Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men with Low Levels of High-Density Lipoprotein Cholesterol

Rubins, Hanna Bloomfield; Robins, Sander J.; Collins, Dorothea; Fye, Carol L.; Anderson, James W.; Elam, Marshall B.; Faas, Fred H.; Linares, Esteban; Schaefer, Ernst J.; Schectman, Gordon; Wilt, Timothy J.; Wittes, Janet

doi:10.1056/nejm199908053410604

Cited by 3,439Lipoproteins and Cardiovascular HealthLipid metabolism and disordersAcute Myocardial Infarction Research

Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men with Low Levels of High-Density Lipoprotein Cholesterol

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Rubins, Hanna Bloomfield, Robins, Sander J., Collins, Dorothea, Fye, Carol L., Anderson, James W., Elam, Marshall B., Faas, Fred H., Linares, Esteban +4 more·1999·New England Journal of Medicine

DOI 10.1056/nejm199908053410604

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Abstract

BACKGROUND: Although it is generally accepted that lowering elevated serum levels of low-density lipoprotein (LDL) cholesterol in patients with coronary heart disease is beneficial, there are few data to guide decisions about therapy for patients whose primary lipid abnormality is a low level of high-density lipoprotein (HDL) cholesterol. METHODS: We conducted a double-blind trial comparing gemfibrozil (1200 mg per day) with placebo in 2531 men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less. The primary study outcome was nonfatal myocardial infarction or death from coronary causes. RESULTS: The median follow-up was 5.1 years. At one year, the mean HDL cholesterol level was 6 percent higher, the mean triglyceride level was 31 percent lower, and the mean total cholesterol level was 4 percent lower in the gemfibrozil group than in the placebo group. LDL cholesterol levels did not differ significantly between the groups. A primary event occurred in 275 of the 1267 patients assigned to placebo (21.7 percent) and in 219 of the 1264 patients assigned to gemfibrozil (17.3 percent). The overall reduction in the risk of an event was 4.4 percentage points, and the reduction in relative risk was 22 percent (95 percent confidence interval, 7 to 35 percent; P=0.006). We observed a 24 percent reduction in the combined outcome of death from coronary heart disease, nonfatal myocardial infarction, and stroke (P< 0.001). There were no significant differences in the rates of coronary revascularization, hospitalization for unstable angina, death from any cause, and cancer. CONCLUSIONS: Gemfibrozil therapy resulted in a significant reduction in the risk of major cardiovascular events in patients with coronary disease whose primary lipid abnormality was a low HDL cholesterol level. The findings suggest that the rate of coronary events is reduced by raising HDL cholesterol levels and lowering levels of triglycerides without lowering LDL cholesterol levels.

