A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
Abstract
Study designDouble-blind, randomized cross-over placebo-controlled pilot study.ObjectivesTo determine the effects of tadalafil on systolic blood pressure (SBP), heart rate (HR), and dizziness of men with American Spinal Injury Association Impairment Scale-A (AIS-A) spinal cord injury (SCI) between cervical-4 (C4) and thoracic-5 (T5) levels.SettingOutpatient rehabilitation clinic.DesignDouble-blind, randomized cross-over placebo-controlled pilot study.Methods20 males with AIS-A SCI, C4-T5 received either tadalafil 20 mg or placebo for the first arm, and then were crossed-over after 1 week to the second arm. SBP, HR, and Visual Analogue Scale (VAS) for dizziness upon sitting up from lying were measured at baseline and again 1, 2, 4, 12, 22, 29, and 36 h post dose administration. The change in each outcome measure (SBP, HR, VAS dizziness) was observed from pre-dose to each time point. A change in VAS dizziness of 2 cm or greater (scale 0–10 cm) was considered positive.ResultsSBP did not change significantly in either group. However, HR increased significantly in the tadalafil group at several time points (12 h p < 0.05, 22 h p <0.05, 29 h p <0.01, and 36 h p <0.05), with no change in the placebo group. The VAS dizziness significantly increased (range 2–6 cm changes) at some time point in 1/4 of the subjects after tadalafil, but not in the placebo group; all reports of dizziness were at 12 h or later.ConclusionsTadalafil use in people with SCI above T6 is safe with respect to…
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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.
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