Sherry Boschert

NEWPORT BEACH, CALIF. — Only one in five female adolescents correctly identified nine common sexually transmitted infections or correctly answered seven true-false questions about their sequelae in a study of 259 subjects.

Questionnaires completed by patients aged 12–20 years at an outpatient clinic showed that most of them did not recognize hepatitis B or C as sexually transmitted infections (see bar chart), and 46% did not know that symptoms of sexually transmitted infections are less likely to appear in males than in females.

Almost half (45%) thought that birth control methods besides condoms could prevent sexually transmitted infection, and a majority of the cohort reported inconsistent condom use, Dr. Seema Menon reported in a poster presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The age of respondents and their primary source of information did not seem to affect their level of knowledge about sexually transmitted infection. The only factor that predicted greater knowledge was having had one of the infections, which was reported by 47% of the cohort, said Dr. Menon of the University of South Carolina, Columbia, and her associates.

“A prior history of sexually transmitted infection should not be the sole driving force for teens to acquire knowledge,” she said. “Health care providers should aim to increase education about sexually transmitted infections during routine visits, as well as actively create new educational tools to improve accurate knowledge in the adolescent population that is so vulnerable to these infections.”

Given a list of nine common sexually transmitted infections, only 19% of participants correctly identified them all as sexually transmitted.

Although 93% correctly identified HIV/AIDS as a sexually transmitted infection, 91% incorrectly said that it is the only serious sexually transmitted infection by marking it true on a list of seven true-or-false statements about sequelae.

The fact that cervical cancer is linked with a sexually transmitted infection was not known by 27%. Asked about gonorrhea and chlamydia infections, 19% of respondents did not know that these infections can affect fertility, 25% did not know that they can lead to surgery, and 13% did not know that they can lead to a serious illness.

Responses to a list of four true-or-false statements about strategies to prevent sexually transmitted infection showed that 11% thought Depo-Provera use prevents infection and 13% thought oral contraceptive pills prevent infection, while 48% did not know that condoms can prevent transmission of herpes simplex virus and human papillomavirus.

Among 253 participants who provided information about their current birth control methods (including condoms), 59% reported inconsistent use of condoms, 24% used condoms consistently, 25% were on Depo-Provera, 18% used contraceptive pills, 2% used a contraceptive ring, 1% used a contraceptive patch, and 30% used no contraception. (More than one response was allowed.)

Reasons for not using condoms were identified as monogamy by 73%, dislike of condoms by 29%, use of another contraceptive method by 17%, refusal by a sexual partner in 11%, embarrassment by 5%, and cost by 2%.

Among 199 participants who identified a source of their information about sexually transmitted infections, 30% said a doctor or nurse, 30% said classes at school, 28% said family, 5% said friends, 2% said boyfriends, and 5% said TV, radio, or the Internet.

The 199 in this subgroup did not reach a preset goal of 200 participants needed to reach a power of 80% in detecting a difference, so it is possible that information from doctors still made a difference in the adolescents' knowledge of sexually transmitted infections.

“The impact a health care provider may have on sexually transmitted infection education or condom use should not be undervalued,” Dr. Manon said.

ELSEVIER GLOBAL MEDICAL NEWS

NEWPORT BEACH, CALIF. — Only one in five female adolescents correctly identified nine common sexually transmitted infections or correctly answered seven true-false questions about their sequelae in a study of 259 subjects.

Questionnaires completed by patients aged 12–20 years at an outpatient clinic showed that most of them did not recognize hepatitis B or C as sexually transmitted infections (see bar chart), and 46% did not know that symptoms of sexually transmitted infections are less likely to appear in males than in females.

Almost half (45%) thought that birth control methods besides condoms could prevent sexually transmitted infection, and a majority of the cohort reported inconsistent condom use, Dr. Seema Menon reported in a poster presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The age of respondents and their primary source of information did not seem to affect their level of knowledge about sexually transmitted infection. The only factor that predicted greater knowledge was having had one of the infections, which was reported by 47% of the cohort, said Dr. Menon of the University of South Carolina, Columbia, and her associates.

“A prior history of sexually transmitted infection should not be the sole driving force for teens to acquire knowledge,” she said. “Health care providers should aim to increase education about sexually transmitted infections during routine visits, as well as actively create new educational tools to improve accurate knowledge in the adolescent population that is so vulnerable to these infections.”

Given a list of nine common sexually transmitted infections, only 19% of participants correctly identified them all as sexually transmitted.

Although 93% correctly identified HIV/AIDS as a sexually transmitted infection, 91% incorrectly said that it is the only serious sexually transmitted infection by marking it true on a list of seven true-or-false statements about sequelae.

The fact that cervical cancer is linked with a sexually transmitted infection was not known by 27%. Asked about gonorrhea and chlamydia infections, 19% of respondents did not know that these infections can affect fertility, 25% did not know that they can lead to surgery, and 13% did not know that they can lead to a serious illness.

Responses to a list of four true-or-false statements about strategies to prevent sexually transmitted infection showed that 11% thought Depo-Provera use prevents infection and 13% thought oral contraceptive pills prevent infection, while 48% did not know that condoms can prevent transmission of herpes simplex virus and human papillomavirus.

Among 253 participants who provided information about their current birth control methods (including condoms), 59% reported inconsistent use of condoms, 24% used condoms consistently, 25% were on Depo-Provera, 18% used contraceptive pills, 2% used a contraceptive ring, 1% used a contraceptive patch, and 30% used no contraception. (More than one response was allowed.)

Reasons for not using condoms were identified as monogamy by 73%, dislike of condoms by 29%, use of another contraceptive method by 17%, refusal by a sexual partner in 11%, embarrassment by 5%, and cost by 2%.

Among 199 participants who identified a source of their information about sexually transmitted infections, 30% said a doctor or nurse, 30% said classes at school, 28% said family, 5% said friends, 2% said boyfriends, and 5% said TV, radio, or the Internet.

The 199 in this subgroup did not reach a preset goal of 200 participants needed to reach a power of 80% in detecting a difference, so it is possible that information from doctors still made a difference in the adolescents' knowledge of sexually transmitted infections.

“The impact a health care provider may have on sexually transmitted infection education or condom use should not be undervalued,” Dr. Manon said.

ELSEVIER GLOBAL MEDICAL NEWS

NEWPORT BEACH, CALIF. — Only one in five female adolescents correctly identified nine common sexually transmitted infections or correctly answered seven true-false questions about their sequelae in a study of 259 subjects.

Questionnaires completed by patients aged 12–20 years at an outpatient clinic showed that most of them did not recognize hepatitis B or C as sexually transmitted infections (see bar chart), and 46% did not know that symptoms of sexually transmitted infections are less likely to appear in males than in females.

Almost half (45%) thought that birth control methods besides condoms could prevent sexually transmitted infection, and a majority of the cohort reported inconsistent condom use, Dr. Seema Menon reported in a poster presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The age of respondents and their primary source of information did not seem to affect their level of knowledge about sexually transmitted infection. The only factor that predicted greater knowledge was having had one of the infections, which was reported by 47% of the cohort, said Dr. Menon of the University of South Carolina, Columbia, and her associates.

“A prior history of sexually transmitted infection should not be the sole driving force for teens to acquire knowledge,” she said. “Health care providers should aim to increase education about sexually transmitted infections during routine visits, as well as actively create new educational tools to improve accurate knowledge in the adolescent population that is so vulnerable to these infections.”

Given a list of nine common sexually transmitted infections, only 19% of participants correctly identified them all as sexually transmitted.

Although 93% correctly identified HIV/AIDS as a sexually transmitted infection, 91% incorrectly said that it is the only serious sexually transmitted infection by marking it true on a list of seven true-or-false statements about sequelae.

The fact that cervical cancer is linked with a sexually transmitted infection was not known by 27%. Asked about gonorrhea and chlamydia infections, 19% of respondents did not know that these infections can affect fertility, 25% did not know that they can lead to surgery, and 13% did not know that they can lead to a serious illness.

Responses to a list of four true-or-false statements about strategies to prevent sexually transmitted infection showed that 11% thought Depo-Provera use prevents infection and 13% thought oral contraceptive pills prevent infection, while 48% did not know that condoms can prevent transmission of herpes simplex virus and human papillomavirus.

Among 253 participants who provided information about their current birth control methods (including condoms), 59% reported inconsistent use of condoms, 24% used condoms consistently, 25% were on Depo-Provera, 18% used contraceptive pills, 2% used a contraceptive ring, 1% used a contraceptive patch, and 30% used no contraception. (More than one response was allowed.)

Reasons for not using condoms were identified as monogamy by 73%, dislike of condoms by 29%, use of another contraceptive method by 17%, refusal by a sexual partner in 11%, embarrassment by 5%, and cost by 2%.

Among 199 participants who identified a source of their information about sexually transmitted infections, 30% said a doctor or nurse, 30% said classes at school, 28% said family, 5% said friends, 2% said boyfriends, and 5% said TV, radio, or the Internet.

The 199 in this subgroup did not reach a preset goal of 200 participants needed to reach a power of 80% in detecting a difference, so it is possible that information from doctors still made a difference in the adolescents' knowledge of sexually transmitted infections.

“The impact a health care provider may have on sexually transmitted infection education or condom use should not be undervalued,” Dr. Manon said.

ELSEVIER GLOBAL MEDICAL NEWS

NEWPORT BEACH, CALIF. – A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9-26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status–either income or educational level–of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education from clinicians about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

“The more yuppified the practice, the higher the rates of late adopters among physicians and parents,” she said. “I don't think we have the baby shot anywhere on the horizon for the near future, so there is definitely time to work towards helping them move away from being late adopters.”

NEWPORT BEACH, CALIF. – A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9-26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status–either income or educational level–of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education from clinicians about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

“The more yuppified the practice, the higher the rates of late adopters among physicians and parents,” she said. “I don't think we have the baby shot anywhere on the horizon for the near future, so there is definitely time to work towards helping them move away from being late adopters.”

NEWPORT BEACH, CALIF. – A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9-26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status–either income or educational level–of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education from clinicians about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

“The more yuppified the practice, the higher the rates of late adopters among physicians and parents,” she said. “I don't think we have the baby shot anywhere on the horizon for the near future, so there is definitely time to work towards helping them move away from being late adopters.”

