REVATIO 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.
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NEWS HIGHLIGHTS
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 1Â %
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.
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.
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 >>
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Page last updated: 2015-08-10
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