Miriam E. Tucker

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

ATLANTA – The shingles vaccine Zostavax significantly reduced the incidence of herpes zoster and was generally well tolerated in a randomized, double-blind, placebo-controlled phase III trial involving more than 22,000 adults aged 50-59 years.

However, there was an elevated risk of local reactions with Zostavax among adults in that age group in both Merck’s phase III study and a separate analysis conducted by the CDC. Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is now under review by the Food and Drug Administration.

The Merck study enrolled 22,439 varicella history–positive, herpes zoster–negative 50- to 59-year olds who were followed for at least 1 year after receipt of a single Zostavax dose. Subjects were asked to notify investigators if they developed a rash or other symptoms suggestive of shingles. Those reporting signs or symptoms were contacted every 3 days for 21 days for assessment, said Dr. Janie Parrino, director of vaccine clinical research at Merck Research Laboratories.

Two-thirds of the subjects were female, and nearly all (94%) were white. More than 20% had hypertension, while 10%-20% had other medical conditions including hypercholesterolemia, drug hypersensitivity, and seasonal allergy.

There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for a vaccine efficacy of about 70%. Zostavax also elicited a higher varicella zoster virus-specific antibody response, and a demonstrated an estimated 73% relative reduction in mean zoster pain severity-by-duration score, Dr. Parrino reported.

Compared with placebo, Zostavax recipients had a higher overall incidence of adverse events within 6 week postvaccination (73% vs. 42%). Injection-site reactions were reported by 64% vs. 14%, and systemic adverse events – primarily pain in the extremity and headache – by 35% vs. 34%. However, rates of serious adverse events were similar: 0.6% Zostavax vs. 0.5% placebo within 42 days post vaccination and 2.1% vs. 1.9% by 182 days. One Zostavax recipient had an anaphylactic reaction.

Mortality rates were also similar, at 1.18 vs. 1.90 deaths per 1000 person-years in the Zostavax and placebo groups, respectively.

In a separate analysis of 2007-2008 data collected from the CDC’s Vaccine Safety Datalink, local reactions were considerably higher among the 6,832 adults aged 50-59 years who received Zostavax compared with the older age groups. Compared with those receiving placebo, the relative risk for inflammation and/or allergic reaction within 1-7 days of vaccination was 9.5 in the 50- to 59-year age group, compared with 3.0 among 60- to 65-year olds and 1.59 among those aged 70-79.

In the overall study group of 192,467 vaccinees, there were no other increased rates of prespecified conditions, including stroke, cardiovascular events, meningitis, encephalitis, encephalopathy, neurologic conditions, or serious reactions such as cellulitis and infection, said Hung Fu Tseng, Ph.D., of Southern California Kaiser Permanente, a participating site in the Vaccine Safety Datalink.

"The data provide reassurance that the zoster vaccine is generally safe and well tolerated ... The elevated risk of local reaction among the 50- to 59-years group needs further investigation," said Dr. Tseng.

Merck anticipates an FDA response about the 50- to 59-year age group indication by the end of the first half of the year, according to a company spokeswoman.

Dr. Tseng has received research funding from Merck for other vaccine-related studies.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Using the ultra-long-acting basal insulin degludec three times a week produced glycemic control comparable with that of daily insulin glargine in patients with inadequately controlled type 2 diabetes, according to the findings of a phase II study.

In addition, degludec achieved those results without additional adverse events.

"A three times a week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy," explained Dr. Bernard Zinman of the University of Toronto and his associates (Lancet 2011[doi:10.1016/S0140-6736(10)62305-7]).

Novo Nordisk’s insulin degludec forms soluble multihexamers at the injection site, from which monomers gradually separate and are absorbed into the circulation, resulting in a flat, stable pharmacokinetic profile.

Those features suggest that dosing could be reduced to just three times a week in previously insulin-naive patients with type 2 diabetes – thereby reducing the risk for hypoglycemia and potentially improving adherence to insulin treatment, the study’s authors said.

The 16-week, randomized, parallel-group trial of 245 patients was done at 28 clinics in four countries. All patients had type 2 diabetes, were insulin naive, and had been treated with one or two oral antidiabetic agents for more than 2 months.

They were randomized to one of four groups:

• Insulin degludec three times a week (900 nmol/mL formulation, dosed in the evening on Monday, Wednesday, and Friday).

• Insulin degludec once daily (600 nmol/mL formulation).

• Insulin degludec once daily (900 nmol/mL formulation).

• Insulin glargine once daily (600 nmol/mL formulation).

All four drug regimens were given in combination with metformin.

