Literature DB >> 27957214

Does the FDA Owe Us an Explanation?

James A Reiffel1.   

Abstract

The approval process for new medications sometimes appears to require pharmacokinetic data in some circumstances and clinical trial data in others. This editorial calls for more clarity and transparency in the process and uses three examples to raise the issue.

Year:  2015        PMID： 27957214      PMCID： PMC4955898          DOI： 10.4022/jafib.1361

Source DB:  PubMed          Journal:  J Atr Fibrillation        ISSN： 1941-6911


  9 in total

1.  Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

Authors:  Manesh R Patel; Kenneth W Mahaffey; Jyotsna Garg; Guohua Pan; Daniel E Singer; Werner Hacke; Günter Breithardt; Jonathan L Halperin; Graeme J Hankey; Jonathan P Piccini; Richard C Becker; Christopher C Nessel; John F Paolini; Scott D Berkowitz; Keith A A Fox; Robert M Califf
Journal:  N Engl J Med       Date:  2011-08-10       Impact factor: 91.245

Review 2.  Formulation substitution and other pharmacokinetic variability: underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice.

Authors:  J A Reiffel
Journal:  Am J Cardiol       Date:  2000-05-25       Impact factor: 2.778

3.  Efficacy and safety of propafenone sustained release in the prophylaxis of symptomatic paroxysmal atrial fibrillation (The European Rythmol/Rytmonorm Atrial Fibrillation Trial [ERAFT] Study).

Authors:  Thomas Meinertz; Gregory Y H Lip; Fedrico Lombardi; Zigmunt P Sadowski; Brigitte Kalsch; Anne Camez; Ann Hewkin; Siegfried Eberle
Journal:  Am J Cardiol       Date:  2002-12-15       Impact factor: 2.778

4.  Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran.

Authors:  B Nhi Beasley; Ellis F Unger; Robert Temple
Journal:  N Engl J Med       Date:  2011-04-13       Impact factor: 91.245

5.  Reply: regarding the effect of dabigatran plasma concentrations.

Authors:  Paul A Reilly; Stuart J Connolly; Salim Yusuf; John W Eikelboom; Michael D Ezekowitz; Lars Wallentin
Journal:  J Am Coll Cardiol       Date:  2014-05-07       Impact factor: 24.094

6.  The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy).

Authors:  Paul A Reilly; Thorsten Lehr; Sebastian Haertter; Stuart J Connolly; Salim Yusuf; John W Eikelboom; Michael D Ezekowitz; Gerhard Nehmiz; Susan Wang; Lars Wallentin
Journal:  J Am Coll Cardiol       Date:  2013-09-27       Impact factor: 24.094

7.  Efficacy and safety of sustained-release propafenone (propafenone SR) for patients with atrial fibrillation.

Authors:  Edward L C Pritchett; Richard L Page; Mark Carlson; Karl Undesser; Gerald Fava
Journal:  Am J Cardiol       Date:  2003-10-15       Impact factor: 2.778

8.  Dabigatran versus warfarin in patients with atrial fibrillation.

Authors:  Stuart J Connolly; Michael D Ezekowitz; Salim Yusuf; John Eikelboom; Jonas Oldgren; Amit Parekh; Janice Pogue; Paul A Reilly; Ellison Themeles; Jeanne Varrone; Susan Wang; Marco Alings; Denis Xavier; Jun Zhu; Rafael Diaz; Basil S Lewis; Harald Darius; Hans-Christoph Diener; Campbell D Joyner; Lars Wallentin
Journal:  N Engl J Med       Date:  2009-08-30       Impact factor: 91.245

9.  The HARMONY Trial: Combined Ranolazine and Dronedarone in the Management of Paroxysmal Atrial Fibrillation: Mechanistic and Therapeutic Synergism.

Authors:  James A Reiffel; A John Camm; Luiz Belardinelli; Dewan Zeng; Ewa Karwatowska-Prokopczuk; Ann Olmsted; Wojciech Zareba; Spencer Rosero; Peter Kowey
Journal:  Circ Arrhythm Electrophysiol       Date:  2015-07-30
  9 in total

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