Heidi Splete

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

Major Finding: After the intervention, the residents showed significant improvements on 16 of 18 areas.

Data Source: A survey of 24 second-year pediatric medical residents after a 1-day workshop on resuscitation techniques.

Disclosures: None was reported.

WASHINGTON — A 1-day workshop on resuscitation techniques significantly improved the skills and comfort levels of second-year pediatric medical residents, based on a survey of 24 residents who completed the program.

“Many pediatric residents do not have the opportunity to practice the skills required during resuscitation,” said Dr. Margarita Lorch of Children's National Medical Center in Washington.

The 8-hour program included 4 hours of didactic lectures, six skills stations, and two mock Code Blue drills using high-fidelity simulation. The residents' comfort levels were assessed before and after the intervention using a 5-point Likert scale, ranging from 1 (very uncomfortable) to 5 (very comfortable). The study findings were presented in a poster.

After the intervention, the residents showed significant improvements on 16 of 18 areas. Significant improvements were seen in calling and leading a Code Blue (with median Likert score increases from 3 to 4 and 2 to 3, respectively). In addition, significant improvements were seen in both performing and teaching peripheral intravenous techniques, central line placement, inserting an intraosseous needle, bag-valve mask ventilation, endotracheal intubation, and chest needle decompression.

The residents' median comfort level scores for determining whether a child was ill and for telling a senior or attending physician if they were uncomfortable with a resuscitative procedure remained the same before and after the educational program.

The program has been replicated at other institutions, Dr. Lorch said in an interview. Despite this study's small size, the results suggest that a hands-on review of procedures, along with mock code simulations, can fill a gap in the education of pediatric residents that improves patient care and the residents' teaching abilities.

“We're using real-life models, so that they can get a feel for the actual procedure,” she said. “It allows them more confidence, so if they were to come across this [resuscitation] situation in real life, they know that they have managed it before.”

Major Finding: After the intervention, the residents showed significant improvements on 16 of 18 areas.

Data Source: A survey of 24 second-year pediatric medical residents after a 1-day workshop on resuscitation techniques.

Disclosures: None was reported.

WASHINGTON — A 1-day workshop on resuscitation techniques significantly improved the skills and comfort levels of second-year pediatric medical residents, based on a survey of 24 residents who completed the program.

“Many pediatric residents do not have the opportunity to practice the skills required during resuscitation,” said Dr. Margarita Lorch of Children's National Medical Center in Washington.

The 8-hour program included 4 hours of didactic lectures, six skills stations, and two mock Code Blue drills using high-fidelity simulation. The residents' comfort levels were assessed before and after the intervention using a 5-point Likert scale, ranging from 1 (very uncomfortable) to 5 (very comfortable). The study findings were presented in a poster.

After the intervention, the residents showed significant improvements on 16 of 18 areas. Significant improvements were seen in calling and leading a Code Blue (with median Likert score increases from 3 to 4 and 2 to 3, respectively). In addition, significant improvements were seen in both performing and teaching peripheral intravenous techniques, central line placement, inserting an intraosseous needle, bag-valve mask ventilation, endotracheal intubation, and chest needle decompression.

The residents' median comfort level scores for determining whether a child was ill and for telling a senior or attending physician if they were uncomfortable with a resuscitative procedure remained the same before and after the educational program.

The program has been replicated at other institutions, Dr. Lorch said in an interview. Despite this study's small size, the results suggest that a hands-on review of procedures, along with mock code simulations, can fill a gap in the education of pediatric residents that improves patient care and the residents' teaching abilities.

“We're using real-life models, so that they can get a feel for the actual procedure,” she said. “It allows them more confidence, so if they were to come across this [resuscitation] situation in real life, they know that they have managed it before.”

Major Finding: After the intervention, the residents showed significant improvements on 16 of 18 areas.

Data Source: A survey of 24 second-year pediatric medical residents after a 1-day workshop on resuscitation techniques.

Disclosures: None was reported.

WASHINGTON — A 1-day workshop on resuscitation techniques significantly improved the skills and comfort levels of second-year pediatric medical residents, based on a survey of 24 residents who completed the program.

“Many pediatric residents do not have the opportunity to practice the skills required during resuscitation,” said Dr. Margarita Lorch of Children's National Medical Center in Washington.

The 8-hour program included 4 hours of didactic lectures, six skills stations, and two mock Code Blue drills using high-fidelity simulation. The residents' comfort levels were assessed before and after the intervention using a 5-point Likert scale, ranging from 1 (very uncomfortable) to 5 (very comfortable). The study findings were presented in a poster.

After the intervention, the residents showed significant improvements on 16 of 18 areas. Significant improvements were seen in calling and leading a Code Blue (with median Likert score increases from 3 to 4 and 2 to 3, respectively). In addition, significant improvements were seen in both performing and teaching peripheral intravenous techniques, central line placement, inserting an intraosseous needle, bag-valve mask ventilation, endotracheal intubation, and chest needle decompression.

The residents' median comfort level scores for determining whether a child was ill and for telling a senior or attending physician if they were uncomfortable with a resuscitative procedure remained the same before and after the educational program.

The program has been replicated at other institutions, Dr. Lorch said in an interview. Despite this study's small size, the results suggest that a hands-on review of procedures, along with mock code simulations, can fill a gap in the education of pediatric residents that improves patient care and the residents' teaching abilities.

“We're using real-life models, so that they can get a feel for the actual procedure,” she said. “It allows them more confidence, so if they were to come across this [resuscitation] situation in real life, they know that they have managed it before.”

Major Finding: A disposable sheath took significantly less time to use than a germicidal solution (89 seconds vs. 14 minutes), and was as effective in decontaminating flexible endoscopes.

Data Source: A randomized, controlled trial including 100 fiberoptic nasopharyngolaryngoscopes.

Disclosures: The researchers had no financial conflicts to disclose.

