of Oct. 12, 2007, 331 cases of laboratory-confirmed avian influenza have been reported to the World Health Organization, including 202 related deaths.

Participants in the study were randomized to receive two intramuscular doses, 3 weeks apart, of either the MF59-adjuvanted H5N1 influenza vaccine (7.5 mcg H5N1 influenza antigen/dose) or FLUAD (15 mcg each of A/H1N1, A/H3N2 and B antigens). Both vaccines were developed by Novartis Vaccines.

A total of 4,207 patients received dose one and were included in the safety analysis. Of these, 3,155 received the H5N1 vaccine (2,914 adults aged 60 years or younger and 241 elderly aged 61 or older) and 1,052 had FLUAD (971 adults and 81 elderly). A total of 4,143 patients also received dose two.

In all, 66% of adults who received the H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 74% who received FLUAD. Corresponding values for the week following dose two were 47% and 49%.

Most reactions were mild or moderate and short lived, with most patients reaction free by 1 week post dose, the investigators reported at the meeting sponsored by the American Society for Microbiology.

Significantly fewer patients in the H5N1 group than in the FLUAD group experienced induration (10 vs. 15), swelling (7 vs. 11), or pain (53 vs. 61) after dose one. And significantly fewer patients in the H5N1 group experienced chills (10 vs. 15), malaise (15 vs. 22), myalgia (17 vs. 25), headache (17 vs. 24), or fatigue (20 vs. 26) after dose one.

After dose two, the incidence of local and systemic reactions was similar between the two treatment groups.

Severe reactions were reported after dose one by 3% of patients in the H5N1 group versus 7% in the FLUAD group, and by 2% of patients in both groups after dose two. Thirteen adult patients reported 17 serious adverse events up to 3 weeks after dose two.

The proportion of elderly patients experiencing local or systemic reactions following dose one was generally lower than that for adult patients, and was largely similar between the two treatment groups after both doses one and two.

In all, 50% of elderly patients receiving H5N1 vaccine reported any solicited local or systemic reaction in the week following dose one, compared with 48% receiving FLUAD. Corresponding values for the week following dose two were 38% and 27%.

For both doses, most local and systemic reactions were short lived, with the exception of arthralgia, which persisted beyond 1 week in 3% of elderly patients in the H5N1 group following dose one.

Six elderly patients reported eight serious adverse events up to 3 weeks after dose two, the investigators reported.

TORONTO — Pretreating the skin with a low-power erbium:YAG laser significantly reduced the pain of intravenous cannulation in children in a double-blind randomized trial of 94 patients.

The laser treatment works by removing a small area of the stratum corneum, which allows for rapid absorption of local anesthesia, coinvestigator Dr. Deena Berkowitz explained. Laser pretreatment takes less than 10 seconds, followed by a 5-minute application of topical anesthesia before needle placement. This dramatically reduces the time of transdermal absorption, a limiting factor in the use of topical anesthetics before intravenous cannulation.

The study confirms the results of laser-assisted anesthesia previously reported in 30 healthy adults (Acad. Emerg. Med. 2005;12:804–7) and in 61 adult and pediatric emergency department patients (Acad. Emerg. Med. 2006;13:623–8).

Dr. Berkowitz and coauthor Dr. Ira T. Cohen of Children's National Medical Center, Washington, randomized 94 children who required intravenous cannulation to laser or sham laser with the Epiture Easytouch erbium:YAG laser prior to lidocaine 4% cream application and IV cannulation.

Pain was assessed on age-appropriate scales including the Wong-Baker FACES Pain Rating Scale and a 10-cm visual analog scale (a 10-point pain scale measured along a vertical or horizontal line). The patients ranged in age from 3 to 18 years, with an average age of 9 years in the laser group and 11 years in the control group.

The average pain of IV cannulation was significantly less for the 47 children treated with the laser than for the 47 children in the control group (2.94 cm vs. 5.36 cm), Dr. Berkowitz reported at the annual meeting of the Pediatric Academic Societies.

The median pain of laser application was 0 in both groups. Satisfaction surveys indicate that significantly more parents of patients enrolled in the laser group reported their children had less pain with IV cannulation after laser treatment than in the control group (72% vs. 38%).

An audience member questioned whether patients or their parents may have anticipated less pain because of the use of an additional treatment prior to cannulation. "These were children who had had IVs before, but we did see some placebo effect in patients and parents," said Dr. Berkowitz.

Audience member Dr. Lei Chen of Yale-New Haven (Conn.) Children's Hospital, said when he and his colleagues tested the device, some patients were troubled by the laser's gun-like appearance and the release of a small puff of smoke.

Wrapping the device in colorful coverings could have alleviated potential anxiety, but hasn't entirely stopped young boys from wanting to pick up the laser and shoot it, although that's not possible without a key, Dr. Berkowitz said. Only one patient in the treatment arm noticed an odor with the laser application, although staff members did remark on it.

Erythema was observed in some patients with lighter skin color, and hypopigmentation in those with darker skin. Finding the 6 mm in diameter area treated by the laser also can be a problem, but she said stickers can ensure that the exact site is identified for needle insertion.

At $2,500 per laser, "the biggest drawback is going to be cost," said Dr. Berkowitz, who said the study lasers were provided by Norwood Abbey Inc. She disclosed no personal conflicts of interest with the company.

Colorful coverings can reduce the gunlike laser device's ability to induce either anxiety or playfulness in children. COURTESY DR. DEENA BERKOWITZ

TORONTO — Pretreating the skin with a low-power erbium:YAG laser significantly reduced the pain of intravenous cannulation in children in a double-blind randomized trial of 94 patients.

The laser treatment works by removing a small area of the stratum corneum, which allows for rapid absorption of local anesthesia, coinvestigator Dr. Deena Berkowitz explained. Laser pretreatment takes less than 10 seconds, followed by a 5-minute application of topical anesthesia before needle placement. This dramatically reduces the time of transdermal absorption, a limiting factor in the use of topical anesthetics before intravenous cannulation.

The study confirms the results of laser-assisted anesthesia previously reported in 30 healthy adults (Acad. Emerg. Med. 2005;12:804–7) and in 61 adult and pediatric emergency department patients (Acad. Emerg. Med. 2006;13:623–8).

Dr. Berkowitz and coauthor Dr. Ira T. Cohen of Children's National Medical Center, Washington, randomized 94 children who required intravenous cannulation to laser or sham laser with the Epiture Easytouch erbium:YAG laser prior to lidocaine 4% cream application and IV cannulation.

Pain was assessed on age-appropriate scales including the Wong-Baker FACES Pain Rating Scale and a 10-cm visual analog scale (a 10-point pain scale measured along a vertical or horizontal line). The patients ranged in age from 3 to 18 years, with an average age of 9 years in the laser group and 11 years in the control group.

