Journal of Clinical Epidemiology
Volume 59, Issue 8 , Pages 819-828 , August 2006

Selective prescribing led to overestimation of the benefits of lipid-lowering drugs

,Accepted 12 December 2005.

References 

  1. LaRosa JC, Jiang MD, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA. 1999;282:2340–2346
  2. Pignone M, Phillips C, Mulrow C. Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials. BMJ. 2000;321:1–5
  3. Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, et al. Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001;285:1711–1718
  4. 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
  5. Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, et al. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002;360:1623–1630
  6. Hernandez-Perera O, Perez-Sala D, Navarro-Antolin J, Sanchez-Pascuala R, Hernandez G, Diaz C, et al. Effects of the 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors, atorvastatin and simvastatin, on the expression of endothelin-1 and entothelial nitric oxide synthase in vascular endothelial cells. J Clin Invest. 1998;101:11–19
  7. Huhle G, Abletshauser C, Mayer N, Weidinger G, Harenberg J, Heene DL. Reduction of platelet activity markers in type II hypercholesterolemic patients by a HMG-CoA-reductase inhibitor. Thromb Res. 1999;95:229–234
  8. Albert MA, Danielson E, Rifai N, Ridker PM. Effect of statin therapy on C-reactive protein levels: the pravastatin inflammation/CRP evaluation (PRINCE): a randomized trial and cohort study. JAMA. 2001;286:64–70
  9. Ray JG, Mamdani M, Tsuyuki RT, Anderson DR, Yeo EL, Laupacis A. Use of statins and the subsequent development of deep vein thrombosis. Arch Intern Med. 2001;161:1405–1410
  10. Herrington DM, Vittinghoff E, Lin F, Fong J, Harris F, Hunninghake D, et al. Statin therapy, cardiovascular events, and total mortality in the Heart and Estrogen/Progestin Replacement Study (HERS). Circulation. 2002;105:2962–2967
  11. Hall NF, Gale CR, Syddall H, Phillips DI, Martyn CN. Risk of macular degeneration in users of statins: cross sectional study. BMJ. 2001;323:375–376
  12. Wang PS, Solomon DH, Mogun H, Avorn J. HMG-CoA reductase inhibitors and the risk of hip fractures in elderly patients. JAMA. 2000;283:3211–3216
  13. Meier CR, Schlienger RG, Kraenzlin ME, Schlegel B, Jick H. HMG-CoA reductase inhibitors and the risk of fractures. JAMA. 2000;283:3205–3210
  14. Donahue JG, Chan KA, Andrade SE, Beck A, Boles M, Buist DS, et al. Inhibitors of hydroxymethylglutaryl-coenzyme A reductase and risk of fracture among older women. Lancet. 2000;355:2185–2188
  15. Jick H, Zornberg GL, Jick SS, Seshadri S, Drachman DA. Statins and the risk of dementia. Lancet. 2000;356:1627–1631
  16. Wolozin B, Kellman W, Ruosseau P, Celesia GG, Siegel G. Decreased prevalence of Alzheimer's disease associated with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. Arch Neurol. 2000;57:1439–1443
  17. McDermott MM, Guralnik JM, Greenland P, Pearce WH, Criqui MH, Liu K, et al. Statin use and leg functioning in patients with and without lower-extremity peripheral arterial disease. Circulation. 2003;107:757–761
  18. Stenestrand U, Wallentin L for the Swedish Register of Cardiac Intensive Care (RIKS-HIA). Early statin treatment following acute myocardial infarction and 1-year survival. JAMA. 2001;285:430–436
  19. Horne BD, Muhlestein JB, Carlquist JF, Bair TL, Madsen TE, Hart NI, et al. Statin therapy, lipid levels, C-reactive protein and the survival of patients with angiographically severe coronary artery disease. J Am Coll Cardiol. 2000;36:1774–1780
  20. Aronow HD, Topol EJ, Roe MT, Houghtaling PL, Wolski KE, Lincoff AM, et al. Effect of lipid-lowering therapy on early mortality after acute coronary syndromes: an observational study. Lancet. 2001;357:1063–1068
  21. Seliger SL, Weiss NS, Gillen DL, Kestenbaum B, Ball A, Sherrard DJ, et al. HMG-CoA reductase inhibitors are associated with reduced mortality in ESRD patients. Kidney Int. 2002;61:297–304
  22. Chan AW, Bhatt DL, Chew DP, Quinn MJ, Moliterno DJ, Topol EJ, et al. Early sustained survival benefit associated with statin therapy at the time of percutaneous coronary intervention. Circulation. 2002;105:691–696
  23. Reid IR, Hague W, Emberson J, Baker J, Tonkin A, Hunt D, et al. Effect of pravastatin on frequency of fracture in the LIPID study: secondary analysis of a randomised controlled trial. Long-term Intervention with Pravastatin in Ischaemic Disease. Lancet. 2001;357:509–512
