Telmisartan does not deliver in peripheral arterial disease
Treatment with the angiotensin receptor blocker telmisartan does not appear to confer improvements on walking performance in patients with lower extremity peripheral artery disease (PAD), according to the TELEX trial.
Using a two-by-two factorial design, the double-blind TELEX trial randomized 114 patents to one of the following treatment groups: telmisartan plus exercise (n=30), telmisartan plus attention control (n=29), placebo plus exercise (n=28), or placebo plus attention control (n=27). Treatment was given for 6 months.
The population had a mean age of 67.3 years, and 46 were women (40.4 percent) and 81 were Black (71.1 percent). A total of 105 (92 percent) patients completed 6-month follow-up.
At 6 months, the primary outcome of six-minute walk distance (minimum clinically important difference, 8–20 metres) changed from a mean of 341.6 m to 343.0 m in the combined telmisartan groups (within-group change, 1.32 m) and from a mean of 352.3 m to 364.8 m in the combined placebo groups (within-group change, 12.5 m).
Telmisartan exerted no significant effect on the six-minute walk distance compared with placebo (adjusted between-group difference, −16.8 m, 95 percent confidence interval [CI], −35.9 to 2.2; p=0.08).
Furthermore, telmisartan did not produce significant improvements in any of the five secondary outcomes (maximal treadmill walking distance; Walking Impairment Questionnaire scores for distance, speed, and stair climbing; and the 36-Item Short-Form Health Survey physical functioning score).
In terms of safety, hospitalization for PAD (ie, lower extremity revascularization, amputation, or gangrene) was the most common serious adverse event, documented in three participants (5.1 percent) in the telmisartan group and two participants (3.6 percent) in the placebo group.