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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Emerging cardiovascular concerns with rosiglitazone

ADRAC draws to the attention of prescribers an emerging concern about the cardiovascular safety of the thiazolidinedione (TZD) drug rosiglitazone.

TZD drugs (rosiglitazone, pioglitazone) improve glycaemic control (mean HbA1c decrease of 0.8-1.5%) and are approved for the treatment of Type 2 diabetes mellitus. Whether they have long term benefits in reducing the chronic complications of Type 2 diabetes remains an open question. It is well established that TZDs cause fluid retention and can exacerbate or precipitate cardiac failure. These medicines are contraindicated in NYHA heart failure Grades 3 and 4 and are only to be used with caution in Grades 1 and 2.

Recently, three separate meta-analyses of data derived from pooled clinical trials of rosiglitazone have reported an increased risk of cardiac ischaemia.1,2,3 The odds ratio for cardiac ischaemic events was in each case of the order of 1.40, conveying a 40% increase in the chance of a subject having such an event (and NOT that 40% of rosiglitazone treated patients will have such an event).

Some caution is needed in considering these results. Various comparator treatments have been used in the studies that were analysed, including placebo, metformin and sulphonylureas.

An interim analysis of the on-going RECORD study examining cardiovascular events with rosiglitazone was inconclusive (hazard ratio compared with control group 1.08, 95% CI 0.89 1.31).4

The product information for rosiglitazone (Avandia/Avandamet) has been amended to reflect these emerging results and the TGA has now required the following boxed warning: "The use of AVANDIA/AVANDAMET is not recommended in patients with known ischaemic heart disease, particularly in those taking nitrates. AVANDIA/AVANDAMET has been shown to be associated with an increased risk of myocardial ischaemia (angina, infarction) in pooled short-term clinical studies, particularly in those who needed several antidiabetic drugs or nitrates. See Precautions"

The TGA has commissioned an additional review of the information. Pending the outcome of this review, prescribers should include this potential additional risk in their consideration of appropriate drug therapy for Type 2 diabetes, taking into account that rosiglitazone should not be prescribed for patients with known ischaemic heart disease or those considered to be at high risk for ischaemic heart disease.

Reference
  1. Nissen SE & Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. NEJM 2007; 356: 2457-2471 (correction published in volume 357, p 100).
  2. FDA Briefing Document (pdf,6.15Mb)* . Division of Metabolism and Endocrine Products and Office of Surveillance and Epidemiology. July 30, 2007
  3. GlaxoSmithKline Clinical Trial Register. Rosiglitazone studies.Study No.: ZM2005/00181/01 and Study No.: HM2006/00497/00 / WEUSRTP866 .
  4. Home PD et al for the RECORD study Group. Rosiglitazone evaluated for cardiovascular outcomes - An interim analysis. NEJM 2007; 357: 28-38.
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References:
The Australian Adverse Drug Reactions Bulletin, Volume 26, Number 6 (December 2007)

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