ORLANDO — Sterile, disposable sheaths for flexible endoscopes are as effective as germicidal solutions in preventing cross-contamination, and they take less time to use, according to the results of a randomized, controlled trial that included 100 fiberoptic nasopharyngolaryngoscopes.

Cross-contamination from flexible endoscopes remains a problem, highlighted by a recent outbreak in the Veterans Administration health system last year, said Dr. Alphi P. Elackattu, a resident in otolaryngology–head and neck surgery at Boston University. In that outbreak, about 10,000 patients were exposed to cross-contamination due to mechanical failure or human error, he explained at the meeting.

Dr. Elackattu and his colleagues hypothesized that using individually packaged sterile sheaths for flexible endoscopes would cut down on cross-contamination.

In their study, they collected baseline cultures from several sites on each of 100 fiberoptic nasopharyngolaryngoscopes (FNPLs). After use, the FNPLs were randomized to either the sheath protocol or the standard disinfection protocol of immersion in germicidal solution.

The product used in the study was the Slide-On EndoSheath from Medtronic Inc., but Medtronic was not involved in the study.

The researchers noted that the average time spent on the process of disinfection was significantly shorter when using the sheath than it was when using the germicidal solution (89 seconds vs. 14 minutes).

After a single use and disinfection protocol, there were no significant differences in the presence of organisms on the FNPLs in the sheath group, compared with the germicidal solution group.

Subjective observations by staff members suggested that germicidal immersion might actually increase the risk of cross-contamination involving FNPLs because it is more complicated to perform than using a disposable sheath, Dr. Elackattu noted.

In addition, patients might feel more secure and comfortable when they see that a disposable sheath is being used on the nasopharyngolaryngoscope, he said.

More research is needed to assess the value of using a disposable sheath and of combining the use of a sheath with the use of germicidal solution, Dr. Elackattu said at the meeting.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

Major Finding: A disposable sheath took significantly less time to use than a germicidal solution (89 seconds vs. 14 minutes), and was as effective in decontaminating flexible endoscopes.

Data Source: A randomized, controlled trial including 100 fiberoptic nasopharyngolaryngoscopes.

Disclosures: The researchers had no financial conflicts to disclose.

ORLANDO — Sterile, disposable sheaths for flexible endoscopes are as effective as germicidal solutions in preventing cross-contamination, and they take less time to use, according to the results of a randomized, controlled trial that included 100 fiberoptic nasopharyngolaryngoscopes.

Cross-contamination from flexible endoscopes remains a problem, highlighted by a recent outbreak in the Veterans Administration health system last year, said Dr. Alphi P. Elackattu, a resident in otolaryngology–head and neck surgery at Boston University. In that outbreak, about 10,000 patients were exposed to cross-contamination due to mechanical failure or human error, he explained at the meeting.

Dr. Elackattu and his colleagues hypothesized that using individually packaged sterile sheaths for flexible endoscopes would cut down on cross-contamination.

In their study, they collected baseline cultures from several sites on each of 100 fiberoptic nasopharyngolaryngoscopes (FNPLs). After use, the FNPLs were randomized to either the sheath protocol or the standard disinfection protocol of immersion in germicidal solution.

The product used in the study was the Slide-On EndoSheath from Medtronic Inc., but Medtronic was not involved in the study.

The researchers noted that the average time spent on the process of disinfection was significantly shorter when using the sheath than it was when using the germicidal solution (89 seconds vs. 14 minutes).

After a single use and disinfection protocol, there were no significant differences in the presence of organisms on the FNPLs in the sheath group, compared with the germicidal solution group.

Subjective observations by staff members suggested that germicidal immersion might actually increase the risk of cross-contamination involving FNPLs because it is more complicated to perform than using a disposable sheath, Dr. Elackattu noted.

In addition, patients might feel more secure and comfortable when they see that a disposable sheath is being used on the nasopharyngolaryngoscope, he said.

More research is needed to assess the value of using a disposable sheath and of combining the use of a sheath with the use of germicidal solution, Dr. Elackattu said at the meeting.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

Major Finding: A disposable sheath took significantly less time to use than a germicidal solution (89 seconds vs. 14 minutes), and was as effective in decontaminating flexible endoscopes.

Data Source: A randomized, controlled trial including 100 fiberoptic nasopharyngolaryngoscopes.

Disclosures: The researchers had no financial conflicts to disclose.

ORLANDO — Sterile, disposable sheaths for flexible endoscopes are as effective as germicidal solutions in preventing cross-contamination, and they take less time to use, according to the results of a randomized, controlled trial that included 100 fiberoptic nasopharyngolaryngoscopes.

Cross-contamination from flexible endoscopes remains a problem, highlighted by a recent outbreak in the Veterans Administration health system last year, said Dr. Alphi P. Elackattu, a resident in otolaryngology–head and neck surgery at Boston University. In that outbreak, about 10,000 patients were exposed to cross-contamination due to mechanical failure or human error, he explained at the meeting.

Dr. Elackattu and his colleagues hypothesized that using individually packaged sterile sheaths for flexible endoscopes would cut down on cross-contamination.

In their study, they collected baseline cultures from several sites on each of 100 fiberoptic nasopharyngolaryngoscopes (FNPLs). After use, the FNPLs were randomized to either the sheath protocol or the standard disinfection protocol of immersion in germicidal solution.

The product used in the study was the Slide-On EndoSheath from Medtronic Inc., but Medtronic was not involved in the study.

The researchers noted that the average time spent on the process of disinfection was significantly shorter when using the sheath than it was when using the germicidal solution (89 seconds vs. 14 minutes).

After a single use and disinfection protocol, there were no significant differences in the presence of organisms on the FNPLs in the sheath group, compared with the germicidal solution group.

Subjective observations by staff members suggested that germicidal immersion might actually increase the risk of cross-contamination involving FNPLs because it is more complicated to perform than using a disposable sheath, Dr. Elackattu noted.

