Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials

Jordan Fulcher; Rachel O'Connell; Merryn Voysey; Jonathan Emberson; Lisa Blackwell; B. Mihaylova; J. Simes; R. Collins; Adrienne Kirby; Helen Colhoun; Eugene Braunwald; John La Rosa; T. R. Pedersen; Andrew Tonkin; Barry Davis; Peter Sleight; Maria Grazia Franzosi; Colin Baigent; Anthony Keech; J. De Lemos; M. Blazing; S. Murphy; J. R. Downs; A. Gotto; M. Clearfield; H. Holdaas; D. Gordon; M. Koren; B. Dahlöf; N. Poulter; P. Sever; R. H. Knopp; B. Fellström; A. Jardine; R. Schmieder; F. Zannad; U. Goldbourt; E. Kaplinsky; D. J. Betteridge; P. N. Durrington; G. A. Hitman; J. Fuller; A. Neil; C. Wanner; V. Krane; F. Sacks; L. Moyé; M. Pfeffer; C. M. Hawkins; J. Kjekshus; H. Wedel; J. Wikstrand; P. Barter; L. Tavazzi; A. Maggioni; R. Marchioli; G. Tognoni; H. Bloomfield; S. Robins; J. Armitage; S. Parish; R. Peto; P. M. Ridker; R. Holman; T. Meade; S. MacMahon; I. C. Marschner; J. Shaw; P. W. Serruys; H. Nakamura; G. Knatterud; C. Furberg; R. Byington; P. Macfarlane; S. Cobbe; I. Ford; M. Murphy; G. J. Blauw; C. Packard; J. Shepherd; L. Wilhelmsen; C. Cannon; L. Bowman; M. Landray; J. Rossouw; J. Probstfield; S. Cobbe; M. Flather; J. Kastelein; C. Newman; C. Shear; J. Tobert; J. Varigos; H. White; S. Yusuf; E. H. Barnes; W. G. Herrington; L. E. Holland; C. Reith

doi:10.1016/S0140-6736(14)61368-4

Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials

Jordan Fulcher, Rachel O'Connell, Merryn Voysey, Jonathan Emberson, Lisa Blackwell, B. Mihaylova, J. Simes, R. Collins, Adrienne Kirby, Helen Colhoun, Eugene Braunwald, John La Rosa, T. R. Pedersen, Andrew Tonkin, Barry Davis, Peter Sleight, Maria Grazia Franzosi, Colin Baigent, Anthony Keech, J. De LemosM. Blazing, S. Murphy, J. R. Downs, A. Gotto, M. Clearfield, H. Holdaas, D. Gordon, M. Koren, B. Dahlöf, N. Poulter, P. Sever, R. H. Knopp, B. Fellström, A. Jardine, R. Schmieder, F. Zannad, U. Goldbourt, E. Kaplinsky, D. J. Betteridge, P. N. Durrington, G. A. Hitman, J. Fuller, A. Neil, C. Wanner, V. Krane, F. Sacks, L. Moyé, M. Pfeffer, C. M. Hawkins, J. Kjekshus, H. Wedel, J. Wikstrand, P. Barter, L. Tavazzi, A. Maggioni, R. Marchioli, G. Tognoni, H. Bloomfield, S. Robins, J. Armitage, S. Parish, R. Peto, P. M. Ridker, R. Holman, T. Meade, S. MacMahon, I. C. Marschner, J. Shaw, P. W. Serruys, H. Nakamura, G. Knatterud, C. Furberg, R. Byington, P. Macfarlane, S. Cobbe, I. Ford, M. Murphy, G. J. Blauw, C. Packard, J. Shepherd, L. Wilhelmsen, C. Cannon, L. Bowman, M. Landray, J. Rossouw, J. Probstfield, S. Cobbe, M. Flather, J. Kastelein, C. Newman, C. Shear, J. Tobert, J. Varigos, H. White, S. Yusuf, E. H. Barnes, W. G. Herrington, L. E. Holland, C. Reith

