A randomized, placebo-controlled, crossover, double-blind, single-dose multi center was used to to study the effect of Levitra on the cardiovascular response to exercise in men with stable coronary artery disease (CAD).
The clinical trial measured the blood pressure and heart rate effected from Levitra 10 mg (orally) and placebo on limited symptom treadmill exercise time, first awareness of angina or time to ST-segment depression >1 mm change from the starting during treadmill exercise using the Bruce protocol, and at rest as well as during exercise.
Please note that this clinical trial was not performed to prove the efficacy of Levitra – rather the study is to study the cardiovascular response on patients with coronory artery disease. This means that even men who did not have erectile dysfunction were included in the trial.
Placebo was given to subjects in between the run-in screen so that the exertion angina or similar exercise could be verified. A washout period of five to twenty one days was required between the two randomized arms. One hour after the drug was given, exercise testing as well as initial measurements were observed. Out of 53 men, 41 men were randomized and finished the study. As per the protocol, 39 subjects out of them were taken as valid.
The average total treadmill time and the average time to initial angina awareness were almost same with Levitra as well as placebo. As compared to placebo, 10mg of Levitra symbolically increased the average time to ST-segment depression to ≥1 mm.
When the subjects with angina and ≥1 mm ST-segment depression were analyzed, it was found that there was no significant difference in the average total treadmill time or the time to first awareness of angina between Levitra and placebo.
However, the investigators did observe that Levitra for sure increased the average time to ST-segment depression. There were very loud mean differences between Levitra and placebo with regards to systolic and diastolic blood pressure at rest and at the time of highest exercise. At rest, there was an slight mean difference in the heart rate that was not significant.
Negative events were observed at the time of the study were more usual with vardenafil (vs. Placebo) and steady with the others of its category: facial flushing (12% vs. 0), any event (24% vs. 2%), headaches (7% vs. 0) and dizziness (2% each). However these are customary side effects of all PDE5 inhibitors under normal conditions and occurs temporarily.
The conclusion drawn was that the ability of men with coronary artery disease to workout and exercise was not impaired by Levitra(vardenafil). This also means that men with coronary artery disease can safely take Levitra and participate in sex without experiencing any cardiovascular related adverse events due to the rigors of sexual activity.