ACARBOSE IN AMBULATORY TREATMENT OF NON-INSULIN-DEPENDENT DIABETES-MELLITUS ASSOCIATED TO IMMINENT SULFONYLUREA FAILURE - A RANDOMIZED-MULTICENTRIC TRIAL IN PRIMARY HEALTH-CARE

To assess the efficacy and safety of acarbose as an adjunct to high su lfonylurea (SU) doses in patients with imminent SU failure, a randomis ed, multicentric, 6 month double-blind, parallel and placebo-controlle d trial was performed in primary healthcare. Entry criteria were: NIDD M patients in concomitant dietary follow-up, age > 40 year-old, more t han 3 years of diagnosed diabetes, baseline HbA(1c) levels between 8-1 2% (N: 4-6%), stable body mass index < 35 kg m(-2) and glibenclamide d aily dose > 10 mg. After 1 month placebo run-in period all patients we re randomly allocated into two groups of treatment (acarbose 100 mg t. i.d. vs placebo). HbA(1c) levels, the main efficacy variable, lipid pr ofile, fasting and postprandial blood glucose levels were performed an d adverse events were also recorded. A total number of 65 patients wer e randomised, 36 in acarbose and 29 in a placebo group. No statistical differences were found on age (60.2/61.7 year-old), BMI (28.7/27.4 kg m(-2)), glibenclamide dose (14.5/14.0 mg/day) and baseline HbA(1c) (9 .0/8.8%). Acarbose-treated patients significantly reduced HbA(1c) leve ls (9.0/7.9 vs 8.8/8.5%; P < 0.01), based upon a marked decrease, but statistically not significant, in mean postprandial plasma glucose lev els (11.9/9.6 vs 12.4/11.1 mmol l(-1)). No significant differences bet ween fasting plasma glucose and lipid profile were detected. A total o f 31 patients (47.7%) reported adverse events, 20 (55.5%) and 11 (37.9 %) in acarbose and placebo treatment group respectively. Relationship with drug was estimated as possible or probable in 16 (44.4%) of acarb ose-treated patients. None of them were excluded from study participat ion due to insulin requirement. Only seven patients (10.7%), six with acarbose (16.6%) and one with placebo (3.8%), withdrew the study becau se of the adverse events. Thus, acarbose seems to be a useful option i n order to improve HbA(1c) levels in non-insulin-dependent diabetes me llitus with imminent sulfonylurea failure. (C) 1997 Elsevier Science I reland Ltd.