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  1. Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus : A randomized, controlled, double-blind trial.

    Article - En anglais

    Context. - Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent.

    Objective

    - To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM).

    Design

    - Double-blind, randomized, placebo-controlled, parallel trial.

    Setting

    - Sixty-two sites in the United States.

    Participants

    - A total of 569 male and female volunteers with type 2 DM.

    Intervention

    - After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n=377) or placebo (n=192) for 12 weeks.

    Main Outcome Measures

    - Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries.

    Results

    - After 12 weeks, mean (±SE) HbA1c and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5% ±0.1% vs 9.3% ±0.1% and 7.0± 0.1 mmol/L [126± 2 mg/dL] vs 9.3± 0.2 mmol/L [168± 4 mg/dL], respectiveiy ; P<. 001).

    Quality-of-life treatment differences (SD units) for symptom distress (+0.59 ; P<. 001), general perceived health (+0.36 ; P=004), cognitive functioning (+0.34 ; P=005), and the overall visual analog scale (VAS) (+0.24 ; P=04) were significantly more favorable for active therapy. (...)

    Mots-clés Pascal : Diabète non insulinodépendant, Randomisation, Etude double insu, Glycémie, Contrôle, Analyse avantage coût, Qualité vie, Essai thérapeutique contrôlé, Evaluation, Homme, Etats Unis, Amérique du Nord, Amérique, Endocrinopathie, Biologie moléculaire, Economie santé

    Mots-clés Pascal anglais : Non insulin dependent diabetes, Randomization, Double blind study, Glycemia, Check, Cost benefit analysis, Quality of life, Controlled therapeutic trial, Evaluation, Human, United States, North America, America, Endocrinopathy, Molecular biology, Health economy

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 98-0526354

    Code Inist : 002B21E01C. Création : 23/03/1999.