NEWPORT BEACH, CALIF. — A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9–26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

The HPV vaccine could follow the example of the hepatitis B vaccine, she suggested, which started as a vaccine for teenagers and later shifted to administration during infancy. Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status—either income or educational level—of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

She does not believe that religious beliefs played a significant role in accepting or rejecting the vaccine in the study, based on her knowledge of participants and how they answered the questionnaires, but the influence of religion was not analyzed specifically.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

NEWPORT BEACH, CALIF. — A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9–26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

The HPV vaccine could follow the example of the hepatitis B vaccine, she suggested, which started as a vaccine for teenagers and later shifted to administration during infancy. Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status—either income or educational level—of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

She does not believe that religious beliefs played a significant role in accepting or rejecting the vaccine in the study, based on her knowledge of participants and how they answered the questionnaires, but the influence of religion was not analyzed specifically.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

NEWPORT BEACH, CALIF. — A study of 61 parents of infants and children up to 10 years of age suggests that parents may favor the idea of giving the human papillomavirus vaccine at a very young age rather than during adolescence.

The study also found that parents with higher socioeconomic status and education levels were more likely to reject human papillomavirus (HPV) immunization for their children at any age, a finding that could help target educational efforts for the HPV vaccine toward those demographics, Dr. Ellen S. Rome said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

One HPV vaccine, Gardasil, is approved for use in females aged 9–26 years, and another is being considered for approval by the Food and Drug Administration.

Dr. Rome is on the speakers bureau of Merck & Co., which markets Gardasil.

The HPV vaccine could follow the example of the hepatitis B vaccine, she suggested, which started as a vaccine for teenagers and later shifted to administration during infancy. Studies on the use of HPV vaccine in infants and children would need to be conducted for that to happen, added Dr. Rome, head of adolescent medicine at the Cleveland Clinic. She presented the current study on behalf of the lead investigator, Dr. Laura Gillespie, also of the Cleveland Clinic, and her associates.

Parents recruited from the clinic's main campus, emergency department, and regional satellite offices answered a questionnaire about demographics, attitudes about immunization, knowledge about HPV, and willingness to have their children vaccinated against HPV. The parents then were given a one-page educational sheet from the Centers for Disease Control about HPV; after reading it, they completed a second questionnaire.

Before the intervention (the educational sheet), 25 parents said they wanted their children to get the HPV vaccine, 6 did not, and 30 were undecided. The higher the socioeconomic status—either income or educational level—of the parents, the less likely they were to want their children to get the HPV vaccine.

“Low-income families may have more realistic fears about what a sexually transmitted disease or HPV could mean for their child,” Dr. Rome speculated.

None of the parents who initially were for or against the vaccine changed their minds after reading the educational sheet. Among the 30 undecided parents, 12 favored vaccination after they read the sheet, 15 opposed it, and 3 did not answer the question about whether they would accept the HPV vaccine if it was offered for their child.

Beliefs that the HPV vaccine is safe and effective were significantly associated with acceptance after the intervention. Parents with higher education or income may require more aggressive education about the vaccine's safety and efficacy, the investigators suggested.

Among the 37 parents who approved of the HPV vaccine after the intervention, 29 (78%) said they'd prefer that it be given to young children or infants instead of to teenagers.

“They wanted to make it a baby shot,” Dr. Rome said.

The reason for that echoes findings from two previous studies of HPV vaccine acceptance by parents of children aged 10 years or older. “Parents still think that this shot is a license to have sex” if it is given to adolescents, Dr. Rome said. “That's a myth that we're still continuing to try to work towards busting.”

Parents with more boys in their homes were more favorable toward the HPV vaccine, “giving us hope that when the shot is available for boys,” parents will approve, she said. Merck is pursuing approval for the vaccine in boys.

She does not believe that religious beliefs played a significant role in accepting or rejecting the vaccine in the study, based on her knowledge of participants and how they answered the questionnaires, but the influence of religion was not analyzed specifically.

Since the completion of the study, the investigators began a separate study looking at current vaccination rates within their institution, for quality improvement purposes. They're finding near-100% acceptance of the HPV vaccine by physicians and parents in the clinic's urban offices, but the regional satellite offices have higher rates of “late adopters” who are resistant to use of the vaccine or who reserve it for older adolescents, she said.

SAN FRANCISCO — The real-world efficacy of exenatide to lower hemoglobin A_1c levels in patients with type 2 diabetes may not always match the success seen in clinical trials, a small study suggests.

Only 12 (40%) of 30 patients with type 2 diabetes who added the incretin mimetic exenatide to ongoing treatment with oral medications or insulin were still taking exenatide 2 years later. For the group as a whole, much of the weight lost after 6 months of exenatide therapy was regained by 2 years, so final weights were not significantly different from baseline weights, the intent-to-treat analysis found. Hemoglobin A_1c (HbA_1c) levels did not change significantly for the group as a whole, Dr. Jennifer A. Loh of Georgetown University, Washington, said at the annual scientific sessions of the American Diabetes Association.

A separate comparison found trends toward decreased HbA_1c levels in the 15 patients who were taking oral medications plus exenatide, and increased HbA_1c levels in the 15 patients using the off-label combination of insulin and exenatide.

Significant decreases in weight were achieved and sustained only in six patients who took exenatide for 2 years and also were on oral medications, not insulin.

Dr. Loh and coinvestigator Dr. Stephen C. Clement, also of the university, reported no potential conflicts of interest.

Phase III clinical trials have reported significant, long-term efficacy in lowering HbA_1c levels and reducing weight in patients with type 2 diabetes. Weight declined by 2.8 kg on average, and HbA_1c levels fell by 0.8% in a 30-week randomized, double-blind controlled trial (Diabetes Care 2005;28:1092–100). In three open-label extension studies lasting 82–156 weeks, HbA_1c levels decreased by 1.1%–1.3%, and average weight decreased by 4.7–5.3 kg, she noted.

Those open-label studies did not use intent-to-treat analyses, however, and did not include off-label use of insulin. Clinical practices in the studies may not reflect real-world practices, Dr. Loh said.

In the current study, the investigators retrospectively reviewed data on 47 adults who were treated by a single physician and who started exenatide in 2005, shortly after approval of the drug. In all, 17 patients had incomplete data, including 1 patient who simply refused to be weighed. “This is the real world,” Dr. Loh noted.

Of the 30 patients with complete data, 18 (60%) stopped taking exenatide by 2 years. A total of 12 patients stopped because of treatment “failure” and 6 stopped because of side effects.

Patients were moderately obese, with an average body mass index of 35 kg/m

SAN FRANCISCO — The real-world efficacy of exenatide to lower hemoglobin A_1c levels in patients with type 2 diabetes may not always match the success seen in clinical trials, a small study suggests.

Only 12 (40%) of 30 patients with type 2 diabetes who added the incretin mimetic exenatide to ongoing treatment with oral medications or insulin were still taking exenatide 2 years later. For the group as a whole, much of the weight lost after 6 months of exenatide therapy was regained by 2 years, so final weights were not significantly different from baseline weights, the intent-to-treat analysis found. Hemoglobin A_1c (HbA_1c) levels did not change significantly for the group as a whole, Dr. Jennifer A. Loh of Georgetown University, Washington, said at the annual scientific sessions of the American Diabetes Association.

A separate comparison found trends toward decreased HbA_1c levels in the 15 patients who were taking oral medications plus exenatide, and increased HbA_1c levels in the 15 patients using the off-label combination of insulin and exenatide.

Significant decreases in weight were achieved and sustained only in six patients who took exenatide for 2 years and also were on oral medications, not insulin.

Dr. Loh and coinvestigator Dr. Stephen C. Clement, also of the university, reported no potential conflicts of interest.

Phase III clinical trials have reported significant, long-term efficacy in lowering HbA_1c levels and reducing weight in patients with type 2 diabetes. Weight declined by 2.8 kg on average, and HbA_1c levels fell by 0.8% in a 30-week randomized, double-blind controlled trial (Diabetes Care 2005;28:1092–100). In three open-label extension studies lasting 82–156 weeks, HbA_1c levels decreased by 1.1%–1.3%, and average weight decreased by 4.7–5.3 kg, she noted.

Those open-label studies did not use intent-to-treat analyses, however, and did not include off-label use of insulin. Clinical practices in the studies may not reflect real-world practices, Dr. Loh said.

In the current study, the investigators retrospectively reviewed data on 47 adults who were treated by a single physician and who started exenatide in 2005, shortly after approval of the drug. In all, 17 patients had incomplete data, including 1 patient who simply refused to be weighed. “This is the real world,” Dr. Loh noted.

Of the 30 patients with complete data, 18 (60%) stopped taking exenatide by 2 years. A total of 12 patients stopped because of treatment “failure” and 6 stopped because of side effects.

Patients were moderately obese, with an average body mass index of 35 kg/m

SAN FRANCISCO — The real-world efficacy of exenatide to lower hemoglobin A_1c levels in patients with type 2 diabetes may not always match the success seen in clinical trials, a small study suggests.

Only 12 (40%) of 30 patients with type 2 diabetes who added the incretin mimetic exenatide to ongoing treatment with oral medications or insulin were still taking exenatide 2 years later. For the group as a whole, much of the weight lost after 6 months of exenatide therapy was regained by 2 years, so final weights were not significantly different from baseline weights, the intent-to-treat analysis found. Hemoglobin A_1c (HbA_1c) levels did not change significantly for the group as a whole, Dr. Jennifer A. Loh of Georgetown University, Washington, said at the annual scientific sessions of the American Diabetes Association.

A separate comparison found trends toward decreased HbA_1c levels in the 15 patients who were taking oral medications plus exenatide, and increased HbA_1c levels in the 15 patients using the off-label combination of insulin and exenatide.

Significant decreases in weight were achieved and sustained only in six patients who took exenatide for 2 years and also were on oral medications, not insulin.

Dr. Loh and coinvestigator Dr. Stephen C. Clement, also of the university, reported no potential conflicts of interest.