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In the fibrate trials, the mean reduction in plasma triglyceride concentration was only 20 mg/dL to 50 mg/dL, a fraction of what would be needed to significantly reduce major vascular event risk in a short-term trial.
“However, the mean reduction in plasma triglyceride concentration in the fibrate trials was only 20 mg/dL to 50 mg/dL, a fraction of what would be needed to significantly reduce the risk of major vascular events within a shortterm trial.”
From Association of Triglyceride-Lowering LPL Variants and LDL-C–Lowering LDLR Variants With Risk of Coronary Heart Disease (2019) · cites this paper as [30]
The Effects on Lipid Levels section reports triglycerides of 115 mg/dL with gemfibrozil versus 166 mg/dL with placebo, a 51 mg/dL difference. Contrary to the claim that a reduction of roughly this size was too small to yield a significant benefit in a trial, the Outcomes section reports a significant reduction in coronary death or nonfatal myocardial infarction, and the paper reports a significant reduction in the combined outcome including stroke. The paper does not isolate triglyceride lowering from the treatment’s other lipid effects as the cause of that benefit. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured
In VA-HIT, treatment with gemfibrozil versus placebo reduced the primary endpoint of death or nonfatal MI by 32% (P = 0.004), mortality by 41% (P = 0.02), and stroke by 40% (P = 0.046).
“Treatment with gemfibrozil versus placebo reduced the primary endpoint of death or nonfatal MI by 32% (P = 0.004), mortality by 41% (P = 0.02), and stroke by 40% (P = 0.046).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [33]
The Outcomes section reports a 22% reduction in coronary death or nonfatal MI (P=0.006), not 32% (P=0.004). The copy also reports an 11% reduction in overall mortality (P=0.23) and a 25% reduction in confirmed stroke (P=0.10), rather than the claimed 41% and 40%. Page numbers are not provided in the supplied passages. (LLM, conf=0.95)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured
Evidence supporting the prescription of fibrates for cardiovascular prevention remains debated.
“Evidence supporting the prescription of fibrates for cardiovascular prevention remains debated.”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [93]
The discussion following Table 4 notes concern from prior fibrate studies about possible cancer-related deaths and calls for further follow-up on long-term safety. That supports some caution about prescribing fibrates, but the paper reports a significant cardiovascular benefit from gemfibrozil in the men studied; it does not establish that evidence for cardiovascular prevention with fibrates generally remains debated. Page numbers were not available in our copy. (LLM, conf=0.70)
Experimental — accuracy not yet measured
Fibrates decrease triglyceride levels by 30-50% and sometimes increase HDL cholesterol.
“Fibrates decrease triglyceride levels by 30 -50% and sometimes increase HDL cholesterol (165-168).”
From Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline (2012) · cites this paper as [166]
The Effects on Lipid Levels section reports that, after one year, gemfibrozil lowered mean triglycerides by 31% and raised mean HDL cholesterol by 6% relative to placebo. This supports an example of the claimed effects, but the trial studied one fibrate in men with coronary heart disease; it does not establish a 30–50% range for fibrates generally. (LLM, conf=0.87)
Experimental — accuracy not yet measured
In a VA-HIT substudy, patients with diabetes (n=627) compared to those without diabetes (n=142), following 5 years of gemfibrozil, had an average reduction of triglyceride levels by 31% and an increase in high density lipoprotein cholesterol of 6%; these changes were associated with a statistically significant 22% reduction in relative risk of coronary heart disease and a 24% reduction in combined
“A sub study was conducted on patients with diabetes participating in the VA-HIT Trial (n=627) compared to those without diabetes (n=142). Following 5 years of treatment with gemfibrozil the investigators observed an average reduction of TG levels by 31% and a corresponding increase in HDLC of 6%. More importantly, these changes were associated with a, statistically significant 22% reduction in”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [72]
The Effects on Lipid Levels section reports 31% lower triglycerides and 6% higher HDL cholesterol at one year, while the Outcomes section reports a significant 22% reduction in coronary death or nonfatal myocardial infarction for the full trial. Table 2 reports a 24% reduction in the combined outcome for the full trial, and Table 3 lists 627 participants with diabetes (318 plus 309), but 1,904 without diabetes—not 142. The cited paper does not present the lipid changes or the 22% reduction as findings of a diabetes substudy after five years. (LLM, conf=0.91)
Experimental — accuracy not yet measured

