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

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Final Report Update 5 Drug Effectiveness Review Project In the second study, 58 Karalis and colleagues randomized 1732 patients with hypercholesterolemia to treatment with atorvastatin 10 mg or 80 mg daily or simvastatin 20 mg or 80 mg daily for 6 weeks. This study was unblinded and did not use intention-to-treat statistics. Mean baseline low-density lipoprotein cholesterol in the atorvastatin group was reduced by 53% compared with 47% in the simvastatin group (P
Final Report Update 5 Drug Effectiveness Review Project Study, reference Binbrek 2006 16 (DISCOVERY ALPHA) Bots 2005 86 (DUTCH DISCOVERY) Clearfield 2006 17 (PULSAR) Davidson 2002 43 (AstraZeneca Study 24) Faergeman 2008 20 (ECLIPSE) Ferdinand 2006 74 Fonseca 2005 75 Insull 2007 87 (SOLAR) Jones 2003 56 (STELLAR) Drugs, doses Rosuva 10 mg Atorva 10 mg Rosuva 10 mg Atorva 10 mg Rosuva 10 mg Atorva 20 mg Rosuva 5,10 mg Atorva 10 mg Rosuva 10, 20, 40 mg Atorva 10, 20, 40, 80 mg Rosuva 10, 20 mg Atorva 10, 20 mg Rosuva 10 mg Atorva 10 mg Rosuva 10, 20 mg Atorva 10, 20 mg Rosuva 10, 20, 40, 80 mg Atorva 10, 20, 40, 80 mg Number screened/ Randomized Design Duration NR/ 1506 NR/ 1215 (621 rosuva, 189 atorva) NR/ 996 1888/ 519 2696/ 1036 2385/ 774 1644/ 1124 4161/ 1632 NR/ 2431 (1284 rosuva or atorva) Open-label Fixed dose Open-label Fixed dose Open-label Fixed dose Double-blind Fixed dose Open-label Flexible dose Open-label Fixed dose Open-label Fixed dose Open-label Fixed dose for 6 wks, then dose doubled to reach NCEP ATP goal for additional 6 weeks Mean baseline LDL-C 12 weeks 170.5 mg/dL 12 weeks 171.6 mg/dL 6 weeks 165 mg/dL 12 weeks 186.5 mg/dL 24 weeks 188.8 mg/dL 6 weeks 12 weeks Open-label 6 weeks 190.6 mg/dL 173 mg/dL (statin naïve patients) 163 mg/dL (others) 12 weeks 168.5 mg/dL 189.1 mg/dL Other patient characteristics Atherosclerosis, type 2 diabetes, family history of previous CHD Presence of diabetes, atherosclerosis disease, CHD risk, previous lipid lowering therapy Metabolic syndrome, diabetes, CHD or CHD risk equivalents Renal impairment, metabolic syndrome, diabetes mellitus, CHD African Americans History of CHD or CHD risk >20% over 10 years, diabetes, hypertension Statins Page 23 of 128
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(Statins) and Fixed-dose Combination Products Containing a Statin

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