Mean hemoglobin A1c and fasting plasma glucose concentrations were similar between the treatment groups. Reductions in HbA1c from baseline were between 1.3% and 1.5% (to 7.2%-7.5%) and did not differ significantly between the groups. Fasting plasma glucose concentrations dropped 3.4-4.2 mmol/L from baseline and also did not differ between treatment groups.

After 16 weeks, mean nine-point self-monitored blood glucose profiles were similarly lower in all treatment groups than they were at baseline, the investigators said.

Insulin doses were adjusted during the trial to achieve specified fasting plasma glucose targets. The weekly starting doses for insulin degludec three times a week and once daily with the 900 nmol/mL formulation were higher than they were for the other two groups because of the formulation differences. After 16 weeks, mean weekly insulin dose was very similar for all treatment groups, except for the group taking the once-daily 900 nmol/L formulation.

Rates of hypoglycemia were low in all treatment groups, with 77%-92% reporting no episodes. However, the proportion of patients who had hypoglycemia in the once-daily 600 nmol/mL insulin degludec group was lower than was the proportion in the insulin glargine group and the insulin degludec three times a week group, with odds ratios of 0.26 and 0.31, respectively. Rates of nighttime hypoglycemia were low in all treatment groups, Dr. Zinman and his associates said.

Body weight was stable throughout the trial in all treatment groups. Adverse events were mild or moderate in severity, with no apparent treatment-specific pattern.

Novo Nordisk sponsored the study. Dr. Zinman has received fees for consultancy and honoraria for membership on advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin, and Boehringer Ingelheim, and grant support from Novo Nordisk, GlaxoSmithKline, and Merck. Three of the study’s other authors are Novo Nordisk employees.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m² at baseline to 80.1 mL/min per 1.73 m² at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m² with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m² at baseline to 80.1 mL/min per 1.73 m² at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m² with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m² at baseline to 80.1 mL/min per 1.73 m² at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m² with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

Use of the angiotensin II receptor antagonist olmesartan was associated with a delayed onset of microalbuminuria in a randomized, double-blind controlled trial involving more than 4,000 patients with type 2 diabetes.

The time to onset of microalbuminuria was increased by a significant 23% with olmesartan, compared with placebo in the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. But of concern, patients who received olmesartan had a higher rate of fatal cardiovascular events, mostly among patients with preexisting cardiovascular disease, Dr. Hermann Haller and his associates said (N. Engl. J. Med. 2011;364:907-17).

The study randomized 4,449 white patients with type 2 diabetes, aged 18-75 years, to either 40 mg/day of olmesartan or placebo. Additional antihypertensive drugs that do not block the renin-angiotensin system were used as needed to achieve blood pressure control of less than 130/80 mm Hg. Nearly 80% of the olmesartan group and about 71% of the placebo group achieved that level of blood pressure control at month 48, said Dr. Haller of Hanover (Germany) Medical School and his ROADMAP trial colleagues.

During a median follow-up of 3.2 years, microalbuminuria developed in 8.2% of the 2,160 patients in the olmesartan group for whom albumin-to-creatinine ratio could be evaluated, compared with 9.8% of the 2,139 evaluable placebo patients. Microalbuminuria was defined as a urinary albumin-to-creatinine ratio of more than 35 in women or more than 25 in men.

The median time to onset of microalbuminuria – the primary study end point – was 576 days in the placebo group and 722 days in the olmesartan group, with a hazard ratio of 0.77. After adjustment for small baseline differences in body mass index, systolic blood pressure, and lipid levels, the hazard ratio remained significant, at 0.75.

The mean estimated glomerular filtration rate – a secondary end point – dropped from 85.0 mL/min per 1.73 m2 at baseline to 80.1 mL/min per 1.73 m2 at the last assessment in the olmesartan group, compared with 84.7 to 83.7 mL/min per 1.73 m2 with placebo, a significant between-group difference in change from baseline. End-stage renal disease did not develop in any patient, and approximately 1% in each group had a doubling of serum creatinine level, Dr. Haller and his associates reported.

The proportion of patients who reached the composite secondary end point of cardiovascular complications or cardiovascular-related death was also similar between the two groups, 4.3% of the olmesartan group and 4.2% of the placebo group. The death rate overall was very low, just 1.2% of the olmesartan patients and 0.7% of those taking placebo.

However, the number of deaths from cardiovascular causes was higher in the olmesartan group, 15 vs. 3 on placebo, primarily because of fatal myocardial infarction (5 vs. 0) and sudden cardiac death (7 vs. 1). The majority of deaths from cardiovascular causes, 12 of 18, occurred in the subgroup of 1,104 patients who had preexisting coronary heart disease. Among patients with preexisting heart disease, there were 11 deaths from cardiovascular causes with olmesartan vs. 1 in the placebo group, giving event rates of 6.9 vs. 0.7/1,000 person-years, the investigators said.

