The Safety Profile of PRANDIN®
Weight
No average weight gain in a monotherapy clinical trial for patients previously treated with OAD's; 3.3% weight gain in patients not previously treated with sulfonylurea drugs.
Monitoring
No requirement for LFT monitoring*
Renal
May be used in patients with renal insufficiency**
Drug-drug
No drug interactions with digoxin, theophylline, warfarin, or cimetidine
*Prandin® should be used cautiously in patients with impaired liver function.
**No initial dose adjustment required for patients with mild to moderate renal dysfunction. Those with severe renal dysfunction should start with the 0.5-mg dose. Subsequent dosing increases should be made carefully.
See full Prescribing Information for further drug interaction information.
In 1-year controlled trials comparing Prandin® (n=1228) with sulfonylureas (n=498) for efficacy and safety, symptoms of mild to moderate hypoglycemia were reported in 16% of Prandin®-treated patients; none developed coma or required hospitalization. Hypoglycemia was reported in 19 or 20% of patients treated with sulfonylureas (glyburide and glipizide, respectively). In placebo-controlled trials, 31% of patients treated with Prandin® developed hypoglycemia.
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