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Data Linking Glargine to Cancer 'Inconclusive'
ATLANTA — Reaction by medical societies and the Food and Drug Administration to articles suggesting a link between insulin glargine and cancer has been swift and unified: Patients with diabetes who are using glargine should not change their regimen because there is no clear evidence of such a relation.
The American Association of Clinical Endocrinologists, several other professional societies, and the FDA are cautioning patients and physicians not to overinterpret the inconclusive findings from four studies published online by the journal Diabetologia examining a possible association between glargine and cancer (www.diabetologiajournal.org/cancer.html
In an editorial, Dr. Edwin A.M. Gale, editor of Diabetologia, and Dr. Ulf Smith, president of the European Association for the Study of Diabetes, state that “the studies reported are far from conclusive, but they do indicate the need for further investigation of the issue.”
Because the cancer risk was seen within a short period of time from exposure to glargine, the data do not suggest that glargine (Lantus, Sanofi-Aventis) causes cancer, they said. Rather, glargine might accelerate the progress of preexisting malignancies.
But Dr. Paul Jellinger said the studies show no definitive evidence of such a mechanism. “The data are inconclusive, the studies contradict themselves, and it's premature to make any recommendations to change insulin regimens. Each patient's concerns should be addressed individually,” said Dr. Jellinger, a clinical endocrinologist in Hollywood, Fla., and a past president of AACE. He participated in the writing of the AACE position statement, which was led by Dr. Yehuda Handelsman, a clinical endocrinologist in Tarzana, Calif. He added that “there's also a higher incidence of certain cancers in type 2 diabetes to begin with. The subject of diabetes and cancer merits further investigation.”
Like the other groups, the American Diabetes Association advised patients not to stop taking their insulin without consulting their physicians until more information is available. The data comprise four studies published online simultaneously. (See box.)
The FDA noted that the duration of follow-up was shorter for all the studies than is generally considered necessary to evaluate cancer risk from a drug exposure. Further, “inconsistencies in findings within and across the individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.”
The agency said it is reviewing several sources of safety data for glargine, including completed and ongoing controlled clinical trials, to better assess whether there is a risk of cancer associated with the insulin analogue. Discussions are taking place between the FDA and Sanofi-Aventis to determine if additional safety and efficacy studies will need to be performed. The FDA said it will communicate its findings to the public as soon as its review of insulin glargine is complete.
Sanofi-Aventis also issued a statement saying that the company “stands behind the safety of Lantus. … The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus use and the occurrence of malignancies.”
Dr. Gale and Dr. Smith pointed to other noteworthy findings from the studies. For example, the results of the Welch study showed that hazard ratios for cancer increased for all insulin-based regimens is consistent with other data suggesting that insulin use overall increases the risk for malignancy.
The Welch study also demonstrated the protective effect of metformin, including the suggestion that adding metformin to monotherapy with sulfonylureas or insulin slowed the rate of cancer development.
“These observations suggest that metformin may come to play a major role in cancer prevention in diabetes. For present purposes, however, the points to note are that concomitant metformin use is potentially a major confounder when it comes to estimating the risks of insulin therapy. … Furthermore, the lack of effect of metformin on breast cancer, if confirmed, might help to explain why this particular cancer has tended to emerge from the analysis conducted in the previous two studies,” they commented.
“We have no conclusive proof that Lantus is associated with a higher rate of cancer. The German study is suggestive, but relies on a statistical correction for insulin dose. The Swedish and Scottish studies are essentially negative in all respects except that of breast cancer. Individually, as we have emphasised, neither study is in any way conclusive. Taken together, however, they make it clear that there is indeed a case to answer,” Dr. Smith said. He added that new data will be presented at the EASD meeting in Vienna in September.
Dr. Smith and Dr. Gale reporting having no conflict of interest. Dr. Jellinger is on the speakers' bureau for several pharmaceutical companies, including Novo Nordisk, Amylin Lilly, and Takeda.
Four Registry Studies on Insulin Glargine and Cancer Yield Different Results
The first of the four studies, reporting a dose-dependent increase in cancer risk with glargine compared with human insulin in a study of more than 100,000 patients, was submitted to Diabetologia last year, Dr. Gale and Dr. Smith explained in their editorial. Its findings suggested that, compared with people using similar doses of human insulin, out of every 100 people who used Lantus insulin over an average of about 1.5 years, 1 additional person was diagnosed with cancer (Diabetologia 2009 June 26;
However, because of the study's limitations and its enormous implications, the European Association for the Study of Diabetes held the article and requested the three other analyses of data from national diabetes registries in Sweden, Scotland, and Wales to see if the findings could be replicated. All four studies were published simultaneously.
The German Study
The first study included 127,031 insulin-treated diabetic patients from a national health insurance database, all without known malignant disease at baseline and who had received first-time treatment exclusively with either human insulin (95,804), lispro (3,269), aspart (4,103), or glargine (23,855) exclusively (Diabetologia 2009 June 26;
At a mean follow-up of 1.63 years, the unadjusted risk for developing a malignant neoplasm was actually lower in those using all three analogues. But because patients taking a combination of human and analogue insulins had been excluded from the study, the glargine patients were using much lower overall doses than were those on human insulin (median 22 vs. 37 IU/day). After adjustment for daily dose, the risk was significantly increased for those taking glargine, compared with those taking human insulin, with hazard ratios of 1.09 for 10 IU/day, 1.19 for 30 IU/day, and 1.31 for 50 IU/day. No such increases were seen with either of the short-acting analogues lispro or aspart.
The Swedish Study
The Swedish study followed 114,841 individuals aged 35-84 years who had a prescription dispensed for insulin during the latter 6 months of 2005 and linked them with cancer registry data during 2006-2007.
After adjustment for age and sex, the overall rate of malignancy was not elevated for glargine monotherapy, compared with other insulins, nor were the specific rates of prostate or gastrointestinal cancers. However, after adjustment for a variety of other factors, women who took glargine had a significantly higher rate of breast cancer than did women who took other types of insulins as monotherapy (relative risk 1.97).
The Scottish Study
The Scottish group examined a total of 36,254 people using insulin over a 4-month period from a database that includes almost every individual in the country with diabetes. In a 4-year follow-up, the overall group of 3,959 using glargine had the same incidence of all cancers as did those not using glargine (hazard ratio 1.02). However, the subset of 447 patients using glargine as their sole insulin had a significantly higher incidence of all cancers than did the 32,295 using other insulins only (HR 1.55), while those using glargine with other insulins had a slightly lower incidence (HR 0.81).
Overall, there was no increase in breast cancer rates associated with insulin glargine use (HR 1.49), and no differences in breast cancer or all cancers were seen among type 2 diabetic insulin users, they reported.
The authors noted important differences in baseline characteristics between the insulin treatment groups. For example, patients using glargine alone were older than were those on glargine plus other insulins (68 vs. 41 years) and users of other insulins (60 years). Those on glargine alone also were more overweight, more hypertensive, and more likely to be on oral glucose-lowering drugs.
The Welch Study
This study was a retrospective cohort study of 62,809 people treated in U.K. general practices that participate in a national health information network (Diabetologia 2009 June 26;
These patients were all above age 40 at the time of diagnosis and were divided into four treatment groups: monotherapy with metformin or sulfonylurea, combination therapy with the two oral agents, or insulin. The insulin users were further subdivided into users of glargine, long-acting human insulin, biphasic analogue, or human biphasic insulin.
Metformin monotherapy carried the lowest risk of cancer, consistent with previous data suggesting that metformin may have a protective effect against malignancy. Compared with that group, the hazard ratio was 1.08 for those taking metformin plus sulfonylurea, 1.36 for sulfonylurea monotherapy, and 1.42 for insulin-based regimens. The latter finding is also consistent with other data suggesting that insulin use overall increases the risk for malignancy, Dr. Smith and Dr. Gale noted.
Adding metformin to insulin reduced the progression to cancer (HR 0.54). The hazard ratio for those on basal human insulin alone vs. glargine alone was 1.24, the authors noted.
ATLANTA — Reaction by medical societies and the Food and Drug Administration to articles suggesting a link between insulin glargine and cancer has been swift and unified: Patients with diabetes who are using glargine should not change their regimen because there is no clear evidence of such a relation.
The American Association of Clinical Endocrinologists, several other professional societies, and the FDA are cautioning patients and physicians not to overinterpret the inconclusive findings from four studies published online by the journal Diabetologia examining a possible association between glargine and cancer (www.diabetologiajournal.org/cancer.html
In an editorial, Dr. Edwin A.M. Gale, editor of Diabetologia, and Dr. Ulf Smith, president of the European Association for the Study of Diabetes, state that “the studies reported are far from conclusive, but they do indicate the need for further investigation of the issue.”
Because the cancer risk was seen within a short period of time from exposure to glargine, the data do not suggest that glargine (Lantus, Sanofi-Aventis) causes cancer, they said. Rather, glargine might accelerate the progress of preexisting malignancies.
But Dr. Paul Jellinger said the studies show no definitive evidence of such a mechanism. “The data are inconclusive, the studies contradict themselves, and it's premature to make any recommendations to change insulin regimens. Each patient's concerns should be addressed individually,” said Dr. Jellinger, a clinical endocrinologist in Hollywood, Fla., and a past president of AACE. He participated in the writing of the AACE position statement, which was led by Dr. Yehuda Handelsman, a clinical endocrinologist in Tarzana, Calif. He added that “there's also a higher incidence of certain cancers in type 2 diabetes to begin with. The subject of diabetes and cancer merits further investigation.”
Like the other groups, the American Diabetes Association advised patients not to stop taking their insulin without consulting their physicians until more information is available. The data comprise four studies published online simultaneously. (See box.)
The FDA noted that the duration of follow-up was shorter for all the studies than is generally considered necessary to evaluate cancer risk from a drug exposure. Further, “inconsistencies in findings within and across the individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.”
