Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (Combined) dyslipidemia: A phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial

Clinical Therapeutics

Volumn 36, Issue 8, 2014, Pages 1211-1222

  Sponseller, Craig A ^a   Morgan, Roger E ^b   Kryzhanovski, Vladimir A ^c   Campbell, Stuart E ^b   Davidson, Michael H ^d  

^a Kowa Pharmaceuticals America Inc   (United States)

^b Kowa Research Institute Inc   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF CHICAGO   (United States)

Author keywords

hyperlipidemia; LDL C; mixed dyslipidemia; pitavastatin; pravastatin; risk factors

Indexed keywords

ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN B; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PITAVASTATIN; PRAVASTATIN; TRIACYLGLYCEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; QUINOLINE DERIVATIVE;

ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; APPENDIX PERFORATION; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BODY MASS; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; FOLLOW UP; GLUCOSE BLOOD LEVEL; GLUCOSE METABOLISM; HEART ARRHYTHMIA; HEART RATE; HEARTBURN; HUMAN; HYPERLIPIDEMIA; INSULIN BLOOD LEVEL; LUMBAR SPINAL STENOSIS; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MIDDLE AGED; MIXED DYSLIPIDEMIA; MULTICENTER STUDY; MUSCLE SPASM; MYALGIA; MYOSITIS; OSTEOARTHRITIS; PATIENT COMPLIANCE; PHASE 4 CLINICAL TRIAL; PRIMARY HYPERLIPIDEMIA; PROSPECTIVE STUDY; PROSTATE CANCER; QUANTITATIVE INSULIN SENSITIVITY CHECK INDEX; RANDOMIZED CONTROLLED TRIAL; REDUCTION; RHABDOMYOLYSIS; RHINOPHARYNGITIS; TRIACYLGLYCEROL BLOOD LEVEL; UNITED STATES; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; DYSLIPIDEMIAS; HYPERLIPIDEMIAS;

AGED; APOLIPOPROTEINS B; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; DYSLIPIDEMIAS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPIDEMIAS; MALE; MIDDLE AGED; PRAVASTATIN; PROSPECTIVE STUDIES; QUINOLINES; TRIGLYCERIDES;

EID: 84906940613     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2014.06.009     Document Type: Article

References (23)

1. S.J. Lewis Lipid-lowering therapy: who can benefit? Vasc Health Risk Manag 7 2011 525 534
2. S.M. Grundy, J.I. Cleeman, and C.N. Merz et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines [Published correction appears in Circulation. 2004;110:763] Circulation 110 2004 227 239
3. C.D. Fryar, T. Chen, and X. Li Prevalence of uncontrolled risk factors for cardiovascular disease: United States, 1999-2010. NCHS data brief, no 103 August 2012 National Center for Health Statistics Hyattsville, MD http://www.cdc.gov/nchs/data/databriefs/db103.htm Accessed July 31, 2013
4. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 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) final report Circulation 106 2002 3143 3421
5. B. Fletcher, K. Berra, and P. Ades et al. Managing abnormal blood lipids: a collaborative approach Circulation 112 2005 3184 3209
6. A.R. Last, J.D. Ference, and J. Falleroni Pharmacologic treatment of hyperlipidemia Am Fam Physician 84 2011 551 558
7. R. Jeger, and T. Dieterle Statins: have we found the Holy Grail? Swiss Med Wkly 142 2012 w13515
8. H. Ahmad, and A. Cheng-Lai Pitavastatin: a new HMG-CoA reductase inhibitor for the treatment of hypercholesterolemia Cardiol Rev 18 2010 264 267
9. F.P. Guengerich Cytochrome P450 and chemical toxicology Chem Res Toxicol 21 2008 70 83
10. A. Corsini, and R. Ceska Drug-drug interactions with statins: will pitavastatin overcome the statins' Achilles' heel? Curr Med Res Opin 27 2011 1551 1562
11. A.L. Catapano Statin-induced myotoxicity: pharmacokinetic differences among statins and the risk of rhabdomyolysis, with particular reference to pitavastatin Curr Vasc Pharmacol 10 2012 257 267
12. S.T. Duggan Pitavastatin: a review of its use in the management of hypercholesterolaemia or mixed dyslipidaemia Drugs 72 2012 565 584
13. L. Ose, D. Budinski, and N. Hounslow et al. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia [Published correction appears in Curr Med Res Opin. 2010;26:1046. Dosage error in article text] Curr Med Res Opin 25 2009 2755 2764
14. D. Budinski, V. Arneson, and N. Hounslow et al. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia Clin Lipidol 4 2009 291 302
15. J. Gumprecht, M. Gosho, and D. Budinski et al. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia Diabetes Obes Metab 13 2011 1047 1055
16. K. Saku, B. Zhang, and K. Noda for the PATROL Trial Investigators. Randomized head-to-head comparison of pitavastatin, atorvastatin, and rosuvastatin for safety and efficacy (quantity and quality of LDL): the PATROL trial Circ J 75 2011 1493 1505
17. S. Stender, D. Budinski, and M. Gosho et al. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia Eur J Prev Cardiol 20 2013 40 53
18. V. Kryzhanovski, R. Morgan, and C. Sponseller et al. Pitavastatin 4 mg provides significantly greater reduction in LDL-C compared to pravastatin 40 mg with neutral effects on glucose metabolism: prespecified safety analysis from the short-term Phase 4 PREVAIL US trial in patients with primary hyperlipidemia or mixed dyslipidemia J Am Coll Cardiol 59 Suppl 13 2012 E1692
19. C.A. Sponseller, S. Stender, and B. Zhu et al. Neutral effects of pitavastatin and pravastatin on fasting plasma glucose over 12 weeks in elderly patients with primary hyperlipidemia or mixed dyslipidemia Minerva Endocrinol 37 4 Suppl 1 2012 89 90
20. D.B. Hunninghake, R.H. Knopp, and G. Schonfeld et al. Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. I. A dose-response study Atherosclerosis 85 1990 81 89
21. P.H. Jones, M.H. Davidson, E.A. Stein for the STELLAR Study Group Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial) Am J Cardiol 92 2003 152 160
22. Pravachol [prescribing information] October 2012 Bristol-Myers Squibb Company Princeton, NJ
23. H. Naci, J.J. Brugts, and R. Fleurence et al. Comparative benefits of statins in the primary and secondary prevention of major coronary events and all-cause mortality: a network meta-analysis of placebo-controlled and active-comparator trials Eur J Prev Cardiol 20 2013 641 657