Are generic and brand-name statins clinically equivalent? Evidence from a real data-base

European Journal of Internal Medicine

Volumn 25, Issue 8, 2014, Pages 745-750

  Corrao, Giovanni ^a   Soranna, Davide ^a,b   Arfè, Andrea ^a   Casula, Manuela ^c   Tragni, Elena ^c   Merlino, Luca ^d   Mancia, Giuseppe ^a,b   Catapano, Alberico L ^c,e  

^a UNIVERSITY OF MILANO BICOCCA   (Italy)

^b ISTITUTO AUXOLOGICO ITALIANO   (Italy)

^c UNIVERSITY OF MILAN   (Italy)

^d Regione Lombardia   (Italy)

^e IRCCS MULTIMEDICA   (Italy)

Author keywords

Brand name; Cardiovascular events; Databases; Discontinuation; Generic; Statins

Indexed keywords

GENERIC DRUG; SIMVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DATA BASE; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HAZARD RATIO; HEART FAILURE; HOSPITALIZATION; HUMAN; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MONTE CARLO METHOD; AGED; CARDIOVASCULAR DISEASES; MIDDLE AGED; STATISTICS AND NUMERICAL DATA; THERAPEUTIC EQUIVALENCE;

AGED; CARDIOVASCULAR DISEASES; FEMALE; HOSPITALIZATION; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; SIMVASTATIN; THERAPEUTIC EQUIVALENCY;

EID: 84908119817     PISSN: 09536205     EISSN: 18790828     Source Type: Journal    
DOI: 10.1016/j.ejim.2014.08.002     Document Type: Article

References (37)

