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J Clin Epidemiol. 2015 Feb;68(2):200-10. doi: 10.1016/j.jclinepi.2014.09.001. Epub 2014 Nov 26.

Observational and clinical trial findings on the comparative effectiveness of diabetes drugs showed agreement.

Author information

1
Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Weill Cornell Medical College, 525 E 68th Street, 20th Floor Baker Pavilion, New York, NY 10021, USA. Electronic address: jaf9052@nyp.org.
2
Department of Public Health, Weill Cornell Medical College, 425 E 61st Street, 3rd Floor, Suite 301, New York, NY 10065, USA.

Abstract

OBJECTIVES:

This study compares an observational study of diabetes treatment effectiveness to randomized controlled trials to assess their convergent validity.

STUDY DESIGN AND SETTING:

Multivariate models were developed using observational data to describe change in hemoglobin A1c (HbA1c; % unit) and weight (kilograms) after addition of a second-line oral diabetes drug to metformin monotherapy. Randomized trials of these scenarios were systematically identified. The models were used to simulate each trial, and simulated and actual results were compared by linear regression and meta-analysis.

RESULTS:

Thirty-two randomized trials of second-line diabetes oral therapy were identified. For all outcomes and drugs studied, simulation and actual results correlated (P < 0.001). There were no statistically significant differences between meta-analyzed randomized and simulated results for effect on HbA1c. For effect on weight, results were qualitatively comparable, but for sulfonylureas, the simulated weight gain was nominally greater than seen in the randomized controlled trials.

CONCLUSION:

An observational study of diabetes drug effectiveness showed convergent validity with randomized data. This supports cautious use of the observational research to draw conclusions about drug effectiveness in populations not studied in clinical trials. This approach may be useful in other situations where observational and randomized data need integration.

KEYWORDS:

Comparative effectiveness data; Diabetes; HbA1c; Pharmacoepidemiology; Validation; Weight

PMID:
25432086
PMCID:
PMC4349393
DOI:
10.1016/j.jclinepi.2014.09.001
[Indexed for MEDLINE]
Free PMC Article

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