Forbidden fruit: On the analysis of recurrent events in randomized clinical trials

American Journal of Cardiology

Volumn 111, Issue 10, 2013, Pages 1530-1536

  Diamond, George A ^a,b   Kaul, Sanjay ^a,b  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; CLOPIDOGREL; PRASUGREL; PRAVASTATIN;

ACUTE CORONARY SYNDROME; BLEEDING; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; DIABETES MELLITUS; FOLLOW UP; HEART INFARCTION; HUMAN; KINETICS; OUTCOME ASSESSMENT; PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; REVIEW;

EID: 84876991534     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2013.01.310     Document Type: Editorial

References (36)

1. S.A. Murphy, C.P. Cannon, S.D. Wiviott, C.H. McCabe, and E. Braunwald Reduction in recurrent cardiovascular events with intensive lipid-lowering statin therapy compared with moderate lipid-lowering statin therapy after acute coronary syndromes from the PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22) trial J Am Coll Cardiol 54 2009 2358 2362
2. J.C. LaRosa, P.C. Deedwania, J. Shepherd, N.K. Wenger, H. Greten, D.A. DeMicco, A. Breazna TNT Investigators Comparison of 80 versus 10 mg of atorvastatin on occurrence of cardiovascular events after the first event (from the Treating to New Targets [TNT] trial) Am J Cardiol 105 2010 283 287
3. M.J. Tikkanen, M. Szarek, R. Fayyad, I. Holme, N.B. Cater, O. Faergeman, J.J. Kastelein, A.G. Olsson, M.L. Larsen, C. Lindahl, T.R. Pedersen IDEAL Investigators Total cardiovascular disease burden: comparing intensive with moderate statin therapy insights from the IDEAL (Incremental Decrease in End Points through Aggressive Lipid Lowering) trial J Am Coll Cardiol 54 2009 2353 2357
4. S.A. Murphy, E.M. Antman, S.D. Wiviott, G. Weerakkody, G. Morocutti, K. Huber, J. Lopez-Sendon, C.H. McCabe, E. Braunwald TRITON-TIMI 38 Investigators Reduction in recurrent cardiovascular events with prasugrel compared with clopidogrel in patients with acute coronary syndromes from the TRITON-TIMI 38 trial Eur Heart J 29 2008 2473 2479
5. P. Kohli, L. Wallentin, E. Reyes, J. Horrow, S. Husted, R. Storey, S. James, and C.P. Cannon Reduction in first and recurrent cardiovascular and ischemic events with ticagrelor compared with clopidogrel in the PLATO study J Am Coll Card 39 Suppl 2012 E504
6. R.L. Prentice, B.J. Williams, and A.V. Peterson On the regression analysis of multivariate failure time data Biometrika 68 1981 373 389
7. P.K. Andersen, and R.D. Gill Cox's regression model for counting processes: a large sample study Ann Stat 10 1982 1100 1120
8. L. Wei, D. Lin, and L. Weissfeld Regression analysis of multivariate incomplete failure time data by modeling marginal distributions J Am Stat Assoc 84 1989 1065 1073
9. Q.H. Li, and S.W. Lagakos Use of the Wei-Lin-Weissfeld method for the analysis of a recurring and terminating event Stat Med 16 1997 925 940
10. R.J. Cook, and J.F. Lawless Marginal analysis of recurrent events and a terminating event Stat Med 16 1997 911 924
11. D.Y. Lin, L.J. Wei, I. Yang, and Z. Ying Semiparametric regression for the mean and rate functions of recurrent events J R Stat Soc Series B Stat Methodol 62 2000 711 730
12. D. Ghosh, and D.Y. Lin Nonparametric analysis of recurrent events and death Biometrics 56 2000 554 562
13. L. Liu, R.A. Wolfe, and X. Huang Shared frailty models for recurrent events and terminal event Biometrics 60 2004 747 756
14. D. Zeng, and D.Y. Lin Semiparametric transformation models with random effects for joint analysis of recurrent and terminal events Biometrics 65 2009 746 752
15. R.J. Cook, and J.F. Lawless The Statistical Analysis of Recurrent Events 2007 Springer New York
16. O.O. Aalen, Ø. Borgan, and H.K. Gjessing Survival and Event History Analysis 2010 Springer New York
17. G.A. Diamond, and S. Kaul From here to eternity: a unified kinetic model for the pathophysiology of atherosclerotic events Am J Med 120 2007 5 11
18. R.A. Alberty, and W.G. Miller Integrated rate equations for isotopic exchange in simple reversible reactions J Chem Phys 26 1957 1231 1237
19. K.G. Guarevich Formal kinetics of H1N1 epidemic Theor Biol Med Modeling 6 2009 23
20. Wachsstock D. Tenua: The Kinetics Simulator for Java. Available at http://www.bililite.com/tenua/. Accessed July 27, 2012.
21. M.J. Kahley, and M. Novak A practical procedure for determining rate constants in consecutive first-order systems J Chem Educ 73 1996 359 373