In addition, patients might feel more secure and comfortable when they see that a disposable sheath is being used on the nasopharyngolaryngoscope, he said.

More research is needed to assess the value of using a disposable sheath and of combining the use of a sheath with the use of germicidal solution, Dr. Elackattu said at the meeting.

The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

Major Finding: A combination of 2 mg of rosiglitazone and 500 mg of metformin twice daily reduced the relative risk of developing type 2 diabetes in high-risk adults by 66%.

Data Source: A randomized, double-blind, placebo-controlled trial of 207 adults at increased risk for type 2 diabetes.

Disclosures: The study was funded by GlaxoSmithKline, from which Dr. Zinman has received consulting fees, honoraria, and grant support. Dr. Buchanan and Dr. Xiang have received research support from Takeda Pharmaceuticals, and Dr. Buchanan has served on a speakers panel and received travel and accommodation expenses from Takeda.

A combination of low doses of rosiglitazone and metformin reduced the relative risk of developing type 2 diabetes by 66% in high-risk adults, according to a study by Canadian researchers.

Both rosiglitazone and metformin can reduce the risk of developing type 2 diabetes in adults with impaired glucose tolerance, but this study is the first to combine the two drugs to test for similar effectiveness with fewer side effects, said Dr. Bernard Zinman of Mount Sinai Hospital in Toronto, and his colleagues.

In this study, 103 participants were randomized to a combination of 2 mg of rosiglitazone and 500 mg of metformin in a single capsule (Avandamet, GlaxoSmithKline) twice daily, while 104 participants received a placebo capsule. The study, known as the Canadian Normoglycemia Outcomes Evaluation (CANOE) trial, also included a structured lifestyle intervention of five individual counseling sessions during the first year of the study, followed by educational materials that were mailed or e-mailed to participants (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60746-5]).

The primary outcome was a diagnosis of type 2 diabetes, based on two fasting plasma glucose values of 7.0 mmol/L or more, or one positive oral glucose tolerance test with a 2-hour plasma glucose value greater than 11.0 mmol/L.

After an average follow-up period of 3.9 years, 14 patients (14%) in the treatment group and 41 (39%) patients in the placebo group developed type 2 diabetes, for a relative risk reduction of 66%. The absolute risk reduction was 26%, and the number needed to treat was 4.

In addition, significantly more individuals in the treatment group compared with the placebo group had attained normal glucose tolerance levels by the end of the study (80% vs. 53%, respectively). “The magnitude of this effect is equivalent to that of any of the published diabetes prevention strategies,” the researchers said.

The average age of the patients was 55 years in the placebo group and 50 years in the treatment group. The breakdown of gender and ethnicity, and the values of baseline risk factors including total cholesterol, blood pressure, body mass index, and insulin resistance were similar between the two groups.

The treatment group showed no significant increase in myocardial infarction, heart failure fractures, and weight gain or loss of 2 kg or more compared with the placebo group, and the researchers found no significant interaction between statin use and treatment outcome.

No significant differences in beta-cell function were noted, but decreased C-reactive protein levels and reduced alanine aminotransferase levels in the treatment group compared with baseline suggest reduced inflammation and improved liver function, the researchers noted.

Limitations of the study included the fact that it was not powered to address the long-term effects of combination therapy on cardiovascular safety, the researchers noted. The study also was limited by the inability to show whether the effects of the combination drug indicate the prevention or early treatment of type 2 diabetes.

The CANOE study data suggest that combining low doses of rosiglitazone and metformin can reduce the risk of type 2 diabetes with fewer side effects, but the conclusions are not definitive, wrote Dr. Thomas A. Buchanan of the University of Southern California, Los Angeles, and Dr. Anny H. Xiang of Kaiser Permanente Southern California in Pasadena.

“The issue of whether prevention provides better long-term outcomes than does early treatment remains unknown,” they said in a comment (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60900-2]).

Major Finding: A combination of 2 mg of rosiglitazone and 500 mg of metformin twice daily reduced the relative risk of developing type 2 diabetes in high-risk adults by 66%.

Data Source: A randomized, double-blind, placebo-controlled trial of 207 adults at increased risk for type 2 diabetes.

Disclosures: The study was funded by GlaxoSmithKline, from which Dr. Zinman has received consulting fees, honoraria, and grant support. Dr. Buchanan and Dr. Xiang have received research support from Takeda Pharmaceuticals, and Dr. Buchanan has served on a speakers panel and received travel and accommodation expenses from Takeda.

A combination of low doses of rosiglitazone and metformin reduced the relative risk of developing type 2 diabetes by 66% in high-risk adults, according to a study by Canadian researchers.

Both rosiglitazone and metformin can reduce the risk of developing type 2 diabetes in adults with impaired glucose tolerance, but this study is the first to combine the two drugs to test for similar effectiveness with fewer side effects, said Dr. Bernard Zinman of Mount Sinai Hospital in Toronto, and his colleagues.

In this study, 103 participants were randomized to a combination of 2 mg of rosiglitazone and 500 mg of metformin in a single capsule (Avandamet, GlaxoSmithKline) twice daily, while 104 participants received a placebo capsule. The study, known as the Canadian Normoglycemia Outcomes Evaluation (CANOE) trial, also included a structured lifestyle intervention of five individual counseling sessions during the first year of the study, followed by educational materials that were mailed or e-mailed to participants (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60746-5]).

The primary outcome was a diagnosis of type 2 diabetes, based on two fasting plasma glucose values of 7.0 mmol/L or more, or one positive oral glucose tolerance test with a 2-hour plasma glucose value greater than 11.0 mmol/L.

After an average follow-up period of 3.9 years, 14 patients (14%) in the treatment group and 41 (39%) patients in the placebo group developed type 2 diabetes, for a relative risk reduction of 66%. The absolute risk reduction was 26%, and the number needed to treat was 4.