The agency said it is reviewing several sources of safety data for glargine, including completed and ongoing controlled clinical trials, to better assess whether there is a risk of cancer associated with the insulin analogue. Discussions are taking place between the FDA and Sanofi-Aventis to determine if additional safety and efficacy studies will need to be performed. The FDA said it will communicate its findings to the public as soon as its review of insulin glargine is complete.
Sanofi-Aventis also issued a statement saying that the company “stands behind the safety of Lantus. … The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus use and the occurrence of malignancies.”
Dr. Gale and Dr. Smith pointed to other noteworthy findings from the studies. For example, the results of the Welch study showed that hazard ratios for cancer increased for all insulin-based regimens is consistent with other data suggesting that insulin use overall increases the risk for malignancy.
The Welch study also demonstrated the protective effect of metformin, including the suggestion that adding metformin to monotherapy with sulfonylureas or insulin slowed the rate of cancer development.
“These observations suggest that metformin may come to play a major role in cancer prevention in diabetes. For present purposes, however, the points to note are that concomitant metformin use is potentially a major confounder when it comes to estimating the risks of insulin therapy. … Furthermore, the lack of effect of metformin on breast cancer, if confirmed, might help to explain why this particular cancer has tended to emerge from the analysis conducted in the previous two studies,” they commented.
“We have no conclusive proof that Lantus is associated with a higher rate of cancer. The German study is suggestive, but relies on a statistical correction for insulin dose. The Swedish and Scottish studies are essentially negative in all respects except that of breast cancer. Individually, as we have emphasised, neither study is in any way conclusive. Taken together, however, they make it clear that there is indeed a case to answer,” Dr. Smith said. He added that new data will be presented at the EASD meeting in Vienna in September.
Dr. Smith and Dr. Gale reporting having no conflict of interest. Dr. Jellinger is on the speakers' bureau for several pharmaceutical companies, including Novo Nordisk, Amylin Lilly, and Takeda.
Four Registry Studies on Insulin Glargine and Cancer Yield Different Results
The first of the four studies, reporting a dose-dependent increase in cancer risk with glargine compared with human insulin in a study of more than 100,000 patients, was submitted to Diabetologia last year, Dr. Gale and Dr. Smith explained in their editorial. Its findings suggested that, compared with people using similar doses of human insulin, out of every 100 people who used Lantus insulin over an average of about 1.5 years, 1 additional person was diagnosed with cancer (Diabetologia 2009 June 26;
However, because of the study's limitations and its enormous implications, the European Association for the Study of Diabetes held the article and requested the three other analyses of data from national diabetes registries in Sweden, Scotland, and Wales to see if the findings could be replicated. All four studies were published simultaneously.
The German Study
The first study included 127,031 insulin-treated diabetic patients from a national health insurance database, all without known malignant disease at baseline and who had received first-time treatment exclusively with either human insulin (95,804), lispro (3,269), aspart (4,103), or glargine (23,855) exclusively (Diabetologia 2009 June 26;
At a mean follow-up of 1.63 years, the unadjusted risk for developing a malignant neoplasm was actually lower in those using all three analogues. But because patients taking a combination of human and analogue insulins had been excluded from the study, the glargine patients were using much lower overall doses than were those on human insulin (median 22 vs. 37 IU/day). After adjustment for daily dose, the risk was significantly increased for those taking glargine, compared with those taking human insulin, with hazard ratios of 1.09 for 10 IU/day, 1.19 for 30 IU/day, and 1.31 for 50 IU/day. No such increases were seen with either of the short-acting analogues lispro or aspart.
The Swedish Study
The Swedish study followed 114,841 individuals aged 35-84 years who had a prescription dispensed for insulin during the latter 6 months of 2005 and linked them with cancer registry data during 2006-2007.
After adjustment for age and sex, the overall rate of malignancy was not elevated for glargine monotherapy, compared with other insulins, nor were the specific rates of prostate or gastrointestinal cancers. However, after adjustment for a variety of other factors, women who took glargine had a significantly higher rate of breast cancer than did women who took other types of insulins as monotherapy (relative risk 1.97).
The Scottish Study
The Scottish group examined a total of 36,254 people using insulin over a 4-month period from a database that includes almost every individual in the country with diabetes. In a 4-year follow-up, the overall group of 3,959 using glargine had the same incidence of all cancers as did those not using glargine (hazard ratio 1.02). However, the subset of 447 patients using glargine as their sole insulin had a significantly higher incidence of all cancers than did the 32,295 using other insulins only (HR 1.55), while those using glargine with other insulins had a slightly lower incidence (HR 0.81).
Overall, there was no increase in breast cancer rates associated with insulin glargine use (HR 1.49), and no differences in breast cancer or all cancers were seen among type 2 diabetic insulin users, they reported.
The authors noted important differences in baseline characteristics between the insulin treatment groups. For example, patients using glargine alone were older than were those on glargine plus other insulins (68 vs. 41 years) and users of other insulins (60 years). Those on glargine alone also were more overweight, more hypertensive, and more likely to be on oral glucose-lowering drugs.
The Welch Study
This study was a retrospective cohort study of 62,809 people treated in U.K. general practices that participate in a national health information network (Diabetologia 2009 June 26;
These patients were all above age 40 at the time of diagnosis and were divided into four treatment groups: monotherapy with metformin or sulfonylurea, combination therapy with the two oral agents, or insulin. The insulin users were further subdivided into users of glargine, long-acting human insulin, biphasic analogue, or human biphasic insulin.
Metformin monotherapy carried the lowest risk of cancer, consistent with previous data suggesting that metformin may have a protective effect against malignancy. Compared with that group, the hazard ratio was 1.08 for those taking metformin plus sulfonylurea, 1.36 for sulfonylurea monotherapy, and 1.42 for insulin-based regimens. The latter finding is also consistent with other data suggesting that insulin use overall increases the risk for malignancy, Dr. Smith and Dr. Gale noted.
Adding metformin to insulin reduced the progression to cancer (HR 0.54). The hazard ratio for those on basal human insulin alone vs. glargine alone was 1.24, the authors noted.
ATLANTA — Reaction by medical societies and the Food and Drug Administration to articles suggesting a link between insulin glargine and cancer has been swift and unified: Patients with diabetes who are using glargine should not change their regimen because there is no clear evidence of such a relation.
The American Association of Clinical Endocrinologists, several other professional societies, and the FDA are cautioning patients and physicians not to overinterpret the inconclusive findings from four studies published online by the journal Diabetologia examining a possible association between glargine and cancer (www.diabetologiajournal.org/cancer.html
In an editorial, Dr. Edwin A.M. Gale, editor of Diabetologia, and Dr. Ulf Smith, president of the European Association for the Study of Diabetes, state that “the studies reported are far from conclusive, but they do indicate the need for further investigation of the issue.”
Because the cancer risk was seen within a short period of time from exposure to glargine, the data do not suggest that glargine (Lantus, Sanofi-Aventis) causes cancer, they said. Rather, glargine might accelerate the progress of preexisting malignancies.
But Dr. Paul Jellinger said the studies show no definitive evidence of such a mechanism. “The data are inconclusive, the studies contradict themselves, and it's premature to make any recommendations to change insulin regimens. Each patient's concerns should be addressed individually,” said Dr. Jellinger, a clinical endocrinologist in Hollywood, Fla., and a past president of AACE. He participated in the writing of the AACE position statement, which was led by Dr. Yehuda Handelsman, a clinical endocrinologist in Tarzana, Calif. He added that “there's also a higher incidence of certain cancers in type 2 diabetes to begin with. The subject of diabetes and cancer merits further investigation.”
Like the other groups, the American Diabetes Association advised patients not to stop taking their insulin without consulting their physicians until more information is available. The data comprise four studies published online simultaneously. (See box.)
The FDA noted that the duration of follow-up was shorter for all the studies than is generally considered necessary to evaluate cancer risk from a drug exposure. Further, “inconsistencies in findings within and across the individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.”
The agency said it is reviewing several sources of safety data for glargine, including completed and ongoing controlled clinical trials, to better assess whether there is a risk of cancer associated with the insulin analogue. Discussions are taking place between the FDA and Sanofi-Aventis to determine if additional safety and efficacy studies will need to be performed. The FDA said it will communicate its findings to the public as soon as its review of insulin glargine is complete.
Sanofi-Aventis also issued a statement saying that the company “stands behind the safety of Lantus. … The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus use and the occurrence of malignancies.”
Dr. Gale and Dr. Smith pointed to other noteworthy findings from the studies. For example, the results of the Welch study showed that hazard ratios for cancer increased for all insulin-based regimens is consistent with other data suggesting that insulin use overall increases the risk for malignancy.
The Welch study also demonstrated the protective effect of metformin, including the suggestion that adding metformin to monotherapy with sulfonylureas or insulin slowed the rate of cancer development.
“These observations suggest that metformin may come to play a major role in cancer prevention in diabetes. For present purposes, however, the points to note are that concomitant metformin use is potentially a major confounder when it comes to estimating the risks of insulin therapy. … Furthermore, the lack of effect of metformin on breast cancer, if confirmed, might help to explain why this particular cancer has tended to emerge from the analysis conducted in the previous two studies,” they commented.
“We have no conclusive proof that Lantus is associated with a higher rate of cancer. The German study is suggestive, but relies on a statistical correction for insulin dose. The Swedish and Scottish studies are essentially negative in all respects except that of breast cancer. Individually, as we have emphasised, neither study is in any way conclusive. Taken together, however, they make it clear that there is indeed a case to answer,” Dr. Smith said. He added that new data will be presented at the EASD meeting in Vienna in September.
Dr. Smith and Dr. Gale reporting having no conflict of interest. Dr. Jellinger is on the speakers' bureau for several pharmaceutical companies, including Novo Nordisk, Amylin Lilly, and Takeda.
