El 22 d'octubre i de manera anticipada es van publicar on line les noves guies actualitzades per al tractament de la hiperglucèmia en la diabetis de tipus 2, de l'Associació Nord-Americana de Diabetis (ADIGUI, per les seves sigles a engonals)Les guies que en la seva versió anterior (2006) col·locaven la glitazonas com a segona línia de tractament, assenyalen en aquesta oportunitat que "encara que el metanálisis discutit a dalt (es refereix al de Nissen) no és concloent en relació amb el potencial risc cardiovascular associat amb rosiglitazona, ja que existeixen altres alternatives recomanades, els membres de grup de consens unànimement aconsellen en contra de la utilització de rosiglitazona"
Reprenent forces per aquesta asseveració, Public Citizen sol·licito a la FDA que la rosiglitazona (Avandia) sigui retirada del mercat.
En un comunicat de premsa Public Citizen basa la seva sol·licitud, en els greus riscs associats a l'ús de la rosiglitazona, incloent-ne un de nou documentada per una reanàlisi realitzada per l'ONG, que va trobar 14 casos d'insuficiència hepàtica, dels quals 12 van ser mortals. D'altra banda assenyalen que existeixen clares proves prèvies d'un augment del risc d'atacs cardíacs, insuficiència cardíaca, fractures òssies, anèmia i edema macular amb pèrdua de la visió.
Les proves d'aquesta toxicitat es veu agreujat per la falta de proves de benefici clínic, en comparació amb altres medicaments aprovats per a la diabetis, tals com|com a metformina, sulfonilureas i insulina, assenyalen en la nota de premsa.
Noticia de The Lancet:
Rosiglitazone no longer recommendedOriginal Text The Lancet<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=%20The%20Lancet>
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"Last week, GlaxoSmithKline (GSK) suffered a heavy blow at the hands of two
leading diabetes societies. For the first time, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have issued guidelines that explicitly advise against the use of
GSK's rosiglitazone for type-2 diabetes.
Rosiglitazone belongs to a group of PPAR- modulators known as the thiazolidinediones (TZDs). It was licensed in 1999 by the US Food and Drug Administration (FDA) for use as a glycaemia-lowering drug in type-2
diabetes, but a meta-analysis last year showed increased risks of myocardial infarction and death from cardiovascular causes.
GSK avidly defended its product and a flurry of intense research ensuedmost were secondary analyses of trials powered for other outcomes. In August, 2007, the FDA announced black-box warnings for rosiglitazone and
pioglitazone (the other TZD marketed by Takeda). The European Medicines Agency issued their own warning in October, 2007. In January, 2008, the ADA and EASD reaffirmed their position originally outlined in their 2006
consensus <http://dx.doi.org/10.2337/dc08-9025> algorithm that recommended TZDs as second-line treatments for type-2 diabetes, after lifestyle interventions and metformin prescription.
Further concerns about the TZDs were raised earlier this year when the ACCORD trial was terminated early after patients in the intensive treatment arm (91% of whom received rosiglitazone) were at significantly increased
risk of death, specifically from cardiovascular disease. In the strongest response to date, the ADA/EASD Oct 22 consensus relegated the use of pioglitazone to a third-line treatment, additionally stating that rosiglitazone was not recommended at any point during treatment. Since alternative effective options are available, the expert panel rightly felt that a drug with rosiglitazone's safety profile could no longer be advocated. The much awaited RECORD study, the first trial prospectively designed to assess the cardiac outcomes of rosiglitazone in patients with diabetes, is due to end later this year. The ADA and EASD are wise to recall their recommendation of rosiglitazone until the results from RECORD are known."
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