Sharon Worcester

ATLANTA - The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may soon consider whether routine human papillomavirus vaccination should be recommended for males aged 9-26 years, but it does not seem likely that a catch-up dose will be recommended for women who are older than 26.

The vaccine, Gardasil (Merck & Co.), is licensed for males aged 9-26 years for prevention of genital warts associated with HPV-6 and -11, in addition to being recommended by ACIPfor girls aged 11-12 years and for those 13-26 years who have not already been vaccinated. Data also show that the vaccine has 75% efficacy for preventing anal intraepithelial neoplasia grades 2 and 3 in males, Dr. Lauri Markowitz of the center's HPV working group reported at a meeting of the CDC's Advisory Committee on Immunization Practices.

A review by the Food and Drug Administration, which is considering a supplemental biologic license application by Merck for the latter indication, won't be complete before the next ACIP meeting in October, but the working group is reviewing vaccine trial and cost-effectiveness data on male vaccination, and plans to present its findings at that meeting.

Specifically, the group is looking at cost-effectiveness based on different coverage assumptions. From currently available data, vaccination of males does not appear to be cost effective when female vaccination coverage is high, but it may be more cost effective if female vaccination coverage is low, said Dr. Markowitz, who is also with the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.

ACIP had previously stated that the HPV vaccine "may be given" to males aged 9-26 years, but did not include the HPV vaccine in the routine vaccination schedule for this population, she noted.

She added that most of the working group members are opposed to a catch-up dose in women over age 26 on the basis of currently available data. ACIP first considered vaccination in women in this group in 2008, and Merck submitted a supplemental biologic license application to the FDA in 2009 for that indication. That application remains under review by the agency.

National Immunization Survey data show that 25% of girls aged 13-17 years received at least one HPV vaccine dose in 2007, and 37% received it in 2008.

Additional data on vaccination rates, vaccine safety, and private insurance coverage for vaccination will be presented at the October meeting, Dr. Markowitz said.

Dr. Markowitz said she has no relevant disclosures.

ATLANTA - The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may soon consider whether routine human papillomavirus vaccination should be recommended for males aged 9-26 years, but it does not seem likely that a catch-up dose will be recommended for women who are older than 26.

The vaccine, Gardasil (Merck & Co.), is licensed for males aged 9-26 years for prevention of genital warts associated with HPV-6 and -11, in addition to being recommended by ACIPfor girls aged 11-12 years and for those 13-26 years who have not already been vaccinated. Data also show that the vaccine has 75% efficacy for preventing anal intraepithelial neoplasia grades 2 and 3 in males, Dr. Lauri Markowitz of the center's HPV working group reported at a meeting of the CDC's Advisory Committee on Immunization Practices.

A review by the Food and Drug Administration, which is considering a supplemental biologic license application by Merck for the latter indication, won't be complete before the next ACIP meeting in October, but the working group is reviewing vaccine trial and cost-effectiveness data on male vaccination, and plans to present its findings at that meeting.

Specifically, the group is looking at cost-effectiveness based on different coverage assumptions. From currently available data, vaccination of males does not appear to be cost effective when female vaccination coverage is high, but it may be more cost effective if female vaccination coverage is low, said Dr. Markowitz, who is also with the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.

ACIP had previously stated that the HPV vaccine "may be given" to males aged 9-26 years, but did not include the HPV vaccine in the routine vaccination schedule for this population, she noted.

She added that most of the working group members are opposed to a catch-up dose in women over age 26 on the basis of currently available data. ACIP first considered vaccination in women in this group in 2008, and Merck submitted a supplemental biologic license application to the FDA in 2009 for that indication. That application remains under review by the agency.

National Immunization Survey data show that 25% of girls aged 13-17 years received at least one HPV vaccine dose in 2007, and 37% received it in 2008.

Additional data on vaccination rates, vaccine safety, and private insurance coverage for vaccination will be presented at the October meeting, Dr. Markowitz said.

Dr. Markowitz said she has no relevant disclosures.

ATLANTA - The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may soon consider whether routine human papillomavirus vaccination should be recommended for males aged 9-26 years, but it does not seem likely that a catch-up dose will be recommended for women who are older than 26.

The vaccine, Gardasil (Merck & Co.), is licensed for males aged 9-26 years for prevention of genital warts associated with HPV-6 and -11, in addition to being recommended by ACIPfor girls aged 11-12 years and for those 13-26 years who have not already been vaccinated. Data also show that the vaccine has 75% efficacy for preventing anal intraepithelial neoplasia grades 2 and 3 in males, Dr. Lauri Markowitz of the center's HPV working group reported at a meeting of the CDC's Advisory Committee on Immunization Practices.

A review by the Food and Drug Administration, which is considering a supplemental biologic license application by Merck for the latter indication, won't be complete before the next ACIP meeting in October, but the working group is reviewing vaccine trial and cost-effectiveness data on male vaccination, and plans to present its findings at that meeting.

Specifically, the group is looking at cost-effectiveness based on different coverage assumptions. From currently available data, vaccination of males does not appear to be cost effective when female vaccination coverage is high, but it may be more cost effective if female vaccination coverage is low, said Dr. Markowitz, who is also with the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.

ACIP had previously stated that the HPV vaccine "may be given" to males aged 9-26 years, but did not include the HPV vaccine in the routine vaccination schedule for this population, she noted.

She added that most of the working group members are opposed to a catch-up dose in women over age 26 on the basis of currently available data. ACIP first considered vaccination in women in this group in 2008, and Merck submitted a supplemental biologic license application to the FDA in 2009 for that indication. That application remains under review by the agency.

National Immunization Survey data show that 25% of girls aged 13-17 years received at least one HPV vaccine dose in 2007, and 37% received it in 2008.

Additional data on vaccination rates, vaccine safety, and private insurance coverage for vaccination will be presented at the October meeting, Dr. Markowitz said.

Dr. Markowitz said she has no relevant disclosures.

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11–21 years. No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15–19 years. The passive VAERS thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink. That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population. Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of post-vaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11–21 years. No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15–19 years. The passive VAERS thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink. That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population. Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of post-vaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11–21 years. No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15–19 years. The passive VAERS thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink. That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population. Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of post-vaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

ATLANTA — Children aged 6 months through 8 years who did not receive at least one dose of a 2009 H1N1 influenza monovalent vaccine during the 2009–2010 influenza season should receive two doses of a 2010–2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they were vaccinated require only one dose the following season.

The recommendations by the CDC's Advisory Committee on Immunization Practices (ACIP) continue to state that children aged 6 months through 8 years who are receiving a seasonal vaccine for the first time should get two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010–2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of a 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion. Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3–9 years. Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those aged 65 and older.

After two doses, 73%–100% of infants and young children developed protective titers.

Several other studies presented at the ACIP meeting also demonstrated the safety and efficacy of the 2009 H1N1 influenza monovalent vaccines.

Findings from a case-control study involving 4,156 individuals in four communities, and conducted from October 2009 through January 2010, showed that vaccine effectiveness for the prevention of confirmed medically attended 2009 H1N1 flu was 62% after adjusting for site, age, and onset date, Dr. David Shay of the CDC's influenza division reported.

