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Side Effects & Drug Interactions
ADVERSE REACTIONS
The incidence and types of adverse events reported in controlled, 26-week clinical trials in association with rosiglitazone maleate in combination with doses of metformin hydrochloride of 2,500 mg/ day in comparison to adverse reactions reported in association with rosiglitazone and metformin monotherapies are shown in Table 4. 
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Reports of hypoglycemia in patients treated with rosiglitazone and maximum metformin combination therapy were more frequent than in patients treated with rosiglitazone or metformin monotherapies. In double-blind studies, hypoglycemia was reported by 3.0% of patients receiving rosiglitazone in combination with maximum doses of metformin, by 1.3% of patients receiving metformin monotherapy, by 0.6% of patients receiving rosiglitazone as monotherapy, and by 0.2% of patients receiving placebo. There were a small number of patients treated with rosiglitazone who had adverse events of anemia and edema. Overall, these events were generally mild to moderate in severity and usually did not require discontinuation of treatment with rosiglitazone. Edema was reported in 4.8% of patients receiving rosiglitazone compared to 1.3% on placebo, and 2.2% on metformin monotherapy and 4.4% on rosiglitazone in combination with maximum doses of metformin. Overall, the types of adverse experiences reported when rosiglitazone was used in combination with metformin were similar to those during monotherapy with rosiglitazone. Reports of anemia (7.1%) were greater in patients treated with a combination of rosiglitazone and metformin compared to monotherapy with rosiglitazone. Lower pre-treatment hemoglobin/ hematocrit levels in patients enrolled in the metformin combination clinical trials may have contributed to the higher reporting rate of anemia in these studies (see ADVERSE REACTIONS, Laboratory Abnormalities, Hematologic). Page: 1 | 2 | 3 | 4 | 5 | Next >>
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