In addition, significantly more individuals in the treatment group compared with the placebo group had attained normal glucose tolerance levels by the end of the study (80% vs. 53%, respectively). “The magnitude of this effect is equivalent to that of any of the published diabetes prevention strategies,” the researchers said.

The average age of the patients was 55 years in the placebo group and 50 years in the treatment group. The breakdown of gender and ethnicity, and the values of baseline risk factors including total cholesterol, blood pressure, body mass index, and insulin resistance were similar between the two groups.

The treatment group showed no significant increase in myocardial infarction, heart failure fractures, and weight gain or loss of 2 kg or more compared with the placebo group, and the researchers found no significant interaction between statin use and treatment outcome.

No significant differences in beta-cell function were noted, but decreased C-reactive protein levels and reduced alanine aminotransferase levels in the treatment group compared with baseline suggest reduced inflammation and improved liver function, the researchers noted.

Limitations of the study included the fact that it was not powered to address the long-term effects of combination therapy on cardiovascular safety, the researchers noted. The study also was limited by the inability to show whether the effects of the combination drug indicate the prevention or early treatment of type 2 diabetes.

The CANOE study data suggest that combining low doses of rosiglitazone and metformin can reduce the risk of type 2 diabetes with fewer side effects, but the conclusions are not definitive, wrote Dr. Thomas A. Buchanan of the University of Southern California, Los Angeles, and Dr. Anny H. Xiang of Kaiser Permanente Southern California in Pasadena.

“The issue of whether prevention provides better long-term outcomes than does early treatment remains unknown,” they said in a comment (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60900-2]).

Major Finding: A combination of 2 mg of rosiglitazone and 500 mg of metformin twice daily reduced the relative risk of developing type 2 diabetes in high-risk adults by 66%.

Data Source: A randomized, double-blind, placebo-controlled trial of 207 adults at increased risk for type 2 diabetes.

Disclosures: The study was funded by GlaxoSmithKline, from which Dr. Zinman has received consulting fees, honoraria, and grant support. Dr. Buchanan and Dr. Xiang have received research support from Takeda Pharmaceuticals, and Dr. Buchanan has served on a speakers panel and received travel and accommodation expenses from Takeda.

A combination of low doses of rosiglitazone and metformin reduced the relative risk of developing type 2 diabetes by 66% in high-risk adults, according to a study by Canadian researchers.

Both rosiglitazone and metformin can reduce the risk of developing type 2 diabetes in adults with impaired glucose tolerance, but this study is the first to combine the two drugs to test for similar effectiveness with fewer side effects, said Dr. Bernard Zinman of Mount Sinai Hospital in Toronto, and his colleagues.

In this study, 103 participants were randomized to a combination of 2 mg of rosiglitazone and 500 mg of metformin in a single capsule (Avandamet, GlaxoSmithKline) twice daily, while 104 participants received a placebo capsule. The study, known as the Canadian Normoglycemia Outcomes Evaluation (CANOE) trial, also included a structured lifestyle intervention of five individual counseling sessions during the first year of the study, followed by educational materials that were mailed or e-mailed to participants (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60746-5]).

The primary outcome was a diagnosis of type 2 diabetes, based on two fasting plasma glucose values of 7.0 mmol/L or more, or one positive oral glucose tolerance test with a 2-hour plasma glucose value greater than 11.0 mmol/L.

After an average follow-up period of 3.9 years, 14 patients (14%) in the treatment group and 41 (39%) patients in the placebo group developed type 2 diabetes, for a relative risk reduction of 66%. The absolute risk reduction was 26%, and the number needed to treat was 4.

In addition, significantly more individuals in the treatment group compared with the placebo group had attained normal glucose tolerance levels by the end of the study (80% vs. 53%, respectively). “The magnitude of this effect is equivalent to that of any of the published diabetes prevention strategies,” the researchers said.

The average age of the patients was 55 years in the placebo group and 50 years in the treatment group. The breakdown of gender and ethnicity, and the values of baseline risk factors including total cholesterol, blood pressure, body mass index, and insulin resistance were similar between the two groups.

The treatment group showed no significant increase in myocardial infarction, heart failure fractures, and weight gain or loss of 2 kg or more compared with the placebo group, and the researchers found no significant interaction between statin use and treatment outcome.

No significant differences in beta-cell function were noted, but decreased C-reactive protein levels and reduced alanine aminotransferase levels in the treatment group compared with baseline suggest reduced inflammation and improved liver function, the researchers noted.

Limitations of the study included the fact that it was not powered to address the long-term effects of combination therapy on cardiovascular safety, the researchers noted. The study also was limited by the inability to show whether the effects of the combination drug indicate the prevention or early treatment of type 2 diabetes.

The CANOE study data suggest that combining low doses of rosiglitazone and metformin can reduce the risk of type 2 diabetes with fewer side effects, but the conclusions are not definitive, wrote Dr. Thomas A. Buchanan of the University of Southern California, Los Angeles, and Dr. Anny H. Xiang of Kaiser Permanente Southern California in Pasadena.

“The issue of whether prevention provides better long-term outcomes than does early treatment remains unknown,” they said in a comment (Lancet 2010 June 3 [doi: 10.1016/S0140-6736(10)60900-2]).

NEW ORLEANS — Pregnant women who used proton pump inhibitors to treat their gastroesophageal reflux during the first trimester of pregnancy were more than twice as likely to have babies with cardiac defects than were pregnant women who did not use PPIs, based on a retrospective study of over 200,000 women.

Previous data have indicated a nonsignificant trend toward an association between use of proton pump inhibitors (PPIs) early in pregnancy and cardiac malformations, Dr. Andrew D. Rhim of the University of Pennsylvania in Philadelphia said in his presentation.

“Before this study, there were very limited human data [on risk], and this study suggests a possible increased risk of cardiovascular defects,” Dr. Jennifer Niebyl of the University of Iowa, Iowa City, said in an interview. These results, however, are hampered by uncertainties surrounding the trimester of exposure and possible selection bias.