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Abstract

Background: Whether statin therapy is as effective in women as in men is debated, especially for primary prevention. We undertook a meta-analysis of statin trials in the Cholesterol Treatment Trialists' (CTT) Collaboration database to compare the effects of statin therapy between women and men. Methods: We performed meta-analyses on data from 22 trials of statin therapy versus control (n=134 537) and five trials of more-intensive versus less-intensive statin therapy (n=39 612). Effects on major vascular events, major coronary events, stroke, coronary revascularisation and mortality were weighted per 1·0 mmol/L reduction in LDL cholesterol and effects in men and women compared with a Cox model that adjusted for non-sex differences. For subgroup analyses, we used 99% CIs to make allowance for the multiplicity of comparisons. Findings 46 675 (27%) of 174 149 randomly assigned participants were women. Allocation to a statin had similar absolute effects on 1 year lipid concentrations in both men and women (LDL cholesterol reduced by about 1·1 mmol/L in statin vs control trials and roughly 0·5 mmol/L for more-intensive vs less-intensive therapy). Women were generally at lower cardiovascular risk than were men in these trials. The proportional reductions per 1·0 mmol/L reduction in LDL cholesterol in major vascular events were similar overall for women (rate ratio [RR] 0·84, 99% CI 0·78-0·91) and men (RR 0·78, 99% CI 0·75-0·81, adjusted p value for heterogeneity by sex=0·33) and also for those women and men at less than 10% predicted 5 year absolute cardiovascular risk (adjusted heterogeneity p=0·11). Likewise, the proportional reductions in major coronary events, coronary revascularisation, and stroke did not differ significantly by sex. No adverse effect on rates of cancer incidence or non-cardiovascular mortality was noted for either sex. These net benefits translated into all-cause mortality reductions with statin therapy for both women (RR 0·91, 99% CI 0·84-0·99) and men (RR 0·90, 99% CI 0·86-0·95; adjusted heterogeneity p=0·43). Interpretation In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.

Original language	English
Pages (from-to)	1397-1405
Number of pages	9
Journal	The Lancet
Volume	385
Issue number	9976
DOIs	https://doi.org/10.1016/S0140-6736(14)61368-4
State	Published - 1 Jan 2015

Funding

Funders	Funder number
Australian National Health and Medical Research Council	1037786
UK Medical Research Council
AMGEN
Eli Lilly and Company
Pfizer
AstraZeneca
Boehringer Ingelheim
Merck Sharp and Dohme
British Heart Foundation
Cancer Research UK

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/S0140-6736(14)61368-4

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Fulcher, J., O'Connell, R., Voysey, M., Emberson, J., Blackwell, L., Mihaylova, B., Simes, J., Collins, R., Kirby, A., Colhoun, H., Braunwald, E., La Rosa, J., Pedersen, T. R., Tonkin, A., Davis, B., Sleight, P., Franzosi, M. G., Baigent, C., Keech, A., ... Reith, C. (2015). Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials. The Lancet, 385(9976), 1397-1405. https://doi.org/10.1016/S0140-6736(14)61368-4

@article{425a3329b9204f3ebefd59fff75d979c,

title = "Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials",

abstract = "Background: Whether statin therapy is as effective in women as in men is debated, especially for primary prevention. We undertook a meta-analysis of statin trials in the Cholesterol Treatment Trialists' (CTT) Collaboration database to compare the effects of statin therapy between women and men. Methods: We performed meta-analyses on data from 22 trials of statin therapy versus control (n=134 537) and five trials of more-intensive versus less-intensive statin therapy (n=39 612). Effects on major vascular events, major coronary events, stroke, coronary revascularisation and mortality were weighted per 1·0 mmol/L reduction in LDL cholesterol and effects in men and women compared with a Cox model that adjusted for non-sex differences. For subgroup analyses, we used 99% CIs to make allowance for the multiplicity of comparisons. Findings 46 675 (27%) of 174 149 randomly assigned participants were women. Allocation to a statin had similar absolute effects on 1 year lipid concentrations in both men and women (LDL cholesterol reduced by about 1·1 mmol/L in statin vs control trials and roughly 0·5 mmol/L for more-intensive vs less-intensive therapy). Women were generally at lower cardiovascular risk than were men in these trials. The proportional reductions per 1·0 mmol/L reduction in LDL cholesterol in major vascular events were similar overall for women (rate ratio [RR] 0·84, 99% CI 0·78-0·91) and men (RR 0·78, 99% CI 0·75-0·81, adjusted p value for heterogeneity by sex=0·33) and also for those women and men at less than 10% predicted 5 year absolute cardiovascular risk (adjusted heterogeneity p=0·11). Likewise, the proportional reductions in major coronary events, coronary revascularisation, and stroke did not differ significantly by sex. No adverse effect on rates of cancer incidence or non-cardiovascular mortality was noted for either sex. These net benefits translated into all-cause mortality reductions with statin therapy for both women (RR 0·91, 99% CI 0·84-0·99) and men (RR 0·90, 99% CI 0·86-0·95; adjusted heterogeneity p=0·43). Interpretation In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.",