The average pain of IV cannulation was significantly less for the 47 children treated with the laser than for the 47 children in the control group (2.94 cm vs. 5.36 cm), Dr. Berkowitz reported at the annual meeting of the Pediatric Academic Societies.

The median pain of laser application was 0 in both groups. Satisfaction surveys indicate that significantly more parents of patients enrolled in the laser group reported their children had less pain with IV cannulation after laser treatment than in the control group (72% vs. 38%).

An audience member questioned whether patients or their parents may have anticipated less pain because of the use of an additional treatment prior to cannulation. "These were children who had had IVs before, but we did see some placebo effect in patients and parents," said Dr. Berkowitz.

Audience member Dr. Lei Chen of Yale-New Haven (Conn.) Children's Hospital, said when he and his colleagues tested the device, some patients were troubled by the laser's gun-like appearance and the release of a small puff of smoke.

Wrapping the device in colorful coverings could have alleviated potential anxiety, but hasn't entirely stopped young boys from wanting to pick up the laser and shoot it, although that's not possible without a key, Dr. Berkowitz said. Only one patient in the treatment arm noticed an odor with the laser application, although staff members did remark on it.

Erythema was observed in some patients with lighter skin color, and hypopigmentation in those with darker skin. Finding the 6 mm in diameter area treated by the laser also can be a problem, but she said stickers can ensure that the exact site is identified for needle insertion.

At $2,500 per laser, "the biggest drawback is going to be cost," said Dr. Berkowitz, who said the study lasers were provided by Norwood Abbey Inc. She disclosed no personal conflicts of interest with the company.

Colorful coverings can reduce the gunlike laser device's ability to induce either anxiety or playfulness in children. COURTESY DR. DEENA BERKOWITZ

TORONTO — Pretreating the skin with a low-power erbium:YAG laser significantly reduced the pain of intravenous cannulation in children in a double-blind randomized trial of 94 patients.

The laser treatment works by removing a small area of the stratum corneum, which allows for rapid absorption of local anesthesia, coinvestigator Dr. Deena Berkowitz explained. Laser pretreatment takes less than 10 seconds, followed by a 5-minute application of topical anesthesia before needle placement. This dramatically reduces the time of transdermal absorption, a limiting factor in the use of topical anesthetics before intravenous cannulation.

The study confirms the results of laser-assisted anesthesia previously reported in 30 healthy adults (Acad. Emerg. Med. 2005;12:804–7) and in 61 adult and pediatric emergency department patients (Acad. Emerg. Med. 2006;13:623–8).

Dr. Berkowitz and coauthor Dr. Ira T. Cohen of Children's National Medical Center, Washington, randomized 94 children who required intravenous cannulation to laser or sham laser with the Epiture Easytouch erbium:YAG laser prior to lidocaine 4% cream application and IV cannulation.

Pain was assessed on age-appropriate scales including the Wong-Baker FACES Pain Rating Scale and a 10-cm visual analog scale (a 10-point pain scale measured along a vertical or horizontal line). The patients ranged in age from 3 to 18 years, with an average age of 9 years in the laser group and 11 years in the control group.

The average pain of IV cannulation was significantly less for the 47 children treated with the laser than for the 47 children in the control group (2.94 cm vs. 5.36 cm), Dr. Berkowitz reported at the annual meeting of the Pediatric Academic Societies.

The median pain of laser application was 0 in both groups. Satisfaction surveys indicate that significantly more parents of patients enrolled in the laser group reported their children had less pain with IV cannulation after laser treatment than in the control group (72% vs. 38%).

An audience member questioned whether patients or their parents may have anticipated less pain because of the use of an additional treatment prior to cannulation. "These were children who had had IVs before, but we did see some placebo effect in patients and parents," said Dr. Berkowitz.

Audience member Dr. Lei Chen of Yale-New Haven (Conn.) Children's Hospital, said when he and his colleagues tested the device, some patients were troubled by the laser's gun-like appearance and the release of a small puff of smoke.

Wrapping the device in colorful coverings could have alleviated potential anxiety, but hasn't entirely stopped young boys from wanting to pick up the laser and shoot it, although that's not possible without a key, Dr. Berkowitz said. Only one patient in the treatment arm noticed an odor with the laser application, although staff members did remark on it.

Erythema was observed in some patients with lighter skin color, and hypopigmentation in those with darker skin. Finding the 6 mm in diameter area treated by the laser also can be a problem, but she said stickers can ensure that the exact site is identified for needle insertion.

At $2,500 per laser, "the biggest drawback is going to be cost," said Dr. Berkowitz, who said the study lasers were provided by Norwood Abbey Inc. She disclosed no personal conflicts of interest with the company.

Colorful coverings can reduce the gunlike laser device's ability to induce either anxiety or playfulness in children. COURTESY DR. DEENA BERKOWITZ

CHICAGO — Statins have antimicrobial effects in vitro, including against methicillin-resistant Staphylococcus aureus, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The drug concentrations needed to produce bacterial suppression in vitro were several log values higher than those typically found in blood samples from patients taking statins for their cholesterol-lowering or cardiovascular effects. The findings imply, however, that the structure of statins could be altered to enhance their antimicrobial effect, reported Dr. Jon Cohen, professor of infectious diseases and dean of the Brighton and Sussex Medical School, in Brighton, England.

Simvastatin (Zocor, Merck & Co.) had a more potent in vitro antimicrobial effect than did fluvastatin (Lescol, Novartis) against methicillin-sensitive S. aureus (MSSA). Activity also was seen, but to a lesser extent, against methicillin-resistant S. aureus (MRSA).

Statins have immunomodulatory effects and recent observational studies have suggested that the use of statins may be associated with a decreased risk of severe infections, including sepsis and pneumonia.

Dr. Cohen and coinvestigator Dr. Susie Jerwood, of the Royal Sussex County Hospital, Brighton, theorized that statins also may exert antimicrobial effects.

Using a standard microtiter dilution method, the researchers tested simvastatin and fluvastatin against six samples each of MSSA and MRSA, as well as six samples each of vancomycin-sensitive and -resistant enterococci, isolated from blood cultures. The drugs were obtained in pure form from the manufacturers, Merck and Novartis. The control drug was propranolol.

The highest dilution at which there was no visible growth of bacteria after overnight incubation (the minimum inhibitory concentration [MIC]) was recorded. Each drug was tested against each of the isolates in duplicate on each culture plate. The tests then were repeated.

The average MIC for simvastatin was 29.2 mg/L against MSSA and 74.9 mg/L against MRSA. Fluvastatin had significantly less effect. The control drug, propranolol, showed no antimicrobial effect. Dr. Cohen did not provide MIC data on fluvastatin at the meeting.