  24. Ray WA, Daugherty JR, Griffin MR. Lipid-lowering agents and the risk of hip fracture in a Medicaid population. Inj Prev. 2002;8:276–279
  25. LaCroix AZ, Cauley JA, Pettinger M, Hsia J, Bauer DC, McGowan J, et al. Statin use, clinical fracture, and bone density in postmenopausal women: results from the Women's Health Initiative observational study. Ann Intern Med. 2003;139:97–104
  26. Yang CC, Jick SSS, Jick H. Statins and risk of idiopathic venous thromboembolism. Br J Clin Pharmacol. 2002;53:101–105
  27. Glynn RJ, Knight EL, Levin R, Avorn J. Paradoxical relations of drug treatment with mortality in older persons. Epidemiology. 2001;12:682–689
  28. Newby LK, Kristinsson A, Bhapkar MV, Aylward PE, Dimas AP, Klein WW, et al. Sibrafiban vs Aspirin to Yield Maximun Protection From Ischemic Heart Events Post-acute Coronary Syndromes. Early statin initiation and outcomes in patients with acute coronary syndromes. JAMA. 2002;287:3087–3095
  29. 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;288:455–461
  30. Redelmeier DA, Tan SH, Booth GL. The treatment of unrelated disorders in patients with chronic medical diseases. N Engl J Med. 1998;338:1516–1520
  31. Glynn RJ, Monane M, Gurwitz JH, Choodnovskiy I, Avorn J. Agreement between drug treatment data and a discharge diagnosis of diabetes mellitus in the elderly. Am J Epidemiol. 1999;149:541–549
  32. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol. 2003;158:915–920
  33. Glynn RJ, Buring JE, Manson JE, LaMotte F, Hennekens CH. Adherence to aspirin in the prevention of myocardial infarction; The Physicians' Health Study. Arch Intern Med. 1994;154:2649–2657
  34. Yuan Z, Cooper GS, Einstadter D, Cebul RD, Rimm AA. The association between hospital type and mortality and length of stay. Med Care. 2000;38:231–245
  35. The Hearst Corporation . National Drug Data File (NDDF) user manual. San Bruno, CA: The Hearst Corporation; 1988;74–84
  36. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis. 1987;40:373–383
  37. Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol. 1993;46:1075–1079
  38. Schneeweiss S, Seeger JD, Maclure M, Wang PS, Avorn J, Glynn RJ. Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data. Am J Epidemiol. 2001;154:854–864
  39. Schneeweiss S, Wang PS, Avorn J, Glynn RJ. Improved comorbidity adjustment for predicting mortality in Medicare populations. Health Serv Res. 2003;38:1103–1120
  40. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36:8–27
  41. Hosmer DW, Lemeshow S. Applied logistic regression. 2nd ed.. New York: John Wiley and Sons; 2000;160–4
  42. D'Agostino RB, Grundy S, Sullivan LM, Wilson P. Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA. 2001;286:180–187
  43. Maldonado G, Greenland S. Simulation study of confounder-selection strategies. Am J Epidemiol. 1993;138:923–936
  44. Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med. 1997;127:757–763
  45. Parsons LS. Reducing bias in a propensity score matched-pair sample using greedy matching techniques. In: SUGI 26: Proceedings of the Annual SAS Users Group International Conference, 26th. April 22–25, 2001, Long Beach, California. Cary, NC: SAS Institute; 2001 [Available at: http://www2.sas.com/proceedings/sugi26/p214-26.pdf].
  46. Rosenbaum PR. Sensitivity analysis for certain permutation inferences in matched observational studies. Biometrika. 1987;74:13–26
  47. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group . Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002;288:2998–3007
  48. Ko DT, Mamdani M, Alter DA. Lipid-lowering therapy with statins in high-risk elderly patients: the treatment-risk paradox. JAMA. 2004;291:1864–1870
  49. Levinsky NG, Yu W, Ash A, Moskowitz M, Gazelle G, Saynina O, et al. Influence of age on Medicare expenditures and medical care in the last year of life. JAMA. 2001;286:1349–1355
  50. Walker AM, Stampfer MJ. Observational studies of drug safety. [Editorial] Lancet. 1996;348:489
  51. Rosenbaum PR. Rare outcomes, common treatments: analytic strategies using propensity scores. Ann Intern Med. 2002;137:693–695

PII: S0895-4356(06)00047-3

doi: 10.1016/j.jclinepi.2005.12.012

Journal of Clinical Epidemiology
Volume 59, Issue 8 , Pages 819-828 , August 2006