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Updated: Jul 21, 2026
07:30
Homogeneous Time-resolved Förster Resonance Energy Transfer-based Assay for Detection of Insulin Secretion
Published on: May 10, 2018
Summary
Tolbutamide did not show increased mortality in a re-analysis of University Group Diabetes Program (UGDP) data. Cardiovascular deaths were not significantly elevated, even when redefined to test specific hypotheses.
Area of Science:
- Clinical Trials
- Epidemiology
- Biostatistics
Background:
- The University Group Diabetes Program (UGDP) study reported increased cardiovascular mortality with tolbutamide.
- This finding has been controversial and subject to re-analysis.
- Concerns exist regarding the statistical methods used in the original UGDP analysis.
Purpose of the Study:
- To re-evaluate the mortality trends associated with tolbutamide using the UGDP data.
- To address statistical concerns regarding hypothesis generation and testing within the UGDP study.
- To investigate the impact of redefining cardiovascular deaths on mortality findings.
Main Methods:
- Analysis of variance on logit-transformed data from the UGDP study.
- Confirmation of subgrouped cardiovascular mortality findings by the Biometric Committee.
- Re-analysis of data with redefined cardiovascular death categories (myocardial infarcts, sudden deaths).
Main Results:
- No statistically significant increased mortality trend attributable to tolbutamide was found.
- The Biometric Committee confirmed the UGDP's controversial cardiovascular mortality findings, but with reservations.
- Redefining cardiovascular deaths did not reveal a significant increase in mortality.
Conclusions:
- The original UGDP conclusion of increased cardiovascular mortality with tolbutamide is questionable due to data-driven hypothesis and statistical issues.
- The re-analysis suggests tolbutamide is not associated with increased mortality.
- Further investigation into statistical methodologies for clinical trial data is warranted.
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