Phase III clinical trials have reported significant, long-term efficacy in lowering HbA_1c levels and reducing weight in patients with type 2 diabetes. Weight declined by 2.8 kg on average, and HbA_1c levels fell by 0.8% in a 30-week randomized, double-blind controlled trial (Diabetes Care 2005;28:1092–100). In three open-label extension studies lasting 82–156 weeks, HbA_1c levels decreased by 1.1%–1.3%, and average weight decreased by 4.7–5.3 kg, she noted.

Those open-label studies did not use intent-to-treat analyses, however, and did not include off-label use of insulin. Clinical practices in the studies may not reflect real-world practices, Dr. Loh said.

In the current study, the investigators retrospectively reviewed data on 47 adults who were treated by a single physician and who started exenatide in 2005, shortly after approval of the drug. In all, 17 patients had incomplete data, including 1 patient who simply refused to be weighed. “This is the real world,” Dr. Loh noted.

Of the 30 patients with complete data, 18 (60%) stopped taking exenatide by 2 years. A total of 12 patients stopped because of treatment “failure” and 6 stopped because of side effects.

Patients were moderately obese, with an average body mass index of 35 kg/m

SAN FRANCISCO — Intensively lowering blood glucose levels did not significantly reduce cardiovascular risk in older patients with poorly controlled diabetes whose blood pressures and cholesterol levels were well controlled, a major long-term study found.

The 1,791-patient Veterans Affairs Diabetes Trial identified two predictors of cardiovascular risk—hypoglycemic episodes and the duration of diabetes—and included a secondary analysis of the safety of using rosiglitazone. The study found no increased risk for MI in patients on rosiglitazone. (See box.)

The VA Diabetes Trial is the third major randomized, controlled study to report no overall cardiovascular benefit from intensive glycemic control, following on the heels of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, in which intensive glycemic control increased the risk of death, and the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study.

“Our patients had the worst glycemic control of the three trials,” with baseline hemoglobin A_1c levels averaging 9.5%, Dr. Carlos Abraira said at a press conference at the annual scientific sessions of the American Diabetes Association.

The HbA_1c levels fell to a median of 6.9% within 6 months with intensive therapy. The study was designed to maintain a 1.5% difference in HbA_1c levels between the intensive and usual-care group, which reached an HbA_1c level of 8.4%, to highlight any effects of intensive therapy.

Patients in the study averaged 60 years of age at enrollment, and 97% were male. About 40% had a history of prior cardiovascular events. At baseline, 80% had hypertension, 50% had lipid abnormalities, and most were obese. The trial strictly controlled blood pressure and cholesterol levels, achieving targets after 2 years of therapy that were maintained during the average 6-year follow-up, reported Dr. Abraira of the Miami Veterans Affairs Medical Center. Dr. Abraira is cochair of the VA Diabetes Trial and professor of medicine at the University of Miami.

Far fewer cardiovascular events occurred than were expected, totalling 231 events in the intensive group and 263 with usual care, probably because of the excellent control of blood pressure and lipids, improved diet and exercise, and treatment with aspirin, said Dr. William C. Duckworth, cochair of the trial and director of diabetes research at the Veterans Affairs Medical Center in Phoenix. Increases in levels of “good” HDL cholesterol in the study greatly decreased the chance of a cardiovascular event.

The study found cardiovascular benefits in patients who started intensive glycemic therapy early after diagnosis of diabetes, less likelihood of benefits for patients with longer-duration diabetes, and a suggestion of potential harm from intensive glycemic control in those with long-standing diabetes before starting the regimen, he said.

“Start intensively treating early after diagnosis, no matter how old they are,” Dr. Duckworth suggested.

An episode of severe hypoglycemia was associated with roughly a doubling in risk for a cardiovascular event within 3 months and a tripled risk for death from cardiovascular causes. The study may be the first to document the association between hypoglycemia and cardiovascular risk, which most physicians have assumed to be true, Dr. Duckworth added.

The trial will continue as an observational study for another 9 years.

Dr. Duckworth said the results so far illustrate the inadvisability of setting one glycemic target for all patients with diabetes.

Dr. Duckworth consults for, or has received research funds from, companies that make medications for diabetes, hypertension, or hypercholesterolemia including Sanofi Aventis, Novo Nordisk, Kos Pharmaceuticals, and Amylin Pharmaceuticals. Dr. Abraira has received research support from GlaxoSmithKline, which makes rosiglitazone, and from other companies that make medications for diabetes, hypertension, or hyperlipidemia.

No Increase in MI Seen in VA Trial of Rosiglitazone

Three secondary safety analyses of data from the VA Diabetes Trial found neutral effects or protection against cardiovascular events with use of the thiazolidinedione, rosiglitazone, contrary to previous findings.

“We feel that rosiglitazone is not causing any harm to the patients,” said statistician Thomas E. Moritz of the Hynes (Ill.) Veterans Affairs Hospital.

A meta-analysis of 42 randomized, controlled studies previously reported a significant 43% increase in the odds of developing an MI and a trend toward higher risk of death from cardiovascular causes in patients with type 2 diabetes treated with rosiglitazone, he noted (N. Engl. J. Med. 2007;356:2457–71). In response, the VA medical system removed the drug from its formulary and the Food and Drug Administration issued a black box warning about potential cardiovascular risks with rosiglitazone.

The meta-analysis findings prompted the VA Diabetes Trial investigators to take a hard look at their data on rosiglitazone. A retrospective case-control analysis matched patients who had cardiovascular events with similar patients who did not have events. “In every analysis we did, the frequency or dosage of rosiglitazone was increased in the group that did not suffer the event.”

A time-dependent covariate survival analysis looked at changes in rosiglitazone doses over time, and the time to MI, cardiovascular death, a combination of the two outcomes, or heart failure. “If anything, rosiglitazone showed a protective effect rather than a harmful effect” for each outcome, he added.

An intention-to-treat analysis found neither cardiovascular benefit nor harm from taking rosiglitazone. Mr. Moritz has no association with GlaxoSmithKline.

SAN FRANCISCO — Intensively lowering blood glucose levels did not significantly reduce cardiovascular risk in older patients with poorly controlled diabetes whose blood pressures and cholesterol levels were well controlled, a major long-term study found.

The 1,791-patient Veterans Affairs Diabetes Trial identified two predictors of cardiovascular risk—hypoglycemic episodes and the duration of diabetes—and included a secondary analysis of the safety of using rosiglitazone. The study found no increased risk for MI in patients on rosiglitazone. (See box.)

The VA Diabetes Trial is the third major randomized, controlled study to report no overall cardiovascular benefit from intensive glycemic control, following on the heels of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, in which intensive glycemic control increased the risk of death, and the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study.

“Our patients had the worst glycemic control of the three trials,” with baseline hemoglobin A_1c levels averaging 9.5%, Dr. Carlos Abraira said at a press conference at the annual scientific sessions of the American Diabetes Association.

The HbA_1c levels fell to a median of 6.9% within 6 months with intensive therapy. The study was designed to maintain a 1.5% difference in HbA_1c levels between the intensive and usual-care group, which reached an HbA_1c level of 8.4%, to highlight any effects of intensive therapy.

Patients in the study averaged 60 years of age at enrollment, and 97% were male. About 40% had a history of prior cardiovascular events. At baseline, 80% had hypertension, 50% had lipid abnormalities, and most were obese. The trial strictly controlled blood pressure and cholesterol levels, achieving targets after 2 years of therapy that were maintained during the average 6-year follow-up, reported Dr. Abraira of the Miami Veterans Affairs Medical Center. Dr. Abraira is cochair of the VA Diabetes Trial and professor of medicine at the University of Miami.

Far fewer cardiovascular events occurred than were expected, totalling 231 events in the intensive group and 263 with usual care, probably because of the excellent control of blood pressure and lipids, improved diet and exercise, and treatment with aspirin, said Dr. William C. Duckworth, cochair of the trial and director of diabetes research at the Veterans Affairs Medical Center in Phoenix. Increases in levels of “good” HDL cholesterol in the study greatly decreased the chance of a cardiovascular event.

The study found cardiovascular benefits in patients who started intensive glycemic therapy early after diagnosis of diabetes, less likelihood of benefits for patients with longer-duration diabetes, and a suggestion of potential harm from intensive glycemic control in those with long-standing diabetes before starting the regimen, he said.

“Start intensively treating early after diagnosis, no matter how old they are,” Dr. Duckworth suggested.

An episode of severe hypoglycemia was associated with roughly a doubling in risk for a cardiovascular event within 3 months and a tripled risk for death from cardiovascular causes. The study may be the first to document the association between hypoglycemia and cardiovascular risk, which most physicians have assumed to be true, Dr. Duckworth added.

The trial will continue as an observational study for another 9 years.

Dr. Duckworth said the results so far illustrate the inadvisability of setting one glycemic target for all patients with diabetes.

Dr. Duckworth consults for, or has received research funds from, companies that make medications for diabetes, hypertension, or hypercholesterolemia including Sanofi Aventis, Novo Nordisk, Kos Pharmaceuticals, and Amylin Pharmaceuticals. Dr. Abraira has received research support from GlaxoSmithKline, which makes rosiglitazone, and from other companies that make medications for diabetes, hypertension, or hyperlipidemia.

No Increase in MI Seen in VA Trial of Rosiglitazone

Three secondary safety analyses of data from the VA Diabetes Trial found neutral effects or protection against cardiovascular events with use of the thiazolidinedione, rosiglitazone, contrary to previous findings.

“We feel that rosiglitazone is not causing any harm to the patients,” said statistician Thomas E. Moritz of the Hynes (Ill.) Veterans Affairs Hospital.

A meta-analysis of 42 randomized, controlled studies previously reported a significant 43% increase in the odds of developing an MI and a trend toward higher risk of death from cardiovascular causes in patients with type 2 diabetes treated with rosiglitazone, he noted (N. Engl. J. Med. 2007;356:2457–71). In response, the VA medical system removed the drug from its formulary and the Food and Drug Administration issued a black box warning about potential cardiovascular risks with rosiglitazone.

The meta-analysis findings prompted the VA Diabetes Trial investigators to take a hard look at their data on rosiglitazone. A retrospective case-control analysis matched patients who had cardiovascular events with similar patients who did not have events. “In every analysis we did, the frequency or dosage of rosiglitazone was increased in the group that did not suffer the event.”