author = "Jordan Fulcher and Rachel O'Connell and Merryn Voysey and Jonathan Emberson and Lisa Blackwell and B. Mihaylova and J. Simes and R. Collins and Adrienne Kirby and Helen Colhoun and Eugene Braunwald and {La Rosa}, John and Pedersen, {T. R.} and Andrew Tonkin and Barry Davis and Peter Sleight and Franzosi, {Maria Grazia} and Colin Baigent and Anthony Keech and {De Lemos}, J. and M. Blazing and S. Murphy and Downs, {J. R.} and A. Gotto and M. Clearfield and H. Holdaas and D. Gordon and M. Koren and B. Dahl{\"o}f and N. Poulter and P. Sever and Knopp, {R. H.} and B. Fellstr{\"o}m and A. Jardine and R. Schmieder and F. Zannad and U. Goldbourt and E. Kaplinsky and Betteridge, {D. J.} and Durrington, {P. N.} and Hitman, {G. A.} and J. Fuller and A. Neil and C. Wanner and V. Krane and F. Sacks and L. Moy{\'e} and M. Pfeffer and Hawkins, {C. M.} and J. Kjekshus and H. Wedel and J. Wikstrand and P. Barter and L. Tavazzi and A. Maggioni and R. Marchioli and G. Tognoni and H. Bloomfield and S. Robins and J. Armitage and S. Parish and R. Peto and Ridker, {P. M.} and R. Holman and T. Meade and S. MacMahon and Marschner, {I. C.} and J. Shaw and Serruys, {P. W.} and H. Nakamura and G. Knatterud and C. Furberg and R. Byington and P. Macfarlane and S. Cobbe and I. Ford and M. Murphy and Blauw, {G. J.} and C. Packard and J. Shepherd and L. Wilhelmsen and C. Cannon and L. Bowman and M. Landray and J. Rossouw and J. Probstfield and S. Cobbe and M. Flather and J. Kastelein and C. Newman and C. Shear and J. Tobert and J. Varigos and H. White and S. Yusuf and Barnes, {E. H.} and Herrington, {W. G.} and Holland, {L. E.} and C. Reith",

note = "Funding Information: The CTT Collaboration is funded by the UK Medical Research Council, British Heart Foundation, Cancer Research UK, and the Australian National Health and Medical Research Council, and not by the pharmaceutical industry. Most of the trials in this report were supported (at least in part) by research grants from the pharmaceutical industry. Representatives of the pharmaceutical companies funding trials included in the CTT are invited to attend meetings and to comment on draft papers, but the final content of publications is determined by members of the writing committee. JF reports personal fees from AstraZeneca and Pfizer outside the submitted work. RS reports grants from Merck Sharp & Dohme, AstraZeneca, and Pfizer during the conduct of the study and grants from Merck Sharp & Dohme, AstraZeneca, and Pfizer outside the submitted work. HC reports personal fees from Pfizer and Eli Lilly; grants from Boehringer Ingelheim and AstraZeneca; institutional consultancy fees from and shares held in Roche Pharmaceuticals; and institutional consultancy fees from Novartis Pharmaceuticals, Sanofi-Aventis, and Eli Lilly outside the submitted work. EB reports grants to institutions, uncompensated consultancies and lecture fees from Merck Sharpe & Dohme during the conduct of the study; grants to institutions from AstraZeneca, Johnson & Johnson, SanofiAventis, Daiichi Sankyo, GlaxoSmithKline, Bristol-Myers Squibb, Beckman Coulter, Roche Diagnostics, Pfizer, and Duke University outside the submitted work; and personal fees from Genzyme, Amorcyte, Medicines Co, CardioRentis, Sanofi-Aventis, Eli Lilly, Daiichi Sankyo, Menarini International, Medscape, and Bayer outside the submitted work. JLR reports personal fees and honoraria from Pfizer during the conduct of the study and personal fees from Pfizer and Amgen outside the submitted work. TP reports grants, personal fees and non-financial support from Merck Sharpe & Dohme, Pfizer, and Amgen and personal fees and non-financial support from AstraZeneca during the conduct of the study. CB reports grants from Merck Sharp & Dohme during the conduct of the study and grants from Novartis and Pfizer outside the submitted work. AK reports personal fees from Abbott, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Pfizer and honararia for lectures or advisory committees from Abbott and Bristol-Myers Squibb outside the submitted work. Funding Information: The National Health and Medical Research Council Clinical Trials Centre (CTC) in Australia and the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) in the UK coordinate this collaboration jointly. The CTC is supported by a programme grant from the Australian National Health and Medical Research Council ( no 1037786 ) and the CTSU by the UK Medical Research Council, British Heart Foundation, and Cancer Research UK. ",

