In U. S. double-blind studies, anemia was reported for 1.0% of patients treated with ACTOS and 0.0% of placebo-treated patients in monotherapy studies. Anemia was reported for 1.6% of patients treated with ACTOS and 1.6% of placebo-treated patients in com-bination with insulin. Anemia was reported for 0.3% of patients treated with ACTOS and 1.6% of placebo-treated patients in combination with sulfonylurea. Anemia was reported for 1.2% of patients treated with ACTOS and 0.0% of placebo-treated patients in combi-nation with metformin. In monotherapy studies, edema was reported for 4.8% of patients treated with ACTOS versus 1.2% of placebo-treated patients. In combination therapy studies, edema was report-ed for 7.2% of patients treated with ACTOS and sulfonylureas compared to 2.1% of patients on sulfonylureas alone. In combination therapy studies with metformin, edema was report-ed in 6.0% of patients on combination therapy compared to 2.5% of patients on metformin alone. In combination therapy studies with insulin, edema was reported in 15.3% of patients on combination therapy compared to 7.0% of patients on insulin alone. Most of these events were considered mild or moderate in intensity (see PRECAUTIONS, General, Edema). In one 16-week clinical trial of insulin plus ACTOS combination therapy, more patients developed congestive heart failure on combination therapy (1.1%) compared to none on insulin alone (see WARNINGS, Cardiac Failure and Other Cardiac Effects). Laboratory Abnormalities 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 generally occurred within the first 4 to 12 weeks of therapy and remained relatively stable thereafter. These changes may be related to increased plasma volume associated with ACTOS therapy and have not been associated with any significant hematologic clinical effects. | ||||
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