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Effect of Telmisartan on Walking Performance in Patients With Lower Extremity Peripheral Artery Disease: The TELEX Randomized Clinical Trial.
McDermott, Mary M; Bazzano, Lydia; Peterson, Charlotte A; Sufit, Robert; Ferrucci, Luigi; Domanchuk, Kathryn; Zhao, Lihui; Polonsky, Tamar S; Zhang, Dongxue; Lloyd-Jones, Donald; Leeuwenburgh, Christiaan; Guralnik, Jack M; Kibbe, Melina R; Kosmac, Kate; Criqui, Michael H; Tian, Lu.
Afiliación
  • McDermott MM; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Bazzano L; Tulane University, New Orleans, Louisiana.
  • Peterson CA; University of Kentucky, Lexington.
  • Sufit R; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Ferrucci L; Division of Intramural Research, National Institute on Aging, Bethesda, Maryland.
  • Domanchuk K; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Zhao L; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Polonsky TS; Pritzker School of Medicine, University of Chicago, Chicago, Illinois.
  • Zhang D; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Lloyd-Jones D; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Leeuwenburgh C; University of Florida, Gainesville.
  • Guralnik JM; Department of Epidemiology, University of Maryland, College Park.
  • Kibbe MR; School of Medicine, University of Virginia, Charlottesville.
  • Kosmac K; University of Kentucky, Lexington.
  • Criqui MH; University of California, San Diego.
  • Tian L; Department of Health Research and Policy, Stanford University, Stanford, California.
JAMA ; 328(13): 1315-1325, 2022 10 04.
Article en En | MEDLINE | ID: mdl-36194220
Importance: Patients with lower extremity peripheral artery disease (PAD) have reduced lower extremity perfusion, impaired lower extremity skeletal muscle function, and poor walking performance. Telmisartan (an angiotensin receptor blocker) has properties that reverse these abnormalities. Objective: To determine whether telmisartan improves 6-minute walk distance, compared with placebo, in patients with lower extremity PAD at 6-month follow-up. Design, Setting, and Participants: Double-blind, randomized clinical trial conducted at 2 US sites and involving 114 participants. Enrollment occurred between December 28, 2015, and November 9, 2021. Final follow-up occurred on May 6, 2022. Interventions: The trial randomized patients using a 2 × 2 factorial design to compare the effects of telmisartan plus supervised exercise vs telmisartan alone and supervised exercise alone and to compare telmisartan alone vs placebo. Participants with PAD were randomized to 1 of 4 groups: telmisartan plus exercise (n = 30), telmisartan plus attention control (n = 29), placebo plus exercise (n = 28), or placebo plus attention control (n = 27) for 6 months. The originally planned sample size was 240 participants. Due to slower than anticipated enrollment, the primary comparison was changed to the 2 combined telmisartan groups vs the 2 combined placebo groups and the target sample size was changed to 112 participants. Main Outcomes and Measures: The primary outcome was the 6-month change in 6-minute walk distance (minimum clinically important difference, 8-20 m). The secondary outcomes were 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. The results were adjusted for study site, baseline 6-minute walk distance, randomization to exercise vs attention control, sex, and history of heart failure at baseline. Results: Of the 114 randomized patients (mean age, 67.3 [SD, 9.9] years; 46 were women [40.4%]; and 81 were Black individuals [71.1%]), 105 (92%) completed 6-month follow-up. At 6-month follow-up, telmisartan did not significantly improve 6-minute walk distance (from a mean of 341.6 m to 343.0 m; within-group change: 1.32 m) compared with placebo (from a mean of 352.3 m to 364.8 m; within-group change: 12.5 m) and the adjusted between-group difference was -16.8 m (95% CI, -35.9 m to 2.2 m; P = .08). Compared with placebo, telmisartan did not significantly improve any of the 5 secondary outcomes. The most common serious adverse event was hospitalization for PAD (ie, lower extremity revascularization, amputation, or gangrene). Three participants (5.1%) in the telmisartan group and 2 participants (3.6%) in the placebo group were hospitalized for PAD. Conclusions and Relevance: Among patients with PAD, telmisartan did not improve 6-minute walk distance at 6-month follow-up compared with placebo. These results do not support telmisartan for improving walking performance in patients with PAD. Trial Registration: ClinicalTrials.gov Identifier: NCT02593110.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Extremidad Inferior / Bloqueadores del Receptor Tipo 1 de Angiotensina II / Prueba de Esfuerzo / Terapia por Ejercicio / Enfermedad Arterial Periférica / Telmisartán Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JAMA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Extremidad Inferior / Bloqueadores del Receptor Tipo 1 de Angiotensina II / Prueba de Esfuerzo / Terapia por Ejercicio / Enfermedad Arterial Periférica / Telmisartán Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JAMA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos