Revatio (sildenafil) for pulmonary hypertension
Fact-checked by What is Revatio for pulmonary arterial hypertension?
Revatio (sildenafil) is an approved medication that works to improve exercise ability in adults and children with pulmonary arterial hypertension (PAH) and to delay clinical worsening in patients 18 and older.
PAH occurs when the pulmonary arteries, which carry blood to the lungs, become narrowed, restricting blood flow and increasing pressure. As a result, the heart needs to work harder to circulate blood. Symptoms of PAH, which may include fatigue and shortness of breath, can make it more difficult to exercise and do everyday tasks.
Revatio inhibits the enzyme phosphodiesterase-5, which typically breaks down a molecule called cyclic guanosine monophosphate (cGMP) that helps blood vessels relax and widen. This increases cGMP levels, in turn widening the pulmonary arteries, lowering pressure, and reducing heart strain to ease PAH symptoms.
Originally developed by Pfizer and now marketed by Viatris, Revatio is available in the U.S. and Europe in oral tablet, oral liquid suspension, or intravenous (into-the-vein) injection formulations. Generic versions of all three formulations are available. The therapy’s active ingredient, sildenafil, is also sold as oral tablets under the brand name Viagra for treating erectile dysfunction.
Therapy snapshot
| Brand name | Revatio |
| Chemical name | Sildenafil |
| Usage | Used to treat adults and children with PAH, ages 1 and older |
| Administration | Oral tablet, oral liquid suspension, or intravenous injection |
Who can take Revatio?
Revatio is approved in the U.S. for certain people with PAH, designated as World Health Organization (WHO) Group 1. It can be used to:
- improve exercise ability and delay clinical worsening in adults with PAH
- improve exercise ability in children ages 1 to 17, or improve blood flow measures thought to underlie exercise improvements in children too young for exercise testing
The medication is contraindicated, or should not be used, by individuals who:
- are taking Adempas (riociguat) or organic nitrates
- have a history of severe immune reactions to sildenafil or other ingredients in any formulation of Revatio
How is Revatio administered?
Revatio is available as oral tablets, an oral liquid suspension, or an intravenous injection formulation.
The oral versions can be taken at home by adults and children.
- For adults, the recommended starting dose is 20 mg, three times daily, which may be increased to a maximum of 80 mg, three times daily, based on symptoms and tolerability.
- Children receive a weight-based starting dose of either 10 mg or 20 mg, three times daily. For children weighing at least 45 kg (approximately 100 pounds), the dose may be increased to a maximum of 40 mg, administered three times daily.
The oral suspension formulation comes as a powder that must be dissolved in water before administration.
The intravenous formulation is only indicated for adults and is typically administered by medical professionals in a healthcare setting. The recommended dose is 10 mg, three times daily.
Revatio in clinical trials
A number of clinical trials supported Revatio’s approval for adults with PAH.
- The Phase 3 SUPER-1 trial (NCT00644605) showed that Revatio, at any of three daily doses, increased exercise capacity compared with a placebo in adults with PAH.
- A subsequent long-term extension study called SUPER-2 (NCT00159887) found that most participants on Revatio maintained or improved their WHO functional class with up to three years of treatment, suggesting stable or decreased disease burden.
- The Phase 4 AFFILIATE trial (NCT02060487) demonstrated the safety of Revatio at doses ranging from 5-80 mg, with no significant differences in mortality rates observed. Higher doses were associated with greater gains in exercise capacity and a delay in clinical worsening.
Revatio’s pediatric approval is primarily based on a Phase 3 trial and its extension study.
- The Phase 3 STARTS-1 trial (NCT00159913) showed that a measure of oxygen consumption associated with exercise capacity tended to improve with Revatio relative to a placebo in children ages 1-17.
- A subsequent extension study, STARTS-2 (NCT00159874), demonstrated clinical stability in the children after a year of treatment, with favorable survival rates.
In addition to testing Revatio as a monotherapy, two large trials have tested it as part of combination regimens.
- The Phase 3 PACES-1 trial (NCT00159861) found that a combination of Revatio and Flolan (epoprostenol) led to greater improvements in exercise capacity and delayed clinical worsening among PAH patients compared with Flolan alone.
- A Phase 4 study (NCT00323297) performed similar comparisons for Revatio plus Tracleer (bosentan), but found no significant benefits of the combination.
All of these trials involved the Revatio oral tablets. Bioequivalence studies have been conducted to establish that the liquid suspension and intravenous injection formulations are expected to work similarly in the body.
Revatio side effects
The most common side effects of Revatio in adults are:
- headache
- indigestion
- flushing
- pain in limbs
- muscle pain
- back pain
- diarrhea
In children, the most common side effect is prolonged and painful erections (priapism) that are unrelated to sexual stimulation.
Revatio also comes with warnings that it could cause:
- low blood pressure, particularly in people with certain underlying conditions
- nosebleeds
- vision or hearing loss
- priapism
- pain crises in people with pulmonary hypertension secondary to sickle cell disease
Revatio could cause a worsening of pulmonary veno-occlusive disease (PVOD), a rare cause of PAH, and is not recommended for these patients. If fluid accumulation in the lungs occurs on Revatio, patients should be evaluated for PVOD.
Revatio may interact with other medications, including Viagra. Patients should tell their healthcare providers about all medications they are using.
Pulmonary Hypertension News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
