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Sudden Hearing Losses Prompt Label Change for PDE5 inhibitors. The FDA said it found 29 reports of sudden hearing loss, sometimes temporary, associated with the erectile dysfunction agents after scouring the Adverse Event Reporting System. There have also been cases of sudden hearing loss reported in patients using Revatio (sildenafil) for pulmonary arterial hypertension. Medpage Today. 10/22/07. (Also see: Ear Involvement and Raynaud's)
Tracleer(R) Shows Clinical Benefit As Combination Therapy With Sildenafil For Pulmonary Arterial Hypertension. Data from both studies suggest that Tracleer, when given in combination with sildenafil, is well-tolerated and improves hemodynamics in PAH patients. Medical News Today. 10/24/07. (Also see: Bosentan)
Viagra (sildenafil citrate) Information, FDA Warning. FDA received reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension. U.S. FDA. 10/22/07. (Also see: Ear Involvement and Raynaud's)
Fast and efficient healing of scleroderma-associated acral ulcers with sildenafil. This case demonstrates the efficacy of sildenafil in the treatment of scleroderma-associated refractory acral ulcers. PubMed (Hautarzt) 2007 Jul 22. (Also see: Digital Ulcers)
Addition of sildenafil to bosentan monotherapy in pulmonary arterial hypertension. Addition of sildenafil after bosentan monotherapy failure improved NYHA and 6MWD in IPAH (idiopathic PAH) patients, but failed to improve either parameter in PAH-SSD (scleroderma-associated PAH) patients. Additional studies are needed to assess the tolerability and efficacy of this combination in patients with PAH-SSD. PubMed. Eur Respir J. 2006 Nov 1. (Also see: Bosentan)
Revatio Approved to Treat Rare and Incurable Disease. Pfizer Canada announced today that it has received Health Canada approval for Revatio(TM) (sildenafil citrate), an important new treatment for pulmonary arterial hypertension (PAH). Sildenafil citrate is also the active ingredient in Viagra(R). CNW Group. 08/22/06.
Sildenafil Improves Exercise Ability and Hemodynamics in Patients with Pulmonary Arterial Hypertension Associated with Connective Tissue Disease. Oral sildenafil improves exercise capacity, hemodynamics, and functional class in patients with PAH associated with CTD. It is well tolerated and 20 mg three times daily is a reasonable initial treatment dose. G. Simonneau. OP0161 EULAR 2005.
No Clinical Interaction Between Sitaxsentan and Sildenafil. Concomitant use of Sitaxsentan (SITAX) and Sildenafil (SILDEN) should not require adjustment of either therapy. T. C. Coyne. FRI0058 EULAR 2005.
Successful treatment with sildenafil in systemic sclerosis patients with isolated pulmonary arterial hypertension: two case reports. We propose that oral sildenafil may be beneficial as a selective pulmonary vasodilator and as long-term treatment in SSc patients with isolated PAH. PubMed. Rheumatol Int. 2005 May 25.
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