Triglyceride elevation is an independent risk factor for cardiovascular events.
“Clinical and epidemiological studies have demonstrated that triglyceride (TG) elevation is an independent risk factor for increased cardiovascular (CV) events”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [7]
The Discussion reports fewer cardiovascular events with gemfibrozil and suggests that lowering triglycerides, alongside raising HDL cholesterol, may contribute to the benefit. It does not establish that elevated triglycerides are an independent risk factor; the paper explicitly describes low HDL cholesterol, rather than triglycerides, as independently associated with coronary risk. Page numbers are not available in our copy. (LLM, conf=0.82)
Experimental — accuracy not yet measured
Epidemiological, biological, and genetic studies have provided robust evidence of a strong association between elevated TG levels and higher rates of CV events.
“Epidemiological, biological, and genetic studies have provided robust evidence of a strong association between elevated TG levels and higher rates of CV events.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [7]
The Results report that gemfibrozil lowered triglycerides and reduced coronary events in men with established coronary disease and low HDL cholesterol. The Discussion also describes potentially atherogenic triglyceride-rich lipoproteins. But this trial does not establish a strong association between elevated triglycerides themselves and cardiovascular events, or report the claimed body of epidemiological and genetic evidence; HDL levels changed alongside triglycerides. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Earlier fibrate trials, in people with or without diabetes, did not examine these drugs in patients already on statin therapy.
“Previous fibrate studies in subjects with diabetes10,11 or in those without diabetes13–15 did not address the role of such drugs in patients receiving statin therapy.”
From Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus (2010) · cites this paper as [15]
The ACCORD, LEADER and VA-COOP trials could not confirm that fibrates reduce the incidence of MACE at a 5% significance level, whilst a significant MACE reduction was observed in the FIELD and VA-HIT trials.
“The ACCORD, LEADER and VA-COOP trials could not confirm that fibrates reduce the incidence of MACE at a 5% significance level, whilst a significant MACE reduction was observed in the FIELD and VA-HIT trials [91–94].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [93]
Studies to date have not demonstrated an overall benefit of fibrates for reduction of cardiovascular or total mortality.
“Studies to date have not demonstrated an overall benefit of fibrates for reduction of cardiovascular or total mortality (165-169).”
From Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline (2012) · cites this paper as [166]
The VA-HIT Trial, with 2,531 men with a history of coronary heart disease and low high density lipoprotein cholesterol and low density lipoprotein cholesterol, found that gemfibrozil resulted in a significant 22% reduction in the combined incidence of nonfatal myocardial infarction and coronary heart disease death after 5 years.
“For example, the VA-HIT Trial, with a total of 2,531 men with a history of CHD who had low HDLC levels (mean, 32 mg/dl) and low LDLC levels (mean, 111 mg/dl), assigned subjects to receive either 1,200 mg/day of gemfibrozil or placebo. After a 5 year follow-up, treatment with gemfibrozil resulted in a significant 22% reduction in the combined incidence of nonfatal myocardial infarction (MI) and CHD”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [72]
Randomized data from large outcome studies across broad populations regarding pharmacological TG lowering and effect on CV outcomes have been mixed.
“However, randomized data from large outcome studies across broad populations regarding pharmacological TG lowering and effect on CV outcomes have been mixed (Table 4).1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [7]
Subgroup and post hoc analyses of outcome studies suggest possible reductions in major CV events with TG-lowering therapy.
“Furthermore, TG reduction lowers several inflammatory markers associated with CV risk, and subgroup and post hoc analyses of outcome studies suggest possible reductions in major CV events with TG‐lowering therapy.3, 4, 5, 6, 7, 8, 9, 10, 11”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [7]
In the VA-HIT trial, there was no significant difference in all-cause mortality.
“Again, there was no significant difference in allcause mortality”
From The Forgotten Lipids: Triglycerides, Remnant Cholesterol, and Atherosclerotic Cardiovascular Disease Risk (2019) · cites this paper as [136]
The current study's results may help explain why prior randomized trials of fibrates have failed to consistently show that lowering triglyceride levels reduces cardiovascular events.
“The results of this study may also help to explain why prior randomized trials evaluating fibrates, which lower plasma triglyceride levels at least partially through the LPL pathway, have failed to consistently demonstrate that lowering triglyceride levels reduces the risk of cardiovascular events.[29][30][31][32][33]”
From Association of Triglyceride-Lowering LPL Variants and LDL-C–Lowering LDLR Variants With Risk of Coronary Heart Disease (2019) · cites this paper as [30]
TG reduction lowers several inflammatory markers associated with CV risk.
“Furthermore, TG reduction lowers several inflammatory markers associated with CV risk, and subgroup and post hoc analyses of outcome studies suggest possible reductions in major CV events with TG‐lowering therapy.3, 4, 5, 6, 7, 8, 9, 10, 11”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [7]
The Discussion reports reduced cardiovascular events and discusses triglyceride metabolism, but it does not report that triglyceride reduction lowered inflammatory markers. Searches for inflammatory markers, inflammation, C-reactive protein, fibrinogen, and cytokines found no passage addressing the quoted claim. The paper supports the sentence’s separate point about cardiovascular events, not the quoted inflammatory-marker claim. (LLM, conf=0.73)
Experimental — accuracy not yet measured
Qualitative changes in LDL cholesterol may be present in the form of small, dense LDL particles which are more atherogenic and may be associated with higher risk of CVD.
“Additionally, qualitative changes in LDL cholesterol may be present in the form of small, dense LDL particles which are more atherogenic and may be associated with higher risk of CVD [58-60].”
From The case for low carbohydrate diets in diabetes management (2005) · cites this paper as [60]
As monotherapy, fibrates likely reduce ASCVD risk.
“As monotherapy, fibrates likely reduce ASCVD risk.43–45”
From Clinical review on triglycerides (2020) · cites this paper as [45]
Gemfibrozil significantly reduced CV event rate in the Helsinki Heart Study and the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial.
“In the Helsinki Heart Study (HHS) [4] and the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial (VA-HIT) [5], administration of gemfibrozil significantly reduced CV event rate, the primary endpoints of the trials.”
From Pemafibrate, a new selective PPARα modulator: drug concept and its clinical applications for dyslipidemia and metabolic diseases (2020) · cites this paper as [5]
Some studies have described an increase in patient-reported neurocognitive effects with anti-PCSK9 monoclonal antibodies.
“In some studies, an increase of patient-reported neurocognitive effects has been described [293].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [293]
Data on other outcome parameters have remained equivocal.
“However, the data on other outcome parameters have remained equivocal.”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [125]
These trials showed consistent reductions in non-fatal myocardial infarction, often in post-hoc analyses, with the strongest effect in patients with elevated triglycerides and low HDL-C.
“The data from these trials have shown consistent decreases in the rates of non-fatal MI (although often as a result of post-hoc analyses), the effect being most robust in subjects with elevated TG/low HDL-C levels.”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [125]
Four prospective, randomized, placebo-controlled trials-HHS, VA-HIT, BIP, and FIELD-primarily illustrate the clinical benefits of fibrate monotherapy.
“The clinical benefits of fibrates in monotherapy are primarily illustrated by four prospective, randomized, placebo-controlled, clinical trials: Helsinki Heart Study (HHS), Veterans Affairs Highdensity lipoprotein Intervention Trial (VA-HIT), Bezafibrate Infarction Prevention study (BIP), and FIELD.124 -127”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [125]
The Helsinki Heart Study reported significant reduction in CVD outcomes with gemfibrozil, but FIELD and ACCORD did not show reduction in total CVD outcomes.
“Although the Helsinki Heart Study reported a significant reduction in CVD outcomes with gemfibrozil, neither the FIELD nor the ACCORD study showed a reduction in total CVD outcomes.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [266]
Controlling the LDL-C at a target level of < 70 mg/dL is useful for plaque regression in high-risk secondary prevention cases such as ACS or ACS complicated by DM.
“The results of ESTABLISH642), JAPAN-ACS643), the ZEUS study644), and PRECISE-IVUS645) have shown that in cases stratified into a high-risk category even in secondary prevention, such as ACS or ACS complicated by DM, controlling the LDL-C at a target level of < 70 mg/dL is useful for plaque regression.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [645]
The PRECISE-IVUS study reported that decreasing LDL-C to below 70 mg/dL using a combination of statin and ezetimibe resulted in marked plaque volume regression in patients with acute coronary syndrome compared with statins only.
“It was reported in the recent PRECISE-IVUS study that decreasing the LDL-C level to < 70 mg/dL using a combination of statin and ezetimibe resulted in a marked plaque volume regression in patients with ACS, compared to those who were treated with statins only645).”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [645]
Gemfibrozil has been shown to decrease rates of CVD events in subjects without diabetes and in the diabetic subgroup in one of the larger trials.
“Gemfibrozil has been shown to decrease rates of CVD events in subjects without diabetes (195,196) and in the diabetic subgroup in one of the larger trials (195).”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [195]
Additional adjustment for HDL-C and the ratio of apo B to apo AI decreased the predictive ability of on-treatment triglyceride levels, and further adjustment for baseline glucose, BMI, hypertension, T2DM, and smoking eliminated the association.
“However, additional adjustment for HDL-C and the ratio of apo B to apo AI decreased the predictive ability of on-treatment triglyceride levels, and further adjustment for baseline glucose, BMI, hypertension, T2DM, and smoking eliminated the association.501”
From Triglycerides and Cardiovascular Disease: A Scientific Statement From the American Heart Association (2011) · cites this paper as [501]

