Cognitive outcomes after tadalafil treatment in patients with cerebral small vessel disease: ETLAS-2 sub-study
Abstract
• Three months of tadalafil did not improve cognition. • Cerebral small vessel disease was linked to reduced processing speed. • Longer PDE-5 inhibitor treatment duration is warranted in future trials. Cerebral small vessel disease (CSVD) is the dominant cause of vascular cognitive impairment and dementia. We aimed to test whether continuous daily treatment with the vasoactive phosphodiesterase 5 inhibitor tadalafil improved cognitive performance in patients with CSVD. This is a pre-registered sub-study on cognitive outcomes from the ETLAS-2 trial, a randomized, placebo-controlled, double-blind, parallel study investigating 3 months of daily tadalafil (20 mg) treatment against placebo in patients with CSVD and previous stroke or transient ischemic attack. Outcomes were assessed twice, at baseline and after 3 months of treatment. The primary outcomes were changes in the cognitive domains of processing speed, attention, memory, and executive functions assessed by the Symbol Digit Modalities test, digit span forward, and tests from the computer-based Cambridge Neuropsychological Test Automated Battery (CANTAB). The per-protocol sub-study analysis comprised 60 participants, 28 of whom received tadalafil and 32 received placebo. Baseline cognitive impairments involved reduced processing speed and impaired visual learning and memory. At follow-up, we found a slower mean simple reaction time in the tadalafil group compared to placebo (28.8 ± 13.8 ms, p =0.04). There were no…
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: 60 participants or records.
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