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TRANSCEND: Telmisartan may be potential treatment for high-risk diabetes, vascular disease
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Patients with vascular disease or high-risk diabetes who are unable to tolerate ACE inhibitors may have experience reduced CV death, MI or stroke with telmisartan treatment.
Koon K. Teo, MD, PhD, professor at the Michael G. DeGroote School of Medicine at McMaster University in Canada, presented results of the TRANSCEND study.
The study included 5,926 participants who were randomly assigned to telmisartan (Micardis, Boehringer Ingelheim) 80 mg/day (n=2,954) or placebo (n=2,972). The primary endpoint was the composite of CV death, MI, stroke or hospitalization due to HF. The secondary outcome excluded HF. Median follow-up was 56 months.
The primary endpoint occurred in 15.7% of participants in the telmisartan group, compared with 17.0% of those in the placebo group (HR=0.92; 95% CI, 0.81-1.05). The secondary outcome occurred in 384 participants in the telmisartan group, compared with 440 participants in the placebo group (HR=0.87; 95% CI, 0.76-1.00).
The researchers reported CV–related hospitalization in 30.3% of telmisartan participants and 33.0% of placebo participants (RR=0.92; 95% CI, 0.85-0.99). Hypotensive symptoms occurred more often in participants in the telmisartan group (n=29), compared with placebo (n=16), though permanent discontinuation of the study medication occurred less often in the telmisartan group than in the placebo group (21.6% vs. 23.8%; P=.055).
“In conclusion, telmisartan reduces the primary outcome by 8% and reduces significantly the main outcomes of CV death and MIs,” Teo said.
For more information:
- Teo KK. The TRANSCEND study: a randomized placebo-controlled clinical trial evaluating the effects of telmisartan in high risk individuals without heart failure. Hot Line 1. Presented at: the European Society of Cardiology Congress 2008; Aug. 30-Sept. 3, 2008; Munich, Germany.
The composite outcome used in the HOPE study was a strong trend toward benefit, whereas the addition of an outcome on hospitalization for HF was completely neutral in this (TRANSCEND) trial. However, when they combined the data with PROFESS published a few days prior to this presentation in The New England Journal of Medicine, there was a significant benefit, even on the primary composite outcome that seemed to emerge over time.
Primary preventive vascular effects by angiotensin II receptor antagonist therapy are at best modest; the effects take time before emerging. ACE inhibitors should remain the first-line therapy for vascular protection. As AII receptor antagonists have not been documented to be superior to ACE inhibitors but at best similar, can they be used as alternatives in ACE-intolerant patients? If we accept the HOPE criteria, it seems reasonable to use telmisartan as an alternative in ACE-intolerant patients. But, as the mechanisms are unknown behind the lack of effects on the prevention of HF in these trials, the documented AII receptor antagonists candesartan [Atacand, AstraZeneca] and valsartan [Diovan, Novartis] should be used in patients who already have HF.
– Karl Swedberg, MD
Professor of Medicine, Department of Emergency and CV Medicine, Sahlgrenska Academy,
University of Gothenburg, Sahlgrenska University Hospital, Sweden