The safety profile for Avandamet plus insulin was consistent with that of the individual components (rosiglitazone or metformin) and with that of rosiglitazone used in combination with insulin.
The incidence of hypoglycemia (confirmed by fingerstick blood glucose concentration ?50 mg/dL) was 14% for patients on Avandamet plus insulin compared to 10% for patients on insulin monotherapy.
The incidence of edema was 7% when insulin was added to Avandamet compared to 3% with insulin monotherapy. This trial excluded patients with pre-existing heart failure or new or worsening edema on Avandamet therapy.
However, in 26-week double-blind, fixed-dose studies of rosiglitazone added to insulin, edema was reported with higher frequency (rosiglitazone in combination with insulin, 14.7%; insulin, 5.4%). Reports of new-onset or exacerbation of congestive heart failure occurred at rates of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone. There were too few events to confirm a dose relationship; however, the incidence of heart failure appeared higher with rosiglitazone 8 mg daily.
The incidence of anemia was 2% for Avandamet in combination with insulin compared to 1% for insulin monotherapy.
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Tags: Avandamet (Rosiglitazone/Metformin), Conditions & Treatments, Medications, Type 2 Diabetes