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).[1][3]
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.[1][2][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.[1][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][5]
References
edit- ^ a b c d "BioLINCC: Coronary Drug Project (CDP)".
- ^ a b "The Coronary Drug Project. Initial findings leading to modifications of its research protocol". JAMA. 214 (7): 1303–13. November 1970. doi:10.1001/jama.1970.03180070069012. PMID 4320008.
- ^ a b "The Coronary Drug Project: Design, Methods, and Baseline Results". Circulation. 47 (3 Suppl): I1–50. March 1973. doi:10.1161/01.cir.47.3s1.i-1. PMID 4570454. S2CID 22194468.
- ^ "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. doi:10.1001/jama.1973.03230060030009. PMID 4356847.
- ^ a b Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W (December 1986). "Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin". J Am Coll Cardiol. 8 (6): 1245–55. doi:10.1016/s0735-1097(86)80293-5. PMID 3782631.
- ^ Stamler J (1977). "The Coronary Drug Project --- Findings with Regard to Estrogen, Dextrothyroxine, Clofibrate and Niacin". Atherosclerosis. Advances in Experimental Medicine and Biology. Vol. 82. pp. 52–75. doi:10.1007/978-1-4613-4220-5_6. ISBN 978-1-4613-4222-9. PMID 335823.
- ^ Coronary Drug Project Research Group (May 1977). "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. doi:10.1056/NEJM197705262962101. PMID 323705.
- ^ "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. doi:10.1001/jama.1972.03200070084015. PMID 4337170.
- ^ "The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group". Prim Care. 5 (1): 91–5. March 1978. doi:10.1016/S0095-4543(21)00774-0. PMID 349581.
- ^ "Aspirin in coronary heart disease. The Coronary Drug Project Research Group". Circulation. 62 (6 Pt 2): V59–62. December 1980. PMID 7002353.