This is an analysis of existing data that has been previously published (online in Diabetes Care, 29 May 2007) and provides no new information on the risk of heart failure associated with the thiazolinediones (TZD) class.
?The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK. Whilst continued patient safety is paramount, we must also remember that Type II diabetes can have devastating consequences including stroke, blindness, amputation and kidney failure. Rosiglitazone therefore has an important role to play as one of the medicines, doctors can use to treat the 2 million patients currently diagnosed with type 2 diabetes in the UK,? said, Dr. Alastair Benbow, European Medical Director, GlaxoSmithKline.
The analysis does not include the results from the ADOPT2 (A Diabetes Outcome Progression Trial) study, and the RECORD3 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) interim analysis, two recently published long-term prospective studies in which the risk of heart failure is assessed in patients taking rosiglitazone.
The authors correctly point out that diabetic patients are known to be at increased risk of developing congestive heart failure. The authors also report an increased risk of heart failure with TZD therapy. It is well recognized that this class of medicine can cause fluid retention which may exacerbate or lead to heart failure. This is clearly stated in the European prescribing information for rosiglitazone. In addition, in Europe, rosiglitazone is contraindicated for patients with New York Heart Association (NYHA) Class I-IV cardiac failure or those with a history of cardiac failure. These contraindications have been in the SPC since rosiglitazone was approved in Europein June 2000.
Questions about the safety of rosiglitazone are best answered by long-term prospective studies such as ADOPT and RECORD interim analysis. In ADOPT the same number of congestive heart failure (CHF) serious adverse events were reported for rosiglitazone versus metformin in a drug naive diabetic population. However those on glibenclamide experienced a lower rate of serious CHF events compared to both rosiglitazone and metformin.
In the RECORD interim analysis, rosiglitazone was associated with significantly more cases of CHF when compared with patients on control ? metformin and sulphonylurea (hazard ratio 2.24). Despite the increase in CHF however, the primary outcome of cardiovascular hospitalizations and death showed no significant difference between the rosiglitazone group and the met/SU group.
It is important for physicians to use rosiglitazone in appropriate patients in line with the European SPC, which states that rosiglitazone should not be used in patients with CHF. GSK is confident in the overall safety profile of rosiglitazone when used appropriately.
GlaxoSmithKline ? one of the world?s leading research-based pharmaceutical and healthcare companies ? is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
1. Singh et. Al. Thiazolidinediones and Heart Failure: A Teleo-Analysis. Diabetes Care. Published online: 29 May, 2007. Print publication: 27 July 2007
2. Kahn S et al. Glycemic durability of rosiglitazone, metformin or glyburide monotherapy. NEJM 2006 355: 23; 2427-2443
3. Home P D, et al. Rosiglitazone Evaluated for Cardiovascular Outcomes ? An Interim Analysis. NEJM 2007: 357: 28-38