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Effectiveness and cost-effectiveness of diabetes prevention among adherent participants [with consumer summary]
Herman WH, Edelstein SL, Ratner RE, Montez MG, Ackermann RT, Orchard TJ, Foulkes MA, Zhang P, Saudek CD, Brown MB, the Diabetes Prevention Program Research Group
The American Journal of Managed Care 2013 Mar;19(3):194-202
clinical trial
2/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) interventions among participants who were adherent to the interventions. STUDY DESIGN: DPP was a 3-year randomized clinical trial followed by 7 years of open-label modified intervention follow-up. METHODS: Data on resource utilization, cost, and quality of life were collected prospectively. Economic analyses were performed from health system and societal perspectives. Lifestyle adherence was defined as achieving and maintaining a 5% reduction in initial body weight, and metformin adherence as taking metformin at 80% of study visits. RESULTS: The relative risk reduction was 49.4% among adherent lifestyle participants and 20.8% among adherent metformin participants compared with placebo. Over 10 years, the cumulative, undiscounted, per capita direct medical costs of the interventions, as implemented during the DPP, were greater for adherent lifestyle participants ($4,810) than adherent metformin participants ($2,934) or placebo ($768). Over 10 years, the cumulative, per capita non-intervention-related direct medical costs were $4,250 greater for placebo participants compared with adherent lifestyle participants and $3,251 greater compared with adherent metformin participants. The cumulative quality-adjusted life-years (QALYs) accrued over 10 years were greater for lifestyle (6.80) than metformin (6.74) or placebo (6.67). Without discounting, from a modified societal perspective (excluding participant time) and a full societal perspective (including participant time), lifestyle cost < $5,000 per QALY-gained and metformin was cost saving compared with placebo. CONCLUSIONS: Over 10 years, lifestyle intervention and metformin were cost-effective or cost saving compared with placebo. These analyses confirm that lifestyle and metformin represent a good value for money.

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