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The second time as farce: rosiglitazone and the regulators

Nature Reviews Endocrinology volume 7, pages 5–6 (2011)Cite this article

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Hypothetical benefits ... distracted attention from a mounting toll of adverse events...

Rosiglitazone and pioglitazone were hurried through the approval process to replace troglitazone. Expectations remained high, as the glitazones were believed to enhance β-cell survival and function and to offer substantial protection against cardiovascular disease, in addition to their glucose-lowering properties. Hypothetical benefits such as these distracted attention from a mounting toll of adverse events that included fluid retention, heart failure, weight gain and bone fractures. Once again, key head-to-head comparisons with existing therapies were lacking, and subsequent reports focused on the more positive aspects of the new therapies.2 Pioglitazone was given a resolutely positive spin, despite its failure to score on the primary efficacy parameter in the PROACTIVE study.3 The ADOPT study showed that rosiglitazone offered marginally lower HbA1c than metformin after 5 years of monotherapy but skated over the more patient-relevant observation that individuals treated with rosiglitazone gained 7 kg in body weight.4 And, once again, the glitazones failed to offer a serious challenge to metformin, which remains the uncontested first-line choice for the treatment of type 2 diabetes mellitus.

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  1. Diabetes and Metabolism, Learning and Research, Southmead Hospital, BS10 5NB, Bristol, UK

    Edwin A. M. Gale

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  1. Edwin A. M. Gale
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The author declares no competing interests. However, the author chairs the Special Advisory Group to the European Medicines Agency (EMA) on Diabetes and Endocrinology.

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Gale, E. The second time as farce: rosiglitazone and the regulators. Nat Rev Endocrinol 7, 5–6 (2011). https://doi.org/10.1038/nrendo.2010.209

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