Individuals in the study were considered vaccinated if they received at least one dose of vaccine more than 7 days before the onset of respiratory symptoms.

“Receipt of a U.S. monovalent, nonadjuvanted pandemic vaccine was associated with substantial protection against medically attended H1N1 illness,” he said, noting that vaccine efficacy was the same regardless of whether immunization occurred more than 7 days or more than 14 days prior to symptom onset.

As expected, the seasonal 2009–2010 flu vaccine had no effect on H1N1, he said.

As for H1N1 vaccine safety, data from several sources, including the CDC's Vaccine Safety Datalink (VSD), Post-Licensure Rapid Immunization Safety Monitoring (PRISM) project, Vaccine Adverse Event Reporting System (VAERS), and Emerging Infections Program Guillain-Barré Syndrome (GBS) surveillance project all showed that the H1N1 had comparable safety to seasonal vaccines.

The VSD and PRISM included data on 9 million individuals from eight health plans, and 35 million individuals from four health plans and nine state immunization registries, respectively, reported Dr. Tracy Lieu of Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston.

The VSD data showed a possible link between the vaccine and GBS, and indicated a “weak signal” for Bell's palsy, but the larger PRISM network showed no indication of a link between the vaccine and GBS, Bell's palsy, or seizures.

Neither VSD nor PRISM showed any link between the H1N1 flu vaccine and up to 13 other possible outcomes being monitored, including pregnancy-related outcomes such as spontaneous abortion and preeclampsia.

Similarly, data from VAERS and the Emerging Infections Program indicated the H1N1 flu vaccine is relatively safe.

The VAERS data indicated no statistical signals for adverse events. Reported adverse events were consistent with expectations based on the literature; for example, GBS occurred in 1.1 per million doses, compared with an expected rate of 1.5 per million doses, reported Dr. Frank DeStefano of the CDC's immunization safety office.

Like VSD, the Emerging Infections Program showed a possible link between the vaccine and GBS, but as was reported in the Morbidity and Mortality Weekly Report in June (2010;59:657–61), the rate per 100,000 person-years was 1.92 in vaccinated individuals vs. 1.21 in nonvaccinated individuals for an age-adjusted rate ratio of 1.77.

That equates to 0.8 cases of GBS per million vaccinated, which is a rate similar to that seen with seasonal vaccines in some years, Dr. DeStefano said.

Taken together, the data presented to ACIP on H1N1 flu vaccine safety are remarkably reassuring, according to Dr. Carol Baker, ACIP chair and a pediatric infectious disease specialist at Baylor College of Medicine in Houston.

“I think we have incredibly strong and extensive data on how safe this vaccine is. I hope that everyone that's listening … is very assured by this data,” she said, adding: “I do not know of data that are this strong for any vaccine that we have ever used in our country.”

Disclosures: Dr. DeStefano, Dr. Shay, and Dr. Baker said they had no conflicts of interest. Dr. Lieu said she had none other than that the studies were funded by the CDC and the Food and Drug Administration.

ATLANTA — Children aged 6 months through 8 years who did not receive at least one dose of a 2009 H1N1 influenza monovalent vaccine during the 2009–2010 influenza season should receive two doses of a 2010–2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they were vaccinated require only one dose the following season.

The recommendations by the CDC's Advisory Committee on Immunization Practices (ACIP) continue to state that children aged 6 months through 8 years who are receiving a seasonal vaccine for the first time should get two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010–2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of a 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion. Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3–9 years. Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those aged 65 and older.

After two doses, 73%–100% of infants and young children developed protective titers.

Several other studies presented at the ACIP meeting also demonstrated the safety and efficacy of the 2009 H1N1 influenza monovalent vaccines.

Findings from a case-control study involving 4,156 individuals in four communities, and conducted from October 2009 through January 2010, showed that vaccine effectiveness for the prevention of confirmed medically attended 2009 H1N1 flu was 62% after adjusting for site, age, and onset date, Dr. David Shay of the CDC's influenza division reported.

Individuals in the study were considered vaccinated if they received at least one dose of vaccine more than 7 days before the onset of respiratory symptoms.

“Receipt of a U.S. monovalent, nonadjuvanted pandemic vaccine was associated with substantial protection against medically attended H1N1 illness,” he said, noting that vaccine efficacy was the same regardless of whether immunization occurred more than 7 days or more than 14 days prior to symptom onset.

As expected, the seasonal 2009–2010 flu vaccine had no effect on H1N1, he said.

As for H1N1 vaccine safety, data from several sources, including the CDC's Vaccine Safety Datalink (VSD), Post-Licensure Rapid Immunization Safety Monitoring (PRISM) project, Vaccine Adverse Event Reporting System (VAERS), and Emerging Infections Program Guillain-Barré Syndrome (GBS) surveillance project all showed that the H1N1 had comparable safety to seasonal vaccines.

The VSD and PRISM included data on 9 million individuals from eight health plans, and 35 million individuals from four health plans and nine state immunization registries, respectively, reported Dr. Tracy Lieu of Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston.

The VSD data showed a possible link between the vaccine and GBS, and indicated a “weak signal” for Bell's palsy, but the larger PRISM network showed no indication of a link between the vaccine and GBS, Bell's palsy, or seizures.

Neither VSD nor PRISM showed any link between the H1N1 flu vaccine and up to 13 other possible outcomes being monitored, including pregnancy-related outcomes such as spontaneous abortion and preeclampsia.

Similarly, data from VAERS and the Emerging Infections Program indicated the H1N1 flu vaccine is relatively safe.

The VAERS data indicated no statistical signals for adverse events. Reported adverse events were consistent with expectations based on the literature; for example, GBS occurred in 1.1 per million doses, compared with an expected rate of 1.5 per million doses, reported Dr. Frank DeStefano of the CDC's immunization safety office.

Like VSD, the Emerging Infections Program showed a possible link between the vaccine and GBS, but as was reported in the Morbidity and Mortality Weekly Report in June (2010;59:657–61), the rate per 100,000 person-years was 1.92 in vaccinated individuals vs. 1.21 in nonvaccinated individuals for an age-adjusted rate ratio of 1.77.

That equates to 0.8 cases of GBS per million vaccinated, which is a rate similar to that seen with seasonal vaccines in some years, Dr. DeStefano said.

Taken together, the data presented to ACIP on H1N1 flu vaccine safety are remarkably reassuring, according to Dr. Carol Baker, ACIP chair and a pediatric infectious disease specialist at Baylor College of Medicine in Houston.

“I think we have incredibly strong and extensive data on how safe this vaccine is. I hope that everyone that's listening … is very assured by this data,” she said, adding: “I do not know of data that are this strong for any vaccine that we have ever used in our country.”

Disclosures: Dr. DeStefano, Dr. Shay, and Dr. Baker said they had no conflicts of interest. Dr. Lieu said she had none other than that the studies were funded by the CDC and the Food and Drug Administration.