A time-dependent covariate survival analysis looked at changes in rosiglitazone doses over time, and the time to MI, cardiovascular death, a combination of the two outcomes, or heart failure. “If anything, rosiglitazone showed a protective effect rather than a harmful effect” for each outcome, he added.

An intention-to-treat analysis found neither cardiovascular benefit nor harm from taking rosiglitazone. Mr. Moritz has no association with GlaxoSmithKline.

SAN FRANCISCO — Intensively lowering blood glucose levels did not significantly reduce cardiovascular risk in older patients with poorly controlled diabetes whose blood pressures and cholesterol levels were well controlled, a major long-term study found.

The 1,791-patient Veterans Affairs Diabetes Trial identified two predictors of cardiovascular risk—hypoglycemic episodes and the duration of diabetes—and included a secondary analysis of the safety of using rosiglitazone. The study found no increased risk for MI in patients on rosiglitazone. (See box.)

The VA Diabetes Trial is the third major randomized, controlled study to report no overall cardiovascular benefit from intensive glycemic control, following on the heels of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, in which intensive glycemic control increased the risk of death, and the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study.

“Our patients had the worst glycemic control of the three trials,” with baseline hemoglobin A_1c levels averaging 9.5%, Dr. Carlos Abraira said at a press conference at the annual scientific sessions of the American Diabetes Association.

The HbA_1c levels fell to a median of 6.9% within 6 months with intensive therapy. The study was designed to maintain a 1.5% difference in HbA_1c levels between the intensive and usual-care group, which reached an HbA_1c level of 8.4%, to highlight any effects of intensive therapy.

Patients in the study averaged 60 years of age at enrollment, and 97% were male. About 40% had a history of prior cardiovascular events. At baseline, 80% had hypertension, 50% had lipid abnormalities, and most were obese. The trial strictly controlled blood pressure and cholesterol levels, achieving targets after 2 years of therapy that were maintained during the average 6-year follow-up, reported Dr. Abraira of the Miami Veterans Affairs Medical Center. Dr. Abraira is cochair of the VA Diabetes Trial and professor of medicine at the University of Miami.

Far fewer cardiovascular events occurred than were expected, totalling 231 events in the intensive group and 263 with usual care, probably because of the excellent control of blood pressure and lipids, improved diet and exercise, and treatment with aspirin, said Dr. William C. Duckworth, cochair of the trial and director of diabetes research at the Veterans Affairs Medical Center in Phoenix. Increases in levels of “good” HDL cholesterol in the study greatly decreased the chance of a cardiovascular event.

The study found cardiovascular benefits in patients who started intensive glycemic therapy early after diagnosis of diabetes, less likelihood of benefits for patients with longer-duration diabetes, and a suggestion of potential harm from intensive glycemic control in those with long-standing diabetes before starting the regimen, he said.

“Start intensively treating early after diagnosis, no matter how old they are,” Dr. Duckworth suggested.

An episode of severe hypoglycemia was associated with roughly a doubling in risk for a cardiovascular event within 3 months and a tripled risk for death from cardiovascular causes. The study may be the first to document the association between hypoglycemia and cardiovascular risk, which most physicians have assumed to be true, Dr. Duckworth added.

The trial will continue as an observational study for another 9 years.

Dr. Duckworth said the results so far illustrate the inadvisability of setting one glycemic target for all patients with diabetes.

Dr. Duckworth consults for, or has received research funds from, companies that make medications for diabetes, hypertension, or hypercholesterolemia including Sanofi Aventis, Novo Nordisk, Kos Pharmaceuticals, and Amylin Pharmaceuticals. Dr. Abraira has received research support from GlaxoSmithKline, which makes rosiglitazone, and from other companies that make medications for diabetes, hypertension, or hyperlipidemia.

No Increase in MI Seen in VA Trial of Rosiglitazone

Three secondary safety analyses of data from the VA Diabetes Trial found neutral effects or protection against cardiovascular events with use of the thiazolidinedione, rosiglitazone, contrary to previous findings.

“We feel that rosiglitazone is not causing any harm to the patients,” said statistician Thomas E. Moritz of the Hynes (Ill.) Veterans Affairs Hospital.

A meta-analysis of 42 randomized, controlled studies previously reported a significant 43% increase in the odds of developing an MI and a trend toward higher risk of death from cardiovascular causes in patients with type 2 diabetes treated with rosiglitazone, he noted (N. Engl. J. Med. 2007;356:2457–71). In response, the VA medical system removed the drug from its formulary and the Food and Drug Administration issued a black box warning about potential cardiovascular risks with rosiglitazone.

The meta-analysis findings prompted the VA Diabetes Trial investigators to take a hard look at their data on rosiglitazone. A retrospective case-control analysis matched patients who had cardiovascular events with similar patients who did not have events. “In every analysis we did, the frequency or dosage of rosiglitazone was increased in the group that did not suffer the event.”

A time-dependent covariate survival analysis looked at changes in rosiglitazone doses over time, and the time to MI, cardiovascular death, a combination of the two outcomes, or heart failure. “If anything, rosiglitazone showed a protective effect rather than a harmful effect” for each outcome, he added.

An intention-to-treat analysis found neither cardiovascular benefit nor harm from taking rosiglitazone. Mr. Moritz has no association with GlaxoSmithKline.

SAN FRANCISCO — Patients with type 2 diabetes and no cardiac symptoms or prior coronary artery disease had a surprisingly low risk of nonfatal MI or cardiac death with or without routine screening in a study of 1,119 patients.

The 3% event rate over a 5-year period (or 0.5% per year) included cardiac death in 1.5% of 558 patients who were randomized to routine screening for silent ischemia, and 1.2% of 561 patients who were getting usual care. Nonfatal heart attacks occurred in 1.2% of the screening group and in 1.8% of the control group. The differences between groups were not statistically significant, Dr. Frans J. Wackers said at the annual scientific sessions of the American Diabetes Association.

The ADA recommends routine stress testing in patients with diabetes who have cardiac symptoms, are starting an exercise regimen, or have no cardiac symptoms but have multiple risk factors for coronary artery disease.

That approach appears to be sufficient. “Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients with type 2 diabetes” based on results presented from the DIAD (Detection of Ischemia in Asymptomatic Diabetes) study, said Dr. Wackers, professor of diagnostic radiology and medicine at Yale University, New Haven, Conn.

The study enrolled adults aged 50–75 years with type 2 diabetes who had no known coronary artery disease, normal resting ECGs, and no stress testing in the prior 3 years. The screening group underwent adenosine myocardial perfusion imaging (MPI), which detected inducible ischemia in 22%. Except for the initial MPI in the screening group, diagnostic testing in both groups was at the discretion of the patients' physicians.

Cumulative mortality at the 5-year mark was higher for patients with moderate to large defects detected on MPI (12%) than for patients with small or no defects detected (2% mortality for each) or for patients with nonperfusion abnormalities such as ischemic ECG changes (7%).

Screening results predicted cardiac outcomes, but the rates of cardiac events or mortality did not differ between groups. The mortality rate was 3% at 5 years.

The unexpectedly favorable 5-year prognosis probably reflects the benefits of contemporary strategies to optimize medical therapy, Dr. Wackers said.

“In the standard-care group, there was a fair number of stress tests and angiograms performed. I think clinicians made the right decisions,” suggesting that routine screening is not needed, he said.

Patients in the standard-care group were more likely to get nonprotocol stress tests (30%) than were those in the screening group (21%). The proportion of those tests that identified abnormalities was similar between groups (24% of 118 additional tests in the screening group, and 26% of tests in 170 patients in the control group).

Coronary angiograms were as likely to be ordered for patients in the control group as in the screening group (12% vs. 14%), but were significantly more likely to identify abnormalities in the control group (44 of 66 angiograms, or 66%) than in the screening group (40 of 80 angiograms, or 50%). The use of oral medications increased in both groups over time, but did not differ between groups at baseline or at the end of the study.

Characteristics of the two groups were comparable. Patients had a mean age of 62 years and an 8-year history of diabetes. The baseline hemoglobin A_1c level was 7.1%. The cohort was 54% male, and 22% were ethnic minorities. The cohort probably is representative of the general population with type 2 diabetes. Patients were overweight, with a mean body mass index of 31 kg/m

Dr. Wackers has received research support from Bristol Myers Squibb Medical Imaging and from Astellas Pharma, which makes cardiac imaging agents.

'Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients.' DR. WACKERS

SAN FRANCISCO — Patients with type 2 diabetes and no cardiac symptoms or prior coronary artery disease had a surprisingly low risk of nonfatal MI or cardiac death with or without routine screening in a study of 1,119 patients.

The 3% event rate over a 5-year period (or 0.5% per year) included cardiac death in 1.5% of 558 patients who were randomized to routine screening for silent ischemia, and 1.2% of 561 patients who were getting usual care. Nonfatal heart attacks occurred in 1.2% of the screening group and in 1.8% of the control group. The differences between groups were not statistically significant, Dr. Frans J. Wackers said at the annual scientific sessions of the American Diabetes Association.

The ADA recommends routine stress testing in patients with diabetes who have cardiac symptoms, are starting an exercise regimen, or have no cardiac symptoms but have multiple risk factors for coronary artery disease.

That approach appears to be sufficient. “Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients with type 2 diabetes” based on results presented from the DIAD (Detection of Ischemia in Asymptomatic Diabetes) study, said Dr. Wackers, professor of diagnostic radiology and medicine at Yale University, New Haven, Conn.

The study enrolled adults aged 50–75 years with type 2 diabetes who had no known coronary artery disease, normal resting ECGs, and no stress testing in the prior 3 years. The screening group underwent adenosine myocardial perfusion imaging (MPI), which detected inducible ischemia in 22%. Except for the initial MPI in the screening group, diagnostic testing in both groups was at the discretion of the patients' physicians.

Cumulative mortality at the 5-year mark was higher for patients with moderate to large defects detected on MPI (12%) than for patients with small or no defects detected (2% mortality for each) or for patients with nonperfusion abnormalities such as ischemic ECG changes (7%).

