Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study

Wendy E. Hague, John Simes, Adrienne Kirby, Anthony C. Keech, Harvey D. White, David Hunt, Paul J. Nestel, David M. Colquhoun, Helen Pater, Ralph A. Stewart, David R. Sullivan, Peter L. Thompson, Malcolm West, Paul P. Glasziou, Andrew M. Tonkin

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Abstract

BACKGROUND: We aimed to assess the long-term effects of treatment with statin therapy on all-cause mortality, cause-specific mortality, and cancer incidence from extended follow-up of the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) trial.

METHODS AND RESULTS: LIPID initially compared pravastatin and placebo over 6 years in 9014 patients with previous coronary heart disease. After the double-blind period, all patients were offered open-label statin therapy. Data were obtained over a further 10 years from 7721 patients, by direct contact for 2 years, by questionnaires thereafter, and from mortality and cancer registries. During extended follow-up, 85% assigned pravastatin and 84% assigned placebo took statin therapy. Patients assigned pravastatin maintained a significantly lower risk of death from coronary heart disease (relative risk [RR] 0.89; 95% confidence interval [CI], 0.81-0.97; P=0.009), from cardiovascular disease (RR, 0.88; 95% CI, 0.81-0.95; P=0.002), and from any cause (RR, 0.91; 95% CI, 0.85-0.97; absolute risk reduction, 2.6%; P=0.003).Cancer incidence was similar by original treatment group during the double-blind period (RR, 0.94; 95% CI, 0.82-1.08; P=0.41), later follow-up (RR, 1.02; 95% CI, 0.91-1.14; P=0.74), and overall (RR, 0.99; 95% CI, 0.91-1.08; P=0.83). There were no significant differences in cancer mortality, or in the incidence of organ-specific cancers. Cancer findings were confirmed in a meta-analysis with other large statin trials with extended follow-up.

CONCLUSIONS: In LIPID, the absolute survival benefit from 6 years of pravastatin treatment appeared to be maintained for the next 10 years, with a similar risk of death among survivors in both groups after the initial period. Treatment with statins does not influence cancer or death from noncardiovascular causes during long-term follow-up.

Original languageEnglish
Pages (from-to)1851-1860
Number of pages10
JournalCirculation
Volume133
Issue number19
DOIs
Publication statusPublished - 10 May 2016

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Pravastatin
Coronary Disease
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Safety
Confidence Intervals
Neoplasms
Mortality
Therapeutics
Incidence
Placebos
Numbers Needed To Treat
Survivors
Registries
Meta-Analysis
Cause of Death
Cardiovascular Diseases
Survival

Cite this

Hague, Wendy E. ; Simes, John ; Kirby, Adrienne ; Keech, Anthony C. ; White, Harvey D. ; Hunt, David ; Nestel, Paul J. ; Colquhoun, David M. ; Pater, Helen ; Stewart, Ralph A. ; Sullivan, David R. ; Thompson, Peter L. ; West, Malcolm ; Glasziou, Paul P. ; Tonkin, Andrew M. / Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study. In: Circulation. 2016 ; Vol. 133, No. 19. pp. 1851-1860.
@article{1f17140d421d432f9f6748e0877fac32,
title = "Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study",
abstract = "BACKGROUND: We aimed to assess the long-term effects of treatment with statin therapy on all-cause mortality, cause-specific mortality, and cancer incidence from extended follow-up of the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) trial.METHODS AND RESULTS: LIPID initially compared pravastatin and placebo over 6 years in 9014 patients with previous coronary heart disease. After the double-blind period, all patients were offered open-label statin therapy. Data were obtained over a further 10 years from 7721 patients, by direct contact for 2 years, by questionnaires thereafter, and from mortality and cancer registries. During extended follow-up, 85{\%} assigned pravastatin and 84{\%} assigned placebo took statin therapy. Patients assigned pravastatin maintained a significantly lower risk of death from coronary heart disease (relative risk [RR] 0.89; 95{\%} confidence interval [CI], 0.81-0.97; P=0.009), from cardiovascular disease (RR, 0.88; 95{\%} CI, 0.81-0.95; P=0.002), and from any cause (RR, 0.91; 95{\%} CI, 0.85-0.97; absolute risk reduction, 2.6{\%}; P=0.003).Cancer incidence was similar by original treatment group during the double-blind period (RR, 0.94; 95{\%} CI, 0.82-1.08; P=0.41), later follow-up (RR, 1.02; 95{\%} CI, 0.91-1.14; P=0.74), and overall (RR, 0.99; 95{\%} CI, 0.91-1.08; P=0.83). There were no significant differences in cancer mortality, or in the incidence of organ-specific cancers. Cancer findings were confirmed in a meta-analysis with other large statin trials with extended follow-up.CONCLUSIONS: In LIPID, the absolute survival benefit from 6 years of pravastatin treatment appeared to be maintained for the next 10 years, with a similar risk of death among survivors in both groups after the initial period. Treatment with statins does not influence cancer or death from noncardiovascular causes during long-term follow-up.",
author = "Hague, {Wendy E.} and John Simes and Adrienne Kirby and Keech, {Anthony C.} and White, {Harvey D.} and David Hunt and Nestel, {Paul J.} and Colquhoun, {David M.} and Helen Pater and Stewart, {Ralph A.} and Sullivan, {David R.} and Thompson, {Peter L.} and Malcolm West and Glasziou, {Paul P.} and Tonkin, {Andrew M.}",
note = "{\circledC} 2016 American Heart Association, Inc.",
year = "2016",
month = "5",
day = "10",
doi = "10.1161/CIRCULATIONAHA.115.018580",
language = "English",
volume = "133",
pages = "1851--1860",
journal = "Circulation",
issn = "0009-7322",
publisher = "Lippincott Williams & Wilkins",
number = "19",

