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

Spinal Cord Series and Cases, 2018 · DOI: https://doi.org/10.1038/s41394-018-0137-9 · Published: November 1, 2018

Spinal Cord Injury Urology Cardiovascular Science

Simple Explanation

This study investigates the safety of tadalafil (Cialis) on blood pressure and heart rate in men with spinal cord injuries above the T6 level. The study found that tadalafil does not cause a significant drop in blood pressure but does increase heart rate in this population. Some participants reported dizziness, but tadalafil was generally well-tolerated by the study participants.

Study Duration

Not specified

Participants

20 males with AIS-A SCI, C4-T5

Evidence Level

Level 1: Double-blind, randomized cross-over placebo-controlled pilot study

Key Findings

1
Systolic blood pressure did not change significantly in either the tadalafil or placebo group.
2
Heart rate increased significantly in the tadalafil group at several time points (12 h, 22 h, 29 h, and 36 h) compared to baseline.
3
A small percentage of subjects reported dizziness after tadalafil administration, but none in the placebo group.

Research Summary

This study evaluated the effects of tadalafil on cardiovascular responses in men with spinal cord injuries above T6. The results indicated that tadalafil did not cause hypotension but led to a compensatory increase in heart rate. Tadalafil was generally well-tolerated, with some reports of dizziness, suggesting the need for caution, especially in tetraplegic individuals.

Practical Implications

Clinical Practice

Tadalafil can be considered a safe treatment option for erectile dysfunction in men with SCI above T6 with monitoring of heart rate.

Patient Counseling

Patients should be informed about the potential for increased heart rate and dizziness when using tadalafil.

Further Research

Larger studies are needed to confirm these findings and to specifically assess the effects in tetraplegic individuals.

Study Limitations

1
Small sample size may have led to type-2 errors regarding SBP changes.
2
Measurements were only performed up to 36 hours post-administration, potentially missing longer-term effects.
3
Sub-analysis of cervical vs. thoracic level injuries had small numbers in each group, limiting the conclusions that can be drawn.

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