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Authors: Rubins, H. B., Robins, S. J., Collins, D., Fye, C. L., Anderson, J. W., Elam, M. B., Faas, F. H., Linares, E., Schaefer, E. J., Schectman, G., Wilt, T. J., & Wittes, J.
Affiliations: Boston University (US)
West Haven Cooperative Studies Program Coordinating Center (US)
Veterans Health Administration (US)
Memphis VA Medical Center (US)
Tufts University (US)
Minneapolis VA Medical Center (US)
Statistics Collaborative (US)
ORCID: Anderson, James W.
Elam, Marshall B.
Schaefer, Ernst J.
Wilt, Timothy J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1999-08-05
Volume: 341
Issue: 6
Pages: 410-418
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199908053410604
OpenAlex: W2328529137
Semantic Scholar: c59834b2e2f45268e79b64cd3316445882b86f66
Cited by: 3,439
References: 40
Citations by year: 2026: 22 · 2025: 29 · 2024: 38 · 2023: 52 · 2022: 41 · 2021: 44 · 2020: 46 · 2019: 56 · 2018: 54 · 2017: 62 · 2016: 69 · 2015: 80 · 2014: 93 · 2013: 129 · 2012: 114
FWCI: 242.99
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Keywords: gemfibrozil, secondary prevention, coronary artery disease, low HDL cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, nonfatal myocardial infarction, coronary heart disease mortality, stroke, fibrates, men
MeSH terms: Aged, Hypolipidemic Agents, Coronary Disease, Double-Blind Method, Follow-Up Studies, Humans, Hypolipoproteinemias, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Myocardial Infarction, Risk, Triglycerides, Gemfibrozil, Incidence, Proportional Hazards Models

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Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men with Low Levels of High-Density Lipoprotein Cholesterol

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