"Unquestionably, there is an antimicrobial effect here, and it is specific," Dr. Cohen told reporters in a press briefing at the meeting, sponsored by the American Society for Microbiology. "The second point, though, is that the effect that we demonstrated is modest. You'd need quite a lot of statin in order to produce any antimicrobial effect." The typical peak plasma concentration of simvastatin attained after a 40-mg oral dose is 0.0209 mg/L.

Thus, it's unlikely that the antimicrobial effects of statins are directly responsible for the protective benefits observed in previous trials, Dr. Cohen said. However, statins are broken down in the blood to active metabolites that could have greater antibacterial activity than the pure drug.

The findings "might point the way to a class effect," he said. "There is something about the chemical structure of these drugs that indeed does have antimicrobial activity."

"It's quite interesting that there is a difference between simvastatin and fluvastatin, suggesting that there are chemical differences between the drugs and that some of those differences might locate where in the molecule the activity is," Dr. Cohen added.

CHICAGO — Statins have antimicrobial effects in vitro, including against methicillin-resistant Staphylococcus aureus, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The drug concentrations needed to produce bacterial suppression in vitro were several log values higher than those typically found in blood samples from patients taking statins for their cholesterol-lowering or cardiovascular effects. The findings imply, however, that the structure of statins could be altered to enhance their antimicrobial effect, reported Dr. Jon Cohen, professor of infectious diseases and dean of the Brighton and Sussex Medical School, in Brighton, England.

Simvastatin (Zocor, Merck & Co.) had a more potent in vitro antimicrobial effect than did fluvastatin (Lescol, Novartis) against methicillin-sensitive S. aureus (MSSA). Activity also was seen, but to a lesser extent, against methicillin-resistant S. aureus (MRSA).

Statins have immunomodulatory effects and recent observational studies have suggested that the use of statins may be associated with a decreased risk of severe infections, including sepsis and pneumonia.

Dr. Cohen and coinvestigator Dr. Susie Jerwood, of the Royal Sussex County Hospital, Brighton, theorized that statins also may exert antimicrobial effects.

Using a standard microtiter dilution method, the researchers tested simvastatin and fluvastatin against six samples each of MSSA and MRSA, as well as six samples each of vancomycin-sensitive and -resistant enterococci, isolated from blood cultures. The drugs were obtained in pure form from the manufacturers, Merck and Novartis. The control drug was propranolol.

The highest dilution at which there was no visible growth of bacteria after overnight incubation (the minimum inhibitory concentration [MIC]) was recorded. Each drug was tested against each of the isolates in duplicate on each culture plate. The tests then were repeated.

The average MIC for simvastatin was 29.2 mg/L against MSSA and 74.9 mg/L against MRSA. Fluvastatin had significantly less effect. The control drug, propranolol, showed no antimicrobial effect. Dr. Cohen did not provide MIC data on fluvastatin at the meeting.

"Unquestionably, there is an antimicrobial effect here, and it is specific," Dr. Cohen told reporters in a press briefing at the meeting, sponsored by the American Society for Microbiology. "The second point, though, is that the effect that we demonstrated is modest. You'd need quite a lot of statin in order to produce any antimicrobial effect." The typical peak plasma concentration of simvastatin attained after a 40-mg oral dose is 0.0209 mg/L.

Thus, it's unlikely that the antimicrobial effects of statins are directly responsible for the protective benefits observed in previous trials, Dr. Cohen said. However, statins are broken down in the blood to active metabolites that could have greater antibacterial activity than the pure drug.

The findings "might point the way to a class effect," he said. "There is something about the chemical structure of these drugs that indeed does have antimicrobial activity."

"It's quite interesting that there is a difference between simvastatin and fluvastatin, suggesting that there are chemical differences between the drugs and that some of those differences might locate where in the molecule the activity is," Dr. Cohen added.

CHICAGO — Statins have antimicrobial effects in vitro, including against methicillin-resistant Staphylococcus aureus, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The drug concentrations needed to produce bacterial suppression in vitro were several log values higher than those typically found in blood samples from patients taking statins for their cholesterol-lowering or cardiovascular effects. The findings imply, however, that the structure of statins could be altered to enhance their antimicrobial effect, reported Dr. Jon Cohen, professor of infectious diseases and dean of the Brighton and Sussex Medical School, in Brighton, England.

Simvastatin (Zocor, Merck & Co.) had a more potent in vitro antimicrobial effect than did fluvastatin (Lescol, Novartis) against methicillin-sensitive S. aureus (MSSA). Activity also was seen, but to a lesser extent, against methicillin-resistant S. aureus (MRSA).

Statins have immunomodulatory effects and recent observational studies have suggested that the use of statins may be associated with a decreased risk of severe infections, including sepsis and pneumonia.

Dr. Cohen and coinvestigator Dr. Susie Jerwood, of the Royal Sussex County Hospital, Brighton, theorized that statins also may exert antimicrobial effects.

Using a standard microtiter dilution method, the researchers tested simvastatin and fluvastatin against six samples each of MSSA and MRSA, as well as six samples each of vancomycin-sensitive and -resistant enterococci, isolated from blood cultures. The drugs were obtained in pure form from the manufacturers, Merck and Novartis. The control drug was propranolol.

The highest dilution at which there was no visible growth of bacteria after overnight incubation (the minimum inhibitory concentration [MIC]) was recorded. Each drug was tested against each of the isolates in duplicate on each culture plate. The tests then were repeated.

The average MIC for simvastatin was 29.2 mg/L against MSSA and 74.9 mg/L against MRSA. Fluvastatin had significantly less effect. The control drug, propranolol, showed no antimicrobial effect. Dr. Cohen did not provide MIC data on fluvastatin at the meeting.

"Unquestionably, there is an antimicrobial effect here, and it is specific," Dr. Cohen told reporters in a press briefing at the meeting, sponsored by the American Society for Microbiology. "The second point, though, is that the effect that we demonstrated is modest. You'd need quite a lot of statin in order to produce any antimicrobial effect." The typical peak plasma concentration of simvastatin attained after a 40-mg oral dose is 0.0209 mg/L.

Thus, it's unlikely that the antimicrobial effects of statins are directly responsible for the protective benefits observed in previous trials, Dr. Cohen said. However, statins are broken down in the blood to active metabolites that could have greater antibacterial activity than the pure drug.

The findings "might point the way to a class effect," he said. "There is something about the chemical structure of these drugs that indeed does have antimicrobial activity."

"It's quite interesting that there is a difference between simvastatin and fluvastatin, suggesting that there are chemical differences between the drugs and that some of those differences might locate where in the molecule the activity is," Dr. Cohen added.

CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors.

For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are longtime survivors, lead investigator Dr. Lisa Del Giudice said in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care.

There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected shared care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians.

More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care.

And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors.

For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are longtime survivors, lead investigator Dr. Lisa Del Giudice said in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care.

There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected shared care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians.

More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care.

And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors.