Nonfatal cardiac events were reduced with olmesartan, compared with placebo among patients without, but not with, preexisting coronary heart disease.

Other adverse event rates were similar between the two groups. Serious adverse events occurred in 15.0% with olmesartan vs. 15.2% with placebo, and drug-related adverse events occurred in 11.4% vs. 7.5%. That difference was mostly due to more episodes of hypotension (58 vs. 6 patients) and dizziness (103 vs. 61 patients) with olmesartan. More patients in the olmesartan group were withdrawn from the study because of symptomatic hypotensive episodes (10 vs. 1).

The addition of olmesartan to preexisting antihypertensive therapy was also associated with a higher rate of cardiovascular death, compared with placebo in another study, the Olmesartan Reducing Incidence of End-Stage Renal Disease in Diabetic Nephropathy (ORIENT) trial, which involved patients who already had diabetic nephropathy. Based on the findings from ROADMAP and ORIENT, the U.S. Food and Drug Administration is currently reviewing existing data, the investigators said.

This study was funded by Daiichi Sankyo. Dr. Haller reported receiving payment for board membership from Novartis. He said he also receives consulting fees, lecture fees, payment for the development of educational presentations, and/or travel support from Bayer Schering Pharma, Daiichi Sankyo, Roche, Menarini, and Amgen.

ATLANTA – The incidence of acute hepatitis B is nearly twice as high among adults with diabetes as in those without, according to new data from the Centers for Disease Control and Prevention.

The finding, presented by Meredith Reilly, M.P.H., at a meeting of the CDC’s Advisory Committee on Immunization Practices, was based on 2009-2010 data from four sites (Connecticut, Colorado, Oregon, and New York City) that participate in the CDC’s Emerging Infection Program. Data from 2006-2008 from New York City also were included.

Those data were compared with study population denominator data from the Behavioral Risk Factor Surveillance System.

Overall, the prevalence of diabetes in 2009 was 8.4% among more than 12 million individuals at the four sites, ranging from 6.3% in Colorado to 10.0% in New York City. Diabetes prevalence ranged from 5.2% for adults aged 23-59 years, to 18.0% for those aged 60 years and older.

There were 326 reported cases of acute hepatitis B in the study population; diabetes information was available for 226. Of those patients, 15% (34) had diabetes and 85% (192) did not. Thus, the diabetes rate among the hepatitis B cases was nearly double that of the entire study population (15% vs. 8.4%), noted Ms. Reilly of the CDC’s division of viral hepatitis.

Other reported risk factors for acute hepatitis B were less common among those with hepatitis B who had diabetes than in both the nondiabetic subjects and the group of 100 for whom diabetes information was not available. Injection drug use was reported by 3% of those with diabetes, compared with 7% of those without and 27% of those with unknown diabetes status.

The estimated annual incidence of acute hepatitis B per 100,000 adults aged 23 years and older was 1.4 for those with diabetes versus 0.7 for those without, for a rate ratio of 1.9. By age, the rate ratio for acute hepatitis B between those with diabetes and those without was 2.6 for those aged 23-59 years and 2.0 for aged 60 and above. The difference was statistically significant for the younger cohort but not the older, Ms. Reilly noted.

The Advisory Committee on Immunization Practices is currently considering whether to recommend the hepatitis B vaccine for individuals with diabetes, an idea initially triggered by reports of hepatitis B outbreaks traced to improper infection-control practices associated with use of blood glucose testing and insulin injection devices in health care settings.

Next steps include results of a cost-effectiveness analysis and seroprotection studies in residents of assisted living facilities with hepatitis B outbreaks, along with estimates of current vaccination coverage. The plan is to discuss implementation strategies and address an evidence-based proposed recommendation at an upcoming meeting, said Dr. Trudy Murphy, also of the CDC’s division of viral hepatitis.

Dr. Murphy and Ms. Reilly are CDC employees with no disclosures.

ATLANTA – The incidence of acute hepatitis B is nearly twice as high among adults with diabetes as in those without, according to new data from the Centers for Disease Control and Prevention.

The finding, presented by Meredith Reilly, M.P.H., at a meeting of the CDC’s Advisory Committee on Immunization Practices, was based on 2009-2010 data from four sites (Connecticut, Colorado, Oregon, and New York City) that participate in the CDC’s Emerging Infection Program. Data from 2006-2008 from New York City also were included.

Those data were compared with study population denominator data from the Behavioral Risk Factor Surveillance System.

