Literature DB >> 21102545

Therapy: The second time as farce: rosiglitazone and the regulators.

Edwin A M Gale.   

Abstract

Rosiglitazone is the second of the marketed thiazolidinediones to fall from grace, and its demise bears an uncanny resemblance to the earlier downfall of troglitazone. Both narratives demonstrate the inadequacy of a regulatory system that is mandated to place a higher value on commercial secrecy than on patient safety.

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Year:  2010        PMID: 21102545     DOI: 10.1038/nrendo.2010.209

Source DB:  PubMed          Journal:  Nat Rev Endocrinol        ISSN: 1759-5029            Impact factor:   43.330


  9 in total

Review 1.  Lessons from the glitazones: a story of drug development.

Authors:  E A Gale
Journal:  Lancet       Date:  2001-06-09       Impact factor: 79.321

2.  Regulatory action on rosiglitazone by the U.S. Food and Drug Administration.

Authors:  Janet Woodcock; Joshua M Sharfstein; Margaret Hamburg
Journal:  N Engl J Med       Date:  2010-09-23       Impact factor: 91.245

3.  Troglitazone: the lesson that nobody learned?

Authors:  Edwin A M Gale
Journal:  Diabetologia       Date:  2006-01       Impact factor: 10.122

4.  The rise and fall of rosiglitazone.

Authors:  Steven E Nissen
Journal:  Eur Heart J       Date:  2010-02-12       Impact factor: 29.983

5.  Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial.

Authors:  John A Dormandy; Bernard Charbonnel; David J A Eckland; Erland Erdmann; Massimo Massi-Benedetti; Ian K Moules; Allan M Skene; Meng H Tan; Pierre J Lefèbvre; Gordon D Murray; Eberhard Standl; Robert G Wilcox; Lars Wilhelmsen; John Betteridge; Kåre Birkeland; Alain Golay; Robert J Heine; László Korányi; Markku Laakso; Marián Mokán; Antanas Norkus; Valdis Pirags; Toomas Podar; André Scheen; Werner Scherbaum; Guntram Schernthaner; Ole Schmitz; Jan Skrha; Ulf Smith; Jan Taton
Journal:  Lancet       Date:  2005-10-08       Impact factor: 79.321

6.  Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy.

Authors:  Steven E Kahn; Steven M Haffner; Mark A Heise; William H Herman; Rury R Holman; Nigel P Jones; Barbara G Kravitz; John M Lachin; M Colleen O'Neill; Bernard Zinman; Giancarlo Viberti
Journal:  N Engl J Med       Date:  2006-12-04       Impact factor: 91.245

Review 7.  Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality.

Authors:  Steven E Nissen; Kathy Wolski
Journal:  Arch Intern Med       Date:  2010-07-26

8.  Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial.

Authors:  Philip D Home; Stuart J Pocock; Henning Beck-Nielsen; Paula S Curtis; Ramon Gomis; Markolf Hanefeld; Nigel P Jones; Michel Komajda; John J V McMurray
Journal:  Lancet       Date:  2009-06-06       Impact factor: 79.321

9.  Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.

Authors:  Steven E Nissen; Kathy Wolski
Journal:  N Engl J Med       Date:  2007-05-21       Impact factor: 91.245

  9 in total
  3 in total

Review 1.  Advances in pharmacologic therapies for type 2 diabetes.

Authors:  Linde M Morsink; Mark M Smits; Michaela Diamant
Journal:  Curr Atheroscler Rep       Date:  2013-02       Impact factor: 5.113

2.  GLP-1-based therapies and the exocrine pancreas: more light, or just more heat?

Authors:  Edwin A M Gale
Journal:  Diabetes       Date:  2012-05       Impact factor: 9.461

3.  Mitochondrial Respiratory Complexes as Targets of Drugs: The PPAR Agonist Example.

Authors:  Patrizia Bottoni; Alessandro Pontoglio; Salvatore Scarà; Luisa Pieroni; Andrea Urbani; Roberto Scatena
Journal:  Cells       Date:  2022-03-30       Impact factor: 6.600

  3 in total

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