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BMJ. 2007 June 16; 334(7606): 1236.
PMCID: PMC1892477
Rosiglitazone and Heart Deaths

Glycaemic control is a myth

Illtyd R Thomas, general practitioner

Tight control of HbA1c levels has been enshrined in the QOF (quality and outcomes framework) of the new general practitioner contract as being an evidence based proposal. Multiple drugs are licensed on the understanding that they reduce HbA1c levels and that this is a good thing. So should it surprise us that a meta-analysis of trials of rosiglitazone shows a raised risk of myocardial infarction and an increase in cardiovascular deaths?1

The reduction in diabetes related end points, mortality and stroke from using metformin is not explicable on the basis of glycaemic control.2

The data of UKPDS 33, which compared tight glycaemic control with sulphonylureas or insulin with conventional treatment, showed little benefit from tight control.3 The outcomes that did show some clinical benefit were cataract extractions, retinal photocoagulation, and non-fatal myocardial infarction and all cause mortality—that is, if you can call absolute risk reductions of between 1 and 3 per 1000 patient years as being clinically relevant.

The wonder with drug licensing is that we continue to accept surrogate end points in trials to license new treatments for conditions for which we already have treatments. Show me better data or accept that the control of blood glucose means metformin--anything else is merely for symptom control.

Notes

Competing interests: IRT has coauthored with Adrian Edwards, Glyn Elwin, and Rhys Williams a paper on explaining risk information over the internet to patients with diabetes, which was funded by the BMJ Group.

References

1. Tanne JH. Study indicates diabetes drug linked to cardiovascular death. BMJ 2007;334:1073 (26 May.) doi: 10.1136/bmj.39224.364630.DB [PMC free article] [PubMed]
2. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65. [PubMed]
3. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risks of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53. [PubMed]

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