Four Registry Studies on Insulin Glargine and Cancer Yield Different Results
The first of the four studies, reporting a dose-dependent increase in cancer risk with glargine compared with human insulin in a study of more than 100,000 patients, was submitted to Diabetologia last year, Dr. Gale and Dr. Smith explained in their editorial. Its findings suggested that, compared with people using similar doses of human insulin, out of every 100 people who used Lantus insulin over an average of about 1.5 years, 1 additional person was diagnosed with cancer (Diabetologia 2009 June 26;
However, because of the study's limitations and its enormous implications, the European Association for the Study of Diabetes held the article and requested the three other analyses of data from national diabetes registries in Sweden, Scotland, and Wales to see if the findings could be replicated. All four studies were published simultaneously.
The German Study
The first study included 127,031 insulin-treated diabetic patients from a national health insurance database, all without known malignant disease at baseline and who had received first-time treatment exclusively with either human insulin (95,804), lispro (3,269), aspart (4,103), or glargine (23,855) exclusively (Diabetologia 2009 June 26;
At a mean follow-up of 1.63 years, the unadjusted risk for developing a malignant neoplasm was actually lower in those using all three analogues. But because patients taking a combination of human and analogue insulins had been excluded from the study, the glargine patients were using much lower overall doses than were those on human insulin (median 22 vs. 37 IU/day). After adjustment for daily dose, the risk was significantly increased for those taking glargine, compared with those taking human insulin, with hazard ratios of 1.09 for 10 IU/day, 1.19 for 30 IU/day, and 1.31 for 50 IU/day. No such increases were seen with either of the short-acting analogues lispro or aspart.
The Swedish Study
The Swedish study followed 114,841 individuals aged 35-84 years who had a prescription dispensed for insulin during the latter 6 months of 2005 and linked them with cancer registry data during 2006-2007.
After adjustment for age and sex, the overall rate of malignancy was not elevated for glargine monotherapy, compared with other insulins, nor were the specific rates of prostate or gastrointestinal cancers. However, after adjustment for a variety of other factors, women who took glargine had a significantly higher rate of breast cancer than did women who took other types of insulins as monotherapy (relative risk 1.97).
The Scottish Study
The Scottish group examined a total of 36,254 people using insulin over a 4-month period from a database that includes almost every individual in the country with diabetes. In a 4-year follow-up, the overall group of 3,959 using glargine had the same incidence of all cancers as did those not using glargine (hazard ratio 1.02). However, the subset of 447 patients using glargine as their sole insulin had a significantly higher incidence of all cancers than did the 32,295 using other insulins only (HR 1.55), while those using glargine with other insulins had a slightly lower incidence (HR 0.81).
Overall, there was no increase in breast cancer rates associated with insulin glargine use (HR 1.49), and no differences in breast cancer or all cancers were seen among type 2 diabetic insulin users, they reported.
The authors noted important differences in baseline characteristics between the insulin treatment groups. For example, patients using glargine alone were older than were those on glargine plus other insulins (68 vs. 41 years) and users of other insulins (60 years). Those on glargine alone also were more overweight, more hypertensive, and more likely to be on oral glucose-lowering drugs.
The Welch Study
This study was a retrospective cohort study of 62,809 people treated in U.K. general practices that participate in a national health information network (Diabetologia 2009 June 26;
These patients were all above age 40 at the time of diagnosis and were divided into four treatment groups: monotherapy with metformin or sulfonylurea, combination therapy with the two oral agents, or insulin. The insulin users were further subdivided into users of glargine, long-acting human insulin, biphasic analogue, or human biphasic insulin.
Metformin monotherapy carried the lowest risk of cancer, consistent with previous data suggesting that metformin may have a protective effect against malignancy. Compared with that group, the hazard ratio was 1.08 for those taking metformin plus sulfonylurea, 1.36 for sulfonylurea monotherapy, and 1.42 for insulin-based regimens. The latter finding is also consistent with other data suggesting that insulin use overall increases the risk for malignancy, Dr. Smith and Dr. Gale noted.
Adding metformin to insulin reduced the progression to cancer (HR 0.54). The hazard ratio for those on basal human insulin alone vs. glargine alone was 1.24, the authors noted.
Oseltamivir-Resistant Novel H1N1 Reported
Oseltamivir-resistant novel influenza A(H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients treated for leukemia in Seattle hospitals.
The teenaged male and a woman in her 40s had undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses that later developed resistance. The two patients were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers, the Centers for Disease Control and Prevention reported.
In both patients, the viruses were susceptible to zanamivir. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A(H1N1) virus.
Immunosuppressed patients should receive annual influenza vaccination. Clinicians caring for immunosuppressed patients infected with novel H1N1 should be aware of the potential for antiviral drug resistance and prolonged viral shedding, the CDC said.
The public health risk of virus transmission from these two cases appears to be low. Washington state, working with the CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains.
Oseltamivir or zanamivir are recommended for all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.
For guidance on treating and preventing novel H1N1, go to www.cdc.gov/h1n1flu
Oseltamivir-resistant novel influenza A(H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients treated for leukemia in Seattle hospitals.
The teenaged male and a woman in her 40s had undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses that later developed resistance. The two patients were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers, the Centers for Disease Control and Prevention reported.
In both patients, the viruses were susceptible to zanamivir. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A(H1N1) virus.
Immunosuppressed patients should receive annual influenza vaccination. Clinicians caring for immunosuppressed patients infected with novel H1N1 should be aware of the potential for antiviral drug resistance and prolonged viral shedding, the CDC said.
The public health risk of virus transmission from these two cases appears to be low. Washington state, working with the CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains.
Oseltamivir or zanamivir are recommended for all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.
For guidance on treating and preventing novel H1N1, go to www.cdc.gov/h1n1flu
Oseltamivir-resistant novel influenza A(H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients treated for leukemia in Seattle hospitals.
The teenaged male and a woman in her 40s had undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses that later developed resistance. The two patients were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers, the Centers for Disease Control and Prevention reported.
In both patients, the viruses were susceptible to zanamivir. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A(H1N1) virus.
Immunosuppressed patients should receive annual influenza vaccination. Clinicians caring for immunosuppressed patients infected with novel H1N1 should be aware of the potential for antiviral drug resistance and prolonged viral shedding, the CDC said.
The public health risk of virus transmission from these two cases appears to be low. Washington state, working with the CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains.
Oseltamivir or zanamivir are recommended for all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.
For guidance on treating and preventing novel H1N1, go to www.cdc.gov/h1n1flu
Japanese Encephalitis Vaccination Urged for Travel to Asia
ATLANTA — Japanese encephalitis was identified in four U.S. travelers who returned from Asia during 2003-2008.
The four are the only known cases of Japanese encephalitis among U.S. residents to have occurred since the licensure of a vaccine against the mosquito-borne infection in 1992.
All were civilian travelers or Asian expatriates, the Centers for Disease Control and Prevention reported (MMWR 2009;58:737-40).
Japanese encephalitis should be suspected in a patient with evidence of a neuroinvasive viral infection such as encephalitis, aseptic meningitis, or acute flaccid paralysis, who recently returned from a Japanese encephalitis-endemic country in Asia or the western Pacific.
Health care providers should contact their state or local health department or the CDC's Division of Vector-Borne Infectious Diseases at 970-221-6400 for assistance with diagnostic testing, the CDC said.
In June, the CDC's Advisory Committee on Immunization Practices recommended Japanese encephalitis vaccination for travelers who plan to spend a month or longer in endemic areas during transmission season.
The committee also advised that vaccination be considered for short-term (less than 1 month) travelers to endemic areas during transmission season if they will both travel outside of urban areas and engage in activities that increase the risk of exposure to mosquito bites.
The virus circulates in parts of China, India, Japan, and Southeast Asia, and all travelers to endemic countries should be advised of the risks of Japanese encephalitis disease and the importance of measures to reduce mosquito bites.
However, vaccination is not recommended for short-term travelers whose visit will be restricted to urban areas or whose visit will occur outside of a well-defined Japanese encephalitis virus transmission season, which varies by region, according to the ACIP. The CDC usually follows the recommendations of the committee.
Japanese encephalitis is the leading cause of encephalitis in Asia, with 35,000-50,000 cases annually, a case-fatality rate of 20%-30%, and a 30%-50% risk for significant sequelae among survivors.
There is no antiviral therapy, Dr. Marc Fischer, of the CDC's Arboviral Diseases Branch, said at the ACIP meeting.
One of the four Japanese encephalitis cases, a previously healthy unvaccinated 22-year-old student returning from a study-abroad program in Thailand, was initially reported in 2004. She recovered without apparent sequelae (MMWR 2005;54:123-5).
The other three cases had not been reported until now. All three patients were Asian immigrants or family members who traveled to Asia to visit friends or relatives and had not been vaccinated against Japanese encephalitis.
All recovered, but two had residual neurologic deficits, the CDC said.
In March 2009, the Food and Drug Administration licensed a new Japanese encephalitis vaccine, Intercell's Ixiaro (distributed by Novartis), for use in adults aged 17 years and older.
The only other Japanese encephalitis vaccine available in the United States, JE-Vax (Biken/Sanofi Pasteur), was associated with hypersensitivity reactions (20-600 cases per 100,000 vaccine recipients) as well as rare neurologic events (0.1-2 cases per 100,000 recipients).
JE-Vax is licensed for children and adults aged 1 year and older, but is no longer being produced. Sanofi Pasteur maintains a stockpile for children 1-16 years of age who meet the travel criteria, Dr. Fischer noted at the ACIP meeting.
More information about Japanese encephalitis (including seasonality) is available at the CDC Web site at www.cdc.gov/ncidod/dvbid/jencephalitis
ATLANTA — Japanese encephalitis was identified in four U.S. travelers who returned from Asia during 2003-2008.
The four are the only known cases of Japanese encephalitis among U.S. residents to have occurred since the licensure of a vaccine against the mosquito-borne infection in 1992.
All were civilian travelers or Asian expatriates, the Centers for Disease Control and Prevention reported (MMWR 2009;58:737-40).
Japanese encephalitis should be suspected in a patient with evidence of a neuroinvasive viral infection such as encephalitis, aseptic meningitis, or acute flaccid paralysis, who recently returned from a Japanese encephalitis-endemic country in Asia or the western Pacific.
