Evaluating the impact and cost- effectiveness of statin use guidelines for primary prevention of coronary heart disease and stroke

Circulation

Volumn 136, Issue 12, 2017, Pages 1087-1098

  Heller, David J ^a   Coxson, Pamela G ^b   Penko, Joanne ^b   Pletcher, Mark J ^b   Goldman, Lee ^c   Odden, Michelle C ^d   Kazi, Dhruv S ^b   Bibbins Domingo, Kirsten ^b  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Och Spine at New York Presbyterian Hospitals   (United States)

^d OREGON STATE UNIVERSITY   (United States)

Author keywords

Coronary disease; Cost benefit analysis; Hydroxymethylglutaryl CoA reductase inhibitors; Primary prevention

Indexed keywords

HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COHORT ANALYSIS; CONTROLLED STUDY; COST CONTROL; COST EFFECTIVENESS ANALYSIS; FEMALE; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MARKOV CHAIN; NUMBERS NEEDED TO TREAT; PRACTICE GUIDELINE; PRIMARY PREVENTION; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RISK BENEFIT ANALYSIS; SENSITIVITY ANALYSIS; STATISTICAL ANALYSIS; UNITED STATES; BLOOD; CORONARY DISEASE; COST BENEFIT ANALYSIS; ECONOMICS; MEDICAL SOCIETY; MIDDLE AGED; MONTE CARLO METHOD; QUALITY OF LIFE; STROKE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; AMERICAN HEART ASSOCIATION; CHOLESTEROL, LDL; CORONARY DISEASE; COST-BENEFIT ANALYSIS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; MONTE CARLO METHOD; PRACTICE GUIDELINES AS TOPIC; QUALITY OF LIFE; STROKE; UNITED STATES;

EID: 85023759129     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.117.027067     Document Type: Article

References (58)

