188
Views
2
CrossRef citations to date
0
Altmetric
Drug Profile

Pravastatin and fenofibrate in combination (Pravafenix®) for the treatment of high-risk patients with mixed hyperlipidemia

Pages 565-575 | Published online: 10 Jan 2014

References

  • Chapman MJ, Ginsberg HN, Amarenco P et al.; 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. 32(11), 1345–1361 (2011).
  • Kontush A, Chapman MJ. Functionally defective high-density lipoprotein: a new therapeutic target at the crossroads of dyslipidemia, inflammation, and atherosclerosis. Pharmacol. Rev. 58(3), 342–374 (2006).
  • Grundy SM, Cleeman JI, Merz CN et al.; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 110(2), 227–239 (2004).
  • Smith SC Jr, Allen J, Blair SN et al.; AHA/ACC National Heart, Lung, and Blood Institute. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation 113(19), 2363–2372 (2006).
  • Genest J, McPherson R, Frohlich J et al. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can. J. Cardiol. 25(10), 567–579 (2009).
  • 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. 32(14), 1769–1818 (2011).
  • Kastelein JJ, van der Steeg WA, Holme I et al.; TNT Study Group; IDEAL Study Group. Lipids, apolipoproteins, and their ratios in relation to cardiovascular events with statin treatment. Circulation 117(23), 3002–3009 (2008).
  • Robinson JG, Wang S, Smith BJ, Jacobson TA. Meta-analysis of the relationship between non-high-density lipoprotein cholesterol reduction and coronary heart disease risk. J. Am. Coll. Cardiol. 53(4), 316–322 (2009).
  • Sniderman A, McQueen M, Contois J, Williams K, Furberg CD. Why is non-high-density lipoprotein cholesterol a better marker of the risk of vascular disease than low-density lipoprotein cholesterol? J. Clin. Lipidol. 4(3), 152–155 (2010).
  • Brunzell JD, Davidson M, Furberg CD et al. Lipoprotein management in patients with cardiometabolic risk: consensus conference report from the American Diabetes Association and the American College of Cardiology Foundation. J. Am. Coll. Cardiol. 51(15), 1512–1524 (2008).
  • Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 326(7404), 1423–1427 (2003).
  • Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised, trials of statins. Lancet 366(9493), 1267–1278 (2005).
  • Shepherd J, Cobbe SM, Ford I et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N. Engl. J. Med. 333(20), 1301–1307 (1995).
  • Sacks FM, Pfeffer MA, Moye LA et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N. Engl. J. Med. 335(14), 1001–1009 (1996).
  • The Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart-disease and a broad range of initial cholesterol levels. N. Engl. J. Med. 339(19), 1349–1357 (1998).
  • Shepherd J, Blauw GJ, Murphy MB et al.; PROSPER Study Group. Prospective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 360(9346), 1623–1630 (2002).
  • ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care. JAMA 288(23), 2998–3007 (2002).
  • Gitt AK, Drexel H, Feely J et al.; on behalf of the DYSIS Investigators. Persistent lipid abnormalities in statin-treated patients and predictors of LDL-cholesterol goal achievement in clinical practice in Europe and Canada. Eur. J. Prev. Cardiol. 19(2), 221–230 (2012).
  • Fruchart JC, Sacks F, Hermans MP et al. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am. J. Cardiol. 102(Suppl. 10), 1K–34K (2008).
  • Carey VJ, Bishop L, Laranjo N, Harshfield BJ, Kwiat C, Sacks FM. Contribution of high plasma triglycerides and low high-density lipoprotein cholesterol to residual risk of coronary heart disease after establishment of low-density lipoprotein cholesterol control. Am. J. Cardiol. 106(6), 757–763 (2010).
  • Arsenault BJ, Barter P, DeMicco DA et al.; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J. Am. Coll. Cardiol. 57(1), 63–69 (2011).
  • Jun M, Foote C, Lv J et al. Effects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis. Lancet 375(9729), 1875–1884 (2010).
  • Sacks FM, Carey VJ, Fruchart J-C. Combination lipid therapy in Type 2 diabetes. N. Engl. J. Med. 363(7), 692–694 (2010).
  • Lee M, Saver JL, Towfighi A, Chow J, Ovbiagele B. Efficacy of fibrates for cardiovascular risk reduction in persons with atherogenic dyslipidemia: a meta-analysis. Atherosclerosis 217(2), 492–498 (2011).
  • Enger C, Gately R, Ming EE, Niemcryk SJ, Williams L, McAfee AT. Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. Am. J. Cardiol. 106(11), 1594–1601 (2010).