Health care providers should contact their state or local health department or the CDC's Division of Vector-Borne Infectious Diseases at 970-221-6400 for assistance with diagnostic testing, the CDC said.
In June, the CDC's Advisory Committee on Immunization Practices recommended Japanese encephalitis vaccination for travelers who plan to spend a month or longer in endemic areas during transmission season.
The committee also advised that vaccination be considered for short-term (less than 1 month) travelers to endemic areas during transmission season if they will both travel outside of urban areas and engage in activities that increase the risk of exposure to mosquito bites.
The virus circulates in parts of China, India, Japan, and Southeast Asia, and all travelers to endemic countries should be advised of the risks of Japanese encephalitis disease and the importance of measures to reduce mosquito bites.
However, vaccination is not recommended for short-term travelers whose visit will be restricted to urban areas or whose visit will occur outside of a well-defined Japanese encephalitis virus transmission season, which varies by region, according to the ACIP. The CDC usually follows the recommendations of the committee.
Japanese encephalitis is the leading cause of encephalitis in Asia, with 35,000-50,000 cases annually, a case-fatality rate of 20%-30%, and a 30%-50% risk for significant sequelae among survivors.
There is no antiviral therapy, Dr. Marc Fischer, of the CDC's Arboviral Diseases Branch, said at the ACIP meeting.
One of the four Japanese encephalitis cases, a previously healthy unvaccinated 22-year-old student returning from a study-abroad program in Thailand, was initially reported in 2004. She recovered without apparent sequelae (MMWR 2005;54:123-5).
The other three cases had not been reported until now. All three patients were Asian immigrants or family members who traveled to Asia to visit friends or relatives and had not been vaccinated against Japanese encephalitis.
All recovered, but two had residual neurologic deficits, the CDC said.
In March 2009, the Food and Drug Administration licensed a new Japanese encephalitis vaccine, Intercell's Ixiaro (distributed by Novartis), for use in adults aged 17 years and older.
The only other Japanese encephalitis vaccine available in the United States, JE-Vax (Biken/Sanofi Pasteur), was associated with hypersensitivity reactions (20-600 cases per 100,000 vaccine recipients) as well as rare neurologic events (0.1-2 cases per 100,000 recipients).
JE-Vax is licensed for children and adults aged 1 year and older, but is no longer being produced. Sanofi Pasteur maintains a stockpile for children 1-16 years of age who meet the travel criteria, Dr. Fischer noted at the ACIP meeting.
More information about Japanese encephalitis (including seasonality) is available at the CDC Web site at www.cdc.gov/ncidod/dvbid/jencephalitis
ATLANTA — Japanese encephalitis was identified in four U.S. travelers who returned from Asia during 2003-2008.
The four are the only known cases of Japanese encephalitis among U.S. residents to have occurred since the licensure of a vaccine against the mosquito-borne infection in 1992.
All were civilian travelers or Asian expatriates, the Centers for Disease Control and Prevention reported (MMWR 2009;58:737-40).
Japanese encephalitis should be suspected in a patient with evidence of a neuroinvasive viral infection such as encephalitis, aseptic meningitis, or acute flaccid paralysis, who recently returned from a Japanese encephalitis-endemic country in Asia or the western Pacific.
Health care providers should contact their state or local health department or the CDC's Division of Vector-Borne Infectious Diseases at 970-221-6400 for assistance with diagnostic testing, the CDC said.
In June, the CDC's Advisory Committee on Immunization Practices recommended Japanese encephalitis vaccination for travelers who plan to spend a month or longer in endemic areas during transmission season.
The committee also advised that vaccination be considered for short-term (less than 1 month) travelers to endemic areas during transmission season if they will both travel outside of urban areas and engage in activities that increase the risk of exposure to mosquito bites.
The virus circulates in parts of China, India, Japan, and Southeast Asia, and all travelers to endemic countries should be advised of the risks of Japanese encephalitis disease and the importance of measures to reduce mosquito bites.
However, vaccination is not recommended for short-term travelers whose visit will be restricted to urban areas or whose visit will occur outside of a well-defined Japanese encephalitis virus transmission season, which varies by region, according to the ACIP. The CDC usually follows the recommendations of the committee.
Japanese encephalitis is the leading cause of encephalitis in Asia, with 35,000-50,000 cases annually, a case-fatality rate of 20%-30%, and a 30%-50% risk for significant sequelae among survivors.
There is no antiviral therapy, Dr. Marc Fischer, of the CDC's Arboviral Diseases Branch, said at the ACIP meeting.
One of the four Japanese encephalitis cases, a previously healthy unvaccinated 22-year-old student returning from a study-abroad program in Thailand, was initially reported in 2004. She recovered without apparent sequelae (MMWR 2005;54:123-5).
The other three cases had not been reported until now. All three patients were Asian immigrants or family members who traveled to Asia to visit friends or relatives and had not been vaccinated against Japanese encephalitis.
All recovered, but two had residual neurologic deficits, the CDC said.
In March 2009, the Food and Drug Administration licensed a new Japanese encephalitis vaccine, Intercell's Ixiaro (distributed by Novartis), for use in adults aged 17 years and older.
The only other Japanese encephalitis vaccine available in the United States, JE-Vax (Biken/Sanofi Pasteur), was associated with hypersensitivity reactions (20-600 cases per 100,000 vaccine recipients) as well as rare neurologic events (0.1-2 cases per 100,000 recipients).
JE-Vax is licensed for children and adults aged 1 year and older, but is no longer being produced. Sanofi Pasteur maintains a stockpile for children 1-16 years of age who meet the travel criteria, Dr. Fischer noted at the ACIP meeting.
More information about Japanese encephalitis (including seasonality) is available at the CDC Web site at www.cdc.gov/ncidod/dvbid/jencephalitis
Five Populations Targeted for Priority H1N1 Vaccination
ATLANTA Initial vaccination efforts against the novel influenza A(H1N1) should focus on immunizing as many people as possible in five target groups, while smaller subsets of some of those groups should be targeted if demand for vaccine exceeds supply. As more supply becomes available, the rest of the population should be targeted for vaccination.
Those recommendations were made by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. Primary targets for novel influenza A(H1N1) immunization efforts include the following five groups, which together total approximately 159 million individuals in the United States. Current seasonal influenza coverage among these groups is only 20%50%, said Dr. Anthony J. Fiore of the CDC's Influenza Division.
▸Group 1Pregnant women. They have been found to be at higher risk for complications from seasonal influenza in past pandemics, and several deaths have been reported among pregnant women during the current 2009 pandemic. The vaccination of pregnant women also is seen as a way to potentially protect infants who cannot be vaccinated, via transfer of maternal antibodies to newborns.
▸Group 2Household contacts and caregivers for infants younger than 6 months of age. The aim is to provide a possible "cocooning effect," providing indirect protection for young infants who cannot be vaccinated but are at higher risk for influenza-related complications.
▸Group 3Health care personnel and emergency medical personnel (including emergency medical technicians, firefighters, and others whose jobs involve routinely providing emergency medical care in communities). These individuals are seen as a potential source of infection for vulnerable patients. In addition, increased absenteeism could reduce the health care capacity.
▸Group 4Children and adults from 6 months through 24 years of age. Children have the highest incidence of illness, and "explosive" outbreaks in schools have been a prominent feature of the spring 2009 epidemiology of the novel influenza A(H1N1). Children younger than 5 years of age are at the highest risk for hospitalization, and are sources of infection for the community and in schools. Moreover, illness in children keeps parents home from work. Young adults also have high attack rates and are seen as vectors.
▸Group 5Adults aged 2564 years with certain medical conditions that place them at greater risk for influenza-related complications. These include chronic pulmonary, cardiovascular, renal, hepatic, cognitive, neuromuscular, hematologic, and metabolic disorders, as well as immunosuppression caused by medications or HIV infection. About 70% of adults hospitalized thus far with novel H1N1 infections had one of these conditions.
If vaccine demand exceeds availability, subgroups of the larger group, totaling 42 million people, should receive priority. The first subgroupspregnant women and household and caregiver contacts for infants younger than 6 months of ageremain unchanged as a priority. The next subgroups include health care and emergency personnel in direct contact with patients; children aged 6 months through 4 years; and children with chronic medical conditions.
When vaccine availability is sufficient at the local level to routinely vaccinate initial target populations, a decision should be made in cooperation with state and local health authorities to vaccinate healthy adults aged 2564 years first, then individuals aged 65 years and older. The last recommendation, in contrast to seasonal influenza vaccination recommendations, reflects the fact that older individuals thus far have been at lower risk for the novel influenza A(H1N1) virus.
New recommendations were needed, Dr. Fiore said, because the federal government's 2007 pandemic vaccine priority guidance had been developed for the scenario of a severe pandemic with the potential for social disruption of critical infrastructure. ACIP's Influenza Working Group concluded that current epidemiologic and immunologic evidence, combined with updated information on vaccine supply and availability, indicated a need to revise recommendations that had been made during prepandemic planning.
In drafting the document that ACIP voted on, the working group assumed the following: The severity of illness and groups at higher risk for infection or complications will be similar to what has already been observed; the safety profile and antigen content of novel H1N1 vaccines will be similar to that of seasonal vaccine; and adequate supplies of licensed unadjuvanted vaccine can be produced for all by approximately February 2010 but that enough vaccines for all will not be available before the next pandemic wave, expected this fall.
ATLANTA Initial vaccination efforts against the novel influenza A(H1N1) should focus on immunizing as many people as possible in five target groups, while smaller subsets of some of those groups should be targeted if demand for vaccine exceeds supply. As more supply becomes available, the rest of the population should be targeted for vaccination.
Those recommendations were made by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. Primary targets for novel influenza A(H1N1) immunization efforts include the following five groups, which together total approximately 159 million individuals in the United States. Current seasonal influenza coverage among these groups is only 20%50%, said Dr. Anthony J. Fiore of the CDC's Influenza Division.
▸Group 1Pregnant women. They have been found to be at higher risk for complications from seasonal influenza in past pandemics, and several deaths have been reported among pregnant women during the current 2009 pandemic. The vaccination of pregnant women also is seen as a way to potentially protect infants who cannot be vaccinated, via transfer of maternal antibodies to newborns.