year = "2015",

month = jan,

day = "1",

doi = "10.1016/S0140-6736(14)61368-4",

language = "אנגלית",

volume = "385",

pages = "1397--1405",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "9976",

}

Fulcher, J, O'Connell, R, Voysey, M, Emberson, J, Blackwell, L, Mihaylova, B, Simes, J, Collins, R, Kirby, A, Colhoun, H, Braunwald, E, La Rosa, J, Pedersen, TR, Tonkin, A, Davis, B, Sleight, P, Franzosi, MG, Baigent, C, Keech, A, De Lemos, J, Blazing, M, Murphy, S, Downs, JR, Gotto, A, Clearfield, M, Holdaas, H, Gordon, D, Koren, M, Dahlöf, B, Poulter, N, Sever, P, Knopp, RH, Fellström, B, Jardine, A, Schmieder, R, Zannad, F, Goldbourt, U , Kaplinsky, E, Betteridge, DJ, Durrington, PN, Hitman, GA, Fuller, J, Neil, A, Wanner, C, Krane, V, Sacks, F, Moyé, L, Pfeffer, M, Hawkins, CM, Kjekshus, J, Wedel, H, Wikstrand, J, Barter, P, Tavazzi, L, Maggioni, A, Marchioli, R, Tognoni, G, Bloomfield, H, Robins, S, Armitage, J, Parish, S, Peto, R, Ridker, PM, Holman, R, Meade, T, MacMahon, S, Marschner, IC, Shaw, J, Serruys, PW, Nakamura, H, Knatterud, G, Furberg, C, Byington, R, Macfarlane, P, Cobbe, S, Ford, I, Murphy, M, Blauw, GJ, Packard, C, Shepherd, J, Wilhelmsen, L, Cannon, C, Bowman, L, Landray, M, Rossouw, J, Probstfield, J, Cobbe, S, Flather, M, Kastelein, J, Newman, C, Shear, C, Tobert, J, Varigos, J, White, H, Yusuf, S, Barnes, EH, Herrington, WG, Holland, LE & Reith, C 2015, 'Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials', The Lancet, vol. 385, no. 9976, pp. 1397-1405. https://doi.org/10.1016/S0140-6736(14)61368-4

TY - JOUR

T1 - Efficacy and safety of LDL-lowering therapy among men and women

T2 - Meta-analysis of individual data from 174 000 participants in 27 randomised trials

AU - Fulcher, Jordan

AU - O'Connell, Rachel

AU - Voysey, Merryn

AU - Emberson, Jonathan

AU - Blackwell, Lisa

AU - Mihaylova, B.

AU - Simes, J.

AU - Collins, R.

AU - Kirby, Adrienne

AU - Colhoun, Helen

AU - Braunwald, Eugene

AU - La Rosa, John

AU - Pedersen, T. R.

AU - Tonkin, Andrew

AU - Davis, Barry

AU - Sleight, Peter

AU - Franzosi, Maria Grazia

AU - Baigent, Colin

AU - Keech, Anthony

AU - De Lemos, J.

AU - Blazing, M.

AU - Murphy, S.

AU - Downs, J. R.

AU - Gotto, A.

AU - Clearfield, M.

AU - Holdaas, H.

AU - Gordon, D.

AU - Koren, M.

AU - Dahlöf, B.

AU - Poulter, N.

AU - Sever, P.

AU - Knopp, R. H.

AU - Fellström, B.

AU - Jardine, A.

AU - Schmieder, R.

