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Cited by 659Lipoproteins and Cardiovascular HealthMedication Adherence and ComplianceStatistical Methods in Clinical Trials

Influence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug Project

The Coronary Drug Project Research Group·1980·New England Journal of Medicine
DOI 10.1056/nejm198010303031804
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Abstract

The Coronary Drug Project was carried out to evaluate the efficacy and safety of several lipid-influencing drugs in the long-term treatment of coronary heart disease. The five-year mortality in 1103 men treated with clofibrate was 20.0 per cent, as compared with 20.9 per cent in 2789 men given placebo (P = 0.55). Good adherers to clofibrate, i.e., patients who took 80 per cent of more of the protocol prescription during the five-year follow-up period, had a substantially lower five-year mortality than did poor adherers to clofibrate (15.0 vs. 24.6 per cent; P = 0.00011). However, similar findings were noted in the placebo group, i.e., 15.1 per cent mortality for good adherers and 28.3 per cent for poor adherers (P = 4.7x10-16). These findings and various other analyses of mortality in the clofibrate and placebo groups of the project show the serious difficulty, if not impossibility, of evaluating treatment efficacy in subgroups determined by patient responses (e.g., adherence or cholesterol change) to the treatment protocol after randomization.

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Crossref · 10.1056/nejm198010303031804

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  • In RCTs, failure to compare outcomes by the original randomized groups or subversion of the randomized process by researchers or participants is a likely key source of confounding.

    “In RCTs, failure to compare outcomes by the original randomized groups or subversion of the randomized process by researchers or participants is a likely key source of confounding.”

    From Triangulation in aetiological epidemiology (2017) · cites this paper as [17]

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Authors
The Coronary Drug Project Research Group
Corresponding author
The Coronary Drug Project Research Group
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
1980-10-30
Volume
303
Issue
18
Pages
1038-1041
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm198010303031804
OpenAlex
W4230501493
Cited by
659
References
9
Citations by year
2026: 6 · 2025: 11 · 2024: 13 · 2023: 9 · 2022: 6 · 2021: 7 · 2020: 7 · 2019: 12 · 2018: 12 · 2017: 15 · 2016: 14 · 2015: 18 · 2014: 21 · 2013: 16 · 2012: 17
FWCI
27.08
Type
journal article
Language
en
Open access
closed
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
medication adherence, clofibrate, coronary artery disease, mortality, lipid-lowering drugs, Coronary Drug Project, long-term drug therapy
MeSH terms
Adult, Cholesterol, Clinical Trials as Topic, Clofibrate, Coronary Disease, Follow-Up Studies, Humans, Male, Middle Aged, Patient Compliance, Prognosis, Random Allocation, Risk, Time Factors

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