▸Group 2Household contacts and caregivers for infants younger than 6 months of age. The aim is to provide a possible "cocooning effect," providing indirect protection for young infants who cannot be vaccinated but are at higher risk for influenza-related complications.
▸Group 3Health care personnel and emergency medical personnel (including emergency medical technicians, firefighters, and others whose jobs involve routinely providing emergency medical care in communities). These individuals are seen as a potential source of infection for vulnerable patients. In addition, increased absenteeism could reduce the health care capacity.
▸Group 4Children and adults from 6 months through 24 years of age. Children have the highest incidence of illness, and "explosive" outbreaks in schools have been a prominent feature of the spring 2009 epidemiology of the novel influenza A(H1N1). Children younger than 5 years of age are at the highest risk for hospitalization, and are sources of infection for the community and in schools. Moreover, illness in children keeps parents home from work. Young adults also have high attack rates and are seen as vectors.
▸Group 5Adults aged 2564 years with certain medical conditions that place them at greater risk for influenza-related complications. These include chronic pulmonary, cardiovascular, renal, hepatic, cognitive, neuromuscular, hematologic, and metabolic disorders, as well as immunosuppression caused by medications or HIV infection. About 70% of adults hospitalized thus far with novel H1N1 infections had one of these conditions.
If vaccine demand exceeds availability, subgroups of the larger group, totaling 42 million people, should receive priority. The first subgroupspregnant women and household and caregiver contacts for infants younger than 6 months of ageremain unchanged as a priority. The next subgroups include health care and emergency personnel in direct contact with patients; children aged 6 months through 4 years; and children with chronic medical conditions.
When vaccine availability is sufficient at the local level to routinely vaccinate initial target populations, a decision should be made in cooperation with state and local health authorities to vaccinate healthy adults aged 2564 years first, then individuals aged 65 years and older. The last recommendation, in contrast to seasonal influenza vaccination recommendations, reflects the fact that older individuals thus far have been at lower risk for the novel influenza A(H1N1) virus.
New recommendations were needed, Dr. Fiore said, because the federal government's 2007 pandemic vaccine priority guidance had been developed for the scenario of a severe pandemic with the potential for social disruption of critical infrastructure. ACIP's Influenza Working Group concluded that current epidemiologic and immunologic evidence, combined with updated information on vaccine supply and availability, indicated a need to revise recommendations that had been made during prepandemic planning.
In drafting the document that ACIP voted on, the working group assumed the following: The severity of illness and groups at higher risk for infection or complications will be similar to what has already been observed; the safety profile and antigen content of novel H1N1 vaccines will be similar to that of seasonal vaccine; and adequate supplies of licensed unadjuvanted vaccine can be produced for all by approximately February 2010 but that enough vaccines for all will not be available before the next pandemic wave, expected this fall.
ATLANTA Initial vaccination efforts against the novel influenza A(H1N1) should focus on immunizing as many people as possible in five target groups, while smaller subsets of some of those groups should be targeted if demand for vaccine exceeds supply. As more supply becomes available, the rest of the population should be targeted for vaccination.
Those recommendations were made by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. Primary targets for novel influenza A(H1N1) immunization efforts include the following five groups, which together total approximately 159 million individuals in the United States. Current seasonal influenza coverage among these groups is only 20%50%, said Dr. Anthony J. Fiore of the CDC's Influenza Division.
▸Group 1Pregnant women. They have been found to be at higher risk for complications from seasonal influenza in past pandemics, and several deaths have been reported among pregnant women during the current 2009 pandemic. The vaccination of pregnant women also is seen as a way to potentially protect infants who cannot be vaccinated, via transfer of maternal antibodies to newborns.
▸Group 2Household contacts and caregivers for infants younger than 6 months of age. The aim is to provide a possible "cocooning effect," providing indirect protection for young infants who cannot be vaccinated but are at higher risk for influenza-related complications.
▸Group 3Health care personnel and emergency medical personnel (including emergency medical technicians, firefighters, and others whose jobs involve routinely providing emergency medical care in communities). These individuals are seen as a potential source of infection for vulnerable patients. In addition, increased absenteeism could reduce the health care capacity.
▸Group 4Children and adults from 6 months through 24 years of age. Children have the highest incidence of illness, and "explosive" outbreaks in schools have been a prominent feature of the spring 2009 epidemiology of the novel influenza A(H1N1). Children younger than 5 years of age are at the highest risk for hospitalization, and are sources of infection for the community and in schools. Moreover, illness in children keeps parents home from work. Young adults also have high attack rates and are seen as vectors.
▸Group 5Adults aged 2564 years with certain medical conditions that place them at greater risk for influenza-related complications. These include chronic pulmonary, cardiovascular, renal, hepatic, cognitive, neuromuscular, hematologic, and metabolic disorders, as well as immunosuppression caused by medications or HIV infection. About 70% of adults hospitalized thus far with novel H1N1 infections had one of these conditions.
If vaccine demand exceeds availability, subgroups of the larger group, totaling 42 million people, should receive priority. The first subgroupspregnant women and household and caregiver contacts for infants younger than 6 months of ageremain unchanged as a priority. The next subgroups include health care and emergency personnel in direct contact with patients; children aged 6 months through 4 years; and children with chronic medical conditions.
When vaccine availability is sufficient at the local level to routinely vaccinate initial target populations, a decision should be made in cooperation with state and local health authorities to vaccinate healthy adults aged 2564 years first, then individuals aged 65 years and older. The last recommendation, in contrast to seasonal influenza vaccination recommendations, reflects the fact that older individuals thus far have been at lower risk for the novel influenza A(H1N1) virus.
New recommendations were needed, Dr. Fiore said, because the federal government's 2007 pandemic vaccine priority guidance had been developed for the scenario of a severe pandemic with the potential for social disruption of critical infrastructure. ACIP's Influenza Working Group concluded that current epidemiologic and immunologic evidence, combined with updated information on vaccine supply and availability, indicated a need to revise recommendations that had been made during prepandemic planning.
In drafting the document that ACIP voted on, the working group assumed the following: The severity of illness and groups at higher risk for infection or complications will be similar to what has already been observed; the safety profile and antigen content of novel H1N1 vaccines will be similar to that of seasonal vaccine; and adequate supplies of licensed unadjuvanted vaccine can be produced for all by approximately February 2010 but that enough vaccines for all will not be available before the next pandemic wave, expected this fall.
Overweight, Obesity Account for 46% of Gestational Diabetes Cases
NEW ORLEANS — The proportion of gestational diabetes cases attributable to overweight and obesity totaled 46% in a population-based study of more than 20,000 women from seven states.
The data, from the Centers for Disease Control and Prevention's Pregnancy Risk Assessment Monitoring System (PRAMS), were used to generate a population-based estimate of the contribution of prepregnancy overweight and obesity to the development of gestational diabetes mellitus (GDM). The results were reported by Shin Y. Kim at the annual scientific sessions of the American Diabetes Association.
“If we assume that the relationship between GDM and obesity and overweight is causal and no other confounders exist, then a large proportion of GDM cases are potentially preventable,” said Dr. Kim of the CDC's Division of Reproductive Health.
She and her associates analyzed PRAMS data from the seven states that had implemented the 2003 revised birth certificate, which distinguishes GDM from diabetes that existed prior to pregnancy. The surveillance system collects data via a questionnaire from mothers of newborns 2-6 months after delivery.
A total of 22,767 women with complete chart information who did not have pre-existing diabetes were included.
The overall GDM prevalence was 4%, ranging from 3.1% in Florida to 5% in Ohio. (The other five states were Nebraska, South Carolina, Utah, Washington, and New York, excluding New York City.)
More than 70% of the women with GDM had a prepregnancy body mass index greater than or equal to 25 kg/m
The GDM prevalence was 0.7% for women classified as underweight (BMI 13-18.4 kg/m
With normal weight used as the reference group, the unadjusted relative risks of developing GDM were 2.1, 2.4, and 5 for women who were overweight, obese, and extremely obese, respectively.
“The probability of GDM increases with increasing BMI, with no clear BMI threshold below which a dose-response relationship was not evident,” Ms. Kim said.
The relative risks did not change after adjustment for maternal age, race/ethnicity, marital status, or parity. Once adjusted, the proportions of gestational diabetes cases attributable to overweight, obesity, and extreme obesity were 15%, 10%, and 21%, for a total of 46%.
“In other words, if all women with a BMI of 25 or greater had a GDM risk equal to that of women in the normal BMI category, nearly half of GDM cases could be prevented. Lifestyle interventions to reduce BMI have the potential to lower GDM risk,” she said.
There are a few possible reasons for why overweight/obesity contributed to only about half of GDM cases, Ms. Kim said in a follow-up interview.
“First, prepregnancy weight was self-reported, and women tend to underreport their weight. This may have led us to underestimate the contribution of overweight and obesity to the fraction of GDM attributable to weight. Also, there may be a race/ethnic difference in the relationship between BMI and GDM risk, and our analysis overrepresents non-Hispanic white women compared to the general population,” she noted.
Ms. Kim indicated that she had no conflicts of interest to disclose.
NEW ORLEANS — The proportion of gestational diabetes cases attributable to overweight and obesity totaled 46% in a population-based study of more than 20,000 women from seven states.
The data, from the Centers for Disease Control and Prevention's Pregnancy Risk Assessment Monitoring System (PRAMS), were used to generate a population-based estimate of the contribution of prepregnancy overweight and obesity to the development of gestational diabetes mellitus (GDM). The results were reported by Shin Y. Kim at the annual scientific sessions of the American Diabetes Association.
“If we assume that the relationship between GDM and obesity and overweight is causal and no other confounders exist, then a large proportion of GDM cases are potentially preventable,” said Dr. Kim of the CDC's Division of Reproductive Health.
