EFFICACY AND SAFETY OF 2 DIFFERENT DOSAGES OF ACARBOSE IN NON-INSULIN-DEPENDENT DIABETIC-PATIENTS TREATED BY DIET ALONE

The use of acarbose has been suggested in NIDDM patients, when diet al one is not able to guarantee a satisfactory metabolic control. This al pha-glucosidase inhibitor has been extensively studied worldwide in do ses ranging between 100-300 mg three times daily. Although the suggest ed dosages in the European countries where the drug is marketed are 10 0-150 mg three times daily, in this study the efficacy and safety of t wo different doses of acarbose, that is 50 and 100 mg three times dail y, and placebo were compared in NIDDM outpatients. Three groups of NID DM subjects, treated by diet alone, were recruited and randomized in g roup A (placebo, n=29): group B (acarbose 50 mg three times daily; n=2 8); group C (acarbose 100 mg three times daily; n=27). The patients we re instructed to continue an isocaloric diet (50-55% as carbohydrates, 30% as lipids. 15-20% as proteins and 10 g/1000 kcal as fibre) to mai ntain stable body weight. The treatment lasted 16 weeks. Twenty-two dr opouts occurred during the study, due to early withdrawal (n=7), adver se events (n=6) and protocol violation (n=9). HbA1c fasting plasma glu cose, cholesterol (total and HDL), triglycerides were measured before the beginning of the treatment and at 8 and 16 weeks of double-blind t reatment. At the same intervals all patients underwent a mixed meal te st. HbA,, decreased from the baseline value 7.07 +/- 0.17% to 6.47 +/- 0.22% (Mean +/- SEM) at the end of the treatment in group B and from 1.15 +/- 0.18% to 6.41 +/- 0.24% (Mean +/- SEM) in group C, while a sl ight increase occurred in the placebo group. The main contrast between Least Square means after analysis of covariance had a related p value <0.0001. The same behaviour was observed in regard to fasting plasma glucose and plasma glucose area under curve (AUC) during meal test. Pl asma insulin during meal test and fasting cholesterol and triglyceride s did not change in either of the three groups. Adverse events were pr edominantly intestinal. Particularly flatulence occurred in 14 patient s receiving 100 mg three times daily of acarbose, in 8 subjects treate d with 50 mg three times daily and in 7 subjects treated with placebo. The results of this study confirm that acarbose is effective in NIDDM patients treated by diet alone, even at doses of 50 mg three times da ily. Furthermore the low dose of acarbose was able to minimize the gas trointestinal side-effects.