  • Farnier M. Safety review of combination drugs for hyperlipidemia. Expert Opin. Drug Saf. 10(3), 363–371 (2011).
  • Jacobson TA. Myopathy with statin–fibrate combination therapy: clinical considerations. Nat. Rev. Endocrinol. 5(9), 507–518 (2009).
  • Corsini A, Bellosta S, Davidson MH. Pharmacokinetic interactions between statins and fibrates. Am. J. Cardiol. 96(9A), 44K–49K; discussion 34K (2005).
  • Davidson MH, Armani A, McKenney JM, Jacobson TA. Safety considerations with fibrate therapy. Am. J. Cardiol. 99(6A), 3C–18C (2007).
  • Ginsberg HN, Elam MB, Lovato LC et al.; ACCORD Study Group. Effects of combination lipid therapy in Type 2 diabetes mellitus. N. Engl. J. Med. 362(17), 1563–1574 (2010).
  • The ACCORD Study Group and ACCORD Eye Study Group. Effects of medical therapies on retinopathy progression in Type 2 diabetes. N. Engl. J. Med. 363(3), 233–244 (2010).
  • Haria M, McTavish D. Pravastatin. A reappraisal of its pharmacological properties and clinical effectiveness in the management of coronary heart disease. Drugs 53(2), 299–336 (1997).
  • Staels B, Dallongeville J, Auwerx J, Schoonjans K, Leitersdorf E, Fruchart JC. Mechanism of action of fibrates on lipid and lipoprotein metabolism. Circulation 98(19), 2088–2093 (1998).
  • Chapman MJ. Fibrates: therapeutic review. Br. J. Diabetes Vasc. Dis. 6(1), 11–20 (2006).
  • Davignon J, Laaksonen R. Low-density lipoprotein-independent effects of statins. Curr. Opin. Lipidol. 10(6), 543–559 (1999).
  • Ray KK, Cannon CP. The potential relevance of the multiple lipid-independent (pleiotropic) effects of statins in the management of acute coronary syndromes. J. Am. Coll. Cardiol. 46(8), 1425–1433 (2005).
  • Paumelle R, Staels B. Cross-talk between statins and PPARalpha in cardiovascular diseases: clinical evidence and basic mechanisms. Trends Cardiovasc. Med. 18(3), 73–78 (2008).
  • Fruchart JC, Duriez P. Mode of action of fibrates in the regulation of triglyceride and HDL-cholesterol metabolism. Drugs Today 42(1), 39–64 (2006).
  • McKeage K, Keating GM. Fenofibrate: a review of its use in dyslipidaemia. Drugs 71(14), 1917–1946 (2011).
  • Farnier M. Update on the clinical utility of fenofibrate in mixed dyslipidemias: mechanisms of action and rational prescribing. Vasc. Health Risk Manag. 4(5), 991–1000 (2008).
  • Liamis G, Bairaktari ET, Elisaf MS. Effect of fenofibrate on serum uric acid levels. Am. J. Kidney Dis. 34(3), 594 (1999).
  • Farnier M. Combination therapy with an HMG-CoA reductase inhibitor and a fibric acid derivative: a critical review of potential benefits and drawbacks. Am. J. Cardiovasc. Drugs 3(3), 169–178 (2003).
  • Wierzbicki AS, Mikhailidis DP, Wray R et al. Statin–fibrate combination: therapy for hyperlipidemia: a review. Curr. Med. Res. Opin. 19(3), 155–168 (2003).
  • Inoue I, Itoh F, Aoyagi S et al. Fibrate and statin synergistically increase the transcriptional activities of PPARalpha/RXRalpha and decrease the transactivation of NFkappaB. Biochem. Biophys. Res. Commun. 290(1), 131–139 (2002).
  • Paumelle R, Blanquart C, Briand O et al. Acute antiinflammatory properties of statins involve peroxisome proliferator-activated receptor-alpha via inhibition of the protein kinase C signaling pathway. Circ. Res. 98(3), 361–369 (2006).
  • Kiortsis DN, Millionis H, Bairaktari E, Elisaf MS. Efficacy of combination of atorvastatin and micronized fenofibrate in the treatment of severe mixed hyperlipidemia. Eur. J. Clin. Pharmacol. 56(9–10), 631–635 (2000).
  • Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in Type 2 diabetes with combined hyperlipidemia. Diabetes Care 25(7), 1198–1202 (2002).
  • Vega GL, Ma PT, Cater NB et al. Effects of adding fenofibrate (200 mg/day) to simvastatin (10 mg/day) in patients with combined hyperlipidemia and metabolic syndrome. Am. J. Cardiol. 91(8), 956–960 (2003).
