[Treatment of type 2 diabetes mellitus with the alpha-glucosidase inhibitor Miglitol in the doctor's office].

Abstract

Background and method: In an observational study carried out in accordance with paragraph 67 (6) of the AMG and beginning in May 1998, 846 patients with type 2 diabetes mellitus were followed for a period of three months by general practitioners and internists. The aim was to acquire data on the efficacy and tolerability of the alpha-glucosidase inhibitor, Miglitol, used in the doctor's office setting. A major point of interest was to determine the feasibility of using a regimen of gradually increasing doses in daily practice. The parameters investigated were HbA1c, fasting blood glucose and changes in the patient's weight. Any side effects were recorded by the care-providing physician and evaluated in the global tolerability analysis.

Results: The demographic data showed a balanced distribution of male and female patients. The average age of the men was 62 years, of the women 65 years. At the start of the observation, 62% of the patients had polyneuropathy, 35% retinopathy, and 25% nephropathy. 620 patients (73.3%) had received prior antidiabetic treatment. Depending on tolerability, the dose of Miglitol was increased individually from an initial 3 x 50 mg to 3 x 100 mg. 63.8% of the patients remained at the initial dose of 3 x 50 mg. A clear decrease in both HbA1c and fasting blood glucose was observed under treatment. During the course of the three months, the BMI decreased slightly by an average of 0.4 kg/m2, a desirable side effect in this patient group. Adverse reactions occurred in 39 ofthe 846 patients in the form of flatulence, diarrhea and enterospasm.

Conclusion: Treatment with the alpha-glucosidase inhibitor Miglitol proved to be highly effective and readily combinable with other antidiabetics. Its efficacy was assessed to be "very good" or "good" by 86.5% of the physicians, and more than 90% assessed its tolerability to be "very good" or "good".