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Table 6 Weight Changes (kg) from Baseline during Double-Blind Clinical Trials with ACTOS Control Group ACTOS ACTOS ACTOS (Placebo) 15 mg 30 mg 45 mg Median Median Median Median (25 th /75 th (25 th /75 th (25 th /75 th (25 th /75 th percentile) percentile) percentile) percentile)
Monotherapy -1.4 (-2.7/ 0.0) 0.9 (-0.5/ 3.4) 1.0 (-0.9/ 3.4) 2.6 (0.2/ 5.4) n= 256 n= 79 n= 188 n= 79 Combination Sulfonylurea -0.5 (-1.8/ 0.7) 2.0 (0.2/ 3.2) 2.7 (1.1/ 4.5) N/ A Therapy n= 187 n= 183 n= 186
Metformin -1.4 (-3.2/ 0.3) N/ A 1.4 (-0.9/ 3.0) N/ A n= 160 n= 167
Insulin 0.2 (-1.4/ 1.4) 2.3 (0.5/ 4.3) 3.6 (1.4/ 5.9) N/ A n= 182 n= 190 n= 188 Text Continues Below
Ovulation: Therapy with ACTOS, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking ACTOS. Thus, adequate contraception in pre-menopausal women should be recommended. This possible effect has not been investi-gated in clinical studies so the frequency of this occurrence is not known. Hematologic: ACTOS may cause decreases in hemoglobin and hematocrit. Across all clinical studies, mean hemoglobin values declined by 2% to 4% in patients treated with ACTOS. These changes primarily occurred within the first 4 to 12 weeks of therapy and remained relatively constant thereafter. These changes may be related to increased plasma volume and have not been associated with any significant hematologic clinical effects (see ADVERSE REACTIONS, Laboratory Abnormalities). Hepatic Effects: Another drug of the thiazolidinedione class, troglitazone, has been associ-ated with idiosyncratic hepatotoxicity, and very rare cases of liver failure, liver transplants, and death have been reported during postmarketing clinical use. In pre-approval controlled clinical trials in patients with type 2 diabetes, troglitazone was more frequently associat-ed with clinically significant elevations of hepatic enzymes (ALT > 3 times the upper limit of normal) compared to placebo, and very rare cases of reversible jaundice were reported. In pre-approval clinical studies worldwide, over 4500 subjects were treated with ACTOS. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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