ATLANTA — Children aged 6 months through 8 years who did not receive at least one dose of a 2009 H1N1 influenza monovalent vaccine during the 2009–2010 influenza season should receive two doses of a 2010–2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they were vaccinated require only one dose the following season.

The recommendations by the CDC's Advisory Committee on Immunization Practices (ACIP) continue to state that children aged 6 months through 8 years who are receiving a seasonal vaccine for the first time should get two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010–2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of a 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion. Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3–9 years. Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those aged 65 and older.

After two doses, 73%–100% of infants and young children developed protective titers.

Several other studies presented at the ACIP meeting also demonstrated the safety and efficacy of the 2009 H1N1 influenza monovalent vaccines.

Findings from a case-control study involving 4,156 individuals in four communities, and conducted from October 2009 through January 2010, showed that vaccine effectiveness for the prevention of confirmed medically attended 2009 H1N1 flu was 62% after adjusting for site, age, and onset date, Dr. David Shay of the CDC's influenza division reported.

Individuals in the study were considered vaccinated if they received at least one dose of vaccine more than 7 days before the onset of respiratory symptoms.

“Receipt of a U.S. monovalent, nonadjuvanted pandemic vaccine was associated with substantial protection against medically attended H1N1 illness,” he said, noting that vaccine efficacy was the same regardless of whether immunization occurred more than 7 days or more than 14 days prior to symptom onset.

As expected, the seasonal 2009–2010 flu vaccine had no effect on H1N1, he said.

As for H1N1 vaccine safety, data from several sources, including the CDC's Vaccine Safety Datalink (VSD), Post-Licensure Rapid Immunization Safety Monitoring (PRISM) project, Vaccine Adverse Event Reporting System (VAERS), and Emerging Infections Program Guillain-Barré Syndrome (GBS) surveillance project all showed that the H1N1 had comparable safety to seasonal vaccines.

The VSD and PRISM included data on 9 million individuals from eight health plans, and 35 million individuals from four health plans and nine state immunization registries, respectively, reported Dr. Tracy Lieu of Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston.

The VSD data showed a possible link between the vaccine and GBS, and indicated a “weak signal” for Bell's palsy, but the larger PRISM network showed no indication of a link between the vaccine and GBS, Bell's palsy, or seizures.

Neither VSD nor PRISM showed any link between the H1N1 flu vaccine and up to 13 other possible outcomes being monitored, including pregnancy-related outcomes such as spontaneous abortion and preeclampsia.

Similarly, data from VAERS and the Emerging Infections Program indicated the H1N1 flu vaccine is relatively safe.

The VAERS data indicated no statistical signals for adverse events. Reported adverse events were consistent with expectations based on the literature; for example, GBS occurred in 1.1 per million doses, compared with an expected rate of 1.5 per million doses, reported Dr. Frank DeStefano of the CDC's immunization safety office.

Like VSD, the Emerging Infections Program showed a possible link between the vaccine and GBS, but as was reported in the Morbidity and Mortality Weekly Report in June (2010;59:657–61), the rate per 100,000 person-years was 1.92 in vaccinated individuals vs. 1.21 in nonvaccinated individuals for an age-adjusted rate ratio of 1.77.

That equates to 0.8 cases of GBS per million vaccinated, which is a rate similar to that seen with seasonal vaccines in some years, Dr. DeStefano said.

Taken together, the data presented to ACIP on H1N1 flu vaccine safety are remarkably reassuring, according to Dr. Carol Baker, ACIP chair and a pediatric infectious disease specialist at Baylor College of Medicine in Houston.

“I think we have incredibly strong and extensive data on how safe this vaccine is. I hope that everyone that's listening … is very assured by this data,” she said, adding: “I do not know of data that are this strong for any vaccine that we have ever used in our country.”

Disclosures: Dr. DeStefano, Dr. Shay, and Dr. Baker said they had no conflicts of interest. Dr. Lieu said she had none other than that the studies were funded by the CDC and the Food and Drug Administration.

ATLANTA — Children ages 6 months through 8 years who did not receive at least one dose of the 2009 influenza A(H1N1) monovalent vaccine during the 2009-2010 influenza season should receive two doses of a 2010-2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they are vaccinated require only one dose the following season.

The CDC's Advisory Committee on Immunization Practices (ACIP) voted June 24 to make this change to its existing seasonal influenza vaccination recommendations.

The recommendations continue to state that children ages 6 months through 8 years who are receiving a seasonal vaccine for the first time should receive two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010-2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of an 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion.

Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3-9 years.

Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those age 65 and older.

After two doses, 73%-100% of infants and young children developed protective titers.

Disclosures: Dr. Shay said he had no conflicts of interest, and Dr. Lieu said she had none other than that the studies were funded by the CDC and FDA.

If a child aged 6 months to 8 years received at least one dose of 2009 H1N1 flu vaccine last year, he needs only one dose of the seasonal vaccine in 2010-2011, provided he received two doses of seasonal flu vaccine in his first year of receiving seasonal flu vaccine.

Source ©Gina Sanders/Fotolia.com

ATLANTA — Children ages 6 months through 8 years who did not receive at least one dose of the 2009 influenza A(H1N1) monovalent vaccine during the 2009-2010 influenza season should receive two doses of a 2010-2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they are vaccinated require only one dose the following season.

The CDC's Advisory Committee on Immunization Practices (ACIP) voted June 24 to make this change to its existing seasonal influenza vaccination recommendations.

The recommendations continue to state that children ages 6 months through 8 years who are receiving a seasonal vaccine for the first time should receive two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010-2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of an 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion.

Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3-9 years.

Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those age 65 and older.

After two doses, 73%-100% of infants and young children developed protective titers.

Disclosures: Dr. Shay said he had no conflicts of interest, and Dr. Lieu said she had none other than that the studies were funded by the CDC and FDA.

If a child aged 6 months to 8 years received at least one dose of 2009 H1N1 flu vaccine last year, he needs only one dose of the seasonal vaccine in 2010-2011, provided he received two doses of seasonal flu vaccine in his first year of receiving seasonal flu vaccine.

Source ©Gina Sanders/Fotolia.com

ATLANTA — Children ages 6 months through 8 years who did not receive at least one dose of the 2009 influenza A(H1N1) monovalent vaccine during the 2009-2010 influenza season should receive two doses of a 2010-2011 seasonal influenza vaccine, which will include H1N1 coverage, according to a new recommendation from the Centers for Disease Control and Prevention.

Prior recommendations stated that children in this age group who received two doses in the first influenza season in which they are vaccinated require only one dose the following season.

The CDC's Advisory Committee on Immunization Practices (ACIP) voted June 24 to make this change to its existing seasonal influenza vaccination recommendations.

The recommendations continue to state that children ages 6 months through 8 years who are receiving a seasonal vaccine for the first time should receive two doses, and that those who received only one dose of a seasonal vaccine in the first influenza season in which they were vaccinated should receive two doses in the following season.