She and her associates analyzed PRAMS data from the seven states that had implemented the 2003 revised birth certificate, which distinguishes GDM from diabetes that existed prior to pregnancy. The surveillance system collects data via a questionnaire from mothers of newborns 2-6 months after delivery.
A total of 22,767 women with complete chart information who did not have pre-existing diabetes were included.
The overall GDM prevalence was 4%, ranging from 3.1% in Florida to 5% in Ohio. (The other five states were Nebraska, South Carolina, Utah, Washington, and New York, excluding New York City.)
More than 70% of the women with GDM had a prepregnancy body mass index greater than or equal to 25 kg/m
The GDM prevalence was 0.7% for women classified as underweight (BMI 13-18.4 kg/m
With normal weight used as the reference group, the unadjusted relative risks of developing GDM were 2.1, 2.4, and 5 for women who were overweight, obese, and extremely obese, respectively.
“The probability of GDM increases with increasing BMI, with no clear BMI threshold below which a dose-response relationship was not evident,” Ms. Kim said.
The relative risks did not change after adjustment for maternal age, race/ethnicity, marital status, or parity. Once adjusted, the proportions of gestational diabetes cases attributable to overweight, obesity, and extreme obesity were 15%, 10%, and 21%, for a total of 46%.
“In other words, if all women with a BMI of 25 or greater had a GDM risk equal to that of women in the normal BMI category, nearly half of GDM cases could be prevented. Lifestyle interventions to reduce BMI have the potential to lower GDM risk,” she said.
There are a few possible reasons for why overweight/obesity contributed to only about half of GDM cases, Ms. Kim said in a follow-up interview.
“First, prepregnancy weight was self-reported, and women tend to underreport their weight. This may have led us to underestimate the contribution of overweight and obesity to the fraction of GDM attributable to weight. Also, there may be a race/ethnic difference in the relationship between BMI and GDM risk, and our analysis overrepresents non-Hispanic white women compared to the general population,” she noted.
Ms. Kim indicated that she had no conflicts of interest to disclose.
NEW ORLEANS — The proportion of gestational diabetes cases attributable to overweight and obesity totaled 46% in a population-based study of more than 20,000 women from seven states.
The data, from the Centers for Disease Control and Prevention's Pregnancy Risk Assessment Monitoring System (PRAMS), were used to generate a population-based estimate of the contribution of prepregnancy overweight and obesity to the development of gestational diabetes mellitus (GDM). The results were reported by Shin Y. Kim at the annual scientific sessions of the American Diabetes Association.
“If we assume that the relationship between GDM and obesity and overweight is causal and no other confounders exist, then a large proportion of GDM cases are potentially preventable,” said Dr. Kim of the CDC's Division of Reproductive Health.
She and her associates analyzed PRAMS data from the seven states that had implemented the 2003 revised birth certificate, which distinguishes GDM from diabetes that existed prior to pregnancy. The surveillance system collects data via a questionnaire from mothers of newborns 2-6 months after delivery.
A total of 22,767 women with complete chart information who did not have pre-existing diabetes were included.
The overall GDM prevalence was 4%, ranging from 3.1% in Florida to 5% in Ohio. (The other five states were Nebraska, South Carolina, Utah, Washington, and New York, excluding New York City.)
More than 70% of the women with GDM had a prepregnancy body mass index greater than or equal to 25 kg/m
The GDM prevalence was 0.7% for women classified as underweight (BMI 13-18.4 kg/m
With normal weight used as the reference group, the unadjusted relative risks of developing GDM were 2.1, 2.4, and 5 for women who were overweight, obese, and extremely obese, respectively.
“The probability of GDM increases with increasing BMI, with no clear BMI threshold below which a dose-response relationship was not evident,” Ms. Kim said.
The relative risks did not change after adjustment for maternal age, race/ethnicity, marital status, or parity. Once adjusted, the proportions of gestational diabetes cases attributable to overweight, obesity, and extreme obesity were 15%, 10%, and 21%, for a total of 46%.
“In other words, if all women with a BMI of 25 or greater had a GDM risk equal to that of women in the normal BMI category, nearly half of GDM cases could be prevented. Lifestyle interventions to reduce BMI have the potential to lower GDM risk,” she said.
There are a few possible reasons for why overweight/obesity contributed to only about half of GDM cases, Ms. Kim said in a follow-up interview.
“First, prepregnancy weight was self-reported, and women tend to underreport their weight. This may have led us to underestimate the contribution of overweight and obesity to the fraction of GDM attributable to weight. Also, there may be a race/ethnic difference in the relationship between BMI and GDM risk, and our analysis overrepresents non-Hispanic white women compared to the general population,” she noted.
Ms. Kim indicated that she had no conflicts of interest to disclose.
Obesity Prevalence Higher Among Blacks, Hispanics
Prevalence of obesity was 51% higher for blacks and 21% higher for Hispanics, compared with whites in the United States during 2006-2008, according to Centers for Disease Control and Prevention data.
An analysis of data from the Behavioral Risk Factor Surveillance System surveys revealed an overall obesity rate of 25.6% for non-Hispanic blacks, non-Hispanic whites, and Hispanics. Individually, blacks had an obesity rate of 35.7%, Hispanics 28.7%, and whites 23.7%, the CDC said in Morbidity and Mortality Weekly Report (2009;58:740-4).
Obesity was defined as a body mass index of 30 kg/m
The pattern was consistent across most U.S. states. However, state obesity prevalences by race varied considerably. For blacks, the range was from 23.0% in New Hampshire to 45.1% in Maine. For Hispanics, obesity rates ranged from 21.0% in Maryland to 36.7% in Tennessee. And for whites, the range was from 9.0% in the District of Columbia to 30.2% in West Virginia.
By sex and racial/ethnic group, black women had the greatest prevalence of obesity (39.2%), followed by black men (31.6%), and Hispanic women (29.4%), the report said. White women had the lowest prevalence, 21.8%. Possible reasons for the population differences include differing behaviors surrounding food and exercise, attitudes and cultural norms, and lack of access to healthful foods in many minority neighborhoods, the CDC noted.
“If we have any hope of stemming the rise in obesity, we must intensify our efforts to create an environment for healthy living in these communities,” said Dr. William H. Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity.
The CDC currently provides funding and technical assistance to 25 states to develop their own effective obesity prevention and control programs, the report said. As part of this funding, states are implementing their own evidence-based policies, systems, and environmental strategies to address health disparities. For example, the New York State Department of Health uses both federal and state funds to increase access to fruits and vegetables for low-income, primarily minority populations.
Prevalence of obesity was 51% higher for blacks and 21% higher for Hispanics, compared with whites in the United States during 2006-2008, according to Centers for Disease Control and Prevention data.
An analysis of data from the Behavioral Risk Factor Surveillance System surveys revealed an overall obesity rate of 25.6% for non-Hispanic blacks, non-Hispanic whites, and Hispanics. Individually, blacks had an obesity rate of 35.7%, Hispanics 28.7%, and whites 23.7%, the CDC said in Morbidity and Mortality Weekly Report (2009;58:740-4).
Obesity was defined as a body mass index of 30 kg/m
The pattern was consistent across most U.S. states. However, state obesity prevalences by race varied considerably. For blacks, the range was from 23.0% in New Hampshire to 45.1% in Maine. For Hispanics, obesity rates ranged from 21.0% in Maryland to 36.7% in Tennessee. And for whites, the range was from 9.0% in the District of Columbia to 30.2% in West Virginia.
By sex and racial/ethnic group, black women had the greatest prevalence of obesity (39.2%), followed by black men (31.6%), and Hispanic women (29.4%), the report said. White women had the lowest prevalence, 21.8%. Possible reasons for the population differences include differing behaviors surrounding food and exercise, attitudes and cultural norms, and lack of access to healthful foods in many minority neighborhoods, the CDC noted.
“If we have any hope of stemming the rise in obesity, we must intensify our efforts to create an environment for healthy living in these communities,” said Dr. William H. Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity.
The CDC currently provides funding and technical assistance to 25 states to develop their own effective obesity prevention and control programs, the report said. As part of this funding, states are implementing their own evidence-based policies, systems, and environmental strategies to address health disparities. For example, the New York State Department of Health uses both federal and state funds to increase access to fruits and vegetables for low-income, primarily minority populations.
Prevalence of obesity was 51% higher for blacks and 21% higher for Hispanics, compared with whites in the United States during 2006-2008, according to Centers for Disease Control and Prevention data.
An analysis of data from the Behavioral Risk Factor Surveillance System surveys revealed an overall obesity rate of 25.6% for non-Hispanic blacks, non-Hispanic whites, and Hispanics. Individually, blacks had an obesity rate of 35.7%, Hispanics 28.7%, and whites 23.7%, the CDC said in Morbidity and Mortality Weekly Report (2009;58:740-4).
Obesity was defined as a body mass index of 30 kg/m
The pattern was consistent across most U.S. states. However, state obesity prevalences by race varied considerably. For blacks, the range was from 23.0% in New Hampshire to 45.1% in Maine. For Hispanics, obesity rates ranged from 21.0% in Maryland to 36.7% in Tennessee. And for whites, the range was from 9.0% in the District of Columbia to 30.2% in West Virginia.
By sex and racial/ethnic group, black women had the greatest prevalence of obesity (39.2%), followed by black men (31.6%), and Hispanic women (29.4%), the report said. White women had the lowest prevalence, 21.8%. Possible reasons for the population differences include differing behaviors surrounding food and exercise, attitudes and cultural norms, and lack of access to healthful foods in many minority neighborhoods, the CDC noted.
“If we have any hope of stemming the rise in obesity, we must intensify our efforts to create an environment for healthy living in these communities,” said Dr. William H. Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity.
The CDC currently provides funding and technical assistance to 25 states to develop their own effective obesity prevention and control programs, the report said. As part of this funding, states are implementing their own evidence-based policies, systems, and environmental strategies to address health disparities. For example, the New York State Department of Health uses both federal and state funds to increase access to fruits and vegetables for low-income, primarily minority populations.
Cervarix Is Effective Against CIN2+ Lesions
ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher has been confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.