For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are longtime survivors, lead investigator Dr. Lisa Del Giudice said in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care.

There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected shared care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians.

More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care.

And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach utilizing a wide variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

Pain can be continuous or intermittent, and is often aggravated by activities such as sitting, riding, or sexual intercourse. The treatment of vulvar pain is confounded by the fact that the etiology is unknown in the majority of cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

Vulvar care measures to review with patients include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, 100% cotton pads may be helpful, but the drawback is that none are disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6).

Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products (Can. Med. Assoc. J. 1996;155:1036).”

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, as it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, she said.

Recent studies have shown some benefit in vestibulodynia with capsaicin ointment, which contains the extract of red chili peppers. Research has also been done in botulinum toxin type A injections for vulvar pain, with some reported benefits.

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those who wish to avoid the associated drowsiness. Contraception should be discussed with patients who are prescribed antidepressants, she said.

If there is no response after 4 weeks of tricyclics, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family, said Dr. Haefner, who disclosed no relevant conflicts of interest.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned. “If you use 40 mg total on the perineum, it can cause entire erosion and loss of the perineum.”

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range and are particularly helpful if there is concomitant vaginismus.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women in whom other strategies have failed, Dr. Haefner said.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach utilizing a wide variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

Pain can be continuous or intermittent, and is often aggravated by activities such as sitting, riding, or sexual intercourse. The treatment of vulvar pain is confounded by the fact that the etiology is unknown in the majority of cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

Vulvar care measures to review with patients include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, 100% cotton pads may be helpful, but the drawback is that none are disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6).

Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products (Can. Med. Assoc. J. 1996;155:1036).”

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, as it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, she said.

Recent studies have shown some benefit in vestibulodynia with capsaicin ointment, which contains the extract of red chili peppers. Research has also been done in botulinum toxin type A injections for vulvar pain, with some reported benefits.

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those who wish to avoid the associated drowsiness. Contraception should be discussed with patients who are prescribed antidepressants, she said.

If there is no response after 4 weeks of tricyclics, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family, said Dr. Haefner, who disclosed no relevant conflicts of interest.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned. “If you use 40 mg total on the perineum, it can cause entire erosion and loss of the perineum.”

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range and are particularly helpful if there is concomitant vaginismus.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women in whom other strategies have failed, Dr. Haefner said.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach utilizing a wide variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

Pain can be continuous or intermittent, and is often aggravated by activities such as sitting, riding, or sexual intercourse. The treatment of vulvar pain is confounded by the fact that the etiology is unknown in the majority of cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

Vulvar care measures to review with patients include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, 100% cotton pads may be helpful, but the drawback is that none are disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6).

Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products (Can. Med. Assoc. J. 1996;155:1036).”

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, as it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, she said.

Recent studies have shown some benefit in vestibulodynia with capsaicin ointment, which contains the extract of red chili peppers. Research has also been done in botulinum toxin type A injections for vulvar pain, with some reported benefits.

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those who wish to avoid the associated drowsiness. Contraception should be discussed with patients who are prescribed antidepressants, she said.

If there is no response after 4 weeks of tricyclics, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family, said Dr. Haefner, who disclosed no relevant conflicts of interest.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned. “If you use 40 mg total on the perineum, it can cause entire erosion and loss of the perineum.”

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range and are particularly helpful if there is concomitant vaginismus.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women in whom other strategies have failed, Dr. Haefner said.

TORONTO — A catheter-free capsule may be a viable alternative to conventional esophageal pH monitoring in children with gastroesophageal reflux disease symptoms, according to data from a retrospective study in 33 patients aged 10–18 years.

A notable advantage for children is that the capsule allows them to go to school and continue normal activities without a catheter hanging from their nose, Dr. Mirza Beg said during a poster presentation at the annual meeting of the Pediatric Academic Societies. The system is not indicated for the pediatric population.

Conventional esophageal monitoring uses a catheter, typically placed transnasally through the oropharynx into the esophagus. One end of the catheter protrudes from the nose and is connected to a battery-powered recorder worn by the patient.

The Bravo pH monitoring system (Medtronic Inc.) uses a capsule attached to the esophageal lining with a clip. It contains an acid probe and transmits pH data to a receiver worn by the patient for 48 hours, after which the patient returns the receiver to the physician and the data are downloaded. The capsule device falls off the lining after 5 or more days and is passed in the stool, reported Dr. Beg and his associates at the State University of New York (Syracuse) Upstate Medical University. The researchers were led by Dr. Manoochehr Karjoo. They disclosed no conflicts of interest with Medtronic and received no research support from it.

In the current study, Bravo monitoring was generally well-tolerated, and no significant complications were reported. Four patients had a mild sensation of substernal pain for 2 hours after placement. Most of the capsules were passed within 7–8 days.

TORONTO — A catheter-free capsule may be a viable alternative to conventional esophageal pH monitoring in children with gastroesophageal reflux disease symptoms, according to data from a retrospective study in 33 patients aged 10–18 years.

A notable advantage for children is that the capsule allows them to go to school and continue normal activities without a catheter hanging from their nose, Dr. Mirza Beg said during a poster presentation at the annual meeting of the Pediatric Academic Societies. The system is not indicated for the pediatric population.

Conventional esophageal monitoring uses a catheter, typically placed transnasally through the oropharynx into the esophagus. One end of the catheter protrudes from the nose and is connected to a battery-powered recorder worn by the patient.

The Bravo pH monitoring system (Medtronic Inc.) uses a capsule attached to the esophageal lining with a clip. It contains an acid probe and transmits pH data to a receiver worn by the patient for 48 hours, after which the patient returns the receiver to the physician and the data are downloaded. The capsule device falls off the lining after 5 or more days and is passed in the stool, reported Dr. Beg and his associates at the State University of New York (Syracuse) Upstate Medical University. The researchers were led by Dr. Manoochehr Karjoo. They disclosed no conflicts of interest with Medtronic and received no research support from it.

In the current study, Bravo monitoring was generally well-tolerated, and no significant complications were reported. Four patients had a mild sensation of substernal pain for 2 hours after placement. Most of the capsules were passed within 7–8 days.

TORONTO — A catheter-free capsule may be a viable alternative to conventional esophageal pH monitoring in children with gastroesophageal reflux disease symptoms, according to data from a retrospective study in 33 patients aged 10–18 years.

A notable advantage for children is that the capsule allows them to go to school and continue normal activities without a catheter hanging from their nose, Dr. Mirza Beg said during a poster presentation at the annual meeting of the Pediatric Academic Societies. The system is not indicated for the pediatric population.

Conventional esophageal monitoring uses a catheter, typically placed transnasally through the oropharynx into the esophagus. One end of the catheter protrudes from the nose and is connected to a battery-powered recorder worn by the patient.