Overall, the prevalence of diabetes in 2009 was 8.4% among more than 12 million individuals at the four sites, ranging from 6.3% in Colorado to 10.0% in New York City. Diabetes prevalence ranged from 5.2% for adults aged 23-59 years, to 18.0% for those aged 60 years and older.

There were 326 reported cases of acute hepatitis B in the study population; diabetes information was available for 226. Of those patients, 15% (34) had diabetes and 85% (192) did not. Thus, the diabetes rate among the hepatitis B cases was nearly double that of the entire study population (15% vs. 8.4%), noted Ms. Reilly of the CDC’s division of viral hepatitis.

Other reported risk factors for acute hepatitis B were less common among those with hepatitis B who had diabetes than in both the nondiabetic subjects and the group of 100 for whom diabetes information was not available. Injection drug use was reported by 3% of those with diabetes, compared with 7% of those without and 27% of those with unknown diabetes status.

The estimated annual incidence of acute hepatitis B per 100,000 adults aged 23 years and older was 1.4 for those with diabetes versus 0.7 for those without, for a rate ratio of 1.9. By age, the rate ratio for acute hepatitis B between those with diabetes and those without was 2.6 for those aged 23-59 years and 2.0 for aged 60 and above. The difference was statistically significant for the younger cohort but not the older, Ms. Reilly noted.

The Advisory Committee on Immunization Practices is currently considering whether to recommend the hepatitis B vaccine for individuals with diabetes, an idea initially triggered by reports of hepatitis B outbreaks traced to improper infection-control practices associated with use of blood glucose testing and insulin injection devices in health care settings.

Next steps include results of a cost-effectiveness analysis and seroprotection studies in residents of assisted living facilities with hepatitis B outbreaks, along with estimates of current vaccination coverage. The plan is to discuss implementation strategies and address an evidence-based proposed recommendation at an upcoming meeting, said Dr. Trudy Murphy, also of the CDC’s division of viral hepatitis.

Dr. Murphy and Ms. Reilly are CDC employees with no disclosures.

ATLANTA – The incidence of acute hepatitis B is nearly twice as high among adults with diabetes as in those without, according to new data from the Centers for Disease Control and Prevention.

The finding, presented by Meredith Reilly, M.P.H., at a meeting of the CDC’s Advisory Committee on Immunization Practices, was based on 2009-2010 data from four sites (Connecticut, Colorado, Oregon, and New York City) that participate in the CDC’s Emerging Infection Program. Data from 2006-2008 from New York City also were included.

Those data were compared with study population denominator data from the Behavioral Risk Factor Surveillance System.

Overall, the prevalence of diabetes in 2009 was 8.4% among more than 12 million individuals at the four sites, ranging from 6.3% in Colorado to 10.0% in New York City. Diabetes prevalence ranged from 5.2% for adults aged 23-59 years, to 18.0% for those aged 60 years and older.

There were 326 reported cases of acute hepatitis B in the study population; diabetes information was available for 226. Of those patients, 15% (34) had diabetes and 85% (192) did not. Thus, the diabetes rate among the hepatitis B cases was nearly double that of the entire study population (15% vs. 8.4%), noted Ms. Reilly of the CDC’s division of viral hepatitis.

Other reported risk factors for acute hepatitis B were less common among those with hepatitis B who had diabetes than in both the nondiabetic subjects and the group of 100 for whom diabetes information was not available. Injection drug use was reported by 3% of those with diabetes, compared with 7% of those without and 27% of those with unknown diabetes status.

The estimated annual incidence of acute hepatitis B per 100,000 adults aged 23 years and older was 1.4 for those with diabetes versus 0.7 for those without, for a rate ratio of 1.9. By age, the rate ratio for acute hepatitis B between those with diabetes and those without was 2.6 for those aged 23-59 years and 2.0 for aged 60 and above. The difference was statistically significant for the younger cohort but not the older, Ms. Reilly noted.

The Advisory Committee on Immunization Practices is currently considering whether to recommend the hepatitis B vaccine for individuals with diabetes, an idea initially triggered by reports of hepatitis B outbreaks traced to improper infection-control practices associated with use of blood glucose testing and insulin injection devices in health care settings.

Next steps include results of a cost-effectiveness analysis and seroprotection studies in residents of assisted living facilities with hepatitis B outbreaks, along with estimates of current vaccination coverage. The plan is to discuss implementation strategies and address an evidence-based proposed recommendation at an upcoming meeting, said Dr. Trudy Murphy, also of the CDC’s division of viral hepatitis.

Dr. Murphy and Ms. Reilly are CDC employees with no disclosures.