If children in this age group received at least one dose of 2009 H1N1 flu vaccine last year, they need only one dose of the seasonal vaccine in 2010-2011, provided they received two doses of seasonal flu vaccine in their first year of receiving seasonal vaccines.

The additional recommendation was made in light of immunogenicity and vaccine effectiveness data suggesting that children under age 9 years who receive only one dose of an 2009 H1N1 flu vaccine instead of the recommended two doses have reduced rates of seroconversion.

Children in that age group also have lower rates of immunity resulting from natural influenza infection.

The ACIP Influenza Vaccine Working Group, which proposed the change, reported that protective titers of hemagglutinin inhibition following a single dose of a 2009 H1N1 monovalent vaccine during the 2009 pandemic occurred in as few as 19% of children aged 6 months to 3 years, and as few as 44% of those aged 3-9 years.

Protective titers were present in at least 90% of older children and adults up to age 65 years, and in 81% of those age 65 and older.

After two doses, 73%-100% of infants and young children developed protective titers.

Disclosures: Dr. Shay said he had no conflicts of interest, and Dr. Lieu said she had none other than that the studies were funded by the CDC and FDA.

If a child aged 6 months to 8 years received at least one dose of 2009 H1N1 flu vaccine last year, he needs only one dose of the seasonal vaccine in 2010-2011, provided he received two doses of seasonal flu vaccine in his first year of receiving seasonal flu vaccine.

Source ©Gina Sanders/Fotolia.com

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted at its June meeting to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11-21 years.

No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15-19 years.

The passive VAERS reporting system thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink.

That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population.

Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of postvaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted at its June meeting to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11-21 years.

No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15-19 years.

The passive VAERS reporting system thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink.

That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population.

Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of postvaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted at its June meeting to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.

The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11-21 years.

No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.

“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.

Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15-19 years.

The passive VAERS reporting system thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink.

That investigation also found no link between MCV4 and increased risk of GBS.

On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population.

Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of postvaccine GBS.

Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.

Major Finding: Allopurinol in patients with angina pectoris improved time to ST depression from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively, for an absolute improvement of 43 seconds (19%).

Data Source: A randomized, placebo-controlled, double-blinded, crossover study of 65 patients.

Disclosures: The study was funded by the British Heart Foundation. The University of Dundee and one of the study authors have applied for a patent for the use of xanthine oxidase inhibitors to treat anginal chest pain. Dr. Noman and the other authors declared no conflicts of interest. Dr. Antony and Dr. Dargie indicated that they have no financial conflicts.

High-dose allopurinol, a safe and inexpensive xanthine oxidase inhibitor used for decades for the treatment of gout, also appears to be an effective anti-ischemic drug in patients with angina pectoris, according to findings from a randomized, placebo-controlled study.

In 65 patients in the double-blind crossover study, allopurinol was shown during a standard exercise test to significantly improve median overall time to ST depression—the primary end point of the study—by a point estimate (the absolute difference between allopurinol and placebo) of 43 seconds, for a 19% improvement. It also significantly improved median exercise time and time to chest pain by point estimates of 58 and 38 seconds, respectively, Dr. Awsan Noman of the University of Dundee, Scotland, and colleagues reported online June 8 in The Lancet.

Time to ST depression improved from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively; total exercise time improved from 301 seconds at baseline to 307 seconds and 393 seconds in the two groups, respectively; and time to symptoms improved from 234 seconds at baseline to 272 seconds and 304 seconds in the two groups, respectively, the investigators reported (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60391-1]).

The patients were aged 18-85 years and had angiographically documented coronary artery disease, a positive exercise tolerance test, and stable chronic angina pectoris for at least 2 months prior to enrollment. They were randomized to receive allopurinol daily or placebo for 6 weeks. Allopurinol in the first phase of the study was given at a dose of 100 mg once daily in the first week, 300 mg once daily in the second week, and 300 mg twice daily in weeks 3-6; the 600-mg daily dose was used in the crossover phase, which immediately followed the first phase, because it was shown to be the most effective dose for improving endothelial function and oxidative stress, they said.

The findings suggest that “endogenous xanthine oxidase activity contributes somehow to exercise-induced myocardial ischaemia,” the investigators wrote, adding that the magnitude of the anti-ischemic effect of allopurinol in this study appeared similar to that seen with other antianginal drugs.

“Allopurinol might now be regarded as a potential drug for angina,” the investigators wrote, citing numerous advantages over other available antianginal drugs, including lower cost, a favorable long-term safety record over more than 40 years of use in gout patients, and better tolerability; allopurinol does not reduce blood pressure or heart rate, and does not cause side effects such as headache and tiredness common with nitrates and beta-blockers, they noted.

Further study is needed to better characterize the “the precise place of allopurinol in the management of angina pectoris,” but it may be a particularly appealing drug for use in developing countries where the availability of more expensive treatments is limited, they concluded.

Stable angina is the most frequent initial presentation of coronary heart disease; the condition can lead to acute coronary syndrome, particularly in higher risk groups; and it also has high rates of residual symptoms and impaired quality of life even in well-managed patients.

Nonetheless, the condition has received little attention, compared with unstable angina and other acute coronary syndromes, Dr. Renjith Antony and Dr. Henry J. Dargie of the Scottish Advanced Heart Failure Service, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, said in an editorial.

The report by Dr. Noman and colleagues is interesting and welcome in that it will “focus attention on the unmet needs of patients with the most common, and frequently troublesome, manifestation of coronary heart disease,” they wrote (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60578-8]).

Allopurinol significantly improved median overall time to ST depression, the study's primary end point.

Source DR. NOMAN

Major Finding: Allopurinol in patients with angina pectoris improved time to ST depression from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively, for an absolute improvement of 43 seconds (19%).

Data Source: A randomized, placebo-controlled, double-blinded, crossover study of 65 patients.

Disclosures: The study was funded by the British Heart Foundation. The University of Dundee and one of the study authors have applied for a patent for the use of xanthine oxidase inhibitors to treat anginal chest pain. Dr. Noman and the other authors declared no conflicts of interest. Dr. Antony and Dr. Dargie indicated that they have no financial conflicts.

High-dose allopurinol, a safe and inexpensive xanthine oxidase inhibitor used for decades for the treatment of gout, also appears to be an effective anti-ischemic drug in patients with angina pectoris, according to findings from a randomized, placebo-controlled study.

In 65 patients in the double-blind crossover study, allopurinol was shown during a standard exercise test to significantly improve median overall time to ST depression—the primary end point of the study—by a point estimate (the absolute difference between allopurinol and placebo) of 43 seconds, for a 19% improvement. It also significantly improved median exercise time and time to chest pain by point estimates of 58 and 38 seconds, respectively, Dr. Awsan Noman of the University of Dundee, Scotland, and colleagues reported online June 8 in The Lancet.

Time to ST depression improved from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively; total exercise time improved from 301 seconds at baseline to 307 seconds and 393 seconds in the two groups, respectively; and time to symptoms improved from 234 seconds at baseline to 272 seconds and 304 seconds in the two groups, respectively, the investigators reported (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60391-1]).

