Coronary Drug Project Explained

The Coronary Drug Project (CDP) was a large clinical trial which assessed several different treatments for coronary heart disease in men with previous myocardial infarction.^{[1] [2] [3]} The study was conducted from 1965 to 1985 at 53 clinical centers and randomized 8,341 men age 30 to 64 years to six different treatment groups: low-dose estrogen therapy (2.5 mg/day oral conjugated estrogens), high-dose estrogen therapy (5 mg/day oral conjugated estrogens), clofibrate (1.8 g/day), dextrothyroxine (6 mg/day), niacin (3 g/day), and placebo (lactose 3.8 mg/day).

The high-dose estrogen group was discontinued in 1970 due to increased non-fatal cardiovascular complications and an unfavorable trend in overall mortality, while the low-dose estrogen group was discontinued in 1970 due to lack of indication of benefit and also an unfavorable trend in overall mortality.^{[4] [5] [6]} Both dose levels of estrogen as well as clofibrate were also found to increase the incidence of gallbladder disease in the study.^[7] The dextrothyroxine group was discontinued in late 1971 due to increased cardiovascular mortality.^[8]

The Coronary Drug Project Aspirin Study was a substudy of the CDP which randomized men from the estrogen and dextrothyroxine groups of the trial which had been terminated early to either aspirin or placebo.^{[9] [10]}

Notes and References

1. Web site: BioLINCC: Coronary Drug Project (CDP).
2. The Coronary Drug Project. Initial findings leading to modifications of its research protocol . JAMA . 214 . 7 . 1303–13 . November 1970 . 4320008 . 10.1001/jama.1970.03180070069012 .
3. The Coronary Drug Project: Design, Methods, and Baseline Results . Circulation . 47 . 3 Suppl . I1–50 . March 1973 . 4570454 . 10.1161/01.cir.47.3s1.i-1 . 22194468 .
4. The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group . JAMA . 226 . 6 . 652–7 . November 1973 . 4356847 . 10.1001/jama.1973.03230060030009 .
5. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W . Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin . J Am Coll Cardiol . 8 . 6 . 1245–55 . December 1986 . 3782631 . 10.1016/s0735-1097(86)80293-5 . free .
6. Book: Stamler J . The Coronary Drug Project --- Findings with Regard to Estrogen, Dextrothyroxine, Clofibrate and Niacin . Advances in Experimental Medicine and Biology . Atherosclerosis . 82 . 52–75 . 1977 . 335823 . 10.1007/978-1-4613-4220-5_6 . 978-1-4613-4222-9 .
7. Gallbladder disease as a side effect of drugs influencing lipid metabolism. Experience in the Coronary Drug Project . N Engl J Med . 296 . 21 . 1185–90 . May 1977 . 323705 . 10.1056/NEJM197705262962101 . Coronary Drug Project Research Group .
8. The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group . JAMA . 220 . 7 . 996–1008 . May 1972 . 4337170 . 10.1001/jama.1972.03200070084015 .
9. The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group . Prim Care . 5 . 1 . 91–5 . March 1978 . 349581 . 10.1016/S0095-4543(21)00774-0.
10. Aspirin in coronary heart disease. The Coronary Drug Project Research Group . Circulation . 62 . 6 Pt 2 . V59–62 . December 1980 . 7002353 .