Viagra/Sildenafil Clinical Trial on Men With Heart Disease

Men with heart disease history are at higher risk with certain medications and doctors are generally very careful recommending PDE5 inhibitors like Viagra to such patients. Viagra has been analyzed in men with heart failure history, so that its efficacy in treatment of ED, its safety, and its ability to improve the depressive symptoms or life quality, can be determined in such men. In a lot of these medical trials and case studies –  IIEF evaluates the response to erectile dysfunction, the Beck Depression Index (BDI) measures the depressive symptoms and the quality of life is evaluated by the Center for Epidemiologic Studies-Depression Scale (CES-D) as well as the Minnesota Living With Heart Failure Questionnaire (LihFE).

The Study

All the existing medicines that the participants were taking were continued during the trial as well. People who had symptomatic hypotension or SBP < 80 mm Hg at baseline, were not included in this trial. Either placebo or Viagra 50 mg treatment arm was randomized to 35 participants for 6 weeks  and then only they could be taken for other treatment arm. Before the first treatment arm began, all the participants had to participate in a safety protocol where they were given 50 mg of Viagra and then they were observed for 5 hours during which there was ambulatory monitoring of their heart rate and blood pressure. There was intense baseline erectile dysfunction with an average (SEM) IIEF EF Domain score of 9±1.

The protocol was completed by all the 35 participants. There was a good measure of improvement in the erectile dysfunction by week 4 (p<.001) as was measured by IIEF score for men who had been taking Viagra irrespective of the sequence of randomization. Men who were on Viagra reported better scores on the BDI, LihFE and CES-D scales. Men who initially received Viagra showed improvements on all the 3 scales and they later on deteriorated when they were shifted to placebo. Participants who were initially given placebo showed no improvements in the scale scores till the time they were shifted to Viagra and that was when they also showed signs of improvement.

Health changes while on Viagra

There was not much change in the mean blood pressure and heart beat during the four hours after the a 60 mg dose of Viagra had been taken.  A very minor reduction in the blood pressure was observed after one hour of intake of the 50 mg Viagra dosage. There was no reduction of more than 10% in the mean arterial blood pressure at any point of time. No negative effects were reported by any of the participants.

Result

The conclusion drawn by the investigators was that 50 mg of Viagra was safe as well as very effective for the treatment of ED in patients who had NYHA Class II or III heart failure. and definitely improved sexual satisfaction, reduced depressive symptoms and as a result improved the quality of life.

Viagra Clinical Trial On Men With Coronary Artery Problem

In a 12-week randomized double-blind, flexible dose, placebo-controlled study, the safety and efficacy of Viagra was evaluated on men with erectile dysfunction and stable coronary artery problem. Randomization of placebo or Viagra 50 mg was done for 151 men; their doses were adjusted to 25 or 100 mg according to their response. Men who were taking nitrates or CYP3A inhibitors or who were hypotensive, with uncontrolled hypertension, high cardiac risk, unstable angina, hypertrophic obstructive cardiomyopathy or moderate-to-severe stenosis, or who had t taken Viagra earlier were kept out of this study. Initial result measures were IIEF Questions 3 and 4.

Later result measures analayzed Life Satisfaction CheckList (LSC), the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITs), the success rate of intercourse and the two global evaluation questions, “Has treatment improved your ability to have sexual intercourse?” and “Has treatment improved your erection?”. The Partner Questionnaire and the Partner EDITs were given to the partners to complete.

Men who had been randomized to Viagra showed a marked improvement in the penetration frequency as well as the after penetration erection frequency. These results were observed at the end of the treatment. Very high differences were noted between Viagra and placebo in the second result measures as well as in domains of IIEF such as orgasm function, erectile function, intercourse satisfaction and total satisfaction, global as well as assessment questions and in the average scores for 10 of the 11 EDITS things.

The average scores of LSC relating to sexual life (p=0.0186) were notably higher in men who took Viagra, as compared to those who took placebo. Partners participating was very few and so a statistical analysis of the Partner Questionnaire and Partner EDIT could not be done.

There was only one participant who suffered cardiovascular effects associated with Viagra, and which were rectified by decreasing the dosage to 25 mg from 50 mg. In the placebo group, one participant informed of angina. There was no change noticed in 94% of the Viagra group and 97% of the placebo group, as far as the Canadian Cardiovascular Society functional classification of angina criteria was concerned. There was an increase in the angina scores of 3 men from Viagra group and 2 men from the placebo group.

Conclusion

The conclusion drawn by the investigators was that the men suffering from stable coronary artery disease, but not requiring nitrates, can safely take 50mg Viagra without the fear of any extra cardiovascular risk.

 


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