Medicine:Coronary Drug Project

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Short description: Clinical trial

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

  1. ↑ 1.0 1.1 1.2 1.3 "BioLINCC: Coronary Drug Project (CDP)". https://biolincc.nhlbi.nih.gov/studies/cdp/. 
  2. ↑ 2.0 2.1 "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. 
  3. ↑ 3.0 3.1 "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. 
  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. doi:10.1001/jama.1973.03230060030009. PMID 4356847. 
  5. ↑ 5.0 5.1 "Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin". J Am Coll Cardiol 8 (6): 1245–55. December 1986. doi:10.1016/s0735-1097(86)80293-5. PMID 3782631. 
  6. ↑ "The Coronary Drug Project --- Findings with Regard to Estrogen, Dextrothyroxine, Clofibrate and Niacin". Adv Exp Med Biol 82: 52–75. 1977. doi:10.1007/978-1-4613-4220-5_6. ISBN 978-1-4613-4222-9. PMID 335823. 
  7. ↑ 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. 
  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. doi:10.1001/jama.1972.03200070084015. PMID 4337170. 
  9. ↑ "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. 
  10. ↑ "Aspirin in coronary heart disease. The Coronary Drug Project Research Group". Circulation 62 (6 Pt 2): V59–62. December 1980. PMID 7002353. 



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