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RECORD: Effect of rosiglitazone on coronary events in the RECORD study

Clinical Trial Update II


Presenter | see Discussant report

John McMurray, FESC (United Kingdom)

Presentation webcast

Presentation slides

List of Authors:
J McMurray, M Komajda, H Beck-Nielsen, R Gomis, M Hanefeld, S Pocock, P Curtis, N Jones & P Home on behalf of the RECORD Committees and Investigators


Concern had been raised that treatment with rosiglitazone might increase the risk of myocardial infarction in patients with diabetes on the basis of a meta-analysis of small, short-term, trials that had methodological limitations (Nissen and Wolski N Engl J Med 2007; 356: 2457-71) . The present analyses describe the occurrence of prospectively identified coronary events occurring during a large-scale, long-term (average follow-up 5.5 years), randomized trial comparing treatment with rosiglitazone added to background metformin or sulfonylurea monotherapy (n=2220) with combination metformin plus sulfonylurea treatment (n=2227) in patients with type II diabetes mellitus – the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes (RECORD) study. All events were adjudicated by an endpoint committee blinded to treatment allocation using pre-specified definitions. The composite outcome of fatal and non-fatal myocardial infarction (a pre-defined secondary endpoint) was reported in the primary paper (Home et al Lancet 2009; 373; 2125-35). The present report describes i) subsequent acute coronary events and mortality in these patients ii) a range of post hoc composite coronary outcomes, analysed as time to first event and iii) total coronary events, taking account of recurrent events (i.e. that patients can experience more than one event).

The additional coronary composites analysed included a) Any acute coronary syndrome (fatal MI, sudden death, hospitalization for cardiac arrest, hospitalization for acute MI or hospitalization for unstable angina) b) Any acute coronary syndrome (ACS) or other angina (above plus patients with an “other” cardiovascular hospitalization attributed to angina pectoris) and c) Any ACS, other angina or coronary revascularization (above plus either percutaneous coronary intervention or coronary artery bypass surgery).

The attached slides show these outcomes. Among the 60 survivors of a first MI in the rosiglitazone group, there were 7 recurrent MIs and 3 cases of unstable angina pectoris. There were 11 deaths (of which 7 were cardiovascular). Among the 52 survivors of a first MI in the control group (metformin plus a sulfonylurea), there were 11 recurrent MIs and 2 cases of angina pectoris. There were 12 deaths (of which 10 were cardiovascular). The expanded coronary composites showed similar event rates in both treatment groups. The total number of coronary events were similar in the two groups – for the broadest composite, 127 patients in the rosiglitazone group experienced 221 events compared to 128 patients (230 events) in the control group.

In summary, there was no statistically significant increase in coronary events in patients treated with rosiglitazone in the RECORD trial.


Discussant | see Presenter abstract

Bernard Charbonnel, FESC (France)

Presentation webcast

Presentation slides




Effect of rosiglitazone on coronary events in the RECORD study

Notes to editor

This congress report accompanies a presentation given at the ESC Congress 2009. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.