The Bravo pH monitoring system (Medtronic Inc.) uses a capsule attached to the esophageal lining with a clip. It contains an acid probe and transmits pH data to a receiver worn by the patient for 48 hours, after which the patient returns the receiver to the physician and the data are downloaded. The capsule device falls off the lining after 5 or more days and is passed in the stool, reported Dr. Beg and his associates at the State University of New York (Syracuse) Upstate Medical University. The researchers were led by Dr. Manoochehr Karjoo. They disclosed no conflicts of interest with Medtronic and received no research support from it.

In the current study, Bravo monitoring was generally well-tolerated, and no significant complications were reported. Four patients had a mild sensation of substernal pain for 2 hours after placement. Most of the capsules were passed within 7–8 days.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach that draws on a variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

The pain can be continuous or intermittent and is often aggravated by activities such as sitting, riding, or sexual intercourse. Treatment of the condition is confounded by the fact that the etiology is unknown in most cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

One should review the routine vulvar care measures with patients, which would include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, then it may help to use 100% cotton pads, though they are not disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6). However, Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products” (Can. Med. Assoc. J. 1996;155:1036).

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, because it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, but it is difficult in insert them, because “these patients are so tender.”

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those reluctant to use the medication because of associated drowsiness.

If there is no response after 4 weeks of tricyclic therapy, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family. “It hasn't helped as many patients as I'd hoped, but it can be beneficial,” said Dr. Haefner, who disclosed no relevant conflicts of interest.

The use of oral calcium citrate with a low oxalate diet is of limited value, but may help some women who experience a burning sensation with certain foods, she said.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned.

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women with longstanding and localized vestibular pain where other strategies have failed, Dr. Haefner said.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach that draws on a variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

The pain can be continuous or intermittent and is often aggravated by activities such as sitting, riding, or sexual intercourse. Treatment of the condition is confounded by the fact that the etiology is unknown in most cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

One should review the routine vulvar care measures with patients, which would include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, then it may help to use 100% cotton pads, though they are not disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6). However, Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products” (Can. Med. Assoc. J. 1996;155:1036).

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, because it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, but it is difficult in insert them, because “these patients are so tender.”

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those reluctant to use the medication because of associated drowsiness.

If there is no response after 4 weeks of tricyclic therapy, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family. “It hasn't helped as many patients as I'd hoped, but it can be beneficial,” said Dr. Haefner, who disclosed no relevant conflicts of interest.

The use of oral calcium citrate with a low oxalate diet is of limited value, but may help some women who experience a burning sensation with certain foods, she said.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned.

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women with longstanding and localized vestibular pain where other strategies have failed, Dr. Haefner said.

CHICAGO — Vulvodynia is best managed with a multidisciplinary approach that draws on a variety of therapeutic options, Dr. Hope K. Haefner said at a conference on vulvovaginal diseases sponsored by the American Society for Colposcopy and Cervical Pathology.

Vulvodynia is a complex pain disorder that can be challenging to treat. Although spontaneous remission of symptoms has occurred in some women, rapid resolution of symptomatic vulvar pain is unusual, even with appropriate therapy.

The pain can be continuous or intermittent and is often aggravated by activities such as sitting, riding, or sexual intercourse. Treatment of the condition is confounded by the fact that the etiology is unknown in most cases.

“I don't think it's one disease, so I don't think there's going to be one cure,” said Dr. Haefner, a recognized expert on the subject, and professor of obstetrics and gynecology and codirector of the University of Michigan Center for Vulvar Diseases.

One should review the routine vulvar care measures with patients, which would include using mild soaps for bathing, avoiding soap on the vulva, keeping the vulva dry without the use of hair dryers, wearing white 100% cotton underwear during the day, and sleeping without underwear. Wicking briefs can be used if sweating is a problem.

If menstrual pads are irritating, then it may help to use 100% cotton pads, though they are not disposable. Dr. Haefner expressed concern about the use of Always brand sanitary pads, which was a common variable among patients with vulvodynia in a small Canadian case series (Can. Med. Assoc. J. 1996;154:1173–6). However, Procter & Gamble, the manufacturer of Always, stated in a letter that its premarket clinical trials, which included over 1,500 women and specifically evaluated the genital area, did not detect “any increased risk (either in frequency or severity) of irritation as a result of Always products in comparison with other marketed products” (Can. Med. Assoc. J. 1996;155:1036).

Vaginal lubricants such as olive oil, Replens, Slippery Stuff, Astroglide, KY Liquid, and Probe are recommended to provide adequate lubrication for intercourse.

Topical 5% lidocaine may be useful in treating vestibulodynia, but “it's not the answer for most patients,” Dr. Haefner said. For point tenderness, she prefers 0.5 cc of topical amitriptyline 2% with baclofen 2% in a water-washable base squirted from a syringe onto the finger and applied to the affected area daily and titrated up to three times a day if needed.

Vagisil (benzocaine) is not recommended, because it is a sensitizing agent and can cause rebound vasodilation and pain. Estrogen vaginal rings help some patients, but it is difficult in insert them, because “these patients are so tender.”

Among oral medications, Dr. Haefner favors the tricyclic antidepressants, particularly amitriptyline, rather than SSRIs. She starts amitriptyline at a dose of 25 mg orally every night for 1 week, or 10 mg nightly in patients age 60 or older or in those reluctant to use the medication because of associated drowsiness.

If there is no response after 4 weeks of tricyclic therapy, Dr. Haefner typically switches to anticonvulsants such as Neurontin (gabapentin) or rarely Tegretol (carbamazepine), which have a clearly demonstrated role in the treatment of neuropathic pain. Lyrica (pregabalin) is the newest addition to this family. “It hasn't helped as many patients as I'd hoped, but it can be beneficial,” said Dr. Haefner, who disclosed no relevant conflicts of interest.

The use of oral calcium citrate with a low oxalate diet is of limited value, but may help some women who experience a burning sensation with certain foods, she said.

Dr. Haefner occasionally uses bupivacaine (0.25% or 0.5%) and Kenalog (triamcinolone acetonide) injections for patients with localized vulvodynia. “But you've got to make sure you're not using too high a steroid dose,” she warned.

Physical therapy and biofeedback are commonly used in the treatment of vulvar pain, with success rates reported in the 60%–80% range.

Surgical excision of the vulvar vestibule has met with success in up to 80% of reported cases, but should be reserved for women with longstanding and localized vestibular pain where other strategies have failed, Dr. Haefner said.

CHICAGO — The quadrivalent human papillomavirus vaccine Gardasil offers cross-protection against cancer-causing HPV types that are not included in the vaccine, according to data reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

A three-dose regimen of the human papillomavirus (HPV) type 6/11/16/18 vaccine demonstrated 62% efficacy in preventing cervical intraepithelial neoplasia (CIN) grades 2 and 3 or adenocarcinoma in situ (AIS) caused by HPV 31 or 45, the two most common HPV types found in cervical cancer after HPV 16 and 18.

