Neurovascular effects of tadalafil in patients with cerebral small vessel disease: ETLAS-2 substudy
Abstract
Abstract Cerebral small vessel disease is a major contributor to stroke and cognitive impairment, often associated with reduced cerebral blood flow and cerebrovascular reactivity. In this study, we used MRI to investigate if daily treatment with the phosphodiesterase-5 inhibitor tadalafil over 3 months improved cerebral blood flow and cerebrovascular reactivity in patients with cerebral small vessel disease. Using a randomized, placebo-controlled, parallel-group design, this MRI sub-study was prospectively performed as part of the Effect of Tadalafil in Lacunar Stroke 2 trial, which included a total of 76 participants, of whom 60 were included in the per-protocol analysis. Patients with cerebral small vessel disease and prior stroke or transient ischaemic attack received either tadalafil (20 mg/day) or placebo for 3 months and completed the study. Neurovascular outcomes were assessed at baseline and at the 3-month follow-up using dual-echo pseudo-continuous arterial spin labelling MRI to evaluate reactivity to hypercapnia and visual stimulation. Endpoints included changes in whole-brain baseline cerebral blood flow and cerebrovascular reactivity, visual stimulation response, and neurovascular coupling index. In addition, we investigated arterial transit time measured using diffusion-prepared pseudo-continuous arterial spin labelling and changes in event-related sensory blood-oxygen-level-dependent responses in the primary somatosensory cortex (S1) after stimulation of the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 76 participants or records.
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