Comparative effectiveness of lipid-lowering treatments to reduce cardiovascular disease

References

• Writing Group M, Mozaffarian D, Benjamin EJ, et al. Heart disease and stroke statistics-2016 update: a report from the American Heart Association. Circulation. 2016;133:e38–360.
   PubMed Web of Science ®Google Scholar
• Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123:933–944.
   PubMed Web of Science ®Google Scholar
• Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670–1681.
   PubMed Web of Science ®Google Scholar
• Trialists CT. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012;380:581–590.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387–2397.
   PubMed Web of Science ®Google Scholar
• Murphy SA, Cannon CP, Blazing MA, et al. Reduction in total cardiovascular events with ezetimibe/simvastatin post-acute coronary syndrome: the IMPROVE-IT trial. J Am Coll Cardiol. 2016;67:353–361.
   PubMed Web of Science ®Google Scholar
• Wong ND, Blaha M. IMPROVE-IT: how much really is the IMPROVEment? Am Coll Cardiol. 2014 December 18. Available at: http://www.acc.org/latest-in-cardiology/articles/2014/12/18/11/57/improve-it-how-much-really-is-the-improvement Last accessed 16 October 2017.
   Google Scholar
• O’Riordan M. IMPROVE-IT: ‘Modest’ benefit when adding ezetimibe to statins in post-ACS patients. Medscape Medical News from the American Hearth Association 2014 Scientific sessions. November 21, 2014. Available at: https://www.medscape.com/viewarticle/835030 Last accessed 16 October 2017.
   Google Scholar
• Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713–1722.
   PubMed Web of Science ®Google Scholar
• Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College Of Cardiology Task Force On Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016;68(1):92–125.
   PubMed Web of Science ®Google Scholar
• Catapano AL, Graham I, De Backer G, et al. ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J. 2016;2016(37):2999–3058.
   Google Scholar
• Evolocumab (Repatha) – a second PCSK9 inhibitor to lower LDL-cholesterol. Jama. 2015;314:2298–2299.
   PubMed Web of Science ®Google Scholar
• Pollack A New drug sharply lowers cholesterol, but it’s costly. The New York Times. July 24, 2015. Available at: https://www.nytimes.com/2015/07/25/business/us-approves-drug-that-can-sharply-lower-cholesterol-levels.html?mcubz=0 Last accessed 11 June 2017.
   Google Scholar
• Amirsadri M, Hassani A. Cost-effectiveness and cost-utility analysis of OTC use of simvastatin 10 mg for the primary prevention of myocardial infarction in Iranian men. Daru. 2015;23:56.
   PubMed Web of Science ®Google Scholar
• Ara R, Pandor A, Tumur I, et al. Cost effectiveness of ezetimibe in patients with cardiovascular disease and statin intolerance or contraindications: a Markov model. Am J Cardiovasc Drugs. 2008;8:419–427.
   PubMed Web of Science ®Google Scholar
• Ara R, Pandor A, Tumur I, et al. Estimating the health benefits and costs associated with ezetimibe coadministered with statin therapy compared with higher dose statin monotherapy in patients with established cardiovascular disease: results of a Markov model for UK costs using data registries. Clin Ther. 2008;30:1508–1523.
   PubMed Web of Science ®Google Scholar
• Arrieta A, Page TF, Veledar E, et al. Economic evaluation of PCSK9 inhibitors in reducing cardiovascular risk from health system and private payer perspectives. PloS One. 2017;12:e0169761.
   PubMed Web of Science ®Google Scholar
• Barrios V, Lobos JM, Serrano A, et al. Cost-effectiveness analysis of rosuvastatin vs. generic atorvastatin in Spain. J Med Econ. 2012;15:45–54.
   PubMedGoogle Scholar
• Chan PS, Nallamothu BK, Gurm HS, et al. Incremental benefit and cost-effectiveness of high-dose statin therapy in high-risk patients with coronary artery disease. Circulation. 2007;115:2398–2409.
