Gliclazide modified release*: results of a 2-year study in patients with type 2 diabetes

被引:24
|
作者
Drouin, P
Standl, E
机构
[1] Hop Jeanne Darc, Ctr Hosp Univ Nancy, F-54201 Toul, France
[2] Akad Krankenhaus Munchen Schwabing, Med Abt, Munich, Germany
[3] Akad Krankenhaus Munchen Schwabing, Inst Diabet Forsch, Munich, Germany
关键词
elderly; gliclazide modified release; impaired renal function; long-term efficacy; type; 2; diabetes;
D O I
10.1111/j.1462-8902.2004.00404.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aim: To evaluate the efficacy and safety of gliclazide modified release (MR), alone or combined with other oral antidiabetic drug(s) over 2 years in type 2 diabetic patients. Methods: Two consecutive periods: (i) a 10-month, double-blind comparative study, where 800 type 2 diabetic patients were randomized either to gliclazide MR (30-120 mg) once daily or to gliclazide (80-320 mg) twice daily. All the patients were then treated with gliclazide MR for a 2-month switch period; (ii) 549 patients were subsequently enrolled in a 12-month, open-label period on gliclazide MR alone or in combination according to glycaemic control, 507 of whom completed the study. Results: Glycated haemoglobin (HbA1c) significantly decreased from baseline over 2 years by -0.46 +/- 1.08% in the whole cohort of 2-year completed patients, -0.95% in the subgroup of diet-failed patients and by -0.34% in the subgroup of patients pretreated with one oral antidiabetic drug. HbA1c was reduced by -0.43 +/- 1.02% and by -0.51 +/- 1.16%, when gliclazide MR was used in monotherapy and in combination therapy, respectively. The overall incidence of symptoms suggestive of hypoglycaemia was 4.8 episodes/100 patient-year, with no severe episode. This incidence was similarly low in elderly patients and patients with impaired renal function. Conclusion: Gliclazide MR alone or in combination with another oral antidiabetic drug significantly improved glycaemic control in type 2 diabetic patients over 2 years with a very good safety profile, notably in the elderly and in patients with impaired renal function.
引用
收藏
页码:414 / 421
页数:8
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