The patients were aged 18-85 years and had angiographically documented coronary artery disease, a positive exercise tolerance test, and stable chronic angina pectoris for at least 2 months prior to enrollment. They were randomized to receive allopurinol daily or placebo for 6 weeks. Allopurinol in the first phase of the study was given at a dose of 100 mg once daily in the first week, 300 mg once daily in the second week, and 300 mg twice daily in weeks 3-6; the 600-mg daily dose was used in the crossover phase, which immediately followed the first phase, because it was shown to be the most effective dose for improving endothelial function and oxidative stress, they said.

The findings suggest that “endogenous xanthine oxidase activity contributes somehow to exercise-induced myocardial ischaemia,” the investigators wrote, adding that the magnitude of the anti-ischemic effect of allopurinol in this study appeared similar to that seen with other antianginal drugs.

“Allopurinol might now be regarded as a potential drug for angina,” the investigators wrote, citing numerous advantages over other available antianginal drugs, including lower cost, a favorable long-term safety record over more than 40 years of use in gout patients, and better tolerability; allopurinol does not reduce blood pressure or heart rate, and does not cause side effects such as headache and tiredness common with nitrates and beta-blockers, they noted.

Further study is needed to better characterize the “the precise place of allopurinol in the management of angina pectoris,” but it may be a particularly appealing drug for use in developing countries where the availability of more expensive treatments is limited, they concluded.

Stable angina is the most frequent initial presentation of coronary heart disease; the condition can lead to acute coronary syndrome, particularly in higher risk groups; and it also has high rates of residual symptoms and impaired quality of life even in well-managed patients.

Nonetheless, the condition has received little attention, compared with unstable angina and other acute coronary syndromes, Dr. Renjith Antony and Dr. Henry J. Dargie of the Scottish Advanced Heart Failure Service, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, said in an editorial.

The report by Dr. Noman and colleagues is interesting and welcome in that it will “focus attention on the unmet needs of patients with the most common, and frequently troublesome, manifestation of coronary heart disease,” they wrote (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60578-8]).

Allopurinol significantly improved median overall time to ST depression, the study's primary end point.

Source DR. NOMAN

Major Finding: Allopurinol in patients with angina pectoris improved time to ST depression from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively, for an absolute improvement of 43 seconds (19%).

Data Source: A randomized, placebo-controlled, double-blinded, crossover study of 65 patients.

Disclosures: The study was funded by the British Heart Foundation. The University of Dundee and one of the study authors have applied for a patent for the use of xanthine oxidase inhibitors to treat anginal chest pain. Dr. Noman and the other authors declared no conflicts of interest. Dr. Antony and Dr. Dargie indicated that they have no financial conflicts.

High-dose allopurinol, a safe and inexpensive xanthine oxidase inhibitor used for decades for the treatment of gout, also appears to be an effective anti-ischemic drug in patients with angina pectoris, according to findings from a randomized, placebo-controlled study.

In 65 patients in the double-blind crossover study, allopurinol was shown during a standard exercise test to significantly improve median overall time to ST depression—the primary end point of the study—by a point estimate (the absolute difference between allopurinol and placebo) of 43 seconds, for a 19% improvement. It also significantly improved median exercise time and time to chest pain by point estimates of 58 and 38 seconds, respectively, Dr. Awsan Noman of the University of Dundee, Scotland, and colleagues reported online June 8 in The Lancet.

Time to ST depression improved from 232 seconds at baseline to 249 seconds and 298 seconds in the placebo and treatment groups, respectively; total exercise time improved from 301 seconds at baseline to 307 seconds and 393 seconds in the two groups, respectively; and time to symptoms improved from 234 seconds at baseline to 272 seconds and 304 seconds in the two groups, respectively, the investigators reported (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60391-1]).

The patients were aged 18-85 years and had angiographically documented coronary artery disease, a positive exercise tolerance test, and stable chronic angina pectoris for at least 2 months prior to enrollment. They were randomized to receive allopurinol daily or placebo for 6 weeks. Allopurinol in the first phase of the study was given at a dose of 100 mg once daily in the first week, 300 mg once daily in the second week, and 300 mg twice daily in weeks 3-6; the 600-mg daily dose was used in the crossover phase, which immediately followed the first phase, because it was shown to be the most effective dose for improving endothelial function and oxidative stress, they said.

The findings suggest that “endogenous xanthine oxidase activity contributes somehow to exercise-induced myocardial ischaemia,” the investigators wrote, adding that the magnitude of the anti-ischemic effect of allopurinol in this study appeared similar to that seen with other antianginal drugs.

“Allopurinol might now be regarded as a potential drug for angina,” the investigators wrote, citing numerous advantages over other available antianginal drugs, including lower cost, a favorable long-term safety record over more than 40 years of use in gout patients, and better tolerability; allopurinol does not reduce blood pressure or heart rate, and does not cause side effects such as headache and tiredness common with nitrates and beta-blockers, they noted.

Further study is needed to better characterize the “the precise place of allopurinol in the management of angina pectoris,” but it may be a particularly appealing drug for use in developing countries where the availability of more expensive treatments is limited, they concluded.

Stable angina is the most frequent initial presentation of coronary heart disease; the condition can lead to acute coronary syndrome, particularly in higher risk groups; and it also has high rates of residual symptoms and impaired quality of life even in well-managed patients.

Nonetheless, the condition has received little attention, compared with unstable angina and other acute coronary syndromes, Dr. Renjith Antony and Dr. Henry J. Dargie of the Scottish Advanced Heart Failure Service, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, said in an editorial.

The report by Dr. Noman and colleagues is interesting and welcome in that it will “focus attention on the unmet needs of patients with the most common, and frequently troublesome, manifestation of coronary heart disease,” they wrote (Lancet 2010 June 8 [doi:10.1016/S0140-6736(10)60578-8]).

Allopurinol significantly improved median overall time to ST depression, the study's primary end point.

Source DR. NOMAN

ATLANTA — Adults with diabetes are more likely than those without the disease to be infected with the hepatitis B virus, according to unpublished data from the Centers for Disease Control and Prevention.

The finding, along with other data suggesting that the problem may be associated with a lack of proper infection control at many health care facilities, prompted a new proposal from the Hepatitis Working Group of the CDC's Advisory Committee on Immunization Practices (ACIP) that all adults with diabetes receive hepatitis B vaccination.

The working group, which introduced the proposed policy changes at a June meeting, plans to present the proposals for a vote at the committee's next meeting in October, said Dr. Mark Sawyer, chair of the working group.

Specifically, in light of increasing evidence of heightened risk in the diabetic population, the group will recommend that all unvaccinated adults with diabetes complete the vaccination series as soon as feasible after diagnosis, and that those age 60 years and older undergo postvaccination serology for antibody to hepatitis B surface antigen 1-2 months after completion of the vaccination series.

Those who fail to achieve a seroprotective level of 10 mIU/mL anti-HBs would receive three additional doses of hepatitis B vaccine and repeat postvaccination serology under the working group's proposed policy.