Last year, Dr. Niebyl and her colleagues published the results of a study of 3,458 women, which suggested that metoclopramide may be a safe option for pregnant women (N. Engl. J. Med. 2009;360:2528–35). She advised that pregnant women avoid PPIs during the first trimester.

From a database of 208,951 pregnancies, Dr. Rhim and his colleagues identified 2,445 cases of cardiac malformations in newborns and compared them with 19,530 matched controls. All of the newborns were registered between 2000 and 2008 in the Health Improvement Network, a database of information collected by general practitioners in the United Kingdom.

“We found 130 instances of a PPI being prescribed within the first trimester” in the women who gave birth to infants with cardiac birth defects, Dr. Rhim said. After controlling for multiple variables including maternal BMI, smoking status, alcohol use, and use of other medications, the risk for cardiac birth defects remained significant. A history of either cardiac malformations or diabetes in the mother was associated with a significantly increased risk of a cardiac defect in the baby, Dr. Rhim noted.

The researchers identified three types of defects: septal defects, left ventricular defects, and right ventricular defects. The frequencies of the three defects were comparable with those seen in the general population of the United Kingdom, said Dr. Rhim.

My Take

Timing Is Key

Although retrospective case-control studies can show associations, they cannot determine if the associations are causal. Moreover, such studies have major limitations, including selection bias, recall bias, and timing of exposures.

Timing is very important. For example, closure of the ventricular septum occurs by 6 weeks postconception, so an exposure that causes a ventricular septal defect (VSD) must occur before 6 weeks.

Another consideration is the animal reproduction data included by the manufacturers in their package inserts. None of the six PPIs available in the U.S. cause structural defects in animals. This is important because, with only two exceptions, all known human teratogens also are teratogenic in animals.

To my knowledge, no study has shown a significant association between PPIs and cardiac defects. Atrial septal defects and VSDs are among the most common cardiac defects, and VSDs are, overall, one of the most common birth defects.

GERALD BRIGGS, B.Pharm., is pharmacist clinical specialist, Perinatal Support Services, Miller Children's Hospital, Long Beach, Calif.

NEW ORLEANS — Pregnant women who used proton pump inhibitors to treat their gastroesophageal reflux during the first trimester of pregnancy were more than twice as likely to have babies with cardiac defects than were pregnant women who did not use PPIs, based on a retrospective study of over 200,000 women.

Previous data have indicated a nonsignificant trend toward an association between use of proton pump inhibitors (PPIs) early in pregnancy and cardiac malformations, Dr. Andrew D. Rhim of the University of Pennsylvania in Philadelphia said in his presentation.

“Before this study, there were very limited human data [on risk], and this study suggests a possible increased risk of cardiovascular defects,” Dr. Jennifer Niebyl of the University of Iowa, Iowa City, said in an interview. These results, however, are hampered by uncertainties surrounding the trimester of exposure and possible selection bias.

Last year, Dr. Niebyl and her colleagues published the results of a study of 3,458 women, which suggested that metoclopramide may be a safe option for pregnant women (N. Engl. J. Med. 2009;360:2528–35). She advised that pregnant women avoid PPIs during the first trimester.

From a database of 208,951 pregnancies, Dr. Rhim and his colleagues identified 2,445 cases of cardiac malformations in newborns and compared them with 19,530 matched controls. All of the newborns were registered between 2000 and 2008 in the Health Improvement Network, a database of information collected by general practitioners in the United Kingdom.

“We found 130 instances of a PPI being prescribed within the first trimester” in the women who gave birth to infants with cardiac birth defects, Dr. Rhim said. After controlling for multiple variables including maternal BMI, smoking status, alcohol use, and use of other medications, the risk for cardiac birth defects remained significant. A history of either cardiac malformations or diabetes in the mother was associated with a significantly increased risk of a cardiac defect in the baby, Dr. Rhim noted.

The researchers identified three types of defects: septal defects, left ventricular defects, and right ventricular defects. The frequencies of the three defects were comparable with those seen in the general population of the United Kingdom, said Dr. Rhim.

My Take

Timing Is Key

Although retrospective case-control studies can show associations, they cannot determine if the associations are causal. Moreover, such studies have major limitations, including selection bias, recall bias, and timing of exposures.

Timing is very important. For example, closure of the ventricular septum occurs by 6 weeks postconception, so an exposure that causes a ventricular septal defect (VSD) must occur before 6 weeks.

Another consideration is the animal reproduction data included by the manufacturers in their package inserts. None of the six PPIs available in the U.S. cause structural defects in animals. This is important because, with only two exceptions, all known human teratogens also are teratogenic in animals.

To my knowledge, no study has shown a significant association between PPIs and cardiac defects. Atrial septal defects and VSDs are among the most common cardiac defects, and VSDs are, overall, one of the most common birth defects.

GERALD BRIGGS, B.Pharm., is pharmacist clinical specialist, Perinatal Support Services, Miller Children's Hospital, Long Beach, Calif.

NEW ORLEANS — Pregnant women who used proton pump inhibitors to treat their gastroesophageal reflux during the first trimester of pregnancy were more than twice as likely to have babies with cardiac defects than were pregnant women who did not use PPIs, based on a retrospective study of over 200,000 women.

Previous data have indicated a nonsignificant trend toward an association between use of proton pump inhibitors (PPIs) early in pregnancy and cardiac malformations, Dr. Andrew D. Rhim of the University of Pennsylvania in Philadelphia said in his presentation.

“Before this study, there were very limited human data [on risk], and this study suggests a possible increased risk of cardiovascular defects,” Dr. Jennifer Niebyl of the University of Iowa, Iowa City, said in an interview. These results, however, are hampered by uncertainties surrounding the trimester of exposure and possible selection bias.