And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at the June meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
GSK's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries including 27 in the European Union, according to Dr. Dubin, vice president, North American clinical development, GSK.
The final analysis enrolled 18,644 women aged 15–25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months after the first of three doses.
The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis. The final analysis was conducted when at least 36 cases of the primary end point were observed in the according-to-protocol cohort.
Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.
In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.
Irrespective of HPV lesion type, the efficacy of Cervarix in the naive women was 70% against CIN2+ lesions and 87% against CIN3+ lesions. For the total vaccinated cohort, irrespective of HPV lesion type, Cervarix efficacy was 30% for CIN2+ lesions and 33% for CIN3+ lesions.
Examination by the cumulative incidence over time showed that lesion development occurred at the same rates in the vaccine and control groups until about month 18, when the curve separation became apparent.
This is because most of the lesions detected during the first 18 months of the trial were derived from preexisting infections. Only after there was a “washout” of these lesions did the prophylactic effect of the vaccine become apparent, Dr. Dubin pointed out.
Cervarix also had a significant impact on colposcopy referrals, with reductions of 26% in the naive group and 10% in the total vaccinated cohort. Cervical excision procedures were also affected, with reductions of 10% in the naive and 25% in the total vaccinated group compared with the placebo group.
Cervarix also showed efficacy against CIN2+ lesions caused by nonvaccine types that are genetically related to vaccine types, particularly HPV-31 (related to HPV-16) and HPV-45 (related to HPV-18), Dr. Dubin said.
A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both). There were similar rates of medically significant conditions (32% with Cervarix vs. 32% with placebo), congenital anomalies (0.7% vs. 0.5%), and spontaneous abortions (9.1% and 8.7%).
The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.
The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18–26 years. A secondary end point was serum neutralizing geometric mean titers at month 7 in women aged 27–35 and 36–45 years.
The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules: 0, 1, and 6 months for Cervarix and 0, 2, and 6 months for Gardasil. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.
Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18–26, antibody titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27–35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.
Positivity rates at month 7 for HPV-16 and HPV-18 antibodies measured in cervicovaginal secretions were higher with Cervarix than with Gardasil. The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18. These data confirm differences in immunologic response between the two vaccines, Dr. Dubin said.
“Although the importance of these differences is unknown, they may represent determinants of duration of protection against HPV-16/18 and/or protection against nonvaccine types. Disease modeling will help determine how the observed differences in vaccine profiles may translate into differences in public health impact,” he said, adding that the current data “indicate that the GSK HPV vaccine is likely to provide long-lasting protection against cervical cancer.”
ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher has been confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.
And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at the June meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
GSK's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries including 27 in the European Union, according to Dr. Dubin, vice president, North American clinical development, GSK.
The final analysis enrolled 18,644 women aged 15–25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months after the first of three doses.
The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis. The final analysis was conducted when at least 36 cases of the primary end point were observed in the according-to-protocol cohort.
Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.
In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.
Irrespective of HPV lesion type, the efficacy of Cervarix in the naive women was 70% against CIN2+ lesions and 87% against CIN3+ lesions. For the total vaccinated cohort, irrespective of HPV lesion type, Cervarix efficacy was 30% for CIN2+ lesions and 33% for CIN3+ lesions.
Examination by the cumulative incidence over time showed that lesion development occurred at the same rates in the vaccine and control groups until about month 18, when the curve separation became apparent.
This is because most of the lesions detected during the first 18 months of the trial were derived from preexisting infections. Only after there was a “washout” of these lesions did the prophylactic effect of the vaccine become apparent, Dr. Dubin pointed out.
Cervarix also had a significant impact on colposcopy referrals, with reductions of 26% in the naive group and 10% in the total vaccinated cohort. Cervical excision procedures were also affected, with reductions of 10% in the naive and 25% in the total vaccinated group compared with the placebo group.
Cervarix also showed efficacy against CIN2+ lesions caused by nonvaccine types that are genetically related to vaccine types, particularly HPV-31 (related to HPV-16) and HPV-45 (related to HPV-18), Dr. Dubin said.
A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both). There were similar rates of medically significant conditions (32% with Cervarix vs. 32% with placebo), congenital anomalies (0.7% vs. 0.5%), and spontaneous abortions (9.1% and 8.7%).
The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.
The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18–26 years. A secondary end point was serum neutralizing geometric mean titers at month 7 in women aged 27–35 and 36–45 years.
The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules: 0, 1, and 6 months for Cervarix and 0, 2, and 6 months for Gardasil. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.
Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18–26, antibody titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27–35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.
Positivity rates at month 7 for HPV-16 and HPV-18 antibodies measured in cervicovaginal secretions were higher with Cervarix than with Gardasil. The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18. These data confirm differences in immunologic response between the two vaccines, Dr. Dubin said.
“Although the importance of these differences is unknown, they may represent determinants of duration of protection against HPV-16/18 and/or protection against nonvaccine types. Disease modeling will help determine how the observed differences in vaccine profiles may translate into differences in public health impact,” he said, adding that the current data “indicate that the GSK HPV vaccine is likely to provide long-lasting protection against cervical cancer.”
ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher has been confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.
And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at the June meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
GSK's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries including 27 in the European Union, according to Dr. Dubin, vice president, North American clinical development, GSK.
The final analysis enrolled 18,644 women aged 15–25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months after the first of three doses.
The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis. The final analysis was conducted when at least 36 cases of the primary end point were observed in the according-to-protocol cohort.
Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.
In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.
Irrespective of HPV lesion type, the efficacy of Cervarix in the naive women was 70% against CIN2+ lesions and 87% against CIN3+ lesions. For the total vaccinated cohort, irrespective of HPV lesion type, Cervarix efficacy was 30% for CIN2+ lesions and 33% for CIN3+ lesions.
Examination by the cumulative incidence over time showed that lesion development occurred at the same rates in the vaccine and control groups until about month 18, when the curve separation became apparent.
This is because most of the lesions detected during the first 18 months of the trial were derived from preexisting infections. Only after there was a “washout” of these lesions did the prophylactic effect of the vaccine become apparent, Dr. Dubin pointed out.
Cervarix also had a significant impact on colposcopy referrals, with reductions of 26% in the naive group and 10% in the total vaccinated cohort. Cervical excision procedures were also affected, with reductions of 10% in the naive and 25% in the total vaccinated group compared with the placebo group.
Cervarix also showed efficacy against CIN2+ lesions caused by nonvaccine types that are genetically related to vaccine types, particularly HPV-31 (related to HPV-16) and HPV-45 (related to HPV-18), Dr. Dubin said.
A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both). There were similar rates of medically significant conditions (32% with Cervarix vs. 32% with placebo), congenital anomalies (0.7% vs. 0.5%), and spontaneous abortions (9.1% and 8.7%).
The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.
The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18–26 years. A secondary end point was serum neutralizing geometric mean titers at month 7 in women aged 27–35 and 36–45 years.
The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules: 0, 1, and 6 months for Cervarix and 0, 2, and 6 months for Gardasil. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.
Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18–26, antibody titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27–35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.
Positivity rates at month 7 for HPV-16 and HPV-18 antibodies measured in cervicovaginal secretions were higher with Cervarix than with Gardasil. The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18. These data confirm differences in immunologic response between the two vaccines, Dr. Dubin said.
“Although the importance of these differences is unknown, they may represent determinants of duration of protection against HPV-16/18 and/or protection against nonvaccine types. Disease modeling will help determine how the observed differences in vaccine profiles may translate into differences in public health impact,” he said, adding that the current data “indicate that the GSK HPV vaccine is likely to provide long-lasting protection against cervical cancer.”
Menveo Shown Immunogenic in All Age Groups
ATLANTA — An investigational meningococcal conjugate vaccine was immunogenic in all age groups tested down to 2 months of age, and more immunogenic in adolescents than the currently licensed quadrivalent meningococcal conjugate vaccine in tests conducted by Novartis.
The vaccine, Menveo, contains Neisseria meningitidis serotypes A, C, Y, and W-135 and is conjugated with the carrier protein cross-reactive material 197 (MenACWY-CRM). Novartis submitted a Biologics License Application in August 2008 for its use in persons aged 11-55 years, and received a Complete Response letter from the Food and Drug Administration on July 1, 2009, stating that no new clinical trials would be required, a Novartis statement said.
The currently licensed meningococcal conjugate vaccine, Sanofi Pasteur's Menactra, contains the same four serotypes conjugated to diphtheria toxoid protein (MenACYW-D). It is licensed for routine immunization of 11- to 12-years-olds and for individuals aged 2-55 years who are at increased risk for invasive meningococcal disease.
At a meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, Dr. Peter Dull presented phase III data on MenACWY-CRM use in adolescents.
To date, there are a total of 24 clinical trials completed or ongoing, with more than 16,000 subjects having received MenACWY-CRM, said Dr. Dull, head of meningococcal vaccine development at Novartis.
At 1 month post vaccination, a significantly greater proportion of the 1,483 MenACWY-CRM recipients seroresponded than of 501 recipients of MenACYW-D for serotypes A (75% vs. 66%), W-135 (75% vs. 63%), and Y (68% vs. 41%). Responses to serotype C did not differ significantly (75% vs. 73%). The proportions with titers of serogroup-specific serum bactericidal activity using human complement (hSBA) greater than or equal to 1:8 were also significantly greater for MenACWY-CRM for A (75% vs. 67%), W-135 (96% vs. 88%), and Y (88% vs. 69%) but not C (84% for both vaccines).
Both vaccines were well tolerated, with comparable reactogenicity. The incidences of local injection-site reactions and of systemic symptoms were similar between groups. There were no serious adverse events deemed to be vaccine related, and no subjects in either group withdrew because of adverse events, Dr. Dull said.
In a separate investigation, similar safety profiles were seen when MenACWY-CRM was administered concomitantly with human papillomavirus and combined tetanus, diphtheria, and pertussis vaccines as with administration of MenACWY-CRM alone. Noninferior immune responses were also seen with concomitant administration, as measured by the percentage with hSBA titers of 1:8 or greater for all meningococcal serogroups, the percentage with diphtheria and tetanus antibody concentrations of 1.0 IU/mL or greater, the percentage with human papillomavirus seroconversion and geometric mean titers, and the responses to all pertussis antigens.
