Miglitol: Assessment of its role in the treatment of patients with diabetes mellitus

OBJECTIVE: To evaluate miglitol, a new oral alpha -glucosidase inhibitor, a nd discuss its pharmacology, therapeutics, pharmacokinetics, dosing guideli nes, adverse effects, drug interactions, and clinical efficacy. DATA SOURCES: A MEDLINE English-language only database search using the key words miglitol, glyset, and Bay m 1099 (1985 to December 1999), was complet ed to identify relevant articles including reviews, recent studies, and abs tracts; American Diabetes Association 1999 Annual Meeting abstracts; Pharma cia & Upjohn data on file and product information. STUDY SELECTION: The clinical trials that were selected to be reviewed in d etail were randomized, double-blind studies with at least 100 patients in t he intention-to-treat group. DATA EXTRACTION: All articles and abstracts were reviewed along with the pr oduct labeling from Pharmacia & Upjohn. DATA SYNTHESIS: Miglitol is an alpha -glucosidase inhibitor that exerts its effect through the delayed absorption of complex carbohydrates in the smal l intestine, resulting in a decrease in postprandial glucose concentrations that are directly correlated with the dietary carbohydrate content. Both s mall, short-term trials and large, clinical trials show a decrease in postp randial glucose concentrations and a modest decrease in glycosylated hemogl obin of approximately 0.5-1.0% as a result of miglitol's action. The advers e effects of miglitol are mild and transitory and include flatulence, diarr hea, and abdominal pain. The incidence of gastrointestinal problems may be reduced with a small initial dose, which is slowly titrated as tolerated. CONCLUSIONS: Miglitol is an effective and safe treatment option in patients with type 2 diabetes mellitus who are adequately controlled with diet or o ral sulfonylurea therapy. Miglitol is a good choice of therapy in Hispanic, African-American, and elderly patients, or any patients in whom hypoglycem ia, weight gain, or lactic acidosis are risks. No published studies compari ng miglitol with acarbose have been published, but there appears to be no m ajor clinical or financial advantages to using one agent over the other.