Last year, Dr. Niebyl and her colleagues published the results of a study of 3,458 women, which suggested that metoclopramide may be a safe option for pregnant women (N. Engl. J. Med. 2009;360:2528–35). She advised that pregnant women avoid PPIs during the first trimester.

From a database of 208,951 pregnancies, Dr. Rhim and his colleagues identified 2,445 cases of cardiac malformations in newborns and compared them with 19,530 matched controls. All of the newborns were registered between 2000 and 2008 in the Health Improvement Network, a database of information collected by general practitioners in the United Kingdom.

“We found 130 instances of a PPI being prescribed within the first trimester” in the women who gave birth to infants with cardiac birth defects, Dr. Rhim said. After controlling for multiple variables including maternal BMI, smoking status, alcohol use, and use of other medications, the risk for cardiac birth defects remained significant. A history of either cardiac malformations or diabetes in the mother was associated with a significantly increased risk of a cardiac defect in the baby, Dr. Rhim noted.

The researchers identified three types of defects: septal defects, left ventricular defects, and right ventricular defects. The frequencies of the three defects were comparable with those seen in the general population of the United Kingdom, said Dr. Rhim.

My Take

Timing Is Key

Although retrospective case-control studies can show associations, they cannot determine if the associations are causal. Moreover, such studies have major limitations, including selection bias, recall bias, and timing of exposures.

Timing is very important. For example, closure of the ventricular septum occurs by 6 weeks postconception, so an exposure that causes a ventricular septal defect (VSD) must occur before 6 weeks.

Another consideration is the animal reproduction data included by the manufacturers in their package inserts. None of the six PPIs available in the U.S. cause structural defects in animals. This is important because, with only two exceptions, all known human teratogens also are teratogenic in animals.

To my knowledge, no study has shown a significant association between PPIs and cardiac defects. Atrial septal defects and VSDs are among the most common cardiac defects, and VSDs are, overall, one of the most common birth defects.

GERALD BRIGGS, B.Pharm., is pharmacist clinical specialist, Perinatal Support Services, Miller Children's Hospital, Long Beach, Calif.

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with below-average body mass index, according to an analysis of a large data set.

Researchers found that, among subjects with BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. June 2010 [doi: 10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

Median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was supported by a grant from the National Cancer Institute. Dr. Butler stated that she had no financial conflicts to disclose.

My Take

Over 1,000 mg May Be Too Much

These findings are interesting, but I don't think there is a direct message for physicians who counsel men at this time.

Previous studies had indicated that high intakes of calcium over 1,000–1,500 mg/day may increase risk. Since there is no established benefit for men at such high intakes, then I think it makes sense for men to not go much beyond the 1000-mg/day range until further studies have been done. However, too low intakes of calcium less than 700 mg/day may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study.

EDWARD GIOVANNUCCI, M.D., Sc.D., is professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with below-average body mass index, according to an analysis of a large data set.

Researchers found that, among subjects with BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. June 2010 [doi: 10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

Median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was supported by a grant from the National Cancer Institute. Dr. Butler stated that she had no financial conflicts to disclose.

My Take

Over 1,000 mg May Be Too Much

These findings are interesting, but I don't think there is a direct message for physicians who counsel men at this time.

Previous studies had indicated that high intakes of calcium over 1,000–1,500 mg/day may increase risk. Since there is no established benefit for men at such high intakes, then I think it makes sense for men to not go much beyond the 1000-mg/day range until further studies have been done. However, too low intakes of calcium less than 700 mg/day may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study.

EDWARD GIOVANNUCCI, M.D., Sc.D., is professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with below-average body mass index, according to an analysis of a large data set.

Researchers found that, among subjects with BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. June 2010 [doi: 10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

Median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was supported by a grant from the National Cancer Institute. Dr. Butler stated that she had no financial conflicts to disclose.

My Take

Over 1,000 mg May Be Too Much

These findings are interesting, but I don't think there is a direct message for physicians who counsel men at this time.

Previous studies had indicated that high intakes of calcium over 1,000–1,500 mg/day may increase risk. Since there is no established benefit for men at such high intakes, then I think it makes sense for men to not go much beyond the 1000-mg/day range until further studies have been done. However, too low intakes of calcium less than 700 mg/day may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study.

EDWARD GIOVANNUCCI, M.D., Sc.D., is professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18–35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, she said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18–35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group. At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles. Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug. Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication. One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis noted. “I think the next question is to figure out what will be effective for women in that situation.”

Progesterone levels suggestive of ovulation occurred in five of the carbamazepine cycles, compared with one placebo cycle.

Source ©Tina Sbrigato/iStockphoto.com

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18–35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, she said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18–35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group. At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles. Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug. Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication. One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis noted. “I think the next question is to figure out what will be effective for women in that situation.”

Progesterone levels suggestive of ovulation occurred in five of the carbamazepine cycles, compared with one placebo cycle.

Source ©Tina Sbrigato/iStockphoto.com

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18–35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, she said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18–35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group. At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles. Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug. Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication. One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis noted. “I think the next question is to figure out what will be effective for women in that situation.”

Progesterone levels suggestive of ovulation occurred in five of the carbamazepine cycles, compared with one placebo cycle.

Source ©Tina Sbrigato/iStockphoto.com

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry.

Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning.

The data collected by the researchers included skin, hair, and eye color; presence of moles and freckles; lifetime routine sun exposure; age at which tanning beds were first used; duration and frequency of indoor tanning; and type of tanning device used. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Melanoma risk increased significantly as the frequency of indoor tanning increased. In addition, individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote.

“To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

As physicians, “we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference last month to discuss the study findings.

Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said. “I'm hopeful that this study is going to be very helpful in the hands of the FDA to further regulate the industry.”

Dr. Halpern said that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

“I think this study very much strengthens our hand,” said Dr. Halpern, who added that he was encouraged to see the consumer video posted by the FDA earlier last month, which states than any UV indoor tanning device should be avoided.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans.

In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices. However, the agency has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous investigations on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.

