This content has not been reviewed within the past year and may not represent Web MD's most up-to-date information. To find the most current information, please enter your topic of interest into our search box. " June 8, 2005 -- The FDA has approved Viagra's active ingredient to treat pulmonary hypertension, a rare, life-shortening lung disorder that causes high blood pressure in the lungs. Viagra's maker, Pfizer, a Web MD sponsor, announced the approval in a news release. Pfizer will repackage Viagra's key ingredient (sildenafil) and market it as Revatio. Revatio would be used to improve exercise ability in patients with pulmonary hypertension, says Pfizer. The approved dose is limited to 20 milligrams three times daily. Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, has been prematurely discontinued due to a higher incidence of persistent pulmonary hypertension of the newborn (PPHN) and neonatal mortality in the sildenafil arm of the study. Interim data from an independent clinical trial, the Dutch STRIDER (Sildenafil The Rapy in Dismal prognosis Early-onset fetal growth Restriction) study, suggest an increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal mortality when sildenafil was used in pregnancy for intrauterine (fetal) growth restriction compared with placebo. The group assigned to sildenafil had an incidence of 17 cases of PPHN in 64 babies (27%), including 11 deaths before discharge. In the placebo group, 3 of 58 babies (5%) had PPHN, with no reported deaths before discharge. These findings occurred in the absence of any benefit shown on the primary endpoint of neonatal survival until term age. The Dutch STRIDER study was one of 5 independent studies by an international collaboration investigating the use of sildenafil for this unauthorised use.
REVATIO is contraindicated in patients with concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension. REVATIO is contraindicated in patients with concomitant use of riociguat, a soluble guanylate cyclase (s GC) stimulator medication. PDE5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. REVATIO is contraindicated in patients with a known hypersensitivity to sildenafil or any other ingredient in REVATIO. Hypersensitivity, including anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction has been reported in association with the use of sildenafil. Use of REVATIO, particularly chronic use, is not recommended in children. Before starting REVATIO, physicians should carefully consider whether their patients with underlying conditions could be adversely affected by the mild and transient vasodilatory effects of REVATIO on blood pressure. Madrid, Spain—The prescribing of sildenafil to treat residual hypertension in patients with valvular heart disease should raise a red flag for pharmacists. That warning came from late-breaking results of the SIOVAC trial that were presented at the European Society of Cardiology meeting in Barcelona, Spain. At a Hot Line LBCT Session at the ESC Congress, Hospital General Universitario Gregorio Marañon–led researchers reported that off-label use of the drug led to worse clinical outcomes, including twice the risk of hospitalization, compared with placebo.“Valvular disease is considered the next cardiac epidemic because of its strong association with age and the rapid aging of the population worldwide,” said principal investigator Javier Bermejo, MD, Ph D. “The only established treatment is repair or replacement of the valve surgically or percutaneously. But symptoms often remain or reappear in the long-term. Residual pulmonary hypertension is the most important risk factor for death and disability after successful correction of the valvular lesion.”Increased blood pressure in the pulmonary artery might persist after valve treatment, according to the study, which points out that sildenafil—which usually is used to treat erectile dysfunction—is frequently prescribed off-label in patients with retrograde pulmonary hypertension. Conducted in 17 public hospitals and coordinated by the Spanish Network Centre for Cardiovascular Research (CIBERCV), the SIOVAC trial looked at whether sildenafil can improve long-term outcomes in patients with residual pulmonary hypertension after correction of a valvular lesion.
BARCELONA, SPAIN — Patients with residual pulmonary hypertension PH following successful valvular surgery should not be treated with sildenafil, suggest results of the first randomized. Original Article from The New England Journal of Medicine — Sildenafil Citrate Therapy for Pulmonary Arterial Hypertension.