   PubMed Web of Science ®Google Scholar
• Davies GM, Vyas A, Baxter CA. Economic evaluation of ezetimibe treatment in combination with statin therapy in the United States. J Med Econ. 2017;20:1–20.
   Web of Science ®Google Scholar
• Fragoulakis V, Kourlaba G, Maniadakis N. Economic evaluation of statins in high-risk patients treated for primary and secondary prevention of cardiovascular disease in Greece. Clinicoecon Outcomes Res. 2012;4:135–143.
   PubMedGoogle Scholar
• Gandhi SK, Jensen MM, Fox KM, et al. Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events. Clinicoecon Outcomes Res. 2012;4:1–11.
   PubMedGoogle Scholar
• Gandra SR, Villa G, Fonarow GC, et al. Cost-effectiveness of LDL-C lowering with evolocumab in patients with high cardiovascular risk in the United States. Clin Cardiol. 2016;39:313–320.
   PubMed Web of Science ®Google Scholar
• Heart protection study collaborative group. Statin cost-effectiveness in the United States for people at different vascular risk levels. Circ Cardiovasc Qual Outcomes. 2009;2:65-72.
   Web of Science ®Google Scholar
• Kazi DS, Moran AE, Coxson PG, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. Jama. 2016;316:743–753.
   PubMed Web of Science ®Google Scholar
• Kongnakorn T, Ward A, Roberts CS, et al. Economic evaluation of atorvastatin for prevention of recurrent stroke based on the SPARCL trial. Value Health. 2009;12:880–887.
   PubMed Web of Science ®Google Scholar
• Korman M, Wisloff T. Modelling the cost-effectiveness PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting. Eur Heart J Cardiovasc Pharmacother. 2017;pvx010.
   Google Scholar
• Lindgren P, Graff J, Olsson AG, et al. Cost-effectiveness of high-dose atorvastatin compared with regular dose simvastatin. Eur Heart J. 2007;28:1448–1453.
   PubMed Web of Science ®Google Scholar
• MacDonald G. Cost-effectiveness of rosuvastatin for primary prevention of cardiovascular events according to Framingham risk score in patients with elevated C-reactive protein. J Am Osteopath Assoc. 2010;110:427–436.
   PubMedGoogle Scholar
• Mihaylova B, Schlackow I, Herrington W, et al. Cost-effectiveness of simvastatin plus ezetimibe for cardiovascular prevention in CKD: results of the study of heart and renal protection (SHARP). Am J Kidney Dis. 2016;67:576–584.
   PubMed Web of Science ®Google Scholar
• Mould-Quevedo JF, Gutiérrez-Ardila MV, Ordóñez Molina JE, et al. Cost-effectiveness analysis of atorvastatin versus rosuvastatin in primary and secondary cardiovascular prevention populations in Brazil and Columbia. Value Health Reg Issues. 2014;5:48–57.
   Google Scholar
• Ohsfeldt RL, Gandhi SK, Smolen LJ, et al. Cost effectiveness of rosuvastatin in patients at risk of cardiovascular disease based on findings from the JUPITER trial. J Med Econ. 2010;13:428–437.
   PubMedGoogle Scholar
• Ohsfeldt R, Olsson A, Jensen M, et al. Cost-effectiveness of rosuvastatin 20mg for the prevention of cardiovascular morbidity and mortality: a Swedish economic evaluation of the JUPITER trial. J Med Econ. 2012;15:125–133.
   PubMedGoogle Scholar
• Onishi Y, Hinotsu S, Nakao YM, et al. Economic evaluation of pravastatin for primary prevention of coronary artery disease based on risk prediction from JALS-ECC in Japan. Value Health Reg Issues. 2013;2:5–12.
   Google Scholar
• Peura P, Martikainen J, Soini E, et al. Cost-effectiveness of statins in the prevention of coronary heart disease events in middle-aged Finnish men. Curr Med Res Opin. 2008;24:1823–1832.