1. P. McManus, D.J. Birkett, J. Dudley, and A. Stevens Impact of the minimum pricing policy and introduction of brand (generic) substitution into the pharmaceutical benefits scheme in Australia Pharmacoepidemiol Drug Saf 10 2001 295 300
2. J.S. Haas, K.A. Phillips, E.P. Gerstenberger, and A.C. Seger Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997-2000 Ann Intern Med 142 2005 891 897
3. S. Simoens Trends in generic prescribing and dispensing in Europe Expert Rev Clin Pharmacol 1 2008 497 503
4. H. Håkonsen, A.M. Horn, and E.L. Toverud Price control as a strategy for pharmaceutical cost containment - what has been achieved in Norway in the period 1994-2004? Health Policy 90 2009 277 285
5. W. Shrank, E. Cox, M.A. Fischer, J. Mehta, and N.K. Choudhry Patient perceptions of generic medications Health Aff (Millwood) 28 2009 546 556
6. B.F. Banahan, J.K. Bonnarens, and J.P. Bentley Generic substitution of NTI drugs Formulary 33 1998 1082 1096
7. C. Gaither, D. Kirking, F. Ascione, and L. Welage Consumers' views on generic medications J Am Pharm Assoc 41 2001 729 736
8. M.G. Duerden, and D.A. Hughes Generic and therapeutic substitutions in the UK: are they a good thing? Br J Clin Pharmacol 70 2010 335 341
9. Committee for Proprietary Medicinal Products. Notes for Guidance on the Investigation of Bioavailability and Bioequivalence 2001 European Medicines Evaluation Agency London
10. W. Himmel, A. Simmenroth-Nayda, W. Neibling, T. Ledig, R.D. Jansen, and M.M. Kochen What do primary care patients think about generic drugs? Int J Clin Pharmacol Ther 43 2005 472 479
11. C.W. Tseng, R.H. Brook, E. Keeler, W.N. Steers, B.E. Waitzfelder, and C.M. Mangione Effect of generic only drug benefits on seniors' medication use and financial burden Am J Manag Care 12 2006 525 532
12. J. Christian-Herman, M. Emons, and D. George Effects of generic-only drug coverage in a Medicare HMO Health Aff (Millwood) 2004 [(Suppl Web Exclusives):W4-455-468]
13. W.H. Shrank, T. Hoang, S.L. Ettner, P.A. Glassman, K. Nair, and D. DeLapp The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions Arch Intern Med 166 2006 332 337
14. B.A. Briesacher, S.E. Andrade, H. Fouayzi, and K.A. Chan Medication adherence and the use of generic drug therapies Am J Manag Care 15 2009 450 456
15. A.S. Kesselheim, A.S. Misono, J.L. Lee, M.R. Stedman, M.A. Brookhart, and N.K. Choudhry Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis JAMA 300 2008 2514 2526
16. B.L. Carter Equivalence of generic and brand-name drugs for cardiovascular disease JAMA 301 2009 1654
17. G. Corrao, G. Cesana, and L. Merlino Pharmacoepidemiological research and the linking of electronic healthcare databases available in the Italian region of Lombardy Biomed Stat Clin Epidemiol 2 2008 111 125
18. W.A. Ray Evaluating medication effects outside of clinical trials: new-user designs Am J Epidemiol 158 2003 915 920
19. H. Tunstall-Pedoe, K. Kuulasmaa, P. Amouyel, D. Arveiler, A.M. Rajakangas, and A. Pajak Myocardial infarction and coronary deaths in the World Health Organization MONICA Project: registration procedures, event rates, and case-fatality rates in 38 populations from 21 countries in four continents Circulation 90 1994 583 612
20. K. Asplund, R. Bonita, K. Kuulasmaa, A.M. Rajakangas, H. Schaedlich, and K. Suzuki Multinational comparisons of stroke epidemiology: evaluation of case ascertainment in the WHO MONICA stroke study Stroke 26 1995 355 360
21. A. Helin-Salmivaara, P. Lavikainen, M.J. Korhonen, H. Halava, S.Y. Junnila, and R. Kettunen Long-term persistence with statin therapy: a nationwide register study in Finland Clin Ther 30 2008 2228 2240
22. J.N. Rasmussen, A. Chong, and D.A. Alter Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction JAMA 297 2007 177 186
23. M.E. Charlson, R.E. Charlson, J.C. Peterson, S.S. Marinopoulos, W.M. Briggs, and J.P. Hollenberg The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients J Clin Epidemiol 61 2008 1234 1240
24. B.J. Arsenault, S.M. Boekholdt, and J.J. Kastelein Lipid parameters for measuring risk of cardiovascular disease Nat Rev Cardiol 8 2011 197 206
25. S. Greenland Sensitivity analysis, Monte-Carlo risk analysis and Bayesian uncertainty assessment Risk Anal 21 2001 579 583
26. S.M. Boekholdt, B.J. Arsenault, S. Mora, T.R. Pedersen, J.C. LaRosa, and P.J. Nestel Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis JAMA 307 2012 1302 1309
27. G. Corrao, F. Nicotra, A. Parodi, A. Zambon, D. Soranna, and F. Heiman External adjustment for unmeasured confounders improved drug-outcome association estimates based on health care utilization data J Clin Epidemiol 65 2012 1190 1199
28. Helin-Salmivaara, M.J. Korhonen, T. Alanen, and R. Huupponen Impact of out-of-pocket expenses on discontinuation of statin therapy: a cohort study in Finland J Clin Pharm Ther 37 2012 58 64
29. M.R. DiMatteo, P.J. Giordani, H.S. Lepper, and T.W. Croghan Patient adherence and medical treatment outcomes: a meta-analysis Med Care 40 2002 794 811
30. G. Corrao, V. Conti, L. Merlino, A.L. Catapano, and G. Mancia Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy Clin Ther 32 2010 300 310
31. G. Corrao, B. Ibrahim, F. Nicotra, A. Zambon, L. Merlino, and T.S. Pasini Long-term use of statins reduces the risk of hospitalization for dementia Atherosclerosis 230 2013 171 176
32. A.R. Rahalkar, M.R. Ban, and R.A. Hegele Clinical equivalence of proprietary and generic atorvastatin in lipid clinic patients Can J Cardiol 29 2013 418 422
33. B.L. Strom Overview of automated databases in pharmacoepidemiology B.L. Strom, Pharmacoepidemiology 3rd ed. 2000 John Wiley & Sons New York 219 222
34. G. Corrao, A. Parodi, A. Zambon, F. Heiman, A. Filippi, and C. Cricelli Reduced discontinuation of antihypertensive treatment by two-drug combination as first step. Evidence from daily life practice J Hypertens 28 2010 1584 1590
35. G. Corrao, A. Zambon, F. Nicotra, C. Fornari, C. La Vecchia, and M. Mezzanzanica Persistence with oral and transdermal hormone replacement therapy and hospitalisation for cardiovascular outcomes Maturitas 57 2007 315 324
36. J.C. LaRosa, J. He, and S. Vupputuri Effect of statins on risk of coronary disease. A meta-analysis of randomized controlled trials JAMA 282 1999 2340 2346
37. J.J. Brugts, T. Yetgin, S.E. Hoeks, A.M. Gatto, J. Shepherd, and R.G. Westendrop The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomized controlled trials Br Med J 338 2009 b2376