Effect of Ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial

Importance: Approximately one-third of patients with peripheral artery disease experience intermittent claudication, with consequent loss of quality of life. Objective: To determine the efficacy of ramipril for improving walking ability, patient-perceived walking performance, and quality of life in patients with claudication. Design, Setting, and Patients: Randomized, double-blind, placebo-controlled trial conducted among 212 patients with peripheral artery disease (mean age, 65.5 [SD, 6.2] years), initiated in May 2008 and completed in August 2011 and conducted at 3 hospitals in Australia. Intervention: Patients were randomized to receive 10 mg/d of ramipril (n=106) or matching placebo (n=106) for 24 weeks. Main Outcome Measures: Maximum and pain-free walking times were recorded during a standard treadmill test. The Walking Impairment Questionnaire (WIQ) and Short-Form 36 Health Survey (SF-36) were used to assess walking ability and quality of life, respectively. Results: At 6 months, relative to placebo, ramipril was associated with a 75-second (95% CI, 60-89 seconds) increase in mean pain-free walking time (

TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial.

BackgroundExperimental studies suggest that angiotensin II plays a central role in the pathogenesis of abdominal aortic aneurysm. This trial aims to evaluate the efficacy of the angiotensin receptor blocker telmisartan in limiting the progression of abdominal aortic aneurysm.Methods/designTelmisartan in the management of abdominal aortic aneurysm (TEDY) is a multicentre, parallel-design, randomised, double-blind, placebo-controlled trial with an intention-to-treat analysis. We aim to randomly assign 300 participants with small abdominal aortic aneurysm to either 40 mg of telmisartan or identical placebo and follow patients over 2 years. The primary endpoint will be abdominal aortic aneurysm growth as measured by 1) maximum infra-renal aortic volume on computed tomographic angiography, 2) maximum orthogonal diameter on computed tomographic angiography, and 3) maximum diameter on ultrasound. Secondary endpoints include change in resting brachial blood pressure, abdominal aortic aneurysm biomarker profile and health-related quality of life. TEDY is an international collaboration conducted from major vascular centres in Australia, the United States and the Netherlands.DiscussionCurrently, no medication has been convincingly demonstrated to limit abdominal aortic aneurysm progression. TEDY will examine the potential of a promising treatment strategy for patients with small abdominal aortic aneurysms.Trial registrationAustralian and Leiden study centres: Australian New Zealand Clinical Trials Registry ACTRN12611000931976 , registered on 30 August 2011; Stanford study centre: clinicaltrials.gov NCT01683084 , registered on 5 September 2012

A meta-analysis of the outcome of endovascular and non-invasive therapies in the treatment of intermittent claudication

Purpose: Intermittent claudication is a common symptom of peripheral arterial disease. Currently, there is a lack of consensus on the most effective therapies for this problem. We conducted a meta-analysis of randomized trials assessing the efficacy of endovascular therapy (EVT) compared with noninvasive therapies for the treatment of intermittent claudication. Methods: Randomized trials comparing the efficacy of EVT and noninvasive therapies, such as medical therapy (MT) and supervised exercise (SVE) in patients with intermittent claudication were identified by a systematic search. Data were pooled, and combined overall effect sizes (standardized differences of mean values) were calculated for a random effect model in terms of ankle-brachial index (ABI) and treadmill walking for initial claudication distance (ICD) and maximum walking distance (MWD). Nine eligible trials (873 participants) were included: two compared EVT and MT alone, four compared EVT and SVE, and three trials compared EVT plus SVE vs SVE alone. Results: Heterogeneity between studies was marked. Quantitative data analysis suggested that EVT improved outcomes over MT alone at early follow-up evaluations. Outcomes of EVT plus SVE were better than those of SVE alone in terms of both ABI and treadmill walking at immediate, early, and intermediate follow-up. No substantial differences in outcomes of EVT alone compared with SVE alone were found. Conclusion: In patients with intermittent claudication, current evidence supports improved ABI and treadmill walking when EVT is added to MT or SVE during early and intermediate follow-up. There is no evidence that EVT alone provides improved outcome over SVE alone. There is low confidence in these findings for a number of reasons, including the small number of trials, the small size of these studies, the heterogeneity in study design, and the limited use of quality of life tools in assessing outcomes. More consistent data from larger, more homogenous studies, including longer follow-up, are required