Telmisartan fails to improve walking performance in lower extremity PAD patients: JAMA

ILLINOIS: A recent original investigation published in JAMA concluded the role of Telmisartan as "unsupportive" in improving the walking performance of patients with lower extremity peripheral artery disease.

Lower extremity peripheral artery disease (PAD) is a morbid manifestation of atherosclerosis affecting nearly 230 million people worldwide. the prevalence of PAD is expected to increase with rising diabetes cases. PAD patients are at high risk for myocardial infarction and stroke. Functional impairment and adverse limb-associated events like acute ischemia and amputation increase mortality in such cases, and reducing these risks is the primary aim of interventional treatment. Reducing functional impairment is addressed as "beneficial," but "effective therapies" needed remain "unmet."

PAD Patients have reduced perfusion, impaired skeletal muscle function, and poor walking performance (all related to lower extremities). Telmisartan is an angiotensin receptor blocker that can reverse these abnormalities due to its properties. Against the above background, McDermott reported the supportive role of Telmisartan combined with exercises in improving functioning in PAD patients. The team led by Dr Mary M.McDermott with a team of nearly 15 researchers, answered the question,

"Do telmisartan improve walking ability in patients with lower extremity peripheral artery disease compared with placebo?"

The main points of the study are:

• The trial was conducted at 2 University Hospital sites in US. and involved 114 patients with PAD with a mean age of 67.3 years were included in the study.

• The participants were 68 men and 46 women.

• The participants were randomized in a 2 × 2 factorial design.

• The 114 patients were randomized into four groups: Telmisartan plus exercise, Telmisartan plus attention control, Placebo plus exercise, and Placebo plus attention control.

• The number of study participants was 30, 29, 28, and 27 in the four groups respectively.

• For Telmisartan or placebo group, the intervention was ≤ 80mg/d.

• The intervention for exercise was walking on a treadmill at least three times per week for a duration of up to 50 minutes per session.

• In attention-control, educational sessions were given 1 hour weekly by faculty or staff related to the topics of health.

• The final comparison was made between the Telmisartan group( 2 combined groups) vs. control group (2 combined placebo groups)

• 92 % completed 6 month follow-up period.

• The primary outcome was to measure the change in 6-minute walk distance after six months.

• The secondary outcomes were maximal treadmill walking distance, the Walking Impairment Questionnaire, and the 36-Item Short-Form Health Survey physical functioning score.

• In the combined telmisartan group, there was no significant improvement in the 6-minute walking distance from a baseline of 341.6 m to 343.0 m after six months, and the within-group change was 1.32 m.

• In the combined placebo group, the baseline mean was 352.3 m to 364.8 m after six months, and within-group change: 12.05 m)

• The adjusted between-group difference was −16.8 m with a P value of 0 .08. (placebo favoured)

• There was no significant improvement in any of the five secondary outcomes related to Telmisartan compared with placebo.

• The most common adverse event was hospitalization for PAD and was related to lower extremity revascularization, amputation, or gangrene.

• 5.1% of participants in the telmisartan group and 3.6% in the placebo group were hospitalized.

The main aim of our study was to identify if Telmisartan can improve the 6-minute walk distance in patients with lower extremity PAD during the follow-up period of 6 months, they wrote.

The researchers wrote," our study results do not support telmisartan usage in PAD patients in an attempt to improve walking performance.