  • Derosa G, Cicero AE, Bertone G, Piccinni MN, Ciccarelli L, Roggeri DE. Comparison of fluvastatin + fenofibrate combination therapy and fluvastatin monotherapy in the treatment of combined hyperlipidemia, Type 2 diabetes mellitus, and coronary heart disease: a 12-month, randomized, double-blind, controlled trial. Clin. Ther. 26(10), 1599–1607 (2004).
  • Stefanutti C, Bucci A, Di Giacomo S et al. Efficacy, safety and tolerability of combined low-dose simvastatin–fenofibrate treatment in primary mixed hyperlipidaemia. Clin. Drug Investig. 24(8), 465–477 (2004).
  • Durrington PN, Tuomilehto J, Hamann A, Kallend D, Smith K. Rosuvastatin and fenofibrate alone and in combination in Type 2 diabetes patients with combined hyperlipidaemia. Diabetes Res. Clin. Pract. 64(2), 137–151 (2004).
  • Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am. J. Cardiol. 95(4), 462–468 (2005).
  • Koh KK, Quon MJ, Han SH et al. Additive beneficial effects of fenofibrate combined with atorvastatin in the treatment of combined hyperlipidemia. J. Am. Coll. Cardiol. 45(10), 1649–1653 (2005).
  • Muhlestein JB, May HT, Jensen JR et al. The reduction of inflammatory biomarkers by statin, fibrate, and combination therapy among diabetic patients with mixed dyslipidemia: the DIACOR (Diabetes and Combined Lipid Therapy Regimen) study. J. Am. Coll. Cardiol. 48(2), 396–401 (2006).
  • Derosa G, Maffioli P, Salvadeo SA et al. Fenofibrate, simvastatin and their combination in the management of dyslipidaemia in Type 2 diabetic patients. Curr. Med. Res. Opin. 25(8), 1973–1983 (2009).
  • Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin. Ther. 31(12), 2824–2838 (2009).
  • Pan HY, DeVault AR, Wang-Iverson D, Ivashkiv E, Swanson BN, Sugerman AA. Comparative pharmacokinetics and pharmacodynamics of pravastatin and lovastatin. J. Clin. Pharmacol. 30(12), 1128–1135 (1990).
  • Gustavson LE, Schweitzer SM, Koehne-Voss S et al. The effects of multiple doses of fenofibrate on the pharmacokinetics of pravastatin and its 3alpha-hydroxy isomeric metabolite. J. Clin. Pharmacol. 45(8), 947–953 (2005).
  • Pan WJ, Gustavson LE, Achari R et al. Lack of a clinically significant pharmacokinetic interaction between fenofibrate and pravastatin in healthy volunteers. J. Clin. Pharmacol. 40(3), 316–323 (2000).
  • 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 monotherapy. Am. J. Cardiol. 106(6), 787–792 (2010).
  • Farnier M, Steinmetz A, Retterstøl K, Császár A. 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 20 mg: a double-blind, randomized comparative study. Clin. Ther. 33(1), 1–12 (2011).
  • Farnier M, Retterstøl K, Steinmetz A, Császár A. 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. doi:10.1177/1479164111430715 (2012) (Epub ahead of print).
  • 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. 27(11), 2165–2173 (2011).
  • Law M, Rudnicka AR. Statin safety: a systematic review. Am. J. Cardiol. 97(8A), 52C–60C (2006).
  • Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin. Am. J. Cardiol. 95(1), 120–122 (2005).
  • Farnier M, Marcereuil D, De Niet S et al. Safety of a fixed-dose combination fenofibrate/pravastatin 160/40 mg (Pravafenix) in patients with mixed hyperlipidemia: a pooled analysis from a database of clinical trials. Clin. Drug Invest. 32(4), 281–291 (2012).
  • Keech A, Simes RJ, Barter P et al.; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with Type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 366(9500), 1849–1861 (2005).
  • Goldfine AB, Kaul S, Hiatt WR. Fibrates in the treatment of dyslipidemias–time for a reassessment. N. Engl. J. Med. 365(6), 481–484 (2011).
  • Saha SA, Arora RR. Hyperlipidaemia and cardiovascular disease: do fibrates have a role? Curr. Opin. Lipidol. 22(4), 270–276 (2011).
  • Davis TM, Ting R, Best JD et al.; Fenofibrate Intervention and Event Lowering in Diabetes Study investigators. Effects of fenofibrate on renal function in patients with Type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia 54(2), 280–290 (2011).
  • Hermans MP. Non-invited review: prevention of microvascular diabetic complications by fenofibrate: lessons from FIELD and ACCORD. Diab. Vasc. Dis. Res. 8(3), 180–189 (2011).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.