Efficacy was 43% against CIN 2/3 or AIS due to HPV 31, 33, 45, 52, or 58, the five most common types found in cervical cancer after HPV 16 and 18.

Efficacy was 38% for 10 nonvaccine oncogenic types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59), which cause more than 20% of cervical cancers worldwide, Dr. Darron Brown reported on behalf of the FUTURE Study Group.

In all, 38 cases of CIN 2/3 or AIS due to the 10 cancer-causing HPV types were reported among 4,616 Gardasil-vaccinated women, who were participants in the Merck-sponsored phase III Females United To Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II trials, which led to the approval of Gardasil in June 2006.

They underwent cervicovaginal sampling and Pap testing at day 1 and 6–12 month intervals for up to 48 months.

The data have been submitted to the Food and Drug Administration for review.

Kelley P. Dougherty, who is the director of public affairs for Merck & Co., West Point, Pa., said in an interview that it is too early to say if the indication for Gardasil or its marketing campaign will be expanded.

“We expect to hear from them by the end of the first quarter of ′08, and once we determine collectively what these data mean as far as long-term impact, we'll look at that,” she said.

Reductions in disease with Gardasil vaccination were most apparent for the A9 species, which includes HPV 16. CIN 2/3 or AIS due to nonvaccine A9 species (types 31, 33, 35, 52, and 58) was reported in 26 vaccinated women and 48 placebo-treated women, demonstrating a 45% efficacy for Gardasil.

Efficacy was 46% against disease due to nonvaccine A7 species (types 39, 45, and 59), with 8 and 15 cases reported for vaccinated and placebo-treated women, respectively. HPV 18 is the prototype of the A7 species.

Efficacy data were not available for types 51 and 56 because the study was not powered to look at efficacy for individual HPV types.

Data were available on cross-protection for persistent infection. Among 1,036 vaccinated women and 1,029 placebo-treated women, Gardasil had a 45% efficacy against persistent infection with HPV 31 or 45, and 28% efficacy against persistent infection with HPV 31, 33, 45, 52, or 58.

Dr. Brown suggested that HPV 16 and 18 neutralizing antibodies generated by vaccination may bind and neutralize virions of nonvaccine HPV types, thereby preventing them from entering the cervical cell. “By preventing infection, we can prevent disease,” he said.

As for whether Gardasil may provide similar efficacy in men, Dr. Brown said during the presentation, which was sponsored by the American Society for Microbiology, that there is reason to suspect protection might be different because the male and female epithelia are quite different, especially when comparing penile and cervical lesions. The penile epithelium is a stratified squamous epithelium about 20–30 cells thick, whereas the cervical epithelium is a mucosal epithelium, 6–8 cells thick.

“The good news is that the penile epithelium and the vulvar epithelium are actually quite similar, and in our studies, vulvar lesions were nearly 100% prevented in women, giving us hope that analogous penile lesions will be similarly protected against. But that is still being analyzed,” he said.

Indiana University and Merck have an intellectual property agreement for the development of the vaccine, and Dr. Brown receives a portion of his income from that agreement, he disclosed.

CHICAGO — The quadrivalent human papillomavirus vaccine Gardasil offers cross-protection against cancer-causing HPV types that are not included in the vaccine, according to data reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

A three-dose regimen of the human papillomavirus (HPV) type 6/11/16/18 vaccine demonstrated 62% efficacy in preventing cervical intraepithelial neoplasia (CIN) grades 2 and 3 or adenocarcinoma in situ (AIS) caused by HPV 31 or 45, the two most common HPV types found in cervical cancer after HPV 16 and 18.

Efficacy was 43% against CIN 2/3 or AIS due to HPV 31, 33, 45, 52, or 58, the five most common types found in cervical cancer after HPV 16 and 18.

Efficacy was 38% for 10 nonvaccine oncogenic types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59), which cause more than 20% of cervical cancers worldwide, Dr. Darron Brown reported on behalf of the FUTURE Study Group.

In all, 38 cases of CIN 2/3 or AIS due to the 10 cancer-causing HPV types were reported among 4,616 Gardasil-vaccinated women, who were participants in the Merck-sponsored phase III Females United To Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II trials, which led to the approval of Gardasil in June 2006.

They underwent cervicovaginal sampling and Pap testing at day 1 and 6–12 month intervals for up to 48 months.

The data have been submitted to the Food and Drug Administration for review.

Kelley P. Dougherty, who is the director of public affairs for Merck & Co., West Point, Pa., said in an interview that it is too early to say if the indication for Gardasil or its marketing campaign will be expanded.

“We expect to hear from them by the end of the first quarter of ′08, and once we determine collectively what these data mean as far as long-term impact, we'll look at that,” she said.

Reductions in disease with Gardasil vaccination were most apparent for the A9 species, which includes HPV 16. CIN 2/3 or AIS due to nonvaccine A9 species (types 31, 33, 35, 52, and 58) was reported in 26 vaccinated women and 48 placebo-treated women, demonstrating a 45% efficacy for Gardasil.

Efficacy was 46% against disease due to nonvaccine A7 species (types 39, 45, and 59), with 8 and 15 cases reported for vaccinated and placebo-treated women, respectively. HPV 18 is the prototype of the A7 species.

Efficacy data were not available for types 51 and 56 because the study was not powered to look at efficacy for individual HPV types.

Data were available on cross-protection for persistent infection. Among 1,036 vaccinated women and 1,029 placebo-treated women, Gardasil had a 45% efficacy against persistent infection with HPV 31 or 45, and 28% efficacy against persistent infection with HPV 31, 33, 45, 52, or 58.

Dr. Brown suggested that HPV 16 and 18 neutralizing antibodies generated by vaccination may bind and neutralize virions of nonvaccine HPV types, thereby preventing them from entering the cervical cell. “By preventing infection, we can prevent disease,” he said.

As for whether Gardasil may provide similar efficacy in men, Dr. Brown said during the presentation, which was sponsored by the American Society for Microbiology, that there is reason to suspect protection might be different because the male and female epithelia are quite different, especially when comparing penile and cervical lesions. The penile epithelium is a stratified squamous epithelium about 20–30 cells thick, whereas the cervical epithelium is a mucosal epithelium, 6–8 cells thick.

“The good news is that the penile epithelium and the vulvar epithelium are actually quite similar, and in our studies, vulvar lesions were nearly 100% prevented in women, giving us hope that analogous penile lesions will be similarly protected against. But that is still being analyzed,” he said.

Indiana University and Merck have an intellectual property agreement for the development of the vaccine, and Dr. Brown receives a portion of his income from that agreement, he disclosed.

