Comparative effectiveness of generic and brand-name statins on patient outcomes: A cohort study

Annals of Internal Medicine

Volumn 161, Issue 6, 2014, Pages 400-407

  Gagne, Joshua J ^a   Choudhry, Niteesh K ^a   Kesselheim, Aaron S ^a   Polinski, Jennifer M ^a   Hutchins, David ^b   Matlin, Olga S ^b   Brennan, Troyen A ^b   Avorn, Jerry ^a   Shrank, William H ^b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b CVS Caremark   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; MEVINOLIN; PRAVASTATIN; SIMVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ACUTE CORONARY SYNDROME; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; FEMALE; FOLLOW UP; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICARE; MEDICATION COMPLIANCE; MORTALITY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRESCRIPTION; CARDIOVASCULAR DISEASE; COMPARATIVE STUDY; ECONOMICS; FEE; PROPENSITY SCORE; UNITED STATES;

AGED; CARDIOVASCULAR DISEASES; COHORT STUDIES; DRUGS, GENERIC; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MEDICARE; MEDICATION ADHERENCE; PRESCRIPTION FEES; PROPENSITY SCORE; UNITED STATES;

EID: 84907218121     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M13-2942     Document Type: Article

References (43)

1. IMS Institute for Healthcare Informatics. The Use of Medicines in the United States: Review of 2010. Parsippany, NJ: IMS Institute for Healthcare Informatics; 2011. Accessed at www.imshealth.com/deployedfiles/imshealth/Global/Content/IMSInstitute/StaticFile/IHII-UseOfMed-report.pdf on 1 May 2014.
2. 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. [PMID: 12829554]
3. Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, et al; Cholesterol Treatment Trialists' (CTT) Collaborators. 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: 581-90. [PMID: 22607822] doi:10.1016/S0140-6736(12)60367-5
4. Thavendiranathan P, Bagai A, Brookhart MA, Choudhry NK. Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006; 166:2307-13. [PMID: 17130382]
5. Shroufi A, Powles JW. Adherence and chemoprevention in major cardiovascular disease: a simulation study of the benefits of additional use of statins. J Epidemiol Community Health. 2010; 64:109-13. [PMID: 20056964] doi:10.1136/jech.2009.091033
6. Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002; 288:455-61. [PMID: 12132975]
7. Chan DC, Shrank WH, Cutler D, Jan S, Fischer MA, Liu J, et al. Patient, physician, and payment predictors of statin adherence. Med Care. 2010; 48:196-202. [PMID: 19890219] doi:10.1097/MLR.0b013e3181c132ad
8. Avorn J, Monette J, Lacour A, Bohn RL, Monane M, Mogun H, et al. Persistence of use of lipid-lowering medications: a cross-national study. JAMA. 1998; 279:1458-62. [PMID: 9600480]
9. Choudhry NK, Winkelmayer WC. Medication adherence after myocardial infarction: a long way left to go [Editorial]. J Gen Intern Med. 2008; 23:216-8. [PMID: 18183470] doi:10.1007/s11606-007-0478-8
10. Desai NR, Choudhry NK. Impediments to adherence to post myocardial infarction medications. Curr Cardiol Rep. 2013; 15:322. [PMID: 23250659] doi:10.1007/s11886-012-0322-6
11. Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, et al; Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 2011; 365:2088-97. [PMID: 22080794] doi:10.1056/NEJMsa1107913
12. Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K, DeLapp D, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006; 166:332-7. [PMID: 16476874]
13. Choudhry NK, Fischer MA, Avorn JL, Lee JL, Schneeweiss S, Solomon DH, et al. The impact of reducing cardiovascular medication copayments on health spending and resource utilization. J Am Coll Cardiol. 2012; 60:1817-24. [PMID: 23040581] doi:10.1016/j.jacc.2012.06.050
14. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008; 300:2514-26. [PMID: 19050195] doi:10.1001/jama.2008.758
15. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, et al. Seizure outcomes following the use of generic versus brand-name antiepi-leptic drugs: a systematic review and meta-analysis. Drugs. 2010; 70:605-21. [PMID: 20329806] doi:10.2165/10898530-000000000-00000
16. Green JB, Ross JS, Jackevicius CA, Shah ND, Krumholz HM. When choosing statin therapy: the case for generics. JAMA Intern Med. 2013; 173:229-32. [PMID: 23303273] doi:10.1001/jamainternmed.2013.1529
17. U.S. Food and Drug Administration. National Drug Code Directory. Silver Spring, MD: U.S. Food and Drug Administration; 2014. Accessed at www.accessdata.fda.gov/scripts/cder/ndc/default.cfmon 1 May 2014.
18. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.accessdata.fda.gov/scripts/Cder/ob/default.cfm on 1 May 2014.
