THE USE OF ACARBOSE IN THE PRIMARY-CARE SETTING - EVALUATION OF EFFICACY AND TOLERABILITY OF ACARBOSE BY POSTMARKETING SURVEILLANCE STUDY

The efficacy and tolerability of acarbose were examined in a postmarke ting surveillance study of 10,462 patients (829 insulin-dependent diab etes mellitus (IDDM), 9,440 non-insulin-dependent diabetes mellitus (N IDDM), 193 not classified) during a 12-week treatment period. The medi an duration of diabetes was 60 months for men and 72 months for women in IDDM patients, and 40 months for men and 60 months for women in NID DM patients. Of the Type II patients, 28.9% were treated with diet onl y; 58.1% additionally with sulfonylureas; 8.6% with insulin; and 4.3% with both sulfonylureas and insulin. The additional acarbose therapy l ed to a reduction of the mean fasting blood glucose levels (51 mg/dL f or IDDM; 52 mg/dL for NIDDM) and 1 h postprandially (55 mg/dL for IDDM ; 63 mg/dL for NIDDM.) The HbA(1) levels were reduced by 1.5%. Tolerab ility was good: 78.6% of patients had no adverse events; 19% reported meteorism/flatulence; 3.2%, diarrhea. Hypoglycemia was found in 0.8% o f Type I and 0.6% of Type II patients who received concurrent insulin (n = 8) or glibenclamide (n = 1) treatment. Laboratory investigations gave no indication of other adverse effects, e.g. elevated levels of t ransaminases or creatinine. This postmarketing surveillance study docu ments the therapeutic benefit and the good tolerability of acarbose.