Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia

Shepherd, James; Cobbe, Stuart M.; Ford, Ian; Isles, Christopher G.; Lorimer, A. Ross; Macfarlane, Peter W.; McKillop, James H.; Packard, Christopher J.

doi:10.1056/nejm199511163332001

Cited by 7,449Lipoproteins and Cardiovascular HealthAcute Myocardial Infarction ResearchCancer, Lipids, and Metabolism

Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia

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Shepherd, James, Cobbe, Stuart M., Ford, Ian, Isles, Christopher G., Lorimer, A. Ross, Macfarlane, Peter W., McKillop, James H., Packard, Christopher J.·1995·New England Journal of Medicine

DOI 10.1056/nejm199511163332001

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Abstract

BACKGROUND: Lowering the blood cholesterol level may reduce the risk of coronary heart disease. This double-blind study was designed to determine whether the administration of pravastatin to men with hypercholesterolemia and no history of myocardial infarction reduced the combined incidence of nonfatal myocardial infarction and death from coronary heart disease. METHODS: We randomly assigned 6595 men, 45 to 64 years of age, with a mean (+/- SD) plasma cholesterol level of 272 +/- 23 mg per deciliter (7.0 +/- 0.6 mmol per liter) to receive pravastatin (40 mg each evening) or placebo. The average follow-up period was 4.9 years. Medical records, electrocardiographic recordings, and the national death registry were used to determine the clinical end points. RESULTS: Pravastatin lowered plasma cholesterol levels by 20 percent and low-density-lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo. There were 248 definite coronary events (specified as nonfatal myocardial infarction or death from coronary heart disease) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P < 0.001). There were similar reductions in the risk of definite nonfatal myocardial infarctions (31 percent reduction, P < 0.001), death from coronary heart disease (definite cases alone: 28 percent reduction, P = 0.13; definite plus suspected cases: 33 percent reduction, P = 0.042), and death from all cardiovascular causes (32 percent reduction, P = 0.033). There was no excess of deaths from noncardiovascular causes in the pravastatin group. We observed a 22 percent reduction in the risk of death from any cause in the pravastatin group (95 percent confidence interval, 0 to 40 percent; P = 0.051). CONCLUSIONS: Treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial infarction.

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The 2 classic trials of primary prevention patients published in the 1990s showed a reduction in morbidity but not mortality.
“The 2 classic trials of primary prevention patients published in the 1990s showed a reduction in morbidity but not mortality.2,3”
From Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients (2023) · cites this paper as [2]
The Results report significantly fewer nonfatal myocardial infarctions with pravastatin. Death from any cause was lower but did not meet the conventional threshold for statistical significance (P=0.051). However, the End Points section reports a significant reduction in cardiovascular deaths (P=0.033), so the unqualified statement that mortality was not reduced overstates this trial’s findings. This verdict concerns only the cited pravastatin trial, not the other trial mentioned in the sentence. (LLM, conf=0.88)
Experimental — accuracy not yet measured
Current recommendations for statin use in primary prevention are predominantly derived from clinical trials conducted several decades ago during the initial development of statins to reduce LDL-C levels.
“However, the current recommendations are predominantly derived from clinical trials conducted several decades ago during the initial development of statins to reduce low-density lipoprotein cholesterol (LDL-C) levels.2,3”
From Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients (2023) · cites this paper as [2]
Each 1 mmol/L reduction in LDL-C levels is associated with approximately a 30% reduction in the risk of adverse cardiovascular events.
“Large-scale epidemiologic and clinical studies have shown that lowering of low-density lipoprotein cholesterol (LDL-C) levels through pharmacologic and/or non-pharmacologic means is associated with significant CV benefits, with each mmol/L reduction in LDL-C levels leading to an approximately 30% reduction in the risk of adverse CV events [5][6][7][8][9][10].”
From ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia (2016) · cites this paper as [7]

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Authors: Shepherd, J., Cobbe, S. M., Ford, I., Isles, C. G., Lorimer, A. R., Macfarlane, P. W., McKillop, J. H., & Packard, C. J.
Affiliations: Glasgow Royal Infirmary (GB)
University of Glasgow (GB)
NHS Dumfries and Galloway (GB)
ORCID: Ford, Ian
Macfarlane, Peter W.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1995-11-16
Volume: 333
Issue: 20
Pages: 1301-1308
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199511163332001
OpenAlex: W2155598961
Semantic Scholar: 1aa5f64bbe1d0c4c74fc3de7c89ac2dffb48630a
Cited by: 7,449
References: 26
Citations by year: 2026: 31 · 2025: 33 · 2024: 56 · 2023: 54 · 2022: 66 · 2021: 72 · 2020: 95 · 2019: 90 · 2018: 108 · 2017: 121 · 2016: 157 · 2015: 137 · 2014: 177 · 2013: 215 · 2012: 197
FWCI: 344.87
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: Bristol-Myers Squibb
Topics: Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
Keywords: pravastatin, hypercholesterolemia, coronary heart disease prevention, statins, LDL cholesterol lowering, nonfatal myocardial infarction, cardiovascular mortality, men, cholesterol-lowering therapy
MeSH terms: Anticholesteremic Agents, Cholesterol, Coronary Disease, Double-Blind Method, Humans, Hypercholesterolemia, Cholesterol, LDL, Male, Middle Aged, Myocardial Infarction, Neoplasms, Risk, Incidence, Survival Analysis, Pravastatin

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Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia

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