Melanoma was 2.9 times more likely to occur in users of UVB-enhanced tanning devices and 4.4 times more likely in users of primarily UVA-emitting devices, compared with nonusers.

Source ©Vidmantas/iStockphoto.com

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry.

Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning.

The data collected by the researchers included skin, hair, and eye color; presence of moles and freckles; lifetime routine sun exposure; age at which tanning beds were first used; duration and frequency of indoor tanning; and type of tanning device used. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Melanoma risk increased significantly as the frequency of indoor tanning increased. In addition, individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote.

“To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

As physicians, “we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference last month to discuss the study findings.

Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said. “I'm hopeful that this study is going to be very helpful in the hands of the FDA to further regulate the industry.”

Dr. Halpern said that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

“I think this study very much strengthens our hand,” said Dr. Halpern, who added that he was encouraged to see the consumer video posted by the FDA earlier last month, which states than any UV indoor tanning device should be avoided.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans.

In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices. However, the agency has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous investigations on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.

Melanoma was 2.9 times more likely to occur in users of UVB-enhanced tanning devices and 4.4 times more likely in users of primarily UVA-emitting devices, compared with nonusers.

Source ©Vidmantas/iStockphoto.com

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry.

Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning.

The data collected by the researchers included skin, hair, and eye color; presence of moles and freckles; lifetime routine sun exposure; age at which tanning beds were first used; duration and frequency of indoor tanning; and type of tanning device used. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Melanoma risk increased significantly as the frequency of indoor tanning increased. In addition, individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote.

“To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

As physicians, “we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference last month to discuss the study findings.

Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said. “I'm hopeful that this study is going to be very helpful in the hands of the FDA to further regulate the industry.”

Dr. Halpern said that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

“I think this study very much strengthens our hand,” said Dr. Halpern, who added that he was encouraged to see the consumer video posted by the FDA earlier last month, which states than any UV indoor tanning device should be avoided.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans.

In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices. However, the agency has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous investigations on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.

Melanoma was 2.9 times more likely to occur in users of UVB-enhanced tanning devices and 4.4 times more likely in users of primarily UVA-emitting devices, compared with nonusers.

Source ©Vidmantas/iStockphoto.com

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with a below-average body mass index, according to an analysis of a large data set.

Researchers found that among subjects with a BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. 2010 June 1 [doi:10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

The study participants completed a 165-item food frequency questionnaire to assess their diets over the past year. Baseline characteristics including age, education, physical activity, and BMI were similar among the four quartiles.

Overall, the median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was limited by an inability to assess any variation of the calcium/cancer connection based on stage of disease, and more research is needed to evaluate the role of calcium in prostate cancer, compared with other components of dairy products, they added.

Disclosures: The study was supported by a grant from the National Cancer Institute. Dr. Butler reported having no financial conflicts.

My Take

Over 1,000 mg May Be Too Much

Previous studies indicated that high intakes of calcium (more than 1,000–1,500 mg/day) may increase prostate cancer risk. As there is no established benefit for men at such high intakes, it makes sense for men to not go much beyond the 1,000-mg/day range until further studies have been done. However, intakes of calcium that are too low (less than 700 mg/day) may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study. Finally, men with prostate cancer need to be studied, as the results would be most pertinent to them.

In addition, the authors theorize that leaner men may absorb calcium better. The evidence for this is limited at this time. This could be a chance finding, so it also needs to be replicated in other populations.

EDWARD GIOVANNUCCI, M.D., is a professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with a below-average body mass index, according to an analysis of a large data set.

Researchers found that among subjects with a BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. 2010 June 1 [doi:10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

The study participants completed a 165-item food frequency questionnaire to assess their diets over the past year. Baseline characteristics including age, education, physical activity, and BMI were similar among the four quartiles.

Overall, the median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was limited by an inability to assess any variation of the calcium/cancer connection based on stage of disease, and more research is needed to evaluate the role of calcium in prostate cancer, compared with other components of dairy products, they added.

Disclosures: The study was supported by a grant from the National Cancer Institute. Dr. Butler reported having no financial conflicts.

My Take

Over 1,000 mg May Be Too Much

Previous studies indicated that high intakes of calcium (more than 1,000–1,500 mg/day) may increase prostate cancer risk. As there is no established benefit for men at such high intakes, it makes sense for men to not go much beyond the 1,000-mg/day range until further studies have been done. However, intakes of calcium that are too low (less than 700 mg/day) may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study. Finally, men with prostate cancer need to be studied, as the results would be most pertinent to them.

In addition, the authors theorize that leaner men may absorb calcium better. The evidence for this is limited at this time. This could be a chance finding, so it also needs to be replicated in other populations.

EDWARD GIOVANNUCCI, M.D., is a professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Dietary calcium was associated with significantly increased risk of prostate cancer in Chinese men with a below-average body mass index, according to an analysis of a large data set.

Researchers found that among subjects with a BMI below the median 22.9 kg/m

Data from previous studies have suggested a link between calcium and prostate cancer, but these studies have not been able to separate dairy products from calcium, said Lesley M. Butler, Ph.D., of Colorado State University in Fort Collins, and colleagues.

To more accurately assess the link between dietary calcium and prostate cancer, the researchers focused on a population of Chinese men whose dairy intake was relatively low. In general, Asian diets contain few dairy products, compared with Western diets, the researchers noted. Instead, most of the calcium in Asian diets comes from nondairy sources such as broccoli, kale, bok choy, and soy products. The researchers reviewed data from the Singapore Chinese Health Study, focusing on 27,293 men who did not have cancer when they entered the study between April 1993 and December 1998 (Cancer Res. 2010 June 1 [doi:10.1158/0008-5472.CAN-09-4544]).

Overall, dietary calcium was associated with a nonsignificant 25% increase in prostate cancer risk for the highest quartile of calcium intake (median of 659 mg/day) vs. the lowest quartile (median of 211 mg/day).

