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.
Keywords
MedicineClofibratePlaceboRandomizationMedical prescriptionInternal medicineDrugCoronary heart diseaseMortality rateClinical trialPharmacologyAlternative medicine
Related Publications
Helsinki Heart Study: Primary-Prevention Trial with Gemfibrozil in Middle-Aged Men with Dyslipidemia
In a randomized, double-blind five-year trial, we tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein (HDL) cholesterol and lowering levels ...
A co-operative trial in the primary prevention of ischaemic heart disease using clofibrate. Report from the Committee of Principal Investigators.
A co-operative trial in the primary prevention of ischaemic heart disease using clofibrate Report1 from the Committee of Principal Investigators SUMMARY A double-blind intervent...
Effect of Vasodilator Therapy on Mortality in Chronic Congestive Heart Failure
To evaluate the effects of vasodilator therapy on mortality among patients with chronic congestive heart failure, we randomly assigned 642 men with impaired cardiac function and...
Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins
Results of previous randomised trials have shown that interventions that lower LDL cholesterol concentrations can significantly reduce the incidence of coronary heart disease (C...
Beneficial Effects of Combined Colestipol-Niacin Therapy on Coronary Atherosclerosis and Coronary Venous Bypass Grafts
The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol hydrochloride and niacin therapy in 16...
Publication Info
- Year
- 1980
- Type
- article
- Volume
- 303
- Issue
- 18
- Pages
- 1038-1041
- Citations
- 656
- Access
- Closed
External Links
Social Impact
Altmetric
PlumX Metrics
Social media, news, blog, policy document mentions
Citation Metrics
656
OpenAlex
Cite This
THE CORONARY DRUG PROJECT RESEARCH GROUP
(1980).
Influence of Adherence to Treatment and Response of Cholesterol on Mortality in the Coronary Drug Project.
New England Journal of Medicine
, 303
(18)
, 1038-1041.
https://doi.org/10.1056/nejm198010303031804
Identifiers
- DOI
- 10.1056/nejm198010303031804