1. World Health Organization. Global Burden of Disease: projections of mortality and burden of disease, 2002-2030. 2004. http://www.who.int/topics/global-burden-of-disease/en/. Accessed June 22, 2017.
2. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352:1425-1435. doi: 10.1056/NEJMoa050461.
3. Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C. 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.
4. Engstrom A, Jacob J, Lundin D. Sharp drop in prices after the introduction of generic substitution: Swedish Pharmaceutical Benefits Board (LFN) for the World Health Organization Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policy's Information Network (PPRI). Solna. 2006. http://whocc.goeg.at/. Accessed June 22, 2017.
5. Chalasani N, Aljadhey H, Kesterson J, Murray MD, Hall SD. Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. Gastroenterology. 2004;126:1287-1292.
6. Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, La Grenade L, Gurwitz JH, Chan KA, Goodman MJ, Platt R. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA. 2004;292:2585-2590. doi: 10.1001/jama.292.21.2585.
7. Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, López-Jaramillo P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M, Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G, McKelvie R, Pogue J, Jung H, Gao P, Diaz R, Lonn E; HOPE-3 Investigators. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374:2021-2031. doi: 10.1056/NEJMoa1600176.
8. 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. 2002;106:3143-3421.
9. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(pt B):2889-2934. doi: 10.1016/j.jacc.2013.11.002.
10. Ioannidis JP. More than a billion people taking statins? Potential implications of the new cardiovascular guidelines. JAMA. 2014;311:463-464. doi: 10.1001/jama.2013.284657.
11. Egan BM, Li J, White K, Fleming DO, Connell K, Hernandez GT, Jones DW, Ferdinand KC, Sinopoli A. 2013 ACC/AHA cholesterol guideline and implications for Healthy People 2020 cardiovascular disease prevention goals. J Am Heart Assoc. 2016;5:e003558.
12. Fontana M, Asaria P, Moraldo M, Finegold J, Hassanally K, Manisty CH, Francis DP. Patient-accessible tool for shared decision making in cardiovascular primary prevention: balancing longevity benefits against medication disutility. Circulation. 2014;129:2539-2546.
13. Lazar LD, Pletcher MJ, Coxson PG, Bibbins-Domingo K, Goldman L. Cost-effectiveness of statin therapy for primary prevention in a lowcost statin era. Circulation. 2011;124:146-153. doi: 10.1161/CIRCULATIONAHA. 110.986349.
14. Ridker PM, Wilson PW. A trial-based approach to statin guidelines. JAMA. 2013;310:1123-1124. doi: 10.1001/jama.2013.276529.
15. Ray KK, Kastelein JJ, Boekholdt SM, Nicholls SJ, Khaw KT, Ballantyne CM, Catapano AL, Reiner I, Lüscher TF. The ACC/AHA 2013 guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: the good the bad and the uncertain: a comparison with ESC/EAS guidelines for the management of dyslipidaemias 2011. Eur Heart J. 2014;35:960-968. doi: 10.1093/eurheartj/ehu107.
16. Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund I, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D, European Association for Cardiovascular Prevention and Rehabilitation; ESC Committee for Practice Guidelines 2008-2010 and 2010-2012 Committees. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32:1769-1818.
17. Pandya A, Sy S, Cho S, Weinstein MC, Gaziano TA. Cost-effectiveness of 10-year risk thresholds for initiation of statin therapy for primary prevention of cardiovascular disease. JAMA. 2015;314:142-150. doi: 10.1001/jama.2015.6822.
18. Weinstein MC, Coxson PG, Williams LW, Pass TM, Stason WB, Goldman L. Forecasting coronary heart disease incidence, mortality, and cost: the Coronary Heart Disease Policy Model. Am J Public Health. 1987;77:1417-1426.
19. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey. Hyattsville, MD. 2012. http://www.cdc.gov/nchs/data/databriefs/db103.htm. Accessed June 22, 2017.
20. Framingham Heart Study-Cohort (FHS-Cohort) data request site. Biologic Specimen and Data Repository Information Coordinating Center: National Heart, Lung, and Blood Institute 2015. Available from http://biolincc. nhlbi.nih.gov/studies/framcohort/?q=framingham. Accessed June 22, 2017.
21. West of Scotland Coronary Prevention Study Group. Influence of pravastatin and plasma lipids on clinical events in the West of Scotland Coronary Prevention Study (WOSCOPS). Circulation. 1998;97:1440-1445.
22. Odden MC, Pletcher MJ, Coxson PG, Thekkethala D, Guzman D, Heller D, Goldman L, Bibbins-Domingo K. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Ann Intern Med. 2015;162:533-541. doi: 10.7326/M14-1430.
23. Pletcher MJ, Lazar L, Bibbins-Domingo K, Moran A, Rodondi N, Coxson P, Lightwood J, Williams L, Goldman L. Comparing impact and cost-effectiveness of primary prevention strategies for lipid-lowering. Ann Intern Med. 2009;150:243-254.
24. US Census Bureau. U.S. interim projections by Age, Sex, Race, and Hispanic Origin. Washington, DC. 2013. https://www.census.gov/programssurveys/popproj.html. Accessed June 22, 2017.
25. Center for Health Statistics. National Health Interview Survey, 2009-2011. ftp://ftp.cdc.gov/pub/Health-Statistics/NCHS/Datasets/NHIS/. Accessed June 22, 2017.
26. Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying cause of death 1999-2010, CDC WONDER online database. 2012. http://wonder.cdc.gov/ucd-icd10.html. Accessed June 22, 2017.
27. World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10). Geneva. 2010. http://www.who.int/classifications/icd/ICD10Volume2-en-2010.pdf?ua=1. Accessed June 22, 2017.