CHICAGO — The quadrivalent human papillomavirus vaccine Gardasil offers cross-protection against cancer-causing HPV types that are not included in the vaccine, according to data reported in a late-breaking poster at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

A three-dose regimen of the human papillomavirus (HPV) type 6/11/16/18 vaccine demonstrated 62% efficacy in preventing cervical intraepithelial neoplasia (CIN) grades 2 and 3 or adenocarcinoma in situ (AIS) caused by HPV 31 or 45, the two most common HPV types found in cervical cancer after HPV 16 and 18.

Efficacy was 43% against CIN 2/3 or AIS due to HPV 31, 33, 45, 52, or 58, the five most common types found in cervical cancer after HPV 16 and 18.

Efficacy was 38% for 10 nonvaccine oncogenic types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59), which cause more than 20% of cervical cancers worldwide, Dr. Darron Brown reported on behalf of the FUTURE Study Group.

In all, 38 cases of CIN 2/3 or AIS due to the 10 cancer-causing HPV types were reported among 4,616 Gardasil-vaccinated women, who were participants in the Merck-sponsored phase III Females United To Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II trials, which led to the approval of Gardasil in June 2006.

They underwent cervicovaginal sampling and Pap testing at day 1 and 6–12 month intervals for up to 48 months.

The data have been submitted to the Food and Drug Administration for review.

Kelley P. Dougherty, who is the director of public affairs for Merck & Co., West Point, Pa., said in an interview that it is too early to say if the indication for Gardasil or its marketing campaign will be expanded.

“We expect to hear from them by the end of the first quarter of ′08, and once we determine collectively what these data mean as far as long-term impact, we'll look at that,” she said.

Reductions in disease with Gardasil vaccination were most apparent for the A9 species, which includes HPV 16. CIN 2/3 or AIS due to nonvaccine A9 species (types 31, 33, 35, 52, and 58) was reported in 26 vaccinated women and 48 placebo-treated women, demonstrating a 45% efficacy for Gardasil.

Efficacy was 46% against disease due to nonvaccine A7 species (types 39, 45, and 59), with 8 and 15 cases reported for vaccinated and placebo-treated women, respectively. HPV 18 is the prototype of the A7 species.

Efficacy data were not available for types 51 and 56 because the study was not powered to look at efficacy for individual HPV types.

Data were available on cross-protection for persistent infection. Among 1,036 vaccinated women and 1,029 placebo-treated women, Gardasil had a 45% efficacy against persistent infection with HPV 31 or 45, and 28% efficacy against persistent infection with HPV 31, 33, 45, 52, or 58.

Dr. Brown suggested that HPV 16 and 18 neutralizing antibodies generated by vaccination may bind and neutralize virions of nonvaccine HPV types, thereby preventing them from entering the cervical cell. “By preventing infection, we can prevent disease,” he said.

As for whether Gardasil may provide similar efficacy in men, Dr. Brown said during the presentation, which was sponsored by the American Society for Microbiology, that there is reason to suspect protection might be different because the male and female epithelia are quite different, especially when comparing penile and cervical lesions. The penile epithelium is a stratified squamous epithelium about 20–30 cells thick, whereas the cervical epithelium is a mucosal epithelium, 6–8 cells thick.

“The good news is that the penile epithelium and the vulvar epithelium are actually quite similar, and in our studies, vulvar lesions were nearly 100% prevented in women, giving us hope that analogous penile lesions will be similarly protected against. But that is still being analyzed,” he said.

Indiana University and Merck have an intellectual property agreement for the development of the vaccine, and Dr. Brown receives a portion of his income from that agreement, he disclosed.

TORONTO — Bordetella pertussis polymerase chain reaction tests can be positive months after clinical illness, Dr. Bryan Stone reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

It took a full 7 months for patients who initially tested positive for B. pertussis by polymerase chain reaction (PCR) to convert to a negative status, according to data from a prospective cohort study of 36 patients.

Rapid PCR testing has a sensitivity of 94%–98%. But there are concerns the test may be overly sensitive.

Patients with pertussis are believed to be contagious through the first 21 days of illness or completion of 5 days of antibiotics. What hasn't been known is the length of time after reported onset of symptoms that PCR testing remains positive, said Dr. Stone, medical director of the neuroscience trauma unit and assistant professor of pediatrics at the University of Utah, Salt Lake City.

The analysis was based on 36 participants providing 61 samples taken 4–204 days from onset of symptoms. Thirteen “index” cases were PCR-positive infants admitted to a tertiary care center and 23 were in close contact with an infected infant and had a cough lasting 7 or more days. The mean age of the index cases was 78 days, and none had received any pertussis immunizations.

Testing occurred weekly for 3 weeks and then monthly or every other month for 12 months or until the test became negative. Overall, 15 patients allowed serial sampling; 16 allowed only one sample; and 5 were initially negative, but remained ill for more than 21 days from onset of symptoms. There was no difference in antibiotic exposure in patients who tested PCR positive or negative. Half of the participants remained PCR positive between 60 and 150 days after onset of symptoms.

TORONTO — Bordetella pertussis polymerase chain reaction tests can be positive months after clinical illness, Dr. Bryan Stone reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

It took a full 7 months for patients who initially tested positive for B. pertussis by polymerase chain reaction (PCR) to convert to a negative status, according to data from a prospective cohort study of 36 patients.

Rapid PCR testing has a sensitivity of 94%–98%. But there are concerns the test may be overly sensitive.

Patients with pertussis are believed to be contagious through the first 21 days of illness or completion of 5 days of antibiotics. What hasn't been known is the length of time after reported onset of symptoms that PCR testing remains positive, said Dr. Stone, medical director of the neuroscience trauma unit and assistant professor of pediatrics at the University of Utah, Salt Lake City.

The analysis was based on 36 participants providing 61 samples taken 4–204 days from onset of symptoms. Thirteen “index” cases were PCR-positive infants admitted to a tertiary care center and 23 were in close contact with an infected infant and had a cough lasting 7 or more days. The mean age of the index cases was 78 days, and none had received any pertussis immunizations.

Testing occurred weekly for 3 weeks and then monthly or every other month for 12 months or until the test became negative. Overall, 15 patients allowed serial sampling; 16 allowed only one sample; and 5 were initially negative, but remained ill for more than 21 days from onset of symptoms. There was no difference in antibiotic exposure in patients who tested PCR positive or negative. Half of the participants remained PCR positive between 60 and 150 days after onset of symptoms.

TORONTO — Bordetella pertussis polymerase chain reaction tests can be positive months after clinical illness, Dr. Bryan Stone reported in a poster presentation at the annual meeting of the Pediatric Academic Societies.

It took a full 7 months for patients who initially tested positive for B. pertussis by polymerase chain reaction (PCR) to convert to a negative status, according to data from a prospective cohort study of 36 patients.

Rapid PCR testing has a sensitivity of 94%–98%. But there are concerns the test may be overly sensitive.