   PubMed Web of Science ®Google Scholar
• Reckless J, Davies G, Tunceli K, et al. Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study. Value Health. 2010;13:726–734.
   PubMed Web of Science ®Google Scholar
• Slejko JF, Page RL, Sullivan PW. Cost-effectiveness of statin therapy for vascular event prevention in adults with elevated C-reactive protein: implications of JUPITER. Curr Med Res Opin. 2010;26:2485–2497.
   PubMed Web of Science ®Google Scholar
• Soini EJO, Davies G, Martikainen JA, et al. Population-based health-economic evaluation of the secondary prevention of coronary heart disease in Finland. Curr Med Res Opin. 2010;26:25–36.
   PubMed Web of Science ®Google Scholar
• Toth PP, Danese M, Villa G, et al. Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context. J Med Econ. 2017;20:555-564.
   Web of Science ®Google Scholar
• Tumanan-Mendoza BA, Mendoza VL. Economic evaluation of lipid-lowering therapy in the secondary prevention setting in the Philippines. Value Health Reg Issues. 2013;2:13–20.
   Google Scholar
• Van Nooten F, Davies GM, Jukema JW, et al. Economic evaluation of ezetimibe combined with simvastatin for the treatment of primary hypercholesterolaemia. Neth Heart J. 2011;19:61–67.
   PubMed Web of Science ®Google Scholar
• Villa G, Lothgren M, Kutikova L, et al. Cost-effectiveness of evolocumab in patients with high cardiovascular risk in Spain. Clin Ther. 2017;39:771–786.
   PubMed Web of Science ®Google Scholar
• Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372:1500–1509.
   PubMed Web of Science ®Google Scholar
• Heart protection study collaborative group. MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360:7–22.
   PubMed Web of Science ®Google Scholar
• Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195–2207.
   PubMed Web of Science ®Google Scholar
• Talaei M, Sarrafzadegan N, Sadeghi M, et al. Incidence of cardiovascular diseases in an Iranian population: the Isfahan cohort study. Arch Iran Med. 2013;16:138–144.
   PubMed Web of Science ®Google Scholar
• Tanabe N, Iso H, Okada K, et al. Serum total and non-high-density lipoprotein cholesterol and the risk prediction of cardiovascular events - the JALS-ECC. Circ J. 2010;74:1346–1356.
   PubMed Web of Science ®Google Scholar
• Amarenco P, Bogousslavsky J, Callahan A, et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006;355:549–559.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495–1504.
   PubMed Web of Science ®Google Scholar
• De Lemos JA, Blazing MA, Wiviott SD, et al. Early intensive vs. a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. Jama. 2004;292:1307–1316.
   PubMed Web of Science ®Google Scholar
• LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352:1425–1435.
   PubMed Web of Science ®Google Scholar
• Pedersen TR, Faergeman O, Kastelein JJ, et al. High-dose atorvastatin vs. usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. Jama. 2005;294:2437–2445.
   PubMed Web of Science ®Google Scholar
• Jones PH, Davidson MH, Stein EA, et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152–160.
   PubMed Web of Science ®Google Scholar
• Murphy SA, Cannon CP, Wiviott SD, et al. Effect of intensive lipid-lowering therapy on mortality after acute coronary syndrome (a patient-level analysis of the aggrastat to zocor and pravastatin or atorvastatin evaluation and infection therapy-thrombolysis in myocardial infarction 22 trials). Am J Cardiol. 2007;100:1047–1051.
   PubMed Web of Science ®Google Scholar
• Schneck DW, Knopp RH, Ballantyne CM, et al. Comparative effects of rosuvastatin and atorvastatin across their dose ranges in patients with hypercholesterolemia and without active arterial disease. Am J Cardiol. 2003;91:33–41.
   PubMed Web of Science ®Google Scholar
• Lakka HM, Laaksonen DE, Lakka TA, et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. Jama. 2002;288:2709–2716.
   PubMed Web of Science ®Google Scholar
• 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. 2003;326:1423.