28. Centers for Disease Control and Prevention. National Hospital Discharge Survey. Hyattsville, MD. www.cdc.gov/nchs/about/major/hdasd/nhds.htm. Accessed June 22, 2017.
29. Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375:735-742. doi: 10.1016/S0140-6736(09)61965-6.
30. Centers for Medicare & Medicaid Services. National health expenditures by type of service and source of funds, CY 1960-2012. Baltimore. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trendsand- Reports/NationalHealthExpendData/NationalHealthAccountsHistorical. html. Accessed June 22, 2017.
31. California Office of Statewide Health Planning and Development. California patient discharge data, 2000: public version A-24 [CD-ROM]. Sacramento, CA; 2001.
32. California Office of Statewide Health Planning and Development. Hospital annual financial data: 1999-2000. https://www.oshpd.ca.gov/HID/Hospital-Financial.asp. Accessed August 18, 2017.
33. US Census Bureau. 1998 (118th Edition). https://www.census.gov/library/publications/1998/compendia/statab/118ed.html. Accessed August 18, 2017.
34. Bureau of Labor Statistics. Consumer Price Index. Washington, DC. 2008. http://data.bls.gov/cgi-bin/cpicalc.pl. Accessed June 22, 2017.
35. Institute for Health Metrics and Evaluation. Global Burden of Disease Study 2010 disability weights. http://ghdx.healthdata.org/record/globalburden- disease-study-2010-gbd-2010-disability-weights. Accessed June 22, 2017.
36. Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; 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. 2005;366:1267-1278. doi: 10.1016/S0140-6736(05)67394-1.
37. Kendrach MG, Kelly-Freeman M. Approximate equivalent rosuvastatin doses for temporary statin interchange programs. Ann Pharmacother. 2004;38:1286-1292. doi: 10.1345/aph.1D391.
38. Walmart formulary. http://i.walmart.com/i/if/hmp/fusion/genericdruglist. pdf. Accessed June 22, 2017.
39. Target formulary. https://tgtfiles.target.com/pharmacy/WCMP02-032536-RxGenericsList-NM10.pdf. Accessed June 22, 2017.
40. US Department of Veterans Affairs. Pharmacy benefits management services. http://www.pbm.va.gov/PBM/PharmaceuticalPrices.asp. Accessed June 22, 2017.
41. Consumer Reports Health: Best Buy Drugs. Evaluating Statin Drugs to Treat High Cholesterol and Heart Disease: Comparing Effectiveness, Safety, and Price. Consumer Reports. April 2012. http://consumerhealthchoices. org/wp-content/uploads/2012/08/BBD-Statins-Full.pdf. Accessed June 22, 2017.
42. Consumer Reports Health: Best Buy Drugs. Statin Drugs to Treat High Cholesterol and Heart Disease: Comparing Effectiveness, Safety, and Price. Consumer Reports. March 2014. http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/StatinsUpdate-FINAL.pdf. Accessed June 22, 2017.
43. Center for Medicare and Medicaid Services Fee Schedule Search. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FeeSchedule- GenInfo/index.html. Accessed June 26, 2017.
44. Center for Medicare and Medicaid Services Physician fee schedule search. https://www.cms.gov/apps/physician-fee-schedule/overview.aspx. Accessed June 26, 2017.
45. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care. 2013;36:1033-1046.
46. Costco formulary. https://www.costco.com/pharmacy/drug-results-detailsprice? storeId=10301&catalogId=10701&langId=-1&drugId=672&drugName=Atorvastatin&searchAlphabet=A&isPharmacy=true&encodedDrugNa me=Atorvastatin&drugSearch=alphaDrugSearch. Accessed June 22, 2017.
47. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Diabetes Information Clearinghouse. Diabetic neuropathies: the nerve damage of diabetes. http://diabetes.niddk.nih.gov/dm/pubs/neuropathies/. Accessed June 22, 2017.
48. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Diabetes Information Clearinghouse. Prevent diabetes problems: keep your keep healthy. http://diabetes.niddk.nih.gov/dm/pubs/complications- feet/. Accessed June 22, 2017.
49. Pletcher MJ, Tice JA, Pignone M, Browner WS. Using the coronary artery calcium score to predict coronary heart disease events: a systematic review and meta-analysis. Arch Intern Med. 2004;164:1285-1292. doi: 10.1001/archinte.164.12.1285.
50. Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, Ward K, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;1:Cd004816.
51. US Food and Drug Administration. Consumer update. January 2014. http://www.consumermedsafety.org/latest-fda-medication-alerts/specialalerts/item/532-fda-expands-advice-on-statin-risks. Accessed June 26, 2017.
52. Goff DC, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129:S49-S73.
53. Kazmin A, Garcia-Bournissen F, Koren G. Risks of statin use during pregnancy: a systematic review. J Obstet Gynaecol Can. 2007;29:906-908.
54. Savarese G, Gotto AM Jr, Paolillo S, D'Amore C, Losco T, Musella F, Scala O, Marciano C, Ruggiero D, Marsico F, De Luca G, Trimarco B, Perrone- Filardi P. Benefits of statins in elderly subjects without established cardiovascular disease: a meta-analysis. J Am Coll Cardiol. 2013;62:2090-2099. doi: 10.1016/j.jacc.2013.07.069.
55. Stone NJ. Preventing atherosclerotic cardiovascular disease using American College of Cardiology and American Heart Association prevention guidelines: some good news, but caveats remain. J Am Heart Assoc. 2016;5:e004197.
56. Framingham Heart Study. https://www.framinghamheartstudy.org/risk-functions/cardiovascular-disease/10-year-risk.php. Accessed June 22, 2017.
57. Strandberg TE, Tarkkanen A. Cataracts and statin use: cause and effect not confirmed. JAMA Ophthalmol. 2014;132:365. doi: 10.1001/jamaophthalmol. 2014.23.
58. Kostis JB, Dobrzynski JM. Prevention of cataracts by statins: a meta- analysis. J Cardiovasc Pharmacol Ther. 2014;19:191-200. doi: 10.1177/1074248413511690.