The proposals were developed in light of the CDC data from the 1999-2008 National Health and Nutrition Examination Surveys (NHANES), which showed that overall prevalence of hepatitis B among adults older than 18 years of age with diabetes is 8.3%, compared with 5.2% in those without diabetes, Dr. Dale Hu reported at the meeting.

The odds ratio and prevalence ratio for hepatitis B in diabetic patients based on those survey data were 1.66 and 1.61, respectively, said Dr. Hu of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

In one CDC investigation of 13 outbreaks involving serosurveys of 1,278 patients, 30.5% of 338 diabetic patients vs. 1.0% of 940 nondiabetic patients had acute infection, and 6.3% vs. 0.4% of the groups, respectively, had chronic infection, Dr. Hu said.

Numerous reports of outbreaks of hepatitis B infection in diabetic patients suggest that poor infection control practices involving the use of glucose meters may play a role in the increased risk in this population. For example, a study published earlier this year showed that 46 of 68 (68%) ambulatory care centers had at least one lapse in infection control, and that 21% of the 68 centers used single-use lancing penlets for blood glucose monitoring in multiple patients; 32% failed to clean and disinfect glucose meters after each use (JAMA 2010;303:2273-9).

The working group is recommending a similar vaccination program to that used for healthcare workers.

“Hepatitis B vaccine, coupled with universal precautions and increased infection control, has been very effective in reducing the prevalence and incidence among health care personnel, and has the potential to do the same among adults with diabetes,” Dr. Hu said.

The working group is planning a cost-effectiveness analysis to be presented to ACIP in October in regard to their recommendations, along with proposals for implementing the policies, said Dr. Sawyer, professor of clinical pediatrics in the division of pediatric infectious disease, University of California, San Diego.

ACIP members who commented on the proposals generally agreed with the working group regarding the need for vaccination of adults with diabetes.

Dr. Sawyer said he had no conflicts of interest.

ATLANTA — Adults with diabetes are more likely than those without the disease to be infected with the hepatitis B virus, according to unpublished data from the Centers for Disease Control and Prevention.

The finding, along with other data suggesting that the problem may be associated with a lack of proper infection control at many health care facilities, prompted a new proposal from the Hepatitis Working Group of the CDC's Advisory Committee on Immunization Practices (ACIP) that all adults with diabetes receive hepatitis B vaccination.

The working group, which introduced the proposed policy changes at a June meeting, plans to present the proposals for a vote at the committee's next meeting in October, said Dr. Mark Sawyer, chair of the working group.

Specifically, in light of increasing evidence of heightened risk in the diabetic population, the group will recommend that all unvaccinated adults with diabetes complete the vaccination series as soon as feasible after diagnosis, and that those age 60 years and older undergo postvaccination serology for antibody to hepatitis B surface antigen 1-2 months after completion of the vaccination series.

Those who fail to achieve a seroprotective level of 10 mIU/mL anti-HBs would receive three additional doses of hepatitis B vaccine and repeat postvaccination serology under the working group's proposed policy.

The proposals were developed in light of the CDC data from the 1999-2008 National Health and Nutrition Examination Surveys (NHANES), which showed that overall prevalence of hepatitis B among adults older than 18 years of age with diabetes is 8.3%, compared with 5.2% in those without diabetes, Dr. Dale Hu reported at the meeting.

The odds ratio and prevalence ratio for hepatitis B in diabetic patients based on those survey data were 1.66 and 1.61, respectively, said Dr. Hu of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

In one CDC investigation of 13 outbreaks involving serosurveys of 1,278 patients, 30.5% of 338 diabetic patients vs. 1.0% of 940 nondiabetic patients had acute infection, and 6.3% vs. 0.4% of the groups, respectively, had chronic infection, Dr. Hu said.

Numerous reports of outbreaks of hepatitis B infection in diabetic patients suggest that poor infection control practices involving the use of glucose meters may play a role in the increased risk in this population. For example, a study published earlier this year showed that 46 of 68 (68%) ambulatory care centers had at least one lapse in infection control, and that 21% of the 68 centers used single-use lancing penlets for blood glucose monitoring in multiple patients; 32% failed to clean and disinfect glucose meters after each use (JAMA 2010;303:2273-9).

The working group is recommending a similar vaccination program to that used for healthcare workers.

“Hepatitis B vaccine, coupled with universal precautions and increased infection control, has been very effective in reducing the prevalence and incidence among health care personnel, and has the potential to do the same among adults with diabetes,” Dr. Hu said.

The working group is planning a cost-effectiveness analysis to be presented to ACIP in October in regard to their recommendations, along with proposals for implementing the policies, said Dr. Sawyer, professor of clinical pediatrics in the division of pediatric infectious disease, University of California, San Diego.

ACIP members who commented on the proposals generally agreed with the working group regarding the need for vaccination of adults with diabetes.

Dr. Sawyer said he had no conflicts of interest.

ATLANTA — Adults with diabetes are more likely than those without the disease to be infected with the hepatitis B virus, according to unpublished data from the Centers for Disease Control and Prevention.

The finding, along with other data suggesting that the problem may be associated with a lack of proper infection control at many health care facilities, prompted a new proposal from the Hepatitis Working Group of the CDC's Advisory Committee on Immunization Practices (ACIP) that all adults with diabetes receive hepatitis B vaccination.

The working group, which introduced the proposed policy changes at a June meeting, plans to present the proposals for a vote at the committee's next meeting in October, said Dr. Mark Sawyer, chair of the working group.

Specifically, in light of increasing evidence of heightened risk in the diabetic population, the group will recommend that all unvaccinated adults with diabetes complete the vaccination series as soon as feasible after diagnosis, and that those age 60 years and older undergo postvaccination serology for antibody to hepatitis B surface antigen 1-2 months after completion of the vaccination series.

Those who fail to achieve a seroprotective level of 10 mIU/mL anti-HBs would receive three additional doses of hepatitis B vaccine and repeat postvaccination serology under the working group's proposed policy.

The proposals were developed in light of the CDC data from the 1999-2008 National Health and Nutrition Examination Surveys (NHANES), which showed that overall prevalence of hepatitis B among adults older than 18 years of age with diabetes is 8.3%, compared with 5.2% in those without diabetes, Dr. Dale Hu reported at the meeting.

The odds ratio and prevalence ratio for hepatitis B in diabetic patients based on those survey data were 1.66 and 1.61, respectively, said Dr. Hu of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

In one CDC investigation of 13 outbreaks involving serosurveys of 1,278 patients, 30.5% of 338 diabetic patients vs. 1.0% of 940 nondiabetic patients had acute infection, and 6.3% vs. 0.4% of the groups, respectively, had chronic infection, Dr. Hu said.

Numerous reports of outbreaks of hepatitis B infection in diabetic patients suggest that poor infection control practices involving the use of glucose meters may play a role in the increased risk in this population. For example, a study published earlier this year showed that 46 of 68 (68%) ambulatory care centers had at least one lapse in infection control, and that 21% of the 68 centers used single-use lancing penlets for blood glucose monitoring in multiple patients; 32% failed to clean and disinfect glucose meters after each use (JAMA 2010;303:2273-9).