AU - Zannad, F.

AU - Goldbourt, U.

AU - Kaplinsky, E.

AU - Betteridge, D. J.

AU - Durrington, P. N.

AU - Hitman, G. A.

AU - Fuller, J.

AU - Neil, A.

AU - Wanner, C.

AU - Krane, V.

AU - Sacks, F.

AU - Moyé, L.

AU - Pfeffer, M.

AU - Hawkins, C. M.

AU - Kjekshus, J.

AU - Wedel, H.

AU - Wikstrand, J.

AU - Barter, P.

AU - Tavazzi, L.

AU - Maggioni, A.

AU - Marchioli, R.

AU - Tognoni, G.

AU - Bloomfield, H.

AU - Robins, S.

AU - Armitage, J.

AU - Parish, S.

AU - Peto, R.

AU - Ridker, P. M.

AU - Holman, R.

AU - Meade, T.

AU - MacMahon, S.

AU - Marschner, I. C.

AU - Shaw, J.

AU - Serruys, P. W.

AU - Nakamura, H.

AU - Knatterud, G.

AU - Furberg, C.

AU - Byington, R.

AU - Macfarlane, P.

AU - Cobbe, S.

AU - Ford, I.

AU - Murphy, M.

AU - Blauw, G. J.

AU - Packard, C.

AU - Shepherd, J.

AU - Wilhelmsen, L.

AU - Cannon, C.

AU - Bowman, L.

AU - Landray, M.

AU - Rossouw, J.

AU - Probstfield, J.

AU - Cobbe, S.

AU - Flather, M.

AU - Kastelein, J.

AU - Newman, C.

AU - Shear, C.

AU - Tobert, J.

AU - Varigos, J.

AU - White, H.

AU - Yusuf, S.

AU - Barnes, E. H.

AU - Herrington, W. G.

AU - Holland, L. E.

AU - Reith, C.

N1 - Funding Information: The CTT Collaboration is funded by the UK Medical Research Council, British Heart Foundation, Cancer Research UK, and the Australian National Health and Medical Research Council, and not by the pharmaceutical industry. Most of the trials in this report were supported (at least in part) by research grants from the pharmaceutical industry. Representatives of the pharmaceutical companies funding trials included in the CTT are invited to attend meetings and to comment on draft papers, but the final content of publications is determined by members of the writing committee. JF reports personal fees from AstraZeneca and Pfizer outside the submitted work. RS reports grants from Merck Sharp & Dohme, AstraZeneca, and Pfizer during the conduct of the study and grants from Merck Sharp & Dohme, AstraZeneca, and Pfizer outside the submitted work. HC reports personal fees from Pfizer and Eli Lilly; grants from Boehringer Ingelheim and AstraZeneca; institutional consultancy fees from and shares held in Roche Pharmaceuticals; and institutional consultancy fees from Novartis Pharmaceuticals, Sanofi-Aventis, and Eli Lilly outside the submitted work. EB reports grants to institutions, uncompensated consultancies and lecture fees from Merck Sharpe & Dohme during the conduct of the study; grants to institutions from AstraZeneca, Johnson & Johnson, SanofiAventis, Daiichi Sankyo, GlaxoSmithKline, Bristol-Myers Squibb, Beckman Coulter, Roche Diagnostics, Pfizer, and Duke University outside the submitted work; and personal fees from Genzyme, Amorcyte, Medicines Co, CardioRentis, Sanofi-Aventis, Eli Lilly, Daiichi Sankyo, Menarini International, Medscape, and Bayer outside the submitted work. JLR reports personal fees and honoraria from Pfizer during the conduct of the study and personal fees from Pfizer and Amgen outside the submitted work. TP reports grants, personal fees and non-financial support from Merck Sharpe & Dohme, Pfizer, and Amgen and personal fees and non-financial support from AstraZeneca during the conduct of the study. CB reports grants from Merck Sharp & Dohme during the conduct of the study and grants from Novartis and Pfizer outside the submitted work. AK reports personal fees from Abbott, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Pfizer and honararia for lectures or advisory committees from Abbott and Bristol-Myers Squibb outside the submitted work. Funding Information: The National Health and Medical Research Council Clinical Trials Centre (CTC) in Australia and the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) in the UK coordinate this collaboration jointly. The CTC is supported by a programme grant from the Australian National Health and Medical Research Council ( no 1037786 ) and the CTSU by the UK Medical Research Council, British Heart Foundation, and Cancer Research UK.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background: Whether statin therapy is as effective in women as in men is debated, especially for primary prevention. We undertook a meta-analysis of statin trials in the Cholesterol Treatment Trialists' (CTT) Collaboration database to compare the effects of statin therapy between women and men. Methods: We performed meta-analyses on data from 22 trials of statin therapy versus control (n=134 537) and five trials of more-intensive versus less-intensive statin therapy (n=39 612). Effects on major vascular events, major coronary events, stroke, coronary revascularisation and mortality were weighted per 1·0 mmol/L reduction in LDL cholesterol and effects in men and women compared with a Cox model that adjusted for non-sex differences. For subgroup analyses, we used 99% CIs to make allowance for the multiplicity of comparisons. Findings 46 675 (27%) of 174 149 randomly assigned participants were women. Allocation to a statin had similar absolute effects on 1 year lipid concentrations in both men and women (LDL cholesterol reduced by about 1·1 mmol/L in statin vs control trials and roughly 0·5 mmol/L for more-intensive vs less-intensive therapy). Women were generally at lower cardiovascular risk than were men in these trials. The proportional reductions per 1·0 mmol/L reduction in LDL cholesterol in major vascular events were similar overall for women (rate ratio [RR] 0·84, 99% CI 0·78-0·91) and men (RR 0·78, 99% CI 0·75-0·81, adjusted p value for heterogeneity by sex=0·33) and also for those women and men at less than 10% predicted 5 year absolute cardiovascular risk (adjusted heterogeneity p=0·11). Likewise, the proportional reductions in major coronary events, coronary revascularisation, and stroke did not differ significantly by sex. No adverse effect on rates of cancer incidence or non-cardiovascular mortality was noted for either sex. These net benefits translated into all-cause mortality reductions with statin therapy for both women (RR 0·91, 99% CI 0·84-0·99) and men (RR 0·90, 99% CI 0·86-0·95; adjusted heterogeneity p=0·43). Interpretation In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.

