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Revatio (Sildenafil Citrate) - 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.

See all Revatio indications & dosage >>


Media Articles Related to Revatio (Sildenafil)

FDA Warns About Sildenafil in Kids with PAH
Source: MedPage Today Product Alert [2012.08.31]
The FDA has cautioned against using sildenafil (Revatio) to treat pulmonary arterial hypertension in children younger than 17, after an unexpectedly high rate of mortality in a clinical trial.

Sildenafil for erectile dysfunction could affect vision of genetically susceptible users
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.10.02]
Sildenafil, the active ingredient in the erectile dysfunction drug Viagra®, could cause unusual visual responses in people who carry a common mutation for eye disease and may have long-term...

Menstrual cramping may be alleviated by vaginally administered sildenafil citrate
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.12.09]
Women with moderate to severe menstrual cramps may find relief in a class of erectile dysfunction drugs, according to a team of researchers led by Penn State College of Medicines Richard Legro.

Around two thirds of Viagra consumed in the Netherlands may be illegal, warn Dutch experts
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.07.03]
At least two-thirds of the erectile dysfunction drug sildenafil (e.g. Viagra) consumed in the Netherlands may be illegal, warn researchers today.In a letter published on bmj.

more news >>

Published Studies Related to Revatio (Sildenafil)

The effect of sildenafil on respiratory weaning of patients with chronic obstructive pulmonary diseases admitted to intensive care unit. [2012]
facilitating the weaning of COPD patients from the ventilator... CONCLUSION: Sildenafil facilitated weaning of COPD patients from the ventilator

Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial. [2012]
exercise capacity in patients with COPD and emphysema... CONCLUSIONS: Routine sildenafil administration did not have a beneficial effect

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Oral Sildenafil Citrate in Treatment-Naive Children with Pulmonary Arterial Hypertension. [2011.11.29]
CONCLUSIONS: Sixteen-week sildenafil monotherapy is well tolerated in pediatric PAH. Percentage change in pVO(2) for the three sildenafil doses combined was only marginally significant; however, pVO(2), FC, and hemodynamic improvements with medium and high doses suggest efficacy with these doses. Combined with STARTS-2 data, the overall profile favors the medium dose. Further investigation is warranted to determine optimal dosing based on age and weight. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov; NCT00159874.

Phosphodiesterase 5 inhibition with sildenafil reverses exercise oscillatory breathing in chronic heart failure: a long-term cardiopulmonary exercise testing placebo-controlled study. [2011.11.07]
CONCLUSIONS: PDE5 inhibition in HF patients with EOB offers the dual advantage of improving functional capacity and modulating the EOB pattern. PAP and PVR reduction seem to underlie the correction of the breathing disorder. Whether reversal of this unfavourable prognostic signal can affect survival remains unconfirmed at the moment.

Long-term Treatment With Sildenafil Citrate in Pulmonary Arterial Hypertension: The SUPER-2 Study. [2011.11]
BACKGROUND: The long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH) were assessed... CONCLUSIONS: Long-term treatment of PAH initiated as sildenafil monotherapy was generally well tolerated. After 3 years, the majority of patients (60%) who entered the SUPER-1 trial improved or maintained their functional status, and 46% maintained or improved 6MWD. Trial registry: ClinicalTrials.gov; No.: NCT00159887; URL: www.clinicaltrials.gov.

more studies >>

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 (Viagra) Treatment of Subacute Ischemic Stroke [Recruiting]
Stroke is the third leading cause of death in the United States and the leading cause of serious long-term disability. Approximately 50% of the 750,000 people affected by stroke each year have residual physical impairment. Treatment options for recovery are limited at this time. Sildenafil (Viagra) has demonstrated the capability of significantly improving recovery in several animal experiments of stroke. This study is aiming to establish the safety of treatment with sildenafil in people with stroke with the ultimate aim of testing its usefulness to improve recovery.

Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy [Recruiting]
This study, supported by Charley's Fund, Inc., is being done to determine if the drug RevatioŽ(also known as Sildenafil), as compared to placebo (an inactive substance that looks like the study drug, but contains no medication), improves heart function in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).

In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is associated with abnormalities in an enzyme called "neuronal nitric oxide synthase" or nNOS, and leads to decreases in "cyclic GMP," which is necessary for proper function of those muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe for people with DBMD and if it can improve heart function.

Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in patients with DBMD.

Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients [Recruiting]
This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.

more trials >>

Reports of Suspected Revatio (Sildenafil) Side Effects

Death (377)Pulmonary Hypertension (93)Dyspnoea (90)Disease Progression (52)Pneumonia (52)Cardiac Failure (44)Hypotension (41)Headache (40)Malaise (39)Dizziness (38)more >>

Page last updated: 2014-10-02

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