Phase III studies are in progress to support licensure in infants beginning from 2 months of age, Dr. Dull said.
ATLANTA — An investigational meningococcal conjugate vaccine was immunogenic in all age groups tested down to 2 months of age, and more immunogenic in adolescents than the currently licensed quadrivalent meningococcal conjugate vaccine in tests conducted by Novartis.
The vaccine, Menveo, contains Neisseria meningitidis serotypes A, C, Y, and W-135 and is conjugated with the carrier protein cross-reactive material 197 (MenACWY-CRM). Novartis submitted a Biologics License Application in August 2008 for its use in persons aged 11-55 years, and received a Complete Response letter from the Food and Drug Administration on July 1, 2009, stating that no new clinical trials would be required, a Novartis statement said.
The currently licensed meningococcal conjugate vaccine, Sanofi Pasteur's Menactra, contains the same four serotypes conjugated to diphtheria toxoid protein (MenACYW-D). It is licensed for routine immunization of 11- to 12-years-olds and for individuals aged 2-55 years who are at increased risk for invasive meningococcal disease.
At a meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, Dr. Peter Dull presented phase III data on MenACWY-CRM use in adolescents.
To date, there are a total of 24 clinical trials completed or ongoing, with more than 16,000 subjects having received MenACWY-CRM, said Dr. Dull, head of meningococcal vaccine development at Novartis.
At 1 month post vaccination, a significantly greater proportion of the 1,483 MenACWY-CRM recipients seroresponded than of 501 recipients of MenACYW-D for serotypes A (75% vs. 66%), W-135 (75% vs. 63%), and Y (68% vs. 41%). Responses to serotype C did not differ significantly (75% vs. 73%). The proportions with titers of serogroup-specific serum bactericidal activity using human complement (hSBA) greater than or equal to 1:8 were also significantly greater for MenACWY-CRM for A (75% vs. 67%), W-135 (96% vs. 88%), and Y (88% vs. 69%) but not C (84% for both vaccines).
Both vaccines were well tolerated, with comparable reactogenicity. The incidences of local injection-site reactions and of systemic symptoms were similar between groups. There were no serious adverse events deemed to be vaccine related, and no subjects in either group withdrew because of adverse events, Dr. Dull said.
In a separate investigation, similar safety profiles were seen when MenACWY-CRM was administered concomitantly with human papillomavirus and combined tetanus, diphtheria, and pertussis vaccines as with administration of MenACWY-CRM alone. Noninferior immune responses were also seen with concomitant administration, as measured by the percentage with hSBA titers of 1:8 or greater for all meningococcal serogroups, the percentage with diphtheria and tetanus antibody concentrations of 1.0 IU/mL or greater, the percentage with human papillomavirus seroconversion and geometric mean titers, and the responses to all pertussis antigens.
Phase III studies are in progress to support licensure in infants beginning from 2 months of age, Dr. Dull said.
ATLANTA — An investigational meningococcal conjugate vaccine was immunogenic in all age groups tested down to 2 months of age, and more immunogenic in adolescents than the currently licensed quadrivalent meningococcal conjugate vaccine in tests conducted by Novartis.
The vaccine, Menveo, contains Neisseria meningitidis serotypes A, C, Y, and W-135 and is conjugated with the carrier protein cross-reactive material 197 (MenACWY-CRM). Novartis submitted a Biologics License Application in August 2008 for its use in persons aged 11-55 years, and received a Complete Response letter from the Food and Drug Administration on July 1, 2009, stating that no new clinical trials would be required, a Novartis statement said.
The currently licensed meningococcal conjugate vaccine, Sanofi Pasteur's Menactra, contains the same four serotypes conjugated to diphtheria toxoid protein (MenACYW-D). It is licensed for routine immunization of 11- to 12-years-olds and for individuals aged 2-55 years who are at increased risk for invasive meningococcal disease.
At a meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, Dr. Peter Dull presented phase III data on MenACWY-CRM use in adolescents.
To date, there are a total of 24 clinical trials completed or ongoing, with more than 16,000 subjects having received MenACWY-CRM, said Dr. Dull, head of meningococcal vaccine development at Novartis.
At 1 month post vaccination, a significantly greater proportion of the 1,483 MenACWY-CRM recipients seroresponded than of 501 recipients of MenACYW-D for serotypes A (75% vs. 66%), W-135 (75% vs. 63%), and Y (68% vs. 41%). Responses to serotype C did not differ significantly (75% vs. 73%). The proportions with titers of serogroup-specific serum bactericidal activity using human complement (hSBA) greater than or equal to 1:8 were also significantly greater for MenACWY-CRM for A (75% vs. 67%), W-135 (96% vs. 88%), and Y (88% vs. 69%) but not C (84% for both vaccines).
Both vaccines were well tolerated, with comparable reactogenicity. The incidences of local injection-site reactions and of systemic symptoms were similar between groups. There were no serious adverse events deemed to be vaccine related, and no subjects in either group withdrew because of adverse events, Dr. Dull said.
In a separate investigation, similar safety profiles were seen when MenACWY-CRM was administered concomitantly with human papillomavirus and combined tetanus, diphtheria, and pertussis vaccines as with administration of MenACWY-CRM alone. Noninferior immune responses were also seen with concomitant administration, as measured by the percentage with hSBA titers of 1:8 or greater for all meningococcal serogroups, the percentage with diphtheria and tetanus antibody concentrations of 1.0 IU/mL or greater, the percentage with human papillomavirus seroconversion and geometric mean titers, and the responses to all pertussis antigens.
Phase III studies are in progress to support licensure in infants beginning from 2 months of age, Dr. Dull said.
Meningococcal Disease: Two Doses in High Risk
ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.
The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:
▸ Persons with persistent complement deficiencies.
▸ Persons with anatomic or functional asplenia.
▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.
▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.
Children who received their first dose of MCV4 or polysaccharide vaccine at age 2-6 years because of a high-risk condition and who remain at increased risk for meningococcal disease should be given an additional dose of MCV4 3 years after their first dose.
At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. In 2009, there are very few individuals in these groups who were vaccinated more than 5 years previously. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the division of bacterial diseases at the CDC.
At the time that MCV4 was licensed in 2005, no recommendations were made for revaccination.
Data on duration of protection of vaccination and the safety and efficacy of revaccination are limited. A small study from Sanofi Pasteur showed slightly higher rates of solicited local and systemic reactions after 7 days among recipients of a second dose of MCV4 compared with those receiving a first dose, but there were no increases in unsolicited adverse events or serious adverse events at 28 days. It is unlikely that more data will become available, Dr. Cohn said.
According to Dr. Carol J. Baker of Baylor College of Medicine, Houston, and chair of the ACIP meningococcal working group, “The current FDA labeling is for one dose, the same as the polysaccharide vaccine. I'm not happy, but it's all the data we have and I'm worried about the individuals at high risk. I want more data.”
ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.
The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:
▸ Persons with persistent complement deficiencies.
▸ Persons with anatomic or functional asplenia.
▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.
▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.
Children who received their first dose of MCV4 or polysaccharide vaccine at age 2-6 years because of a high-risk condition and who remain at increased risk for meningococcal disease should be given an additional dose of MCV4 3 years after their first dose.
At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. In 2009, there are very few individuals in these groups who were vaccinated more than 5 years previously. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the division of bacterial diseases at the CDC.
At the time that MCV4 was licensed in 2005, no recommendations were made for revaccination.
Data on duration of protection of vaccination and the safety and efficacy of revaccination are limited. A small study from Sanofi Pasteur showed slightly higher rates of solicited local and systemic reactions after 7 days among recipients of a second dose of MCV4 compared with those receiving a first dose, but there were no increases in unsolicited adverse events or serious adverse events at 28 days. It is unlikely that more data will become available, Dr. Cohn said.
According to Dr. Carol J. Baker of Baylor College of Medicine, Houston, and chair of the ACIP meningococcal working group, “The current FDA labeling is for one dose, the same as the polysaccharide vaccine. I'm not happy, but it's all the data we have and I'm worried about the individuals at high risk. I want more data.”
ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.
The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:
▸ Persons with persistent complement deficiencies.
▸ Persons with anatomic or functional asplenia.
▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.
▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.
Children who received their first dose of MCV4 or polysaccharide vaccine at age 2-6 years because of a high-risk condition and who remain at increased risk for meningococcal disease should be given an additional dose of MCV4 3 years after their first dose.
At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. In 2009, there are very few individuals in these groups who were vaccinated more than 5 years previously. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the division of bacterial diseases at the CDC.
At the time that MCV4 was licensed in 2005, no recommendations were made for revaccination.
Data on duration of protection of vaccination and the safety and efficacy of revaccination are limited. A small study from Sanofi Pasteur showed slightly higher rates of solicited local and systemic reactions after 7 days among recipients of a second dose of MCV4 compared with those receiving a first dose, but there were no increases in unsolicited adverse events or serious adverse events at 28 days. It is unlikely that more data will become available, Dr. Cohn said.
According to Dr. Carol J. Baker of Baylor College of Medicine, Houston, and chair of the ACIP meningococcal working group, “The current FDA labeling is for one dose, the same as the polysaccharide vaccine. I'm not happy, but it's all the data we have and I'm worried about the individuals at high risk. I want more data.”
Deals on Diabetes Drugs Make a Difference
NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.
Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.
An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.
“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.
“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.
He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.
Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com
On the other hand, atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com
The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.
Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.
Source ELSEVIER GLOBAL MEDICAL NEWS
NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.
Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.
An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.
“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.
“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.
He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.
Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com
On the other hand, atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com
The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.
Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.
Source ELSEVIER GLOBAL MEDICAL NEWS
NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.
Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.
An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.
“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.
“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.
He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.
Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com
On the other hand, atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com
The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.
Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.
Source ELSEVIER GLOBAL MEDICAL NEWS