ORIGINAL ARTICLE Effect of treatment with acarbose and insulin in patients with non-insulin-dependent diabetes mellitus associated with non-alcoholic liver cirrhosis S. Gentile, 1 S. Turco, 2 G. Guarino, 1 B. Oliviero, 1 S. Annunziata, 1 D. Cozzolino, 1 F. C. Sasso, 1 A. Turco, 2 T. Salvatore 1 and R. Torella 1 1 Department of Geriatrics and Metabolic Medicine, Second University of Naples, Naples, Italy 2 Department of Experimental and Clinical Medicine, Federico the Second University of Naples, Italy Aim: Non-insulin-dependent diabetes mellitus (type 2 diabetes) not responding to dietary treatment alone in patients with non-alcoholic liver cirrhosis is characterized by high postprandial hyperglycaemia. The control of postprandial hyperglycaemia in such patients, is generally achieved by the means of progressively higher doses of insulin, with an increasing risk of hypoglycaemia in the late postprandial period. The aim of this study was to evaluate the use of acarbose for the control of postprandial hyperglycaemia in 100 patients with well- compensated liver cirrhosis and type 2 diabetes treated with insulin. Methods: The study was double blind with randomization of treatments into acarbose (52 patients) vs. placebo (48 patients) with parallel branches over a period of 28 weeks. Results: All patients tolerated the treatments well and no signi®cant variations in liver function tests were observed (< 5% vs. pretreatment). A signi®cant reduction of several parameters was observed only after acarbose treatment: fasting glycaemia (173 6 28 vs. 146 6 19 mg/dl; p < 0.01), postprandial glycaemia (230 6 24 vs. 148 6 20 mg/dl; p < 0.01), mean glycaemia (206 6 20 vs. 136 6 13 mg/dl; p < 0.01), mean variation (180 6 14 vs. 51 6 10 mg/dl; p < 0.01), HbA 1c (8.9 6 0.8 vs. 7.2 6 0.5; p < 0.05), C-peptide 2 h after a standard meal (4.5 6 1.9 vs. 2.8 6 1.7 ng/ml; p < 0.05), whereas the parameters did not change signi®cantly after the placebo. After acarbose treatment a signi®cant increase of intestinal voiding/week (+ 116% vs. + 10%; p < 0.01) and a parallel reduction of blood ammonia levels (± 52 6 9% vs. ± 9 6 5%; P < 0.01) were observed. Conclusions: The results clearly document the good tolerability and the absence of toxic effects of acarbose on liver, due to the lack of both intestinal absorption and hepatic metabolism of the drug at doses in the therapeutic range. In fact, acarbose increases the peristalsis movements of the gut, stimulates the proliferation of the saccarolytic bacteria and simultaneously reduces the proliferation of proteolytic bacteria, thus resulting active in the reduction of blood ammonia levels. These effects of acarbose may be advantageously exploited in the treatment of type 2 diabetic patients with well-compensated non-alcholic liver cirrhosis. Keywords: diabetes mellitus, liver cirrhosis, acarbose insulin treatment Received January 1999; returned for revision February 1999; revised version accepted August 1999 Correspondence: Professor Sandro Gentile, Cattedra di Medicina Interna, III Padiglione del II Policlinico Universitario, Via Pansini 5, 80131 Naples, Italy. | OA ã 2001 Blackwell Science Ltd Diabetes, Obesity and Metabolism, 3, 2001, 33±40 | 33