22. Y. Zhou, and X. Zhuang Robust reconstruction of the rate constant distribution using the phase function method Biophys J 91 2006 4045 4053
23. A.H. Coles, K.A. Fisher, C. Darling, D. McManus, O. Maitas, J. Yarzebski, J.M. Gore, D. Lessard, and R.J. Goldberg Recent trends in post-discharge mortality among patients with an initial acute myocardial infarction Am J Cardiol 110 2012 1073 1077
24. M.T. Roe, P.W. Armstrong, K.A.A. Fox, H.D. White, D. Prabhakaran, S.G. Goodman, J.H. Cornel, D.L. Bhatt, P. Clemmensen, F. Martinez, D. Ardissino, J.C. Nicolau, W.E. Boden, P.A. Gurbel, W. Ruzyllo, A.J. Dalby, D.K. McGuire, J.L. Leiva-Pons, A. Parkhomenko, S. Gottlieb, G.O. Topacio, C. Hamm, G. Pavlides, A.R. Goudev, A. Oto, C.D. Tseng, B. Merkely, V. Gasparovic, R. Corbalan, M. Cintezǎ, C. McLendon, K.G. Winters, E.B. Brown, Y. Lokhnygina, P.E. Aylward, K. Huber, J.S. Hochman, E.M. Ohman TRILOGY ACS Investigators Prasugrel versus clopidogrel for acute coronary syndromes without revascularization N Engl J Med 367 2012 1297 1309
25. S.N. Raipathak, D.J. Kumbhani, J. Crandall, N. Barzilai, M. Alterman, and P.M. Ridker Statin therapy and risk of developing type 2 diabetes: a meta-analysis Diabetes Care 32 2009 1924 1929
26. N. Sattar, D. Preiss, H.M. Murray, P. Welsh, B.M. Buckley, A.J.M. de Craen, S.R.K. Seshasai, J.J. McMurray, D.J. Freeman, J.W. Jukema, P.W. Macfarlane, C.J. Packard, D.J. Stott, R.G. Westendorp, J. Shepherd, B.R. Davis, S.L. Pressel, R. Marchioli, R.M. Marfisi, A.P. Maggioni, L. Tavazzi, G. Tognoni, J. Kjekshus, T.R. Pedersen, T.J. Cook, A.M. Gotto, M.B. Clearfield, J.R. Downs, H. Nakamura, Y. Ohashi, K. Mizuno, K.K. Ray, and I. Ford Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statin trials Lancet 375 2010 735 742
27. D. Preiss, S.R.K. Seshasi, P. Welsh, S.A. Murphy, J.E. Ho, D.D. Waters, D.A. DeMicco, P. Barter, C.P. Cannon, M.S. Sabitine, E. Braunwald, J.J.P. Kastelein, J.A. deLemos, M.A. Blazing, T.R. Pedersen, M.J. Tikkanen, N. Sattar, and K.K. Ray Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis JAMA 305 2011 2556 2564
28. A.L. Culver, I.S. Ockene, R. Balasubramanian, B.C. Olendzki, D.M. Sepavich, J. Wactawski-Wende, J.E. Manson, Y. Qiao, S. Liu, P.A. Merriam, C. Rahilly-Tierny, F. Thomas, J.S. Berger, J.K. Ockene, J.D. Curb, and Y. Ma Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative Arch Intern Med 172 2012 144 152
29. A. Allignol, M. Schumacher, C. Wanner, C. Drechsler, and J. Beyersmann Understanding competing risks: a simulation point of view BMC Med Res Methodol 11 2011 86
30. S.D. Wiviott, E. Braunwald, C.H. McCabe, G. Montalescot, W. Ruzyllo, S. Gottlieb, F.J. Newmann, D. Ardissino, S. De Servi, S.A. Murphy, J. Riesmeyer, G. Weerakkody, C.M. Gibson, E.M. Antman TRITON-TIMI 38 Investigators Prasugrel versus clopidogrel in patients with acute coronary syndromes N Engl J Med 357 2007 2001 2015
31. P.C. Cannon, E. Braunwald, C.H. McCabe, D.J. Rader, J.L. Rouleau, R. Belder, S.V. Joyal, K.A. Hill, M.A. Pfeffer, A.M. Skene Pravastatin or Atorvastatin Evaluation and Infection Therapy - Thrombolysis In Myocardial Infarction 22 Investigators Intensive versus moderate lipid lowering with statins after acute coronary syndromes N Engl J Med 350 2004 495 504
32. G.A. Diamond, and S. Kaul On reporting of effect size in randomized clinical trials Am J Cardiol 111 2013 613 617
33. E.N. Rappaport, J.L. Franklin, L.A. Avila, S.R. Baig, J.L. Beven II, E.S. Blake, C.A. Burr, J.G. Jiing, C.A. Juckins, R.D. Knabb, C.W. Landsea, M. Mainelli, M. Mayfield, C.J. McAdie, R.J. Pasch, C. Sisko, S.R. Steward, and A.N. Tribble Advances and challenges at the National Hurricane Center Weather Forecast 24 2009 395 419
34. Aldrich S. Clinical trial outsourcing report. Where are the opportunities in the $36.6 billion market for outsourcing clinical trials? Available at: http://www.contractpharma.com/issues/2012-03/view-features/clinical-trial- outsourcing-report/. Accessed August 23, 2012.
35. CERN experiments observe particle consistent with long-sought Higgs boson. Available at: http://press.web.cern.ch/press/PressReleases/Releases2012/ PR17.12E.html. Accessed August 23, 2012.
36. A. Yavchitz, I. Boutron, A. Bafeta, I. Marroun, P. Charles, J. Mantz, and P. Ravaud Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study PLOS Med 9 2012 e1001308