The study participants completed a 165-item food frequency questionnaire to assess their diets over the past year. Baseline characteristics including age, education, physical activity, and BMI were similar among the four quartiles.

Overall, the median daily intake of dairy products in the study population was 19.3 g. The greatest contributions of different food sources to daily calcium intake were vegetables (19.3%), dairy (17.3%), grain products (14.7%), soy products (11.8%), fruit (7.3%), and fish (6.2%). The variety of food sources suggest that the link between prostate cancer risk and calcium intake is not likely to be related to any particular food group, the researchers noted.

Neither age nor physical activity had an effect on the association between calcium and cancer, the researchers wrote.

“Our study is the first to report a positive association between calcium and prostate cancer risk at such a low calcium level,” the researchers said. Previous studies have shown that calcium is absorbed more efficiently in the Chinese population, compared with the white population, and among thinner people compared with heavier people, which is why a study of relatively thin Chinese men might be more likely to reveal a cancer/calcium connection than a study of heavier white men, the researchers wrote.

The study was limited by an inability to assess any variation of the calcium/cancer connection based on stage of disease, and more research is needed to evaluate the role of calcium in prostate cancer, compared with other components of dairy products, they added.

Disclosures: The study was supported by a grant from the National Cancer Institute. Dr. Butler reported having no financial conflicts.

My Take

Over 1,000 mg May Be Too Much

Previous studies indicated that high intakes of calcium (more than 1,000–1,500 mg/day) may increase prostate cancer risk. As there is no established benefit for men at such high intakes, it makes sense for men to not go much beyond the 1,000-mg/day range until further studies have been done. However, intakes of calcium that are too low (less than 700 mg/day) may increase risk of some conditions, such as hypertension and colorectal cancer. Thus, it is reasonable for men to be in the range of 700–1,000 mg/day, but prudent not to go too much lower.

These results need to be confirmed in other studies where calcium intake is relatively low and there are not many dairy products. Also, since many men take calcium supplements, that might be an informative group to study. Finally, men with prostate cancer need to be studied, as the results would be most pertinent to them.

In addition, the authors theorize that leaner men may absorb calcium better. The evidence for this is limited at this time. This could be a chance finding, so it also needs to be replicated in other populations.

EDWARD GIOVANNUCCI, M.D., is a professor of epidemiology and nutrition at Harvard University, Cambridge, Mass.

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry. Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 May 26 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and her colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning. Melanoma risk increased significantly as the frequency of indoor tanning increased. Individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote. “To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

“As dermatologists, we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference to discuss the study findings. Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said, adding that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans. In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices, but the FDA has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous studies on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry. Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 May 26 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and her colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning. Melanoma risk increased significantly as the frequency of indoor tanning increased. Individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote. “To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

“As dermatologists, we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference to discuss the study findings. Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said, adding that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans. In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices, but the FDA has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous studies on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.

Major Finding: Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning.

Data Source: A population-based, case-control study of 1,167 melanoma cases and 1,101 controls.

Disclosures: None of the study authors stated that they had any conflicts of interest. The study was supported in part by a grant from the American Cancer Society and the National Cancer Institute.

Indoor tanning is associated with a fourfold increased risk of melanoma, according to findings from the Skin Health Study, a population-based, case-control study of 1,167 cases and 1,101 controls.

Melanoma was 2.9 times more likely to occur in users of high-speed/high-intensity (UVB-enhanced) tanning devices and 4.4 times more likely in users of high-pressure (primarily UVA-emitting) devices, compared with individuals who had never used the devices.

In addition, melanoma was 1.8 and 1.9 times more likely in users of conventional indoor tanning devices and sunlamps, respectively, compared with never users.

The study population included individuals aged 25–59 years who were diagnosed with invasive cutaneous melanoma between July 2004 and December 2007 in Minnesota and who were enrolled in a state cancer registry. Controls were selected at random from the Minnesota state driver's license list. Study participants completed a self-administered questionnaire and a detailed 1-hour phone interview (Cancer Epidemiol. Biomarkers Prev. 2010 May 26 [doi: 10.1158/1055-9965.EPI-09-1249]).

DeAnn Lazovich, Ph.D., of the University of Minnesota, Minneapolis, and her colleagues began the Skin Health Study in 2004 in Minnesota, a state with a documented high rate of indoor tanning. Overall, 63% of individuals with melanoma and 51% of controls reported any indoor tanning. Melanoma risk increased significantly as the frequency of indoor tanning increased. Individuals with melanoma were more than twice as likely as controls to report painful burns resulting from indoor tanning, and they reported significantly more of these painful burns than controls.

The researchers also noted that a dose-response relationship between the number of tanning sessions and the number of melanoma lesions on the trunk was identified in both men and women.

“We did not find lifetime routine sun exposure or sun exposure via recreational outdoor activities or occupations to be associated with melanoma risk,” Dr. Lazovich and associates wrote. “To the extent that sunburns are a marker of intermittent sun exposure, then our results adequately represent the independent effect of indoor tanning use on the risk of melanoma.”

“As dermatologists, we see the horrible price paid for using these devices,” Dr. Allan C. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York, said during a teleconference to discuss the study findings. Dr. Halpern was not involved in the study.

“We now know that the total amount of UV exposure in tanning beds over time is important,” Dr. Halpern said, adding that dermatologists have long understood the importance of educating patients about the dangers of indoor tanning devices, but that misinformation about the risks and benefits of indoor tanning persist.

In 2009, the International Agency for Research on Cancer classified tanning beds as carcinogenic to humans. In 2010, a Food and Drug Administration advisory panel recommended tighter restrictions on the use of indoor tanning devices, but the FDA has yet to issue any guidelines based on these recommendations.

The findings address several limitations of previous studies on this topic, including the ability to control for confounding variables such as sun exposure, the investigators noted.