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Comparing Medications for Adults With Type 2 Diabetes

Slide: 24 of 35

Comparative Adverse Events and Side Effects

For the analysis of adverse events and side effects, the following outcomes were included: hypoglycemia, liver injury, congestive heart failure,  severe lactic acidosis, cancer, severe allergic reactions, hip and nonhip fractures, pancreatitis, cholecystitis, macular edema or decreased vision,  and GI side effects. There were 107 studies (these included RCTs, non-RCTs, cohort studies with a comparison group, and case-control studies) that addressed adverse events and side effects. Overall, few studies contained sufficient data on event rates to make it possible to analyze major clinically important adverse events. Few observational studies were identified that examined macular edema, cancer, and fractures as related to thiazolidinediones, insulin, and other medications.

Notably, after the CER titled Oral Diabetes Medications for Adults With Type 2 Diabetes: An Update was published, the U.S. Food and Drug Administration (FDA) released a report citing a planned five-year interim analysis of an ongoing, ten-year epidemiological study. It included data on 193,099 diabetic patients who were treated with pioglitazone (Actos®) for a median of two years. The study found that patients on the drug for more than a year had a 40% increased risk of bladder cancer compared with those who never took it, although the finding was of borderline significance. The significance increased after two years of treatment (OR 1.4, 95% CI 1.03 to 2.0). Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.