Safety of a fixed-dose combination of fenofibrate/pravastatin 160 mg/40 mg in patients with mixed hyperlipidaemia: A pooled analysis from a database of clinical trials

Clinical Drug Investigation

Volumn 32, Issue 4, 2012, Pages 281-291

  Farnier, Michel ^a   Marcereuil, David ^b   De Niet, Sophie ^b   Ducobu, Jean ^c   Steinmetz, Armin ^d   Retterstøl, Kjetil ^e   Bryniarski, Leszek ^f   Császár, Albert ^g   Vanderbist, Francis ^b  

^a Point Médical ^*  (France)

^b Laboratoires SMB SA   (Belgium)

^c UNIVERSITY OF MONS   (Belgium)

^d UNIVERSITY OF BONN   (Germany)

^e OSLO UNIVERSITY HOSPITAL   (Norway)

^f JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^g State Health Centre   (Hungary)

Author keywords

fenofibrate; hyperlipidaemia; pravastatin

Indexed keywords

FENOFIBRATE; FENOFIBRATE PLUS PRAVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ABNORMAL LABORATORY RESULT; AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; CHOLELITHIASIS; COMBINATION CHEMOTHERAPY; CONSTIPATION; COUGHING; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DATA BASE; DEATH; DIARRHEA; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HEADACHE; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; INCIDENCE; KIDNEY FAILURE; LIMB PAIN; LIVER FAILURE; LIVER INJURY; LUNG EMBOLISM; MONOTHERAPY; MUSCLE SPASM; MYALGIA; MYOPATHY; NAUSEA; PANCREATITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RHABDOMYOLYSIS; RHINOPHARYNGITIS; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION;

ADULT; AGED; CLINICAL TRIALS, PHASE III AS TOPIC; DATABASES, FACTUAL; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FENOFIBRATE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPIDEMIAS; HYPOLIPIDEMIC AGENTS; MALE; MIDDLE AGED; PRAVASTATIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS;

EID: 84858041747     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11630820-000000000-00000     Document Type: Article

References (25)

1. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010; 362 (17): 1563-74
2. Chapman MJ, Ginsberg HN, Amarenco P, et al., for the European Atherosclerosis Society Consensus Panel. Triglyceride- rich lipoproteins and high-density lipoprotein cholesterol in patients at high risk of cardiovascular disease: evidence and guidance for management. Eur Heart J 2011; 32 (11): 1345-61
3. Sacks FM, Carey VJ, Fruchart J-C. Combination lipid therapy in type 2 diabetes. N Engl JMed 2010; 363 (7): 692-4
4. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97 (8A): 52C-60C
5. Davidson MH, Armani A, McKenney JM, et al. Safety considerations with fibrate therapy. Am J Cardiol 2007; 99 (6A): 3C-18C
6. Jacobson TA. Myopathy with statin-fibrate combination therapy: clinical considerations. Nat Rev Endocrinol 2009; 5 (9): 507-18
7. Corsini A, Bellosta S, Davidson MH. Pharmacokinetic interactions between statins and fibrates. Am J Cardiol 2005; 96 (9A): 44K-9K (Pubitemid 41598112)
8. Enger C, Gately R, Ming EE, et al. Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. Am J Cardiol 2010; 106 (11): 1594-601
9. Grundy SM, Cleeman JI, Merz CNB, et al., for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation 2004; 110 (2): 227-39 (Pubitemid 38924592)
10. The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 2011; 32 (14): 1769-818
11. Abbott Healthcare Products Limited. Supralip (micronised fenofibrate) 160 mg: summary of product characteristics [online]. Available from URL: http://www.medicines.org. uk/EMC/medicine/3719/SPC/Supralip+160mg/ [Accessed 2011, Oct 19]
12. Pravafenix, fenofibrate/pravastatin. European Medicines Agency; 20 January 2011 [online]. Available from URL: http://www.ema.europa.eu [Accessed 2011, Oct 19]
13. Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg. Am J Cardiol 2010; 106 (6): 787-92
14. Farnier M, Ducobu J, Bryniarski L. Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy. Curr Med Res Opin 2011; 27 (11): 2165-73
15. Farnier M, Steinmetz A, Retterstøl K, et al. Fixed-dose combination fenofibrate/pravastatin 160/40 mg versus simvastatin 20 mg monotherapy in adults with type 2 diabetes and mixed hyperlipidemia uncontrolled with simvastatin 20mg: a double-blind, randomized comparative study. Clin Ther 2011; 33 (1): 1-12
16. Farnier M, Steinmetz A, Retterstøl K, et al. Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia and cardiovascular disease. Diab Vasc Dis Res 2012. Epub 2012 Jan 6
17. Davidson MH. Reducing residual risk for patients on statin therapy: the potential role of combination therapy. Am J Cardiol 2005; 96 (9A): 3-13K
18. 3i). The residual risk reduction initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol 2008; 102 (10 Suppl.): 1-34K
19. Athyros VG, Papageorgiou AA, Athyrou VV, et al. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care 2002; 25 (7): 1198-202 (Pubitemid 41071172)
20. Grundy SM, Vega GL, Yuan Z, et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (The SAFARI trial). Am J Cardiol 2005; 95 (4): 462-8 (Pubitemid 40247539)
21. Durrington PN, Tuomilehto J, Hamann A, et al. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidemia. Diab Res Clin Pract 2004; 64 (2): 137-51 (Pubitemid 38456692)
22. Derosa G, Maffioli P, Salvadeo SAT, et al. Fenofibrate, simvastatin and their combination in the management of dyslipidaemia in type 2 diabetic patients. Curr Med Res Opin 2009; 25 (8): 1973-83
23. Kipnes MS, Roth EM, Rhyne JM, et al. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig 2010; 30 (1): 51-61
24. Bays HE, Jones PH, Mohiuddin SM, et al. Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. J Clin Lipidol 2008; 2 (6): 426-35 (Pubitemid 352795715)
25. Tenenbaum A, Fisman EZ. "If it ain't broke, don't fix it": a commentary on the positive-negative results of the ACCORD Lipid study. Cardiovasc Diabetol 2010; 9: 24