Portal de Periódicos da CAPES

The statin wars

2003; Elsevier BV; Volume: 362; Issue: 9398 Linguagem: Inglês

10.1016/s0140-6736(03)14934-3

1474-547X

Gunnar Olsson, James W. Blasetto, Brian Bryzinski, Richard Caplan, Alex Gold,

Cardiac, Anesthesia and Surgical Outcomes

We offer an abridged response to your Oct 25 Editorial1The LancetThe statin wars: why AstraZeneca must retreat.Lancet. 2003; 362: 1341Summary Full Text Full Text PDF PubMed Scopus (38) Google Scholar because we believe the assertions that rosuvastatin (Crestor) is somehow an "inadequately investigated" medicine and "has an inferior evidence base supporting its safe use", compared with currently marketed cholesterol-lowering medications, are false and misleading. Readers who require additional information should view our full-length reply available at http://image.thelancet.com/extras/03cor10176web.pdf. The key facts, as they relate to the Editorial, are outlined below. The clinical development programme for rosuvastatin is the largest ever for a statin preapproval, and included more than 12500 rosuvastatin-treated patients with a broad range of dyslipidaemias (eg, primary hypercholesterolaemia, heterozygous and homozygous familial hypercholesterolaemia, mixed dyslipidaemia, isolated hypertriglyceridaemia) and comorbidities (eg, renal impairment, hypertension, cardiovascular disease, diabetes).2Brewer Jr., HB Benefit-risk assessment of rosuvastatin 10 to 40 milligrams.Am J Cardiol. 2003; 92: 23K-29KSummary Full Text Full Text PDF PubMed Scopus (186) Google Scholar Worldwide regulatory authorities have carefully reviewed the extensive efficacy and safety database from this programme. On the basis of these data supporting the efficacy and safety profiles of rosuvastatin, 36 countries have approved the regulatory applications for rosuvastatin. LDL cholesterol is the appropriate endpoint for measuring the effectiveness of lipid-lowering medications, according to international regulatory authorities and cholesterol management guidelines.3Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in AdultsExecutive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).JAMA. 2001; 285: 2486-2497Crossref PubMed Scopus (23865) Google Scholar, 4Wood D De Backer G Faergeman O Graham I Mancia G Pyörälä K Prevention of coronary heart disease in clinical practice: recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention.Eur Heart J. 1998; 19: 1434-1503Crossref PubMed Scopus (1403) Google Scholar This principle forms the basis of clinical decision-making in managing patients with lipid disorders. All trials in the rosuvastatin clinical programme were done in compliance with Good Clinical Practice requirements and were designed, analysed, and reported to the highest scientific and medical standards. The trials in the GALAXY Programme have been designed with the help of numerous international thought leaders, representing many medical disciplines, to address specific unanswered questions regarding the use of statin therapy, including an ongoing large-scale clinical outcomes trial in patients with congestive heart failure (CORONA Trial). The STELLAR Trial,5Jones PH Davidson MH Stein EA et al.Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial).Am J Cardiol. 2003; 92: 152-160Summary Full Text Full Text PDF PubMed Scopus (1255) Google Scholar which examines the comparative dose efficacy of rosuvastatin versus comparator statins, was the largest trial of its kind to date and should aid doctors in making informed therapeutic choices in the treatment of dyslipidaemia. You specifically mention the safety of the 80-mg dose of rosuvastatin. In 2001, after a thorough benefit-risk evaluation, AstraZeneca chose to suspend further development of this dose and voluntarily withdrew it from consideration in the regulatory approval process; however, you fail to mention that other statins have been studied at doses higher than the approved dose range for clinical use. The efficacy and safety data from the entire clinical programme show a favourable benefit-risk profile for rosuvastatin across its dose range.2Brewer Jr., HB Benefit-risk assessment of rosuvastatin 10 to 40 milligrams.Am J Cardiol. 2003; 92: 23K-29KSummary Full Text Full Text PDF PubMed Scopus (186) Google Scholar Finally, your contention that there are "no reliable data about efficacy and safety" for rosuvastatin is completely inaccurate. In his article assessing the benefit-risk profile of rosuvastatin,2Brewer Jr., HB Benefit-risk assessment of rosuvastatin 10 to 40 milligrams.Am J Cardiol. 2003; 92: 23K-29KSummary Full Text Full Text PDF PubMed Scopus (186) Google Scholar Bryan Brewer Jr, of the National Heart, Lung, and Blood Institute concludes: "the extensive data on the lipoprotein-modifying effects, goal achievement, pharmacologic characteristics, and safety and tolerability of the 10- to 40-mg doses of rosuvastatin indicate that this new statin will be a useful therapeutic agent for the treatment of patients at risk for the development of cardiovascular disease." Your subjective Editorial trivialises years of exhaustive research by AstraZeneca as well as the efforts of hundreds of respected lipid researchers, regulators, clinical trialists, and their patients. Despite an increased awareness of lipid disorders as they relate to cardiovascular disease, underdiagnosis and undertreatment of these disorders remain a serious medical problem worldwide. Rosuvastatin has profound effects on lowering LDL cholesterol concentrations, and should be viewed as a welcome alternative to existing therapies.