The working group is recommending a similar vaccination program to that used for healthcare workers.

“Hepatitis B vaccine, coupled with universal precautions and increased infection control, has been very effective in reducing the prevalence and incidence among health care personnel, and has the potential to do the same among adults with diabetes,” Dr. Hu said.

The working group is planning a cost-effectiveness analysis to be presented to ACIP in October in regard to their recommendations, along with proposals for implementing the policies, said Dr. Sawyer, professor of clinical pediatrics in the division of pediatric infectious disease, University of California, San Diego.

ACIP members who commented on the proposals generally agreed with the working group regarding the need for vaccination of adults with diabetes.

Dr. Sawyer said he had no conflicts of interest.

MIAMI — The use of complementary and alternative medicine is increasing among patients with self-reported skin disease, and patients are also discussing this use more with their physicians, supplementary data from the 2007 National Health Interview Survey indicate.

Data from the survey of nearly 23,400 adults showed that of 2,374 respondents with a skin disorder, 85% reported complementary and alternative medicine (CAM) use in the past year. When vitamin and mineral supplements were excluded, 58% reported CAM use in the past year, up from 49% in a nearly identical survey in 2002, Dr. Nana Smith reported at the meeting.

In the 2007 survey, 52% of respondents said they discuss their CAM use with their physician, compared with just 16% in 2002, said Dr. Smith, a dermatology resident at the University of Rochester (N.Y.).

Patients with skin diseases in the recent survey were significantly more likely to use CAM than were those without skin diseases (odds ratio 2.5), Dr. Smith said.

However, only about 1% of those with skin diseases said they used CAM specifically for their dermatologic condition. Most said they use CAM for general wellness, Dr. Smith noted.

Disclosures: The authors declared no conflicts of interest related to this study.

MIAMI — The use of complementary and alternative medicine is increasing among patients with self-reported skin disease, and patients are also discussing this use more with their physicians, supplementary data from the 2007 National Health Interview Survey indicate.

Data from the survey of nearly 23,400 adults showed that of 2,374 respondents with a skin disorder, 85% reported complementary and alternative medicine (CAM) use in the past year. When vitamin and mineral supplements were excluded, 58% reported CAM use in the past year, up from 49% in a nearly identical survey in 2002, Dr. Nana Smith reported at the meeting.

In the 2007 survey, 52% of respondents said they discuss their CAM use with their physician, compared with just 16% in 2002, said Dr. Smith, a dermatology resident at the University of Rochester (N.Y.).

Patients with skin diseases in the recent survey were significantly more likely to use CAM than were those without skin diseases (odds ratio 2.5), Dr. Smith said.

However, only about 1% of those with skin diseases said they used CAM specifically for their dermatologic condition. Most said they use CAM for general wellness, Dr. Smith noted.

Disclosures: The authors declared no conflicts of interest related to this study.

MIAMI — The use of complementary and alternative medicine is increasing among patients with self-reported skin disease, and patients are also discussing this use more with their physicians, supplementary data from the 2007 National Health Interview Survey indicate.

Data from the survey of nearly 23,400 adults showed that of 2,374 respondents with a skin disorder, 85% reported complementary and alternative medicine (CAM) use in the past year. When vitamin and mineral supplements were excluded, 58% reported CAM use in the past year, up from 49% in a nearly identical survey in 2002, Dr. Nana Smith reported at the meeting.

In the 2007 survey, 52% of respondents said they discuss their CAM use with their physician, compared with just 16% in 2002, said Dr. Smith, a dermatology resident at the University of Rochester (N.Y.).

Patients with skin diseases in the recent survey were significantly more likely to use CAM than were those without skin diseases (odds ratio 2.5), Dr. Smith said.

However, only about 1% of those with skin diseases said they used CAM specifically for their dermatologic condition. Most said they use CAM for general wellness, Dr. Smith noted.

Disclosures: The authors declared no conflicts of interest related to this study.

A novel technique that combines subcision and suction proved safe and effective for promoting significant and lasting improvement of mild to severe depressed facial scars in a study of 58 patients.

In 46 patients who strictly followed the study protocol of subcision followed by frequent suctioning at the time of postsubcision depression recurrence, the depth and size of scars decreased significantly by a mean of nearly 72% at 6-month follow-up, according to assessment by two investigators, and by 75% according to patient assessment.

An improvement of at least 80% occurred in about 28% of patients, according to investigator assessment, and in 42%, according to patient assessment, Dr. S. Aalami Harandi of the Parsian Laser Clinic, Bandar Abbas, Iran, and colleagues reported online in the June 9 issue of the Journal of the European Academy of Dermatology and Venereology.

Mean improvement at 6 months in 12 patients who started suction late or had long intervals between suction sessions was 44% by investigator assessment and 49% by patient assessment, the investigators reported (J. Eur. Acad. Dermatol. Venereol. 2010 June 9 [doi:10.1111/ j.1468-3083.2010.03711.x]).

The study participants - 34 women and 24 men aged 16-44 years - had depressed acne scars of various types, including rolling, superficial boxcar, deep boxcar, and pitted, as well as scars from chicken pox, trauma, and surgery. Superficial dermal undermining was performed on 1-70 scars per patient using mainly 23-gauge needles. Suctioning was initiated on the third day following subcision, and was performed at least every other day for 2 weeks, per protocol.

The best results (80% or better improvement) were seen in 24 of the 46 patients on protocol who had the most frequent suctioning (almost daily versus every other day interval in the first week of suction period), the investigators noted.

Although subcision is a safe, valuable, and practical method in itself, it has only mild to moderate efficacy because of the frequency of depression recurrence. In the investigators' experience, recurrence with subcision alone generally starts 2-5 days after subcision, with rapid progression of re-depression for up to 10 days, and gradual progression of re-depression for about 1 week more; therefore, the protocol for this study involved repeated suctioning at the recurrence period.

The addition of suctioning, which prevents redepression by "induction of repeated haemorrhage in dermal pocket, delay in healing, and more new connective tissue formation at the scar area," appears to improve the efficacy of subcision alone.

The combined subcision and suction treatment in this study was associated with "significant" (greater than 60% improvement) and "excellent" (80% improvement or greater) efficacy, the investigators said.

Bruising occurred in all cases, but resolved within 12 days, and any discoloration that occurred resolved within 2 months; hypertrophic scarring occurred in 1.7% of treated scars (22 scars in six patients), which was mostly due to sub-epidermal like undermining( technical error), and was managed successfully in all cases; and hemorrhagic papules and pustules occurred in 5.6% of subcised scars, and were treated successfully with drainage and topical antibiotics or steroids.

Advantages of the subcision-suction method include ease of application, low cost, short down-time, applicability for various skin types (most had type III in this study), applicability for various scar types, lack of significant complications, and "remarkable and persistent improvement in short time without injury to the skin surface," the investigators reported.