Screening results predicted cardiac outcomes, but the rates of cardiac events or mortality did not differ between groups. The mortality rate was 3% at 5 years.

The unexpectedly favorable 5-year prognosis probably reflects the benefits of contemporary strategies to optimize medical therapy, Dr. Wackers said.

“In the standard-care group, there was a fair number of stress tests and angiograms performed. I think clinicians made the right decisions,” suggesting that routine screening is not needed, he said.

Patients in the standard-care group were more likely to get nonprotocol stress tests (30%) than were those in the screening group (21%). The proportion of those tests that identified abnormalities was similar between groups (24% of 118 additional tests in the screening group, and 26% of tests in 170 patients in the control group).

Coronary angiograms were as likely to be ordered for patients in the control group as in the screening group (12% vs. 14%), but were significantly more likely to identify abnormalities in the control group (44 of 66 angiograms, or 66%) than in the screening group (40 of 80 angiograms, or 50%). The use of oral medications increased in both groups over time, but did not differ between groups at baseline or at the end of the study.

Characteristics of the two groups were comparable. Patients had a mean age of 62 years and an 8-year history of diabetes. The baseline hemoglobin A_1c level was 7.1%. The cohort was 54% male, and 22% were ethnic minorities. The cohort probably is representative of the general population with type 2 diabetes. Patients were overweight, with a mean body mass index of 31 kg/m

Dr. Wackers has received research support from Bristol Myers Squibb Medical Imaging and from Astellas Pharma, which makes cardiac imaging agents.

'Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients.' DR. WACKERS

SAN FRANCISCO — Patients with type 2 diabetes and no cardiac symptoms or prior coronary artery disease had a surprisingly low risk of nonfatal MI or cardiac death with or without routine screening in a study of 1,119 patients.

The 3% event rate over a 5-year period (or 0.5% per year) included cardiac death in 1.5% of 558 patients who were randomized to routine screening for silent ischemia, and 1.2% of 561 patients who were getting usual care. Nonfatal heart attacks occurred in 1.2% of the screening group and in 1.8% of the control group. The differences between groups were not statistically significant, Dr. Frans J. Wackers said at the annual scientific sessions of the American Diabetes Association.

The ADA recommends routine stress testing in patients with diabetes who have cardiac symptoms, are starting an exercise regimen, or have no cardiac symptoms but have multiple risk factors for coronary artery disease.

That approach appears to be sufficient. “Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients with type 2 diabetes” based on results presented from the DIAD (Detection of Ischemia in Asymptomatic Diabetes) study, said Dr. Wackers, professor of diagnostic radiology and medicine at Yale University, New Haven, Conn.

The study enrolled adults aged 50–75 years with type 2 diabetes who had no known coronary artery disease, normal resting ECGs, and no stress testing in the prior 3 years. The screening group underwent adenosine myocardial perfusion imaging (MPI), which detected inducible ischemia in 22%. Except for the initial MPI in the screening group, diagnostic testing in both groups was at the discretion of the patients' physicians.

Cumulative mortality at the 5-year mark was higher for patients with moderate to large defects detected on MPI (12%) than for patients with small or no defects detected (2% mortality for each) or for patients with nonperfusion abnormalities such as ischemic ECG changes (7%).

Screening results predicted cardiac outcomes, but the rates of cardiac events or mortality did not differ between groups. The mortality rate was 3% at 5 years.

The unexpectedly favorable 5-year prognosis probably reflects the benefits of contemporary strategies to optimize medical therapy, Dr. Wackers said.

“In the standard-care group, there was a fair number of stress tests and angiograms performed. I think clinicians made the right decisions,” suggesting that routine screening is not needed, he said.

Patients in the standard-care group were more likely to get nonprotocol stress tests (30%) than were those in the screening group (21%). The proportion of those tests that identified abnormalities was similar between groups (24% of 118 additional tests in the screening group, and 26% of tests in 170 patients in the control group).

Coronary angiograms were as likely to be ordered for patients in the control group as in the screening group (12% vs. 14%), but were significantly more likely to identify abnormalities in the control group (44 of 66 angiograms, or 66%) than in the screening group (40 of 80 angiograms, or 50%). The use of oral medications increased in both groups over time, but did not differ between groups at baseline or at the end of the study.

Characteristics of the two groups were comparable. Patients had a mean age of 62 years and an 8-year history of diabetes. The baseline hemoglobin A_1c level was 7.1%. The cohort was 54% male, and 22% were ethnic minorities. The cohort probably is representative of the general population with type 2 diabetes. Patients were overweight, with a mean body mass index of 31 kg/m

Dr. Wackers has received research support from Bristol Myers Squibb Medical Imaging and from Astellas Pharma, which makes cardiac imaging agents.

'Systematic screening for coronary artery disease cannot be recommended for asymptomatic patients.' DR. WACKERS

SAN FRANCISCO — New guidelines from three major heart-specialty organizations on the use of implantable devices for heart rhythm abnormalities emphasize talking with patients about their needs and desires, and stress optimizing medical therapy.

“For the first time, we have addressed human needs and not just numbers,” such as ejection fractions, when considering implanting pacemakers, defibrillators, or cardiac resynchronization therapy (CRT) devices, Dr. Andrew E. Epstein said at a press conference at the annual meeting of the Hearth Rhythm Society (HRS). “We really need to talk to patients, be at the bedside, find out what they want, and see that their issues are addressed,” he said.

This has been implied in previous guidelines but never made as explicit as in the new guidelines issued jointly by the American College of Cardiology (ACC), the American Heart Association (AHA), and the HRS, said Dr. Epstein, chair of the joint task force that produced the new guidelines and professor of medicine at the University of Alabama at Birmingham.

“Especially with devices, the issue of recalls and safety advisories has interfered with the trust of the public with physicians. I think we have a credibility issue,” he said. In addition to guidance on talking with patients before implanting devices, the guidelines for the first time also provide guidance on talking with patients about end-of-life care and when to turn off the devices.

The ACC/AHA/HRS “2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” updates the 2002 joint guidelines by the ACC and AHA, and, more than ever, emphasizes the need for optimal medical therapy before the implantation of a cardiac device is considered. “We're trying to emphasize that a global approach to patients is what saves lives,” Dr. Epstein said.

The guidelines are the first to cover all cardiac implantable devices.

Data from recent studies and advances in device technology influenced some key changes in recommendations. “We can very strongly tell physicians that primary prevention of sudden cardiac arrest is very important,” Dr. Epstein said.

Some studies published in recent years have made the issue of which ejection fraction should be the cutoff for initiating the consideration of implantable devices “very murky,” he added. The new guidelines clarify that patients with an ejection fraction of 35% or less should be considered for device implantation.

The section on the use of CRTs to manage heart failure has been expanded greatly, thanks to an abundance of recent trial data. The guidelines primarily are evidence based, will be reviewed annually, and will evolve as technology advances.

“Indications for ICDs, CRT devices, and combined ICDs and CRT devices are [continually changing] and can be expected to change further as new trials are reported,” Dr. Epstein said.

In addition to addressing cardiac arrhythmias, heart failure, congenital heart disease, and sudden cardiac arrest as indications for device-based therapy, the new guidelines for the first time also address treatment for genetic disorders, including catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, and short QT syndrome.

The full text of the guidelines is posted on each group's Web site (www.acc.orghttp://my.americanheart.orgwww.hrsonline.org

Before pacemaker implantation, the guidelines stress talking to patients. ©UHB Trust/Getty Images

SAN FRANCISCO — New guidelines from three major heart-specialty organizations on the use of implantable devices for heart rhythm abnormalities emphasize talking with patients about their needs and desires, and stress optimizing medical therapy.

“For the first time, we have addressed human needs and not just numbers,” such as ejection fractions, when considering implanting pacemakers, defibrillators, or cardiac resynchronization therapy (CRT) devices, Dr. Andrew E. Epstein said at a press conference at the annual meeting of the Hearth Rhythm Society (HRS). “We really need to talk to patients, be at the bedside, find out what they want, and see that their issues are addressed,” he said.

This has been implied in previous guidelines but never made as explicit as in the new guidelines issued jointly by the American College of Cardiology (ACC), the American Heart Association (AHA), and the HRS, said Dr. Epstein, chair of the joint task force that produced the new guidelines and professor of medicine at the University of Alabama at Birmingham.

“Especially with devices, the issue of recalls and safety advisories has interfered with the trust of the public with physicians. I think we have a credibility issue,” he said. In addition to guidance on talking with patients before implanting devices, the guidelines for the first time also provide guidance on talking with patients about end-of-life care and when to turn off the devices.

The ACC/AHA/HRS “2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” updates the 2002 joint guidelines by the ACC and AHA, and, more than ever, emphasizes the need for optimal medical therapy before the implantation of a cardiac device is considered. “We're trying to emphasize that a global approach to patients is what saves lives,” Dr. Epstein said.

The guidelines are the first to cover all cardiac implantable devices.

Data from recent studies and advances in device technology influenced some key changes in recommendations. “We can very strongly tell physicians that primary prevention of sudden cardiac arrest is very important,” Dr. Epstein said.

Some studies published in recent years have made the issue of which ejection fraction should be the cutoff for initiating the consideration of implantable devices “very murky,” he added. The new guidelines clarify that patients with an ejection fraction of 35% or less should be considered for device implantation.

The section on the use of CRTs to manage heart failure has been expanded greatly, thanks to an abundance of recent trial data. The guidelines primarily are evidence based, will be reviewed annually, and will evolve as technology advances.

“Indications for ICDs, CRT devices, and combined ICDs and CRT devices are [continually changing] and can be expected to change further as new trials are reported,” Dr. Epstein said.

In addition to addressing cardiac arrhythmias, heart failure, congenital heart disease, and sudden cardiac arrest as indications for device-based therapy, the new guidelines for the first time also address treatment for genetic disorders, including catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, and short QT syndrome.

The full text of the guidelines is posted on each group's Web site (www.acc.orghttp://my.americanheart.orgwww.hrsonline.org

Before pacemaker implantation, the guidelines stress talking to patients. ©UHB Trust/Getty Images

SAN FRANCISCO — New guidelines from three major heart-specialty organizations on the use of implantable devices for heart rhythm abnormalities emphasize talking with patients about their needs and desires, and stress optimizing medical therapy.

