(Statins) and Fixed-dose Combination Products Containing a Statin

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Final Report Update 5 Drug Effectiveness Review Project Study, reference Jukema 2005 76 Kurabayashi 2008 22 (SUBARU) Lloret 2006 23 (STARSHIP) Mazza 2008 24 Milionis 2006 98 (ATOROS) Olsson 2002 69 (AstraZeneca Study 26) Qu 2009 91 Rawlings 2009 28 Schneck 2003 92 (AstraZeneca Study 33) Drugs, doses Rosuva 10, 20, 40 mg Atorva 20, 40, 80 mg Rosuva 5 mg Atorva 10 mg Rosuva 10, 20 mg Atorva 10, 20 mg Rosuva 10 mg Atorva 20 mg Rosuva 10, 20 mg Atorva 20, 40 mg Rosuva 5, 10-80 mg Atorva 10-80 mg Rosuva 10 mg Atorva 10 mg Rosuva 10 mg Atorva 40 mg Rosuva 5, 10, 20, 40, 80 mg Atorva 10, 20, 40, 80 mg Number screened/ Randomized Design Duration NR/ 461 NR/ 427 2750/ 696 NR/ 106 NR/ 120 1521/ 412 NR/ 69 NR/ 30 NR/ 978 eligible/ 374 enrolled Open-label Fixed dose for 6 weeks, then dose increased every 6 weeks Open-label Fixed dose Open-label Fixed dose Open-label Fixed dose Open-label Fixed dose Double-blind 12 weeks at fixed dose, then titration to goal Mean baseline LDL-C 18 weeks 141 mg/dL 8 weeks 6 weeks 106.1 mg/dL 163.7 mg/dL 48 weeks 225.3 mg/dL 24 weeks 204.5 mg/dL 52 weeks 187.4 mg/dL Fixed dose 12 weeks 150.4 mg/dL Double blind Fixed dose Double-blind Fixed dose 4 weeks 141 mg/dL 6 weeks 189 mg/dL Other patient characteristics Established cardiovascular disease Hypertension, diabetes and family history of coronary artery disease Hispanic, renal impairment, diabetes, hypertension, CHD or CHD risk equivalent Hypertension, family history of CHD Diabetes, hypertension Caucasian men, hypertension, diabetes mellitus, myocardial infarction Statins Page 24 of 128
Final Report Update 5 Drug Effectiveness Review Project Study, reference Schuster 2004 79 (MERCURY I) Schwartz 2004 93 Strandberg 2004 94 Stalenhoef 2005 96 (COMETS) Wolfenbuttel 2005 78 Drugs, doses Rosuva 10 or 20 mg Atorva 10 or 20 mg Rosuva 5,10-80 mg Atorva 10-80 mg Rosuva 10 mg Atorva 10 mg Rosuva 10-20 mg Atorva 10-20 mg Rosuva 10, 20, 40 mg Atorva 20, 40, 80 mg Number screened/ Randomized Design Duration 6508/ 3161 (2043 rosuva or atorva) 1233/ 383 NR/ 1024 1338/ 401 416/ 263 Open-label 8 week at fixed dose; then either remained on current statin or switched to rosuvastatin for 8 weeks Double-blind 12 weeks at fixed dose, then forced titration Open-label 12 weeks at fixed dose, then titration to the Joint Task Force goal if needed Doubleblind; 10 mg for 6 weeks, then increased to 20 mg Open-label Fixed dose for 6 weeks, then dose increased every 6 weeks 16 weeks 24 weeks 12 weeks plus optional 36 week openlabel extension Mean baseline LDL-C 165.1 mg/dL >135 mg/dL in statinnaive patients; >120 mg/dL in patients using the starting dose of another lipidlowering drug. 12 weeks 169.7 mg/dL Other patient characteristics History of CHD or CHD risk >20% over 10 years, atherosclerosis or diabetes Atherosclerosis or diabetes History of CHD or CHD risk >20% over 10 years, atherosclerosis or diabetes Metabolic syndrome 18 weeks 169 mg/dL Type 2 diabetes Abbreviations: CHD, coronary heart disease; low-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; NCEP ATP III, National Cholesterol Education Program Adult Treatment Panel III; NR, not recorded. Nine trials concerned patients who had moderate to no risk factors for coronary artery disease 14, 43, 56, 69, 74, 75, 91, 92, 98 and 19 trials enrolled patients at high risk for cardiovascular disease. 15-17, 19-24, 28, 76, 78, 79, 86, 87, 93-96 All studies comparing rosuvastatin to atorvastatin that reported low-density lipoprotein cholesterol reductions at 12 weeks 36, 43, 69, 86, 87, 91, 93, 94 had Statins Page 25 of 128
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(Statins) and Fixed-dose Combination Products Containing a Statin

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