Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus: a placebo-controlled, double-blind, multicentre study

被引：31

作者：

Riccardi, G ^{[1
]}

Giacco, R ^{[1
]}

Parillo, M ^{[1
]}

Turco, S ^{[1
]}

Rivellese, AA ^{[1
]}

Ventura, MR ^{[1
]}

Contadini, S ^{[1
]}

Marra, G ^{[1
]}

Monteduro, M ^{[1
]}

Santeusanio, F ^{[1
]}

Brunetti, P ^{[1
]}

Librenti, MC ^{[1
]}

Pontiroli, AE ^{[1
]}

Vedani, P ^{[1
]}

Pozza, G ^{[1
]}

Bergamini, L ^{[1
]}

Bianchi, C ^{[1
]}

机构：

[1] Univ Naples Federico II, Dip Med Clin & Sperimentale, Sch Med, I-80131 Naples, Italy

来源：

DIABETIC MEDICINE | 1999年 / 16卷 / 03期

关键词：

acarbose; Type; 1; diabetes; efficacy; safety;

D O I：

10.1046/j.1464-5491.1999.00047.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims The aim of the study was to evaluate the efficacy and safety of acarbose in patients with Type 1 diabetes mellitus (DM). Methods A multicentre double-blind, randomized, placebo-controlled study was performed. After a 6-week run-in, 121 patients were randomized to acarbose or placebo and to high- or low-fibre diet for 24 weeks. Acarbose dose was 50 mg t.d.s. for the first 2 weeks and 100 mg r.d.s. for the subsequent weeks. Results At the end of 24 weeks of treatment the intention to treat analysis showed that acarbose compared with placebo decreased 2 h postprandial plasma glucose levels (12.23 +/- 0.83 vs. 14.93 +/- 0.87 mmol/l; F = 6.1, P < 0.02) (least square means +/- SEM). No significant effect of acarbose was recorded on HbA(1c) or on the number of hypoglycaemic episodes. The effect of acarbose on blood glucose control was not influenced by the amount of carbohydrate and/or fibre intake. The incidence of adverse events were 75% and 39% in acarbose and placebo groups, respectively; they were mild and confined to the gastrointestinal tract. Conclusions The use of acarbose in combination with insulin reduces postprandial plasma glucose levels in Type 1 diabetic patients who are not satisfactorily controlled with insulin alone but without significant effect on HbA(1c).

引用

页码：228 / 232

页数：5