Telmisartan, an angiotensin receptor blocker drug, did not improve walking performance in patients with lower extremity peripheral artery disease, according to results from a recent clinical trial published in JAMA.
The study, led by Mary McDermott, MD, ’92 GME, the Jeremiah Stamler Professor of Medicine in the Division of General Internal Medicine, underscores the need for more effective treatment options for patients.
Peripheral artery disease (PAD) occurs when the blood vessels are narrowed and reduce blood flow to the lower limbs, resulting in impaired muscle function and walking performance. Currently, there are two medications approved by the FDA that treat walking impairment in PAD, but both have demonstrated limited benefit to patients and one is no longer recommended by clinical practice guidelines due to lack of efficacy in recent studies.
Supervised walking exercise is highly effective for treating PAD. However, a 2018 study reported that fewer than 2 percent of patients in the U.S. with PAD and Medicare take advantage of such programs. Additionally, relatively few patients qualify for lower extremity revascularization, which restores blood flow to help ease symptoms. Therefore, more treatment options for PAD, either in combination with walking exercise or by themselves, are needed.
In the current clinical trial, a total of 114 participants with PAD who were enrolled at Northwestern Medicine and at Tulane University were randomized to receive either telmisartan combined with supervised exercise, telmisartan alone, supervised exercise combined with placebo, or placebo alone for six months.
At baseline and at six-month follow up, the investigators measured participants’ walking distance during six minutes, as well treadmill walking distance and patient-reported outcomes, which included a questionnaire completed by participants about their walking ability.
Overall, six-minute walking distance in the telmisartan groups did not significantly improve, compared to the placebo groups. Compared with placebo, telmisartan also did not significantly improve any of the secondary outcomes including treadmill walking distance and patient-reported outcomes.
“We are currently testing a number of interventions to improve walking performance in people with peripheral artery disease. Currently, several of our interventions are therapies that may improve lower extremity perfusion in peripheral artery disease by increasing nitric oxide levels,” said McDermott, who is also a professor of Preventive Medicine in the Division of Epidemiology.
Co-authors include Robert Sufit, MD, professor in the Ken and Ruth Davee Department of Neurology Division of Neuromuscular Disease and of Surgery in the Division of Organ Transplantation; Lihui Zhao, PhD, associate professor of Preventive Medicine in the Division of Biostatistics; and Donald Lloyd-Jones, MD, ScM, chair and Eileen M. Foell Professor of Preventive Medicine.
This work was supported by grant R01-HL126117 from the National Heart, Lung, and Blood Institute, the National Institute on Aging (intramural division) and the Jesse Brown VA Medical Center.
