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Revatio (Sildenafil Citrate) - Summary



REVATIO, a 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 erectile dysfunction.

REVATIO® is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy.

Studies establishing effectiveness included predominately patients with NYHA Functional Class II-III symptoms and etiologies of primary pulmonary hypertension (71%) or pulmonary hypertension associated with connective tissue disease (25%).

Limitation of Use

The efficacy of REVATIO has not been adequately evaluated in patients taking bosentan concurrently.

See all Revatio indications & dosage >>


Published Studies Related to Revatio (Sildenafil)

Treatment of palmar-plantar erythrodysesthesia (PPE) with topical sildenafil: a pilot study. [2015]
treatment of PPE... CONCLUSIONS: In this limited, single-center study, topical cream containing 1 %

Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of a randomized, double-blind, placebo-controlled trial--treatment of interstitial cystitis/painful bladder syndrome with low-dose sildenafil. [2014]
treatment of nonulcer interstitial cystitis (IC) in women... CONCLUSION: Daily low-dose sildenafil is an easy, well-tolerated, and effective

Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease. [2014]
recurrent ischemic priapism associated with sickle cell disease... CONCLUSIONS: Sildenafil use by systematic dosing may offer a strategy to prevent

Effect of sildenafil on skeletal and cardiac muscle in Becker muscular dystrophy. [2014]
heart function in patients with BMD... INTERPRETATION: Despite positive evidence from animal models of dystrophinopathy

Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. [2013]
STUDY QUESTION: Is a vaginal preparation of sildenafil citrate capable of alleviating acute menstrual pain in patients with primary dysmenorrhea (PD)? SUMMARY ANSWER: A vaginal preparation of sildenafil citrate is capable of alleviating acute menstrual pain in patients with PD with no observed adverse effects.

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Clinical Trials Related to Revatio (Sildenafil)

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions [Completed]
The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

Sildenafil in Single Ventricle Patients [Completed]
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation. Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle. The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.

Pharmacokinetics of Sildenafil in Premature Infants [Recruiting]

Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy [Suspended]
This study, supported by Charley's Fund, Inc., is being done to determine if the drug Revatio(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.

Does Oral Sildenafil (Viagra) Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery? [Completed]
Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Several treatments have been used to treat and reduce post operative pulmonary hypertension. Unfortunately none of these treatments are approved for use in this condition and only one (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung vessels, is easy to administer and does not easily cause low blood pressure in other areas of the body. We hypothesize that oral sildenafil 12. 5mg will decrease the baseline (pre-dose) mPAP by at least 20% compared with a placebo.

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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: 2015-08-10

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