   PubMed Web of Science ®Google Scholar
• Ara R, Tumur I, Pandor A, et al. Ezetimibe for the treatment of hypercholesterolaemia: a systematic review and economic evaluation. Health Technol Assess. 2008;12:1–212.
   Web of Science ®Google Scholar
• Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–1278.
   PubMed Web of Science ®Google Scholar
• Baigent C, Landray MJ, Reith C, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011;377:2181–2192.
   PubMed Web of Science ®Google Scholar
• Reckless JP, Henry P, Pomykaj T, et al. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008;62:539–554.
   PubMed Web of Science ®Google Scholar
• D’Agostino RB, Russell MW, Huse DM, et al. Primary and subsequent coronary risk appraisal: new results from the Framingham study. Am Heart J. 2000;139:272–281.
   PubMed Web of Science ®Google Scholar
• Roeters Van Lennep HW, Liem AH, Dunselman PH, et al. The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr Med Res Opin. 2008;24:685–694.
   PubMed Web of Science ®Google Scholar
• National Center for Health Statistics. National health and nutrition examination survey. 192005–2012. Available at: http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm Last accessed 11 June 2017.
   Google Scholar
• Ohman EM, Bhatt DL, Steg PG, et al. The REduction of Atherothrombosis for Continued Health (REACH) Registry: an international, prospective, observational investigation in subjects at risk for atherothrombotic events-study design. Am Heart J. 2006;151:786–e1.
   PubMed Web of Science ®Google Scholar
• D’Agostino RB Sr., Vasan RS, Pencina MJ, et al. General cardiovascular risk profile for use in primary care: the Framingham heart study. Circulation. 2008;117:743–753.
   PubMed Web of Science ®Google Scholar
• Wilson PW, D’Agostino R Sr., Bhatt DL, et al. An international model to predict recurrent cardiovascular disease. Am J Med. 2012;125:695–703.
   PubMed Web of Science ®Google Scholar
• Amgen Inc. Repatha (evolocumab) [package insert]. Available at: http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.ashx Last accessed 11 June 2017.
   Google Scholar
• Perez De Isla L, Alonso R, Watts GF, et al. Attainment of LDL-cholesterol treatment goals in patients with familial hypercholesterolemia: 5-Year SAFEHEART registry follow-up. J Am Coll Cardiol. 2016;67:1278–1285.
   PubMed Web of Science ®Google Scholar
• Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysis. Ann Intern Med. 2015;163:40–51.
   PubMed Web of Science ®Google Scholar
• Ward S, Lloyd Jones M, Pandor A, et al. A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol Assess. 2007;11:1–160.
   Web of Science ®Google Scholar
• Ara R, Pandor A, Stevens J, et al. Early high-dose lipid-lowering therapy to avoid cardiac events: a systematic review and economic evaluation. Health Technol Assess. 2009;13:1–118.
   PubMed Web of Science ®Google Scholar
• LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. Jama. 1999;282:2340–2346.
   PubMed Web of Science ®Google Scholar
• Amarenco P, Labreuche J. Lipid management in the prevention of stroke: review and updated meta-analysis of statins for stroke prevention. Lancet Neurol. 2009;8:453–463.
   PubMed Web of Science ®Google Scholar
• Brugts JJ, Yetgin T, Hoeks SE, et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. Bmj. 2009;338:b2376.
   PubMed Web of Science ®Google Scholar
• Knopp RH. Drug treatment of lipid disorders. N Engl J Med. 1999;341:498–511.
   PubMed Web of Science ®Google Scholar
• Tsevat J, Kuntz KM, Orav EJ, et al. Cost-effectiveness of pravastatin therapy for survivors of myocardial infarction with average cholesterol levels. Am Heart J. 2001;141:727–734.
   PubMed Web of Science ®Google Scholar
• IMS Institue for Healthcare Informatics. Price declines after branded medicines lose exclusivity in the US. January 2016. Available at: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/PhRMA%20Generic%20Price%20Brief%20January%202016.pdf Last accessed 16 October 2017.