“For the first time, we have addressed human needs and not just numbers,” such as ejection fractions, when considering implanting pacemakers, defibrillators, or cardiac resynchronization therapy (CRT) devices, Dr. Andrew E. Epstein said at a press conference at the annual meeting of the Hearth Rhythm Society (HRS). “We really need to talk to patients, be at the bedside, find out what they want, and see that their issues are addressed,” he said.

This has been implied in previous guidelines but never made as explicit as in the new guidelines issued jointly by the American College of Cardiology (ACC), the American Heart Association (AHA), and the HRS, said Dr. Epstein, chair of the joint task force that produced the new guidelines and professor of medicine at the University of Alabama at Birmingham.

“Especially with devices, the issue of recalls and safety advisories has interfered with the trust of the public with physicians. I think we have a credibility issue,” he said. In addition to guidance on talking with patients before implanting devices, the guidelines for the first time also provide guidance on talking with patients about end-of-life care and when to turn off the devices.

The ACC/AHA/HRS “2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” updates the 2002 joint guidelines by the ACC and AHA, and, more than ever, emphasizes the need for optimal medical therapy before the implantation of a cardiac device is considered. “We're trying to emphasize that a global approach to patients is what saves lives,” Dr. Epstein said.

The guidelines are the first to cover all cardiac implantable devices.

Data from recent studies and advances in device technology influenced some key changes in recommendations. “We can very strongly tell physicians that primary prevention of sudden cardiac arrest is very important,” Dr. Epstein said.

Some studies published in recent years have made the issue of which ejection fraction should be the cutoff for initiating the consideration of implantable devices “very murky,” he added. The new guidelines clarify that patients with an ejection fraction of 35% or less should be considered for device implantation.

The section on the use of CRTs to manage heart failure has been expanded greatly, thanks to an abundance of recent trial data. The guidelines primarily are evidence based, will be reviewed annually, and will evolve as technology advances.

“Indications for ICDs, CRT devices, and combined ICDs and CRT devices are [continually changing] and can be expected to change further as new trials are reported,” Dr. Epstein said.

In addition to addressing cardiac arrhythmias, heart failure, congenital heart disease, and sudden cardiac arrest as indications for device-based therapy, the new guidelines for the first time also address treatment for genetic disorders, including catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, and short QT syndrome.

The full text of the guidelines is posted on each group's Web site (www.acc.orghttp://my.americanheart.orgwww.hrsonline.org

Before pacemaker implantation, the guidelines stress talking to patients. ©UHB Trust/Getty Images

NEWPORT BEACH, CALIF. — Women with vaginal agenesis who undergo laparoscopic Davydov surgery to create a neovagina may have impaired sexual function, compared with controls, a study of six such patients found.

The findings of the small study contradict results from the only previous study that also used validated self-report questionnaires to assess psychosocial and functional outcomes after laparoscopic Davydov, Dr. Kerith L. Lucco said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

In that previous study, scores on the Female Sexual Function Index (FSFI) did not differ significantly among 28 women who underwent vaginoplasty via laparoscopic Davydov and a control group (Hum. Reprod. 2005;20:2954-7).

In the current study, the six women reported a mean score of 21 on the FSFI, significantly lower than a mean score of 30 reported for control patients in the medical literature, said Dr. Lucco of the department of pediatric and adolescent gynecology at the Hospital for Sick Children in Toronto. FSFI scores below 24 are considered to represent poor sexual function.

In comparison, a separate recent study found that vaginal dilation improved scores for sexual satisfaction and decreased scores for “sexual depression” in 8 women with vaginal agenesis because of androgen insensitivity syndrome (AIS) but not in 18 women with vaginal agenesis because of Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, Dr. Lucco noted (Hum. Reprod. 2007;22:2020-4).

Approximately 1 in every 4,000 female babies are born without a vagina because of MRKH and approximately 1 in 20,000 female babies lack a vagina at birth because of AIS. First-line treatment is vaginal dilation, but several surgical methods of creating a vagina have been tried, including the laparoscopic Davydov procedure, both in untreated patients and in some who have failed vaginal dilation.

Women in the current study ranged in age from 19 to 52 years. All underwent laparoscopic Davydov vaginoplasty in 2004-2006 at one of two Toronto hospitals, and the surgeries technically went very well. Postoperatively, all were provided with either a vaginal stent or a dilator for an average of 6.5 months, said Dr. Lucco.

Two women reported that their vaginas now were “OK/normal,” two said their vaginas were smaller than average, one patient each said their vagina was short or narrow, and two described their vaginas as small. Three said they would like their vaginas to be longer.

“This requires us to reflect on the outcomes and to consider whether there is cause for revising the surgical technique, potentially by increasing the size of the stent that is placed postoperatively,” Dr. Lucco said.

Women in the study scored significantly lower than controls on the FSFI, out of a total of 6 points per category in measures of arousal (mean scores of 4 vs. 5, respectively), lubrication (4.4 vs. 5.5), orgasm (3.3 vs. 5), and comfort (1.9 vs. 5.5).

The study also had women complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS), another validated self-report questionnaire.

On the GRISS, some of the six women reported being uninterested in sex, more than half said they become tense and anxious when attempting intercourse, and several said that they occasionally or usually had difficulty inserting a penis into the vagina.

Some never achieved orgasm, and several said that they hardly ever or never felt sexually satisfied in their relationships with sexual partners.

One possible reason for reports of impaired sexual function in this cohort, compared with previous data, may be that the current study included responses from two women who had not had sexual intercourse in the previous 4 months, Dr. Lucco said. Of the four women who'd had intercourse, two had FSFI scores in the “good” or better range.

NEWPORT BEACH, CALIF. — Women with vaginal agenesis who undergo laparoscopic Davydov surgery to create a neovagina may have impaired sexual function, compared with controls, a study of six such patients found.

The findings of the small study contradict results from the only previous study that also used validated self-report questionnaires to assess psychosocial and functional outcomes after laparoscopic Davydov, Dr. Kerith L. Lucco said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

In that previous study, scores on the Female Sexual Function Index (FSFI) did not differ significantly among 28 women who underwent vaginoplasty via laparoscopic Davydov and a control group (Hum. Reprod. 2005;20:2954-7).

In the current study, the six women reported a mean score of 21 on the FSFI, significantly lower than a mean score of 30 reported for control patients in the medical literature, said Dr. Lucco of the department of pediatric and adolescent gynecology at the Hospital for Sick Children in Toronto. FSFI scores below 24 are considered to represent poor sexual function.

In comparison, a separate recent study found that vaginal dilation improved scores for sexual satisfaction and decreased scores for “sexual depression” in 8 women with vaginal agenesis because of androgen insensitivity syndrome (AIS) but not in 18 women with vaginal agenesis because of Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, Dr. Lucco noted (Hum. Reprod. 2007;22:2020-4).

Approximately 1 in every 4,000 female babies are born without a vagina because of MRKH and approximately 1 in 20,000 female babies lack a vagina at birth because of AIS. First-line treatment is vaginal dilation, but several surgical methods of creating a vagina have been tried, including the laparoscopic Davydov procedure, both in untreated patients and in some who have failed vaginal dilation.

Women in the current study ranged in age from 19 to 52 years. All underwent laparoscopic Davydov vaginoplasty in 2004-2006 at one of two Toronto hospitals, and the surgeries technically went very well. Postoperatively, all were provided with either a vaginal stent or a dilator for an average of 6.5 months, said Dr. Lucco.

Two women reported that their vaginas now were “OK/normal,” two said their vaginas were smaller than average, one patient each said their vagina was short or narrow, and two described their vaginas as small. Three said they would like their vaginas to be longer.

“This requires us to reflect on the outcomes and to consider whether there is cause for revising the surgical technique, potentially by increasing the size of the stent that is placed postoperatively,” Dr. Lucco said.

Women in the study scored significantly lower than controls on the FSFI, out of a total of 6 points per category in measures of arousal (mean scores of 4 vs. 5, respectively), lubrication (4.4 vs. 5.5), orgasm (3.3 vs. 5), and comfort (1.9 vs. 5.5).

The study also had women complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS), another validated self-report questionnaire.

On the GRISS, some of the six women reported being uninterested in sex, more than half said they become tense and anxious when attempting intercourse, and several said that they occasionally or usually had difficulty inserting a penis into the vagina.

Some never achieved orgasm, and several said that they hardly ever or never felt sexually satisfied in their relationships with sexual partners.

One possible reason for reports of impaired sexual function in this cohort, compared with previous data, may be that the current study included responses from two women who had not had sexual intercourse in the previous 4 months, Dr. Lucco said. Of the four women who'd had intercourse, two had FSFI scores in the “good” or better range.

NEWPORT BEACH, CALIF. — Women with vaginal agenesis who undergo laparoscopic Davydov surgery to create a neovagina may have impaired sexual function, compared with controls, a study of six such patients found.

The findings of the small study contradict results from the only previous study that also used validated self-report questionnaires to assess psychosocial and functional outcomes after laparoscopic Davydov, Dr. Kerith L. Lucco said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

In that previous study, scores on the Female Sexual Function Index (FSFI) did not differ significantly among 28 women who underwent vaginoplasty via laparoscopic Davydov and a control group (Hum. Reprod. 2005;20:2954-7).

In the current study, the six women reported a mean score of 21 on the FSFI, significantly lower than a mean score of 30 reported for control patients in the medical literature, said Dr. Lucco of the department of pediatric and adolescent gynecology at the Hospital for Sick Children in Toronto. FSFI scores below 24 are considered to represent poor sexual function.

In comparison, a separate recent study found that vaginal dilation improved scores for sexual satisfaction and decreased scores for “sexual depression” in 8 women with vaginal agenesis because of androgen insensitivity syndrome (AIS) but not in 18 women with vaginal agenesis because of Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, Dr. Lucco noted (Hum. Reprod. 2007;22:2020-4).

Approximately 1 in every 4,000 female babies are born without a vagina because of MRKH and approximately 1 in 20,000 female babies lack a vagina at birth because of AIS. First-line treatment is vaginal dilation, but several surgical methods of creating a vagina have been tried, including the laparoscopic Davydov procedure, both in untreated patients and in some who have failed vaginal dilation.