19. Choudhry NK, Shrank WH, Levin RL, Lee JL, Jan SA, Brookhart MA, et al. Measuring concurrent adherence to multiple related medications. Am J Manag Care. 2009; 15:457-64. [PMID: 19589013]
20. Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio CC, Avorn J, Solomon DH. Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J. 2004; 148:99-104. [PMID: 15215798]
21. Tirschwell DL, Longstreth WT Jr. Validating administrative data in stroke research. Stroke. 2002; 33:2465-70. [PMID: 12364739]
22. Varas-Lorenzo C, Castellsague J, Stang MR, Tomas L, Aguado J, Perez-Gutthann S. Positive predictive value of ICD-9 codes 410 and 411 in the identification of cases of acute coronary syndromes in the Saskatchewan Hospital automated database. Pharmacoepidemiol Drug Saf. 2008; 17:842-52. [PMID: 18498081] doi:10.1002/pds.1619
23. Gagne JJ, Glynn RJ, Avorn J, Levin R, Schneeweiss S. A combined comor-bidity score predicted mortality in elderly patients better than existing scores. J Clin Epidemiol. 2011; 64:749-59. [PMID: 21208778] doi:10.1016/j.jclinepi.2010.10.004
24. Brookhart MA, Patrick AR, Dormuth C, Avorn J, Shrank W, Cadarette SM, et al. Adherence to lipid-lowering therapy and the use of preventive health services: an investigation of the healthy user effect. Am J Epidemiol. 2007; 166: 348-54. [PMID: 17504779]
25. Shrank WH, Patrick AR, Brookhart MA. Healthy user and related biases in observational studies of preventive interventions: a primer for physicians. J Gen Intern Med. 2011; 26:546-50. [PMID: 21203857] doi:10.1007/s11606-010-1609-1
26. Glynn RJ, Knight EL, Levin R, Avorn J. Paradoxical relations of drug treatment with mortality in older persons. Epidemiology. 2001; 12:682-9. [PMID: 11679797]
27. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983; 70:41-55.
28. Stürmer T, Rothman KJ, Avorn J, Glynn RJ. Treatment effects in the presence of unmeasured confounding: dealing with observations in the tails of the propensity score distribution-a simulation study. Am J Epidemiol. 2010; 172: 843-54. [PMID: 20716704] doi:10.1093/aje/kwq198
29. Claxton G, Rae M, Panchal N, Damico A, Lundy J, Bostick N, et al. Employer Health Benefits 2012 Annual Survey. Menlo Park, CA: Henry J. Kaiser Family Foundation; 2012. Accessed at http://kff.org/private-insurance/report/employer-health-benefits-2012-annual-survey on 1 May 2014.
30. Taira DA, Wong KS, Frech-Tamas F, Chung RS. Copayment level and compliance with antihypertensive medication: analysis and policy implications for managed care. Am J Manag Care. 2006; 12:678-83. [PMID: 17090224]
31. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007; 298:61-9. [PMID: 17609491]
32. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, 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. 1996; 335:1001-9. [PMID: 8801446]
33. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998; 339:1349-57. [PMID: 9841303]
34. Federman AD, Halm EA, Siu AL. Use of generic cardiovascular medications by elderly Medicare beneficiaries receiving generalist or cardiologist care. Med Care. 2007; 45:109-15. [PMID: 17224772]
35. Federman AD, Halm EA, Zhu C, Hochman T, Siu AL. Association of income and prescription drug coverage with generic medication use among older adults with hypertension. Am J Manag Care. 2006; 12:611-8. [PMID: 17026415]
36. Shrank WH, Stedman M, Ettner SL, DeLapp D, Dirstine J, Brookhart MA, et al. Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use. J Gen Intern Med. 2007; 22:1298-304. [PMID: 17647066]
37. Lipsitch M, Tchetgen Tchetgen E, Cohen T. Negative controls: a tool for detecting confounding and bias in observational studies. Epidemiology. 2010; 21: 383-8. [PMID: 20335814] doi:10.1097/EDE.0b013e3181d61eeb
38. Boudreau DM, Yu O, Johnson J. Statin use and cancer risk: a comprehensive review. Expert Opin Drug Saf. 2010; 9:603-21. [PMID: 20377474] doi:10.1517/14740331003662620
39. Dale KM, Coleman CI, Henyan NN, Kluger J, White CM. Statins and cancer risk: a meta-analysis. JAMA. 2006; 295:74-80. [PMID: 16391219]
40. Setoguchi S, Glynn RJ, Avorn J, Mogun H, Schneeweiss S. Statins and the risk of lung, breast, and colorectal cancer in the elderly. Circulation. 2007; 115: 27-33. [PMID: 17179016]
41. Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ. 2010; 340:c2197. [PMID: 20488911] doi:10.1136/bmj.c2197
42. Shrank WH, Liberman JN, Fischer MA, Avorn J, Kilabuk E, Chang A, et al. The consequences of requesting "dispense as written". Am J Med. 2011; 124:309-17. [PMID: 21435421] doi:10.1016/j.amjmed.2010.11.020
43. Gagne JJ, Choudhry NK. How many "me-too" drugs is too many? JAMA. 2011; 305:711-2. [PMID: 21325189] doi:10.1001/jama.2011.152