Here's Rita Rubin summing up the data on Avandia. Maybe she missed the risk of cancer associated with other diabetes drugs.
"A study in the August issue of the journal Diabetes Care concludes that the class of drugs to which Avandia and Actos belong may double heart failure risk. The authors analyzed clinical trials, observational studies and case reports. ?Everyone (who takes the drugs) is at risk,? says co-author Curt Furberg, a Wake Forest University medical epidemiologist who sits on the FDA?s Endocrinologic and Metabolic Drugs panel."
Of course Rita ignores a study in Diabetes care showing no difference in all cause mortality or all the info on Avandia now available for the adcomm hearing. More important, she ignores an even greater threat from oral diabetes drugs.....cancer.
http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm?csp=34
Increased Cancer-Related Mortality for Patients With Type 2 Diabetes Who Use Sulfonylureas or Insulin
Samantha L. Bowker, MSC1,2, Sumit R. Majumdar, MD, MPH1,3, Paul Veugelers, PHD2 and Jeffrey A. Johnson, PHD1,2
OBJECTIVE—Numerous studies have identified an increased risk of cancer in type 2 diabetes. We explored the association between antidiabetic therapies and cancer-related mortality in patients with type 2 diabetes, postulating that agents that increase insulin levels might promote cancer.
RESEARCH DESIGN AND METHODS—This was a population-based cohort study using administrative databases from Saskatchewan Health. Cancer-related mortality was compared among inception cohorts of metformin users and sulfonylurea monotherapy users. Multivariate Cox regression was used to estimate the hazard ratio (HR) of cancer-related mortality, after adjusting for age, sex, insulin use, and chronic disease score. All statistical tests were two-sided.
RESULTS—We identified 10,309 new users of metformin or sulfonylureas with an average follow-up of 5.4 ± 1.9 years (means ± SD). The mean age for the cohort was 63.4 ± 13.3 years, and 55% were men. Cancer mortality over follow-up was 4.9% (162 of 3,340) for sulfonylurea monotherapy users, 3.5% (245 of 6,969) for metformin users, and 5.8% (84 of 1,443) for subjects who used insulin. After multivariate adjustment, the sulfonylurea cohort had greater cancer-related mortality compared with the metformin cohort (adjusted HR 1.3 [95% CI 1.1–1.6]; P = 0.012). Insulin use was associated with an adjusted HR of cancer-related mortality of 1.9 (95% CI 1.5–2.4; P < 0.0001).
CONCLUSIONS—Patients with type 2 diabetes exposed to sulfonylureas and exogenous insulin had a significantly increased risk of cancer-related mortality compared with patients exposed to metformin. It is uncertain whether this increased risk is related to a deleterious effect of sulfonylurea and insulin or a protective effect of metformin or due to some unmeasured effect related to both choice of therapy and cancer risk.
Gee, we don't know do we? But that's because we don't have USA Today/Nissen/Furberg peddling this panic. Maybe because these are generic drugs perhaps, no Big Pharma to attack?
http://care.diabetesjournals.org/cgi/content/abstract/29/2/254?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&minscore=5000&resourcetype=HWCIT
"A study in the August issue of the journal Diabetes Care concludes that the class of drugs to which Avandia and Actos belong may double heart failure risk. The authors analyzed clinical trials, observational studies and case reports. ?Everyone (who takes the drugs) is at risk,? says co-author Curt Furberg, a Wake Forest University medical epidemiologist who sits on the FDA?s Endocrinologic and Metabolic Drugs panel."
Of course Rita ignores a study in Diabetes care showing no difference in all cause mortality or all the info on Avandia now available for the adcomm hearing. More important, she ignores an even greater threat from oral diabetes drugs.....cancer.
http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm?csp=34
Increased Cancer-Related Mortality for Patients With Type 2 Diabetes Who Use Sulfonylureas or Insulin
Samantha L. Bowker, MSC1,2, Sumit R. Majumdar, MD, MPH1,3, Paul Veugelers, PHD2 and Jeffrey A. Johnson, PHD1,2
OBJECTIVE—Numerous studies have identified an increased risk of cancer in type 2 diabetes. We explored the association between antidiabetic therapies and cancer-related mortality in patients with type 2 diabetes, postulating that agents that increase insulin levels might promote cancer.
RESEARCH DESIGN AND METHODS—This was a population-based cohort study using administrative databases from Saskatchewan Health. Cancer-related mortality was compared among inception cohorts of metformin users and sulfonylurea monotherapy users. Multivariate Cox regression was used to estimate the hazard ratio (HR) of cancer-related mortality, after adjusting for age, sex, insulin use, and chronic disease score. All statistical tests were two-sided.
RESULTS—We identified 10,309 new users of metformin or sulfonylureas with an average follow-up of 5.4 ± 1.9 years (means ± SD). The mean age for the cohort was 63.4 ± 13.3 years, and 55% were men. Cancer mortality over follow-up was 4.9% (162 of 3,340) for sulfonylurea monotherapy users, 3.5% (245 of 6,969) for metformin users, and 5.8% (84 of 1,443) for subjects who used insulin. After multivariate adjustment, the sulfonylurea cohort had greater cancer-related mortality compared with the metformin cohort (adjusted HR 1.3 [95% CI 1.1–1.6]; P = 0.012). Insulin use was associated with an adjusted HR of cancer-related mortality of 1.9 (95% CI 1.5–2.4; P < 0.0001).
CONCLUSIONS—Patients with type 2 diabetes exposed to sulfonylureas and exogenous insulin had a significantly increased risk of cancer-related mortality compared with patients exposed to metformin. It is uncertain whether this increased risk is related to a deleterious effect of sulfonylurea and insulin or a protective effect of metformin or due to some unmeasured effect related to both choice of therapy and cancer risk.
Gee, we don't know do we? But that's because we don't have USA Today/Nissen/Furberg peddling this panic. Maybe because these are generic drugs perhaps, no Big Pharma to attack?
http://care.diabetesjournals.org/cgi/content/abstract/29/2/254?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&minscore=5000&resourcetype=HWCIT