Women in the current study ranged in age from 19 to 52 years. All underwent laparoscopic Davydov vaginoplasty in 2004-2006 at one of two Toronto hospitals, and the surgeries technically went very well. Postoperatively, all were provided with either a vaginal stent or a dilator for an average of 6.5 months, said Dr. Lucco.

Two women reported that their vaginas now were “OK/normal,” two said their vaginas were smaller than average, one patient each said their vagina was short or narrow, and two described their vaginas as small. Three said they would like their vaginas to be longer.

“This requires us to reflect on the outcomes and to consider whether there is cause for revising the surgical technique, potentially by increasing the size of the stent that is placed postoperatively,” Dr. Lucco said.

Women in the study scored significantly lower than controls on the FSFI, out of a total of 6 points per category in measures of arousal (mean scores of 4 vs. 5, respectively), lubrication (4.4 vs. 5.5), orgasm (3.3 vs. 5), and comfort (1.9 vs. 5.5).

The study also had women complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS), another validated self-report questionnaire.

On the GRISS, some of the six women reported being uninterested in sex, more than half said they become tense and anxious when attempting intercourse, and several said that they occasionally or usually had difficulty inserting a penis into the vagina.

Some never achieved orgasm, and several said that they hardly ever or never felt sexually satisfied in their relationships with sexual partners.

One possible reason for reports of impaired sexual function in this cohort, compared with previous data, may be that the current study included responses from two women who had not had sexual intercourse in the previous 4 months, Dr. Lucco said. Of the four women who'd had intercourse, two had FSFI scores in the “good” or better range.

NEWPORT BEACH, CALIF. — Compared with pregnant adults, pregnant adolescents are significantly more likely to be anemic, to smoke during pregnancy, and to deliver before 32 weeks' gestation, a retrospective study of nearly 26,000 pregnancies found.

These factors, plus a significantly lower rate of breast-feeding in the 996 pregnant adolescents in the study, put these young mothers and their offspring at higher risk compared with the pregnant adults in the rest of the cohort, Dr. Andrew Stewart of Dalhousie University, Halifax, N.S., said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Stewart and his associates analyzed data on all nulliparous, singleton gestations resulting in live births from 2000 to 2006 in Nova Scotia; these data are from the H.B. Atlee Perinatal Database. The investigators compared the characteristics and outcomes for adolescent mothers aged 18 years and younger with those of older mothers.

Their findings stress the importance of regularly checking hemoglobin levels in pregnant adolescents, of treating anemia, and of making sure they have access to prenatal vitamins and to nutritionists or social workers when needed. Extra effort should be put into encouraging the cessation of smoking, and clinicians should consider educating pregnant adolescents about the signs and symptoms of preterm labor, said Dr. Stewart.

“We must ask ourselves if we should be screening these patients with a transvaginal ultrasound to monitor cervical length,” he added. The results also point to a need for increased promotion of breast-feeding through education and support before and after delivery.

Although it's well accepted that adolescents are a high-risk obstetric population, the medical literature is contradictory about the specific risk factors and outcomes of adolescent pregnancies, he noted. The literature does not reveal whether young maternal age itself enhances the risk for poor obstetric outcomes, or if they are the result of a constellation of biological, psychological, and sociological factors.

In the current study, 39% of adolescents smoked during pregnancy, compared with 18% of adults. In all, 10% percent of adolescents and 8% of adults were anemic.

The adolescents weighed less than the adults before pregnancy (59 kg vs. 69 kg) and gained more weight during pregnancy (17 kg vs. 16 kg); these differences between age groups were statistically significant. The lower an adolescent's weight before pregnancy, the more she gained during pregnancy, he said.

Spontaneous vaginal delivery was significantly more common for adolescent mothers (72%) than for adult mothers (54%). Adolescents had lower rates of assisted vaginal delivery (14%) or C-section (15%), compared with adults (17% and 29%).

Although the mean gestational age at birth was 39 weeks in both groups, 2% of adolescents delivered before 32 weeks' gestation, compared with 1% of adults, which was a significant difference. Adolescents were less likely, however, to deliver a baby needing neonatal intensive care (9%), compared with adults (13%).

After controlling for the effects of smoking and anemia, the investigators found that being age 18 years or younger increased the likelihood of delivery before 32 weeks by 65%, Dr. Stewart reported. After controlling for the effects of young age, investigators found that smoking and anemia remained significant risk factors for preterm birth.

The mean weight of 3,311 g for babies born to adolescents was significantly lower than the mean weight of 3,404 g for babies born to adults. Babies with low birth weight (defined as less than 2,500 g) constituted 8% of births to adolescents and 6% of births to adults, a significant difference.

Adolescents were less likely than adults to develop gestational diabetes (1% vs. 2%) or mild pregnancy-induced hypertension (5% vs. 9%), or to give birth to a macrosomic baby (10% vs. 13%).

At discharge from the hospital, 40% of adolescent mothers were breast-feeding, compared with 72% of adult mothers.

The investigators hope to conduct future research on the potential influence of diet, socioeconomic status, small stature, and sexually transmitted infections on the increased risk for preterm delivery in pregnant adolescents.

NEWPORT BEACH, CALIF. — Compared with pregnant adults, pregnant adolescents are significantly more likely to be anemic, to smoke during pregnancy, and to deliver before 32 weeks' gestation, a retrospective study of nearly 26,000 pregnancies found.

These factors, plus a significantly lower rate of breast-feeding in the 996 pregnant adolescents in the study, put these young mothers and their offspring at higher risk compared with the pregnant adults in the rest of the cohort, Dr. Andrew Stewart of Dalhousie University, Halifax, N.S., said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Stewart and his associates analyzed data on all nulliparous, singleton gestations resulting in live births from 2000 to 2006 in Nova Scotia; these data are from the H.B. Atlee Perinatal Database. The investigators compared the characteristics and outcomes for adolescent mothers aged 18 years and younger with those of older mothers.

Their findings stress the importance of regularly checking hemoglobin levels in pregnant adolescents, of treating anemia, and of making sure they have access to prenatal vitamins and to nutritionists or social workers when needed. Extra effort should be put into encouraging the cessation of smoking, and clinicians should consider educating pregnant adolescents about the signs and symptoms of preterm labor, said Dr. Stewart.

“We must ask ourselves if we should be screening these patients with a transvaginal ultrasound to monitor cervical length,” he added. The results also point to a need for increased promotion of breast-feeding through education and support before and after delivery.

Although it's well accepted that adolescents are a high-risk obstetric population, the medical literature is contradictory about the specific risk factors and outcomes of adolescent pregnancies, he noted. The literature does not reveal whether young maternal age itself enhances the risk for poor obstetric outcomes, or if they are the result of a constellation of biological, psychological, and sociological factors.

In the current study, 39% of adolescents smoked during pregnancy, compared with 18% of adults. In all, 10% percent of adolescents and 8% of adults were anemic.

The adolescents weighed less than the adults before pregnancy (59 kg vs. 69 kg) and gained more weight during pregnancy (17 kg vs. 16 kg); these differences between age groups were statistically significant. The lower an adolescent's weight before pregnancy, the more she gained during pregnancy, he said.

Spontaneous vaginal delivery was significantly more common for adolescent mothers (72%) than for adult mothers (54%). Adolescents had lower rates of assisted vaginal delivery (14%) or C-section (15%), compared with adults (17% and 29%).

Although the mean gestational age at birth was 39 weeks in both groups, 2% of adolescents delivered before 32 weeks' gestation, compared with 1% of adults, which was a significant difference. Adolescents were less likely, however, to deliver a baby needing neonatal intensive care (9%), compared with adults (13%).

After controlling for the effects of smoking and anemia, the investigators found that being age 18 years or younger increased the likelihood of delivery before 32 weeks by 65%, Dr. Stewart reported. After controlling for the effects of young age, investigators found that smoking and anemia remained significant risk factors for preterm birth.

The mean weight of 3,311 g for babies born to adolescents was significantly lower than the mean weight of 3,404 g for babies born to adults. Babies with low birth weight (defined as less than 2,500 g) constituted 8% of births to adolescents and 6% of births to adults, a significant difference.

Adolescents were less likely than adults to develop gestational diabetes (1% vs. 2%) or mild pregnancy-induced hypertension (5% vs. 9%), or to give birth to a macrosomic baby (10% vs. 13%).

At discharge from the hospital, 40% of adolescent mothers were breast-feeding, compared with 72% of adult mothers.

The investigators hope to conduct future research on the potential influence of diet, socioeconomic status, small stature, and sexually transmitted infections on the increased risk for preterm delivery in pregnant adolescents.

NEWPORT BEACH, CALIF. — Compared with pregnant adults, pregnant adolescents are significantly more likely to be anemic, to smoke during pregnancy, and to deliver before 32 weeks' gestation, a retrospective study of nearly 26,000 pregnancies found.

These factors, plus a significantly lower rate of breast-feeding in the 996 pregnant adolescents in the study, put these young mothers and their offspring at higher risk compared with the pregnant adults in the rest of the cohort, Dr. Andrew Stewart of Dalhousie University, Halifax, N.S., said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Stewart and his associates analyzed data on all nulliparous, singleton gestations resulting in live births from 2000 to 2006 in Nova Scotia; these data are from the H.B. Atlee Perinatal Database. The investigators compared the characteristics and outcomes for adolescent mothers aged 18 years and younger with those of older mothers.

Their findings stress the importance of regularly checking hemoglobin levels in pregnant adolescents, of treating anemia, and of making sure they have access to prenatal vitamins and to nutritionists or social workers when needed. Extra effort should be put into encouraging the cessation of smoking, and clinicians should consider educating pregnant adolescents about the signs and symptoms of preterm labor, said Dr. Stewart.

“We must ask ourselves if we should be screening these patients with a transvaginal ultrasound to monitor cervical length,” he added. The results also point to a need for increased promotion of breast-feeding through education and support before and after delivery.