Patients with pertussis are believed to be contagious through the first 21 days of illness or completion of 5 days of antibiotics. What hasn't been known is the length of time after reported onset of symptoms that PCR testing remains positive, said Dr. Stone, medical director of the neuroscience trauma unit and assistant professor of pediatrics at the University of Utah, Salt Lake City.

The analysis was based on 36 participants providing 61 samples taken 4–204 days from onset of symptoms. Thirteen “index” cases were PCR-positive infants admitted to a tertiary care center and 23 were in close contact with an infected infant and had a cough lasting 7 or more days. The mean age of the index cases was 78 days, and none had received any pertussis immunizations.

Testing occurred weekly for 3 weeks and then monthly or every other month for 12 months or until the test became negative. Overall, 15 patients allowed serial sampling; 16 allowed only one sample; and 5 were initially negative, but remained ill for more than 21 days from onset of symptoms. There was no difference in antibiotic exposure in patients who tested PCR positive or negative. Half of the participants remained PCR positive between 60 and 150 days after onset of symptoms.

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).

With use of the very stringent Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% using the 5-day regimen were cured, compared with 5.7% receiving 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 taken twice a day for 7 days, with clindamycin 300 mg taken 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 clearly inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation that uses similar technology as single-dose butoconazole-1 cream, which gynecologists may be familiar with, 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%) (Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV, as 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.

Lactobacillus-impregnated tampons used after a course of clindamycin ovules did not improve cure rates at 2 months in one study (Acta Derm. Venereol. 2005;85:42–6). Early results with the Lactobacillus crispatus CTV-05 strain have not shown a benefit, he said at the conference sponsored by the American Society for Colposcopy and Cervical Pathology.

However, a recent study did report high satisfaction rates for an intravaginal lactobacillus capsule (J. Womens Health 2006;15:1053–60). In a separate study of 32 women with BV, 88% treated with yogurt douches for 7 days during the first trimester of pregnancy were cured, compared with 5% who were not treated (Acta Obstet. Gynecol. Scand. 1993;72:17–9).

“The bottom line is that there is no well-studied product available and no well-demonstrated benefits,” said Dr. Nyirjesy, who noted that most of the lactobacillus products are not available in the U.S.

He suggests individualizing BV therapy based on a variety of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference.

As for whether one antibiotic is better than another, the question has taken on new relevance in light of increasing evidence that not all BV is the same. 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, 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 did patients on multiple doses of 0.75% metronidazole gel (97.5% vs. 80%).

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%).

That information prompted audience members to question whether they should identify species on wet mount for all of their BV patients.

“The answer is absolutely not,” he said. “The study shows that not all bacterial vaginosis is the same and that there may be different responses to antibiotics in women with BV.”

He stressed that this last was a retrospective study from pooled data, and that marketing efforts notwithstanding, it was a preliminary paper that calls for further investigation.

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).

With use of the very stringent Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% using the 5-day regimen were cured, compared with 5.7% receiving 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 taken twice a day for 7 days, with clindamycin 300 mg taken 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 clearly inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation that uses similar technology as single-dose butoconazole-1 cream, which gynecologists may be familiar with, 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%) (Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV, as 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.

Lactobacillus-impregnated tampons used after a course of clindamycin ovules did not improve cure rates at 2 months in one study (Acta Derm. Venereol. 2005;85:42–6). Early results with the Lactobacillus crispatus CTV-05 strain have not shown a benefit, he said at the conference sponsored by the American Society for Colposcopy and Cervical Pathology.

However, a recent study did report high satisfaction rates for an intravaginal lactobacillus capsule (J. Womens Health 2006;15:1053–60). In a separate study of 32 women with BV, 88% treated with yogurt douches for 7 days during the first trimester of pregnancy were cured, compared with 5% who were not treated (Acta Obstet. Gynecol. Scand. 1993;72:17–9).

“The bottom line is that there is no well-studied product available and no well-demonstrated benefits,” said Dr. Nyirjesy, who noted that most of the lactobacillus products are not available in the U.S.

He suggests individualizing BV therapy based on a variety of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference.

As for whether one antibiotic is better than another, the question has taken on new relevance in light of increasing evidence that not all BV is the same. 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, 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 did patients on multiple doses of 0.75% metronidazole gel (97.5% vs. 80%).

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%).

That information prompted audience members to question whether they should identify species on wet mount for all of their BV patients.

“The answer is absolutely not,” he said. “The study shows that not all bacterial vaginosis is the same and that there may be different responses to antibiotics in women with BV.”

He stressed that this last was a retrospective study from pooled data, and that marketing efforts notwithstanding, it was a preliminary paper that calls for further investigation.

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).

With use of the very stringent Food and Drug Administration guidelines for cure, 32% of women using the 2-day regimen and 41% using the 5-day regimen were cured, compared with 5.7% receiving 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 taken twice a day for 7 days, with clindamycin 300 mg taken 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 clearly inadequate as a treatment for BV, he added.

Single-dose clindamycin 2% vaginal cream is a sustained-release preparation that uses similar technology as single-dose butoconazole-1 cream, which gynecologists may be familiar with, 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%) (Infect. Dis. Obstet. Gynecol. 2005;13:155–60).

Lactobacillus products would seem to have a role in BV, as 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.

Lactobacillus-impregnated tampons used after a course of clindamycin ovules did not improve cure rates at 2 months in one study (Acta Derm. Venereol. 2005;85:42–6). Early results with the Lactobacillus crispatus CTV-05 strain have not shown a benefit, he said at the conference sponsored by the American Society for Colposcopy and Cervical Pathology.

However, a recent study did report high satisfaction rates for an intravaginal lactobacillus capsule (J. Womens Health 2006;15:1053–60). In a separate study of 32 women with BV, 88% treated with yogurt douches for 7 days during the first trimester of pregnancy were cured, compared with 5% who were not treated (Acta Obstet. Gynecol. Scand. 1993;72:17–9).

“The bottom line is that there is no well-studied product available and no well-demonstrated benefits,” said Dr. Nyirjesy, who noted that most of the lactobacillus products are not available in the U.S.

He suggests individualizing BV therapy based on a variety of variables including cost, convenience, compliance, efficacy, spectrum coverage, and patient preference.

As for whether one antibiotic is better than another, the question has taken on new relevance in light of increasing evidence that not all BV is the same. 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, 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 did patients on multiple doses of 0.75% metronidazole gel (97.5% vs. 80%).

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%).

That information prompted audience members to question whether they should identify species on wet mount for all of their BV patients.

“The answer is absolutely not,” he said. “The study shows that not all bacterial vaginosis is the same and that there may be different responses to antibiotics in women with BV.”

He stressed that this last was a retrospective study from pooled data, and that marketing efforts notwithstanding, it was a preliminary paper that calls for further investigation.