}

Hague, WE, Simes, J, Kirby, A, Keech, AC, White, HD, Hunt, D, Nestel, PJ, Colquhoun, DM, Pater, H, Stewart, RA, Sullivan, DR, Thompson, PL, West, M, Glasziou, PP & Tonkin, AM 2016, 'Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study' Circulation, vol. 133, no. 19, pp. 1851-1860. https://doi.org/10.1161/CIRCULATIONAHA.115.018580

Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study. / Hague, Wendy E.; Simes, John; Kirby, Adrienne; Keech, Anthony C.; White, Harvey D.; Hunt, David; Nestel, Paul J.; Colquhoun, David M.; Pater, Helen; Stewart, Ralph A.; Sullivan, David R.; Thompson, Peter L.; West, Malcolm; Glasziou, Paul P.; Tonkin, Andrew M.

In: Circulation, Vol. 133, No. 19, 10.05.2016, p. 1851-1860.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Long-term effectiveness and safety of pravastatin in patients with coronary heart disease: Sixteen Years of Follow-Up of the LIPID Study

AU - Hague, Wendy E.

AU - Simes, John

AU - Kirby, Adrienne

AU - Keech, Anthony C.

AU - White, Harvey D.

AU - Hunt, David

AU - Nestel, Paul J.

AU - Colquhoun, David M.

AU - Pater, Helen

AU - Stewart, Ralph A.

AU - Sullivan, David R.

AU - Thompson, Peter L.

AU - West, Malcolm

AU - Glasziou, Paul P.

AU - Tonkin, Andrew M.

N1 - © 2016 American Heart Association, Inc.

PY - 2016/5/10

Y1 - 2016/5/10

N2 - BACKGROUND: We aimed to assess the long-term effects of treatment with statin therapy on all-cause mortality, cause-specific mortality, and cancer incidence from extended follow-up of the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) trial.METHODS AND RESULTS: LIPID initially compared pravastatin and placebo over 6 years in 9014 patients with previous coronary heart disease. After the double-blind period, all patients were offered open-label statin therapy. Data were obtained over a further 10 years from 7721 patients, by direct contact for 2 years, by questionnaires thereafter, and from mortality and cancer registries. During extended follow-up, 85% assigned pravastatin and 84% assigned placebo took statin therapy. Patients assigned pravastatin maintained a significantly lower risk of death from coronary heart disease (relative risk [RR] 0.89; 95% confidence interval [CI], 0.81-0.97; P=0.009), from cardiovascular disease (RR, 0.88; 95% CI, 0.81-0.95; P=0.002), and from any cause (RR, 0.91; 95% CI, 0.85-0.97; absolute risk reduction, 2.6%; P=0.003).Cancer incidence was similar by original treatment group during the double-blind period (RR, 0.94; 95% CI, 0.82-1.08; P=0.41), later follow-up (RR, 1.02; 95% CI, 0.91-1.14; P=0.74), and overall (RR, 0.99; 95% CI, 0.91-1.08; P=0.83). There were no significant differences in cancer mortality, or in the incidence of organ-specific cancers. Cancer findings were confirmed in a meta-analysis with other large statin trials with extended follow-up.CONCLUSIONS: In LIPID, the absolute survival benefit from 6 years of pravastatin treatment appeared to be maintained for the next 10 years, with a similar risk of death among survivors in both groups after the initial period. Treatment with statins does not influence cancer or death from noncardiovascular causes during long-term follow-up.

AB - BACKGROUND: We aimed to assess the long-term effects of treatment with statin therapy on all-cause mortality, cause-specific mortality, and cancer incidence from extended follow-up of the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) trial.METHODS AND RESULTS: LIPID initially compared pravastatin and placebo over 6 years in 9014 patients with previous coronary heart disease. After the double-blind period, all patients were offered open-label statin therapy. Data were obtained over a further 10 years from 7721 patients, by direct contact for 2 years, by questionnaires thereafter, and from mortality and cancer registries. During extended follow-up, 85% assigned pravastatin and 84% assigned placebo took statin therapy. Patients assigned pravastatin maintained a significantly lower risk of death from coronary heart disease (relative risk [RR] 0.89; 95% confidence interval [CI], 0.81-0.97; P=0.009), from cardiovascular disease (RR, 0.88; 95% CI, 0.81-0.95; P=0.002), and from any cause (RR, 0.91; 95% CI, 0.85-0.97; absolute risk reduction, 2.6%; P=0.003).Cancer incidence was similar by original treatment group during the double-blind period (RR, 0.94; 95% CI, 0.82-1.08; P=0.41), later follow-up (RR, 1.02; 95% CI, 0.91-1.14; P=0.74), and overall (RR, 0.99; 95% CI, 0.91-1.08; P=0.83). There were no significant differences in cancer mortality, or in the incidence of organ-specific cancers. Cancer findings were confirmed in a meta-analysis with other large statin trials with extended follow-up.CONCLUSIONS: In LIPID, the absolute survival benefit from 6 years of pravastatin treatment appeared to be maintained for the next 10 years, with a similar risk of death among survivors in both groups after the initial period. Treatment with statins does not influence cancer or death from noncardiovascular causes during long-term follow-up.

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U2 - 10.1161/CIRCULATIONAHA.115.018580

DO - 10.1161/CIRCULATIONAHA.115.018580

M3 - Article

VL - 133

SP - 1851

EP - 1860

JO - Circulation

JF - Circulation

SN - 0009-7322

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