The angiotensin-receptor blocker (ARB) telmisartan should be regarded as a potential treatment for vascular disease or high-risk diabetes, in the 20% of patients who are unable to tolerate the standard treatment of angiotensin-converting enzyme (ACE) inhibitors.
These are the conclusions of the TRANSCEND study, published early Online and in an upcoming edition of The Lancet, which is being presented at the European Society of Cardiology meeting in Munich and is authored by Dr Salim Yusuf, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.
This randomised controlled trial analysed 5926 patients with vascular disease or high risk diabetes and taking other proven therapies, of whom 2954 received telmisartan 80 mg/day and 2972 received placebo. The primary outcome of the trial was a combination of cardiovascular death, heart attack, stroke, or hospitalisation for heart failure. Patients were followed-up for a median of 56 months.
The researchers found that mean blood pressure was lower in the telmisartan group than placebo by 4.0/2.2 mm Hg. The primary outcome was experienced by 465 (15.7%) patients given telmisartan compared with 504 (17.0%) in the placebo group, although the benefit for telmisartan was not statistically significant. One of the secondary outcomes — a combination of cardiovascular death, heart attack or stroke — occurred in 384 (13.0%) of patients on telmisartan compared with 440 (14.8%) on placebo — a relative risk reduction of 13% for telmisartan patients, although this finding was of borderline statistical significance. A lower proportion of telmisartan patients (894/30.3%) were hospitalised for cardiovascular reasons than in the placebo group (980/33.0%) : this result was statistically significant. Finally, fewer patients permanently discontinued medication in the telmisartan group (639/21.6%) than in the placebo group (705/23.8%) (borderline statistical significance). The most common reason for permanent discontinuation was symptoms of low blood pressure (hypotension) in both groups.
The authors conclude: "These data suggest that telmisartan confers a modest benefit when added to other proven therapies. In view of the drug's tolerability and effects on cardiovascular endpoints, telmisartan could be regarded as a potential treatment for patients with vascular disease or high-risk diabetes, if they are unable to tolerate an ACE inhibitor."
In an accompanying Comment, Dr Toni L Ripley and Dr Donald Harrison, University of Oklahoma College of Pharmacy, Oklahoma City, OK, USA, say: "ARBs that have been studied in coronary disease are safe, but possibly less effective alternatives in patients with intolerance to ACE inhibitors. Although data are too limited to reach definitive conclusions, the clinical effect of ARBs seems less robust than that of ACE inhibitors."
For Dr Salim Yusuf, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada please contact Susan Emigh, Public Relations T) +1 905-525-9140, ext. 22555 / +1 905-518-3642 E) emighs@mcmaster.ca/yusufs@mcmaster.ca
Dr Toni L Ripley and Dr Donald Harrison, University of Oklahoma College of Pharmacy, Oklahoma City, OK, USA T) +1 405 271-6878, extension 47245 E) toni-ripley@ouhsc.edu
Full study: http://press.thelancet.com/esctranscend.pdf
Journal
The Lancet