   Google Scholar
• De Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal. Arch Intern Med. 2010;170:1032–1036.
   PubMed Web of Science ®Google Scholar
• Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010;170:1073–1077.
   PubMed Web of Science ®Google Scholar
• Green LA. Cholesterol-lowering therapy for primary prevention: still much we don’t know. Arch Intern Med. 2010;170:1007–1008.
   PubMed Web of Science ®Google Scholar
• Ridker PM, Glynn RJ. The JUPITER Trial: responding to the critics. Am J Cardiol. 2010;106:1351–1356.
   PubMed Web of Science ®Google Scholar
• Wei CY, Quek RG, Villa G, et al. A systematic review of cardiovascular outcomes-based cost-effectiveness analyses of lipid-lowering therapies. Pharmaco Econom. 2017;35:297–318.
   PubMed Web of Science ®Google Scholar
• Birjmohun RS, Hutten BA, Kastelein JJ, et al. Efficacy and safety of high-density lipoprotein cholesterol-increasing compounds: a meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2005;45:185–197.
   PubMed Web of Science ®Google Scholar
• Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366:1849–1861.
   PubMed Web of Science ®Google Scholar
• Sanofi Inc. ODYSSEY outcomes: evaluation of cardiovascular outcomes after an acute coronary syndrome during treatment with alirocumab. Available at: https://clinicaltrials.gov/ct2/show/NCT01663402?term=NCT01663402&rank=1 Last accessed 11 June 2017.
   Google Scholar
• Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372:1489–1499.
   PubMed Web of Science ®Google Scholar
• Institute for Clinical and Economic Review (ICER). Evolocumab for treatment of high cholesterol: effectiveness and value. September 11, 2017. Available at: https://icer-review.org/wp-content/uploads/2017/06/ICER_PCSK9_NEU_091117.pdf Last accessed 16 October 2017.
   Google Scholar
• Auer J, Berent R, Primus C. PCSK9 inhibitors and cardiovascular events. N Engl J Med. 2015;373:773.
   PubMed Web of Science ®Google Scholar
• Goemann IM, Londero TM, Dora JM. PCSK9 inhibitors and cardiovascular events. N Engl J Med. 2015;373:773–774.
   PubMedGoogle Scholar
• Sabatine MS, Wasserman SM, Stein EA. PCSK9 inhibitors and cardiovascular events. N Engl J Med. 2015;373:774–775.
   PubMedGoogle Scholar
• Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;CD004816.
   PubMed Web of Science ®Google Scholar
• Han BH, Sutin D, Williamson JD, et al. Effect of statin treatment vs. usual care on primary cardiovascular prevention among older adults: the ALLHAT-LLT randomized clinical trial. JAMA Intern Med. 2017;177:955–965.
   PubMed Web of Science ®Google Scholar
• Jones M, Tett S, Peeters GM, et al. New-onset diabetes after statin exposure in elderly women: the Australian longitudinal study on women’s health. Drug & Aging. 2017;34:203–209.
   PubMed Web of Science ®Google Scholar
• Ridker PM, Lonn E, Paynter NP, et al. Primary prevention with statin therapy in the elderly: new meta-analyses from the contemporary JUPITER and HOPE-3 randomized trials. Circulation. 2017;135:1979–1981.
   PubMed Web of Science ®Google Scholar
• Vos E, Biron P, Rose CP. Letter by Vos et al Regarding Article. Primary prevention with statin therapy in the elderly: new meta-analyses from the contemporary JUPITER and HOPE-3 randomized trials. Circulation. 2017;136:1454–1455.
   PubMedGoogle Scholar
• Kleipool EEF, Peters MJL, Muller M. Letter by kleipool et al regarding article. Primary prevention with statin therapy in the elderly: new meta-analyses from the contemporary JUPITER and HOPE-3 randomized trials. Circulation. 2017;136:1456–1457.
   PubMedGoogle Scholar