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

Volumn 385, Issue 9976, 2015, Pages 1397-1405

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

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL;

ARTICLE; CANCER INCIDENCE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CLINICAL ASSESSMENT; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; CONCENTRATION RESPONSE; CORONARY ARTERY DISEASE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FEMALE; GENETIC HETEROGENEITY; HEART MUSCLE REVASCULARIZATION; HIGH RISK POPULATION; HUMAN; MALE; META ANALYSIS; OUTCOME ASSESSMENT; PRIMARY PREVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK FACTOR; SECONDARY PREVENTION; SEX ALLOCATION; SEX DIFFERENCE; TREATMENT DURATION; VASCULAR DISEASE; BLOOD; CARDIOVASCULAR DISEASES; CORONARY DISEASE; FACTUAL DATABASE; PERCUTANEOUS CORONARY INTERVENTION; PROPORTIONAL HAZARDS MODEL; STATISTICS AND NUMERICAL DATA; STROKE; TREATMENT OUTCOME;

CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; CORONARY DISEASE; DATABASES, FACTUAL; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; PERCUTANEOUS CORONARY INTERVENTION; PROPORTIONAL HAZARDS MODELS; SEX FACTORS; STROKE; TREATMENT OUTCOME;

EID: 84933673677     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)61368-4     Document Type: Article

References (37)

1. Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 2005; 366: 1267-78.
2. Cholesterol Treatment Trialists' (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581-90.
3. Ward S, Lloyd Jones M, Pandor A, et al A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol Assess 2007; 11: 1-160.
4. Cholesterol Treatment Trialists' (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581-90.
5. Walsh JM, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004; 291: 2243-52.
6. Abramson J, Wright JM Are lipid-lowering guidelines evidence-based? Lancet 2007; 369: 168-89.
7. Reidenberg MM. Statins for primary prevention of coronary artery disease. Lancet 2007; 369: 1078.
8. Mascitelli L, Pezzetta F. Statins for primary prevention of coronary artery disease. Lancet 2007; 369: 1078-79.
9. Taylor F, Huffman M, Macedo A., et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013; 1: CD004816.
10. Petretta M, Costanzo P, Perrone-Filardi P, Chiariello M. Impact of gender in primary prevention of coronary heart disease with statin therapy: a meta-analysis. Int J Cardiol 2010; 138: 25-31.
11. Reiner Z. Statins in the primary prevention of cardiovascular disease. Nat Rev Cardiol 2013; 10: 453-64.
12. Dale KM, Coleman CI, Shah S.A., et al. Impact of gender on statin efficacy. Curr Med Res Opin 2007; 23: 565-74.
13. Hague W, Forder P, Simes J., et al. Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study. Am Heart J 2003; 145: 643-51.
14. Miettinen TA, Pyorala K, Olsson A.G., et al. Cholesterol-lowering therapy in women and elderly patients with myocardial infarction or angina pectoris: findings from the Scandinavian Simvastatin Survival Study (4S). Circulation 1997; 96: 4211-18.
15. Kostis WJ, Cheng JQ, Dobrzynski J.M., Cabrera J., Kostis JB. Meta-analysis of statin effects in women versus men. J Am Coll Cardiol 2012; 59: 572-82.
16. Blauwet LA, Hayes SN, McManus D, Redberg R.F., Walsh MN. Low rate of sex-specific result reporting in cardiovascular trials. Mayo Clin Proc 2007; 82: 166-70.
17. National Research Council. Women's health research: progress, pitfalls, and promise. Washington, DC: The National Academies Press, 2010.
18. Cholesterol Treatment Trialists' (CTT) Collaboration. Protocol for a prospective collaborative overview of all current and planned randomized trials of cholesterol treatment regimens. Am J Cardiol 1995; 75: 1130-04.
19. Hocking RR. Analysis of linear models. Monterey, CA: Brooks-Cole, 1984.
20. de Lemos J.A., Blazing MA, Wiviott S.D., et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004; 292: 1307-16.
21. Cannon CP, Braunwald E, McCabe C.H., et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004; 350: 1495-504.
22. Pedersen TR, Faergeman O, Kastelein J.J., et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005; 294: 2437-45.
23. Kjekshus J, Apetrei E, Barrios V., et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007; 357: 2248.
24. GISSI Prevenzione Investigators (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico). Results of the low-dose (20 mg) pravastatin GISSI Prevenzione trial in 4271 patients with recent myocardial infarction: do stopped trials contribute to overall knowledge? Ital Heart J 2000; 1: 810-20.
25. Ridker PM, Danielson E, Fonseca F.A., et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359: 2195-207.
26. Search Study Collaborative Group, Bowman L, Armitage J, Bulbulia R, Parish S, Collins R. Study of the effectiveness of additional reductions in cholesterol and homocysteine (SEARCH): characteristics of a randomized trial among 12064 myocardial infarction survivors. Am Heart J 2007; 154: 815-23.
27. Abraha I, Bonacini I, Montedori A., Abraha I, Bonacini I, Montedori A. Efficacy and safety of cholesterol-lowering treatment. Lancet 2006; 367: 469.
28. Fenton A, Panay N. Statins in women for primary prevention - is there evidence to back up their use? Climacteric 2010; 13: 403-04.
29. Eisenberg T, Wells MT Statins and adverse events in moderate-risk females: a statistical and legal analysis with implications for FDA preemption claims. J Empir Leg Stud 2008; 5: 507-50.
30. Kim ESH, Menon V. Status of women in cardiovascular clinical trials. Arterioscler Thromb Vasc Biol 2009; 29: 279-83.
31. Reiner Z, Catapano AL, De Backer G, et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J 2011; 32: 1769-818.
32. Ajjan RA. Primary and secondary prevention of cardiovascular disease in diabetes with aspirin. Diab Vasc Dis Res 2012; 9: 243-44.
33. National Institute for Health and Care Excellence. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. Clinical guideline: National Institute for Health and Care Excellence; 2014. Report No: 181. London: National Institute for Health and Care Excellence, 2014.
34. Stone NJ, Robinson J, Lichtenstein A.H., et al. 2013 ACC/AHA Guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129 (suppl 2): S1-45.
35. Armitage J. The safety of statins in clinical practice. Lancet 2007; 370: 1781-90.
36. Sattar N, Preiss D, Murray H.M., et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735-42.
37. Preiss D, Seshasai SRK, Welsh P, et al Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy. A meta-analysis. JAMA 2011; 305: 2556-64.