HEALTH ECONOMIC-BENEFITS AND QUALITY-OF-LIFE DURING IMPROVED GLYCEMICCONTROL IN PATIENTS WITH TYPE-2 DIABETES-MELLITUS - A RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL

Context.-Although the long-term health benefits of good glycemic contr ol 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 glyce mic control in type 2 diabetes mellitus (DM). Design.-Double-blind, ra ndomized, placebo-controlled, parallel trial. Setting.-Sixty-two sites in the United States. Participants.-A total of 569 male and female vo lunteers with type 2 DNI. Intervention.-After a 3-week, single-blind p lacebo-washout period, participants were randomized to diet and titrat ion with either 5 to 20 mg of glipizide gastrointestinal therapeutic s ystem (GITS) (n=377) or placebo (n=192) for 12 weeks. Main Outcome Mea sures.-Change from baseline in glucose and hemoglobin A(1c) (HbA(1c)) levels and symptom distress, QOL, and health economic indicators by qu estionnaires and diaries. Results.-After 12 weeks, mean (+/-SE) HbA(1c ) and fasting blood glucose levels decreased with active therapy (glip izide 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], respectivel y; P<.001), Quality-of-life treatment differences (SD units) for sympt om 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 activ e therapy. Subscales of acuity (+0.38, P=.002), VAS emotional health ( +0.35; P=.003), general health (+0.27; P=.01), sleep (+0.26, P=.04), d epression (+0.25; P=.05), disorientation and detach ment (+0.23, P=.05 ), and vitality (+0.22, P=.04) were most affected. Favorable health ec onomic outcomes for glipizide GITS included higher retained employment (97% vs 85%; P<.001), greater productive capacity (99% vs 87%; P<.001 ), less absenteeism (losses=$24 vs $115 per worker per month; P<.001), fewer bed-days (losses=$1539 vs $1843 per 1000 person-days; P=.05), a nd fewer restricted-activity days (losses=$2660 vs $4275 per 1000 pers on-days; P=.01). Conclusions.-Improved glycemic control of type 2 DM i s associated with substantial short-term symptomatic, QOL, and health economic benefits.