Although it's well accepted that adolescents are a high-risk obstetric population, the medical literature is contradictory about the specific risk factors and outcomes of adolescent pregnancies, he noted. The literature does not reveal whether young maternal age itself enhances the risk for poor obstetric outcomes, or if they are the result of a constellation of biological, psychological, and sociological factors.

In the current study, 39% of adolescents smoked during pregnancy, compared with 18% of adults. In all, 10% percent of adolescents and 8% of adults were anemic.

The adolescents weighed less than the adults before pregnancy (59 kg vs. 69 kg) and gained more weight during pregnancy (17 kg vs. 16 kg); these differences between age groups were statistically significant. The lower an adolescent's weight before pregnancy, the more she gained during pregnancy, he said.

Spontaneous vaginal delivery was significantly more common for adolescent mothers (72%) than for adult mothers (54%). Adolescents had lower rates of assisted vaginal delivery (14%) or C-section (15%), compared with adults (17% and 29%).

Although the mean gestational age at birth was 39 weeks in both groups, 2% of adolescents delivered before 32 weeks' gestation, compared with 1% of adults, which was a significant difference. Adolescents were less likely, however, to deliver a baby needing neonatal intensive care (9%), compared with adults (13%).

After controlling for the effects of smoking and anemia, the investigators found that being age 18 years or younger increased the likelihood of delivery before 32 weeks by 65%, Dr. Stewart reported. After controlling for the effects of young age, investigators found that smoking and anemia remained significant risk factors for preterm birth.

The mean weight of 3,311 g for babies born to adolescents was significantly lower than the mean weight of 3,404 g for babies born to adults. Babies with low birth weight (defined as less than 2,500 g) constituted 8% of births to adolescents and 6% of births to adults, a significant difference.

Adolescents were less likely than adults to develop gestational diabetes (1% vs. 2%) or mild pregnancy-induced hypertension (5% vs. 9%), or to give birth to a macrosomic baby (10% vs. 13%).

At discharge from the hospital, 40% of adolescent mothers were breast-feeding, compared with 72% of adult mothers.

The investigators hope to conduct future research on the potential influence of diet, socioeconomic status, small stature, and sexually transmitted infections on the increased risk for preterm delivery in pregnant adolescents.

NEWPORT BEACH, CALIF. — Disease stage stabilized or improved in 81 of 90 adolescents who were treated for endometriosis with combined surgical and medical therapy, according to results of a retrospective study.

The goals of treating endometriosis in adolescents generally are to control pain, prevent disease progression, and preserve fertility. This study is the first to show that a combined surgical/medical approach to treating endometriosis in adolescents retards disease progression, Dr. Joseph O. Doyle said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

These findings are important because they support a strategy of early intervention and treatment to control pain and prevent progression. Some treatments may impair the fertility of these patients, said Dr. Doyle of Brigham and Women's Hospital, Boston.

The subjects had a mean age of 17 years (range, 12–24 years) and had undergone two laparoscopies separated by a median of 29 months (range, 6–112 months), allowing the researchers to assess disease progression over time.

They underwent the initial laparoscopy for pelvic pain that did not improve adequately after at least 3 months of medical treatment with cyclical hormonal therapy and nonsteroidal anti-inflammatory drugs. Endometriosis was confirmed on laparoscopy, during which the surgeon destroyed any endometrial lesions that were observed and lysed any adhesions.

Patients were then treated medically with continuous combined oral contraceptives (82 patients), continuous progesterone-only therapy (11 patients), or continuous GnRH agonists (70 patients). Some patients tried more than one medical therapy to control pain.

They underwent the second laparoscopy because of persistent pain. “Our … study did not include anyone who had one laparoscopy, received their medical portion of treatment, and had adequate treatment response,” Dr. Doyle said. “We potentially excluded a large proportion of the treatment effect and biased our population toward those with more progressive disease,” yet little disease progression was seen with combined therapy.

The median stage of endometriosis at both the first and second laparoscopy was stage I, using the revised grading system of the American Society for Reproductive Medicine. Most patients had minimal (stage I) or mild (stage II) disease, and no patient had worse than stage III (moderate) disease.

One patient (1%) showed a two-stage improvement in endometriosis at the second laparoscopy, 17 (19%) improved by one stage, 63 patients (70%) had no change in stage; in 9 patients (10%), endometriosis worsened by one stage.

Statistical analysis showed a significant association between stages at first and second laparoscopies after adjusting for the effects of age at first laparoscopy, the interval between laparoscopies, and the type of hormonal therapy used, which “reflects our finding that 70% of patients had stable disease,” he said.

Regardless of the disease stage at the first laparoscopy, there were no statistical trends toward disease progression, but a significant likelihood (especially in patients with stage II or III disease) of improvement in endometriosis by the second surgery.

Patients with other or additional pelvic or abdominal pathologies besides endometriosis, those with a history of prior surgeries or pregnancies, and those with significant medical histories, were excluded.

ELSEVIER GLOBAL MEDICAL NEWS

NEWPORT BEACH, CALIF. — Disease stage stabilized or improved in 81 of 90 adolescents who were treated for endometriosis with combined surgical and medical therapy, according to results of a retrospective study.

The goals of treating endometriosis in adolescents generally are to control pain, prevent disease progression, and preserve fertility. This study is the first to show that a combined surgical/medical approach to treating endometriosis in adolescents retards disease progression, Dr. Joseph O. Doyle said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

These findings are important because they support a strategy of early intervention and treatment to control pain and prevent progression. Some treatments may impair the fertility of these patients, said Dr. Doyle of Brigham and Women's Hospital, Boston.

The subjects had a mean age of 17 years (range, 12–24 years) and had undergone two laparoscopies separated by a median of 29 months (range, 6–112 months), allowing the researchers to assess disease progression over time.

They underwent the initial laparoscopy for pelvic pain that did not improve adequately after at least 3 months of medical treatment with cyclical hormonal therapy and nonsteroidal anti-inflammatory drugs. Endometriosis was confirmed on laparoscopy, during which the surgeon destroyed any endometrial lesions that were observed and lysed any adhesions.

Patients were then treated medically with continuous combined oral contraceptives (82 patients), continuous progesterone-only therapy (11 patients), or continuous GnRH agonists (70 patients). Some patients tried more than one medical therapy to control pain.

They underwent the second laparoscopy because of persistent pain. “Our … study did not include anyone who had one laparoscopy, received their medical portion of treatment, and had adequate treatment response,” Dr. Doyle said. “We potentially excluded a large proportion of the treatment effect and biased our population toward those with more progressive disease,” yet little disease progression was seen with combined therapy.

The median stage of endometriosis at both the first and second laparoscopy was stage I, using the revised grading system of the American Society for Reproductive Medicine. Most patients had minimal (stage I) or mild (stage II) disease, and no patient had worse than stage III (moderate) disease.

One patient (1%) showed a two-stage improvement in endometriosis at the second laparoscopy, 17 (19%) improved by one stage, 63 patients (70%) had no change in stage; in 9 patients (10%), endometriosis worsened by one stage.

Statistical analysis showed a significant association between stages at first and second laparoscopies after adjusting for the effects of age at first laparoscopy, the interval between laparoscopies, and the type of hormonal therapy used, which “reflects our finding that 70% of patients had stable disease,” he said.

Regardless of the disease stage at the first laparoscopy, there were no statistical trends toward disease progression, but a significant likelihood (especially in patients with stage II or III disease) of improvement in endometriosis by the second surgery.

Patients with other or additional pelvic or abdominal pathologies besides endometriosis, those with a history of prior surgeries or pregnancies, and those with significant medical histories, were excluded.

ELSEVIER GLOBAL MEDICAL NEWS

NEWPORT BEACH, CALIF. — Disease stage stabilized or improved in 81 of 90 adolescents who were treated for endometriosis with combined surgical and medical therapy, according to results of a retrospective study.

The goals of treating endometriosis in adolescents generally are to control pain, prevent disease progression, and preserve fertility. This study is the first to show that a combined surgical/medical approach to treating endometriosis in adolescents retards disease progression, Dr. Joseph O. Doyle said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

These findings are important because they support a strategy of early intervention and treatment to control pain and prevent progression. Some treatments may impair the fertility of these patients, said Dr. Doyle of Brigham and Women's Hospital, Boston.

The subjects had a mean age of 17 years (range, 12–24 years) and had undergone two laparoscopies separated by a median of 29 months (range, 6–112 months), allowing the researchers to assess disease progression over time.

They underwent the initial laparoscopy for pelvic pain that did not improve adequately after at least 3 months of medical treatment with cyclical hormonal therapy and nonsteroidal anti-inflammatory drugs. Endometriosis was confirmed on laparoscopy, during which the surgeon destroyed any endometrial lesions that were observed and lysed any adhesions.

Patients were then treated medically with continuous combined oral contraceptives (82 patients), continuous progesterone-only therapy (11 patients), or continuous GnRH agonists (70 patients). Some patients tried more than one medical therapy to control pain.

They underwent the second laparoscopy because of persistent pain. “Our … study did not include anyone who had one laparoscopy, received their medical portion of treatment, and had adequate treatment response,” Dr. Doyle said. “We potentially excluded a large proportion of the treatment effect and biased our population toward those with more progressive disease,” yet little disease progression was seen with combined therapy.

The median stage of endometriosis at both the first and second laparoscopy was stage I, using the revised grading system of the American Society for Reproductive Medicine. Most patients had minimal (stage I) or mild (stage II) disease, and no patient had worse than stage III (moderate) disease.

One patient (1%) showed a two-stage improvement in endometriosis at the second laparoscopy, 17 (19%) improved by one stage, 63 patients (70%) had no change in stage; in 9 patients (10%), endometriosis worsened by one stage.

Statistical analysis showed a significant association between stages at first and second laparoscopies after adjusting for the effects of age at first laparoscopy, the interval between laparoscopies, and the type of hormonal therapy used, which “reflects our finding that 70% of patients had stable disease,” he said.

Regardless of the disease stage at the first laparoscopy, there were no statistical trends toward disease progression, but a significant likelihood (especially in patients with stage II or III disease) of improvement in endometriosis by the second surgery.

Patients with other or additional pelvic or abdominal pathologies besides endometriosis, those with a history of prior surgeries or pregnancies, and those with significant medical histories, were excluded.

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