"It seems that this method has the potential to be used as the first step for acne and other depressed scars management," they wrote, adding that since multistep treatment is necessary for optimal correction of acne scars, treatment may involve the use of other techniques or repeat subcision-suction after several months.

Further study of this technique is warranted, particularly given the prevalence of the problem of depressed scars of the face, they noted.

The investigators had no conflicts of interest to declare.

A novel technique that combines subcision and suction proved safe and effective for promoting significant and lasting improvement of mild to severe depressed facial scars in a study of 58 patients.

In 46 patients who strictly followed the study protocol of subcision followed by frequent suctioning at the time of postsubcision depression recurrence, the depth and size of scars decreased significantly by a mean of nearly 72% at 6-month follow-up, according to assessment by two investigators, and by 75% according to patient assessment.

An improvement of at least 80% occurred in about 28% of patients, according to investigator assessment, and in 42%, according to patient assessment, Dr. S. Aalami Harandi of the Parsian Laser Clinic, Bandar Abbas, Iran, and colleagues reported online in the June 9 issue of the Journal of the European Academy of Dermatology and Venereology.

Mean improvement at 6 months in 12 patients who started suction late or had long intervals between suction sessions was 44% by investigator assessment and 49% by patient assessment, the investigators reported (J. Eur. Acad. Dermatol. Venereol. 2010 June 9 [doi:10.1111/ j.1468-3083.2010.03711.x]).

The study participants - 34 women and 24 men aged 16-44 years - had depressed acne scars of various types, including rolling, superficial boxcar, deep boxcar, and pitted, as well as scars from chicken pox, trauma, and surgery. Superficial dermal undermining was performed on 1-70 scars per patient using mainly 23-gauge needles. Suctioning was initiated on the third day following subcision, and was performed at least every other day for 2 weeks, per protocol.

The best results (80% or better improvement) were seen in 24 of the 46 patients on protocol who had the most frequent suctioning (almost daily versus every other day interval in the first week of suction period), the investigators noted.

Although subcision is a safe, valuable, and practical method in itself, it has only mild to moderate efficacy because of the frequency of depression recurrence. In the investigators' experience, recurrence with subcision alone generally starts 2-5 days after subcision, with rapid progression of re-depression for up to 10 days, and gradual progression of re-depression for about 1 week more; therefore, the protocol for this study involved repeated suctioning at the recurrence period.

The addition of suctioning, which prevents redepression by "induction of repeated haemorrhage in dermal pocket, delay in healing, and more new connective tissue formation at the scar area," appears to improve the efficacy of subcision alone.

The combined subcision and suction treatment in this study was associated with "significant" (greater than 60% improvement) and "excellent" (80% improvement or greater) efficacy, the investigators said.

Bruising occurred in all cases, but resolved within 12 days, and any discoloration that occurred resolved within 2 months; hypertrophic scarring occurred in 1.7% of treated scars (22 scars in six patients), which was mostly due to sub-epidermal like undermining( technical error), and was managed successfully in all cases; and hemorrhagic papules and pustules occurred in 5.6% of subcised scars, and were treated successfully with drainage and topical antibiotics or steroids.

Advantages of the subcision-suction method include ease of application, low cost, short down-time, applicability for various skin types (most had type III in this study), applicability for various scar types, lack of significant complications, and "remarkable and persistent improvement in short time without injury to the skin surface," the investigators reported.

"It seems that this method has the potential to be used as the first step for acne and other depressed scars management," they wrote, adding that since multistep treatment is necessary for optimal correction of acne scars, treatment may involve the use of other techniques or repeat subcision-suction after several months.

Further study of this technique is warranted, particularly given the prevalence of the problem of depressed scars of the face, they noted.

The investigators had no conflicts of interest to declare.

A novel technique that combines subcision and suction proved safe and effective for promoting significant and lasting improvement of mild to severe depressed facial scars in a study of 58 patients.

In 46 patients who strictly followed the study protocol of subcision followed by frequent suctioning at the time of postsubcision depression recurrence, the depth and size of scars decreased significantly by a mean of nearly 72% at 6-month follow-up, according to assessment by two investigators, and by 75% according to patient assessment.

An improvement of at least 80% occurred in about 28% of patients, according to investigator assessment, and in 42%, according to patient assessment, Dr. S. Aalami Harandi of the Parsian Laser Clinic, Bandar Abbas, Iran, and colleagues reported online in the June 9 issue of the Journal of the European Academy of Dermatology and Venereology.

Mean improvement at 6 months in 12 patients who started suction late or had long intervals between suction sessions was 44% by investigator assessment and 49% by patient assessment, the investigators reported (J. Eur. Acad. Dermatol. Venereol. 2010 June 9 [doi:10.1111/ j.1468-3083.2010.03711.x]).

The study participants - 34 women and 24 men aged 16-44 years - had depressed acne scars of various types, including rolling, superficial boxcar, deep boxcar, and pitted, as well as scars from chicken pox, trauma, and surgery. Superficial dermal undermining was performed on 1-70 scars per patient using mainly 23-gauge needles. Suctioning was initiated on the third day following subcision, and was performed at least every other day for 2 weeks, per protocol.

The best results (80% or better improvement) were seen in 24 of the 46 patients on protocol who had the most frequent suctioning (almost daily versus every other day interval in the first week of suction period), the investigators noted.

Although subcision is a safe, valuable, and practical method in itself, it has only mild to moderate efficacy because of the frequency of depression recurrence. In the investigators' experience, recurrence with subcision alone generally starts 2-5 days after subcision, with rapid progression of re-depression for up to 10 days, and gradual progression of re-depression for about 1 week more; therefore, the protocol for this study involved repeated suctioning at the recurrence period.

The addition of suctioning, which prevents redepression by "induction of repeated haemorrhage in dermal pocket, delay in healing, and more new connective tissue formation at the scar area," appears to improve the efficacy of subcision alone.

The combined subcision and suction treatment in this study was associated with "significant" (greater than 60% improvement) and "excellent" (80% improvement or greater) efficacy, the investigators said.

Bruising occurred in all cases, but resolved within 12 days, and any discoloration that occurred resolved within 2 months; hypertrophic scarring occurred in 1.7% of treated scars (22 scars in six patients), which was mostly due to sub-epidermal like undermining( technical error), and was managed successfully in all cases; and hemorrhagic papules and pustules occurred in 5.6% of subcised scars, and were treated successfully with drainage and topical antibiotics or steroids.

Advantages of the subcision-suction method include ease of application, low cost, short down-time, applicability for various skin types (most had type III in this study), applicability for various scar types, lack of significant complications, and "remarkable and persistent improvement in short time without injury to the skin surface," the investigators reported.

"It seems that this method has the potential to be used as the first step for acne and other depressed scars management," they wrote, adding that since multistep treatment is necessary for optimal correction of acne scars, treatment may involve the use of other techniques or repeat subcision-suction after several months.

Further study of this technique is warranted, particularly given the prevalence of the problem of depressed scars of the face, they noted.

The investigators had no conflicts of interest to declare.