AB - Background: Whether statin therapy is as effective in women as in men is debated, especially for primary prevention. We undertook a meta-analysis of statin trials in the Cholesterol Treatment Trialists' (CTT) Collaboration database to compare the effects of statin therapy between women and men. Methods: We performed meta-analyses on data from 22 trials of statin therapy versus control (n=134 537) and five trials of more-intensive versus less-intensive statin therapy (n=39 612). Effects on major vascular events, major coronary events, stroke, coronary revascularisation and mortality were weighted per 1·0 mmol/L reduction in LDL cholesterol and effects in men and women compared with a Cox model that adjusted for non-sex differences. For subgroup analyses, we used 99% CIs to make allowance for the multiplicity of comparisons. Findings 46 675 (27%) of 174 149 randomly assigned participants were women. Allocation to a statin had similar absolute effects on 1 year lipid concentrations in both men and women (LDL cholesterol reduced by about 1·1 mmol/L in statin vs control trials and roughly 0·5 mmol/L for more-intensive vs less-intensive therapy). Women were generally at lower cardiovascular risk than were men in these trials. The proportional reductions per 1·0 mmol/L reduction in LDL cholesterol in major vascular events were similar overall for women (rate ratio [RR] 0·84, 99% CI 0·78-0·91) and men (RR 0·78, 99% CI 0·75-0·81, adjusted p value for heterogeneity by sex=0·33) and also for those women and men at less than 10% predicted 5 year absolute cardiovascular risk (adjusted heterogeneity p=0·11). Likewise, the proportional reductions in major coronary events, coronary revascularisation, and stroke did not differ significantly by sex. No adverse effect on rates of cancer incidence or non-cardiovascular mortality was noted for either sex. These net benefits translated into all-cause mortality reductions with statin therapy for both women (RR 0·91, 99% CI 0·84-0·99) and men (RR 0·90, 99% CI 0·86-0·95; adjusted heterogeneity p=0·43). Interpretation In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.

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DO - 10.1016/S0140-6736(14)61368-4

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AN - SCOPUS:84933673677

SN - 0140-6736

VL - 385

SP - 1397

EP - 1405

JO - The Lancet

JF - The Lancet

IS - 9976

ER -

Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials

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