Revatio (Sildenafil Citrate) - Summary

REVATIO SUMMARY

REVATIO™, an oral therapy for pulmonary arterial hypertension, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Sildenafil is also marketed as VIAGRA^® for male erectile dysfunction.

REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability.

The efficacy of REVATIO has not been evaluated in patients currently on bosentan therapy.

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NEWS HIGHLIGHTS

Media Articles Related to Revatio (Sildenafil)

ED Drug Improves Heart's Pumping Action In Young Patients With Single-Ventricle Disease
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.19]
Heart function significantly improved in children and young adults with single-ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia. Single-ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood.

Tadalafil (Cialis) In The Treatment Of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2009.05.30]
UroToday.com - This updated review of tadalafil (Cialis), one of the three available phosphodiesterase type 5 (PDE5) inhibitors that revolutionized the treatment of erectile dysfunction (ED), analyzes its latest clinical studies. Tadalafil's most unique and identifying characteristic is its long half-life of 17.5 hours, compared with 4 hours for sildenafil (Viagra) and vardenafil (Levitra).

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Published Studies Related to Revatio (Sildenafil)

Emotional Changes in Men Treated With Sildenafil Citrate for Erectile Dysfunction a Double-Blind, Placebo-Controlled Clinical Trial. [2009.09.29]
Introduction. Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem...

A multicenter, randomized, open-labeled, parallel group trial of sildenafil in alcohol-associated erectile dysfunction: the impact on psychosocial outcomes. [2009.09]
To examine the effect of sildenafil on erectile dysfunction (ED) and psychosocial outcomes in alcohol-dependent (AD) men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg) as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks.

Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. [2009.08]
OBJECTIVE: To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat-related post-traumatic stress disorder (PTSD)... CONCLUSIONS: Sildenafil is no better than placebo in treating PTSD-emergent ED. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED.

Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction. [2009.07]
CONCLUSIONS: Although data suggest a possible role of sildenafil for the treatment of FSD, the information should be interpreted cautiously, as many of the studies included small sample sizes, used inappropriate statistical tests, and used nonvalidated assessment tools. A better FSD classification system and consistent use of validated assessment tools might help alleviate differences among clinical trials and provide a more cohesive foundation for assessing the safety and efficacy of sildenafil for the treatment of FSD.

The effects of sildenafil and acetazolamide on breathing efficiency and ventilatory control during hypoxic exercise. [2009.07]
The reduced arterial oxygen tension at high altitude impairs the ability to work. Acetazolamide improves arterial oxygen saturation (SaO(2)) by increasing ventilation but is associated with an increased work and cost of breathing.In conclusion, acetazolamide increased ventilation and reduced breathing efficiency while sildenafil did not affect breathing efficiency despite a trend toward a blunted ventilatory response, possibly due to a reduction in pulmonary hypertension and/or ventilatory drive, during submaximal hypoxic exercise in healthy individuals.

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Clinical Trials Related to Revatio (Sildenafil)

A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes [Completed]
To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire.

A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia [Completed]
The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of sildenafil 50 & 100 mg added to stable antipsychotic treatment in schizophrenia patients to assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory, fluency, attention, spatial memory, motor speed, and executive function) and clinical symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).

Sildenafil Citrate in Waldenstrom's Macroglobulinemia [Terminated]
The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes [Completed]
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.

A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension [Completed]
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

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