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Consistent with its known effects on the nitric oxidecGMP pathway, Viagra was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2. 3), Contraindications (4. 1), Clinical Pharmacology (12.

In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84), mixed erectile dysfunction (77), organic erectile dysfunction (68), elderly (67), diabetes mellitus (59), ischaemic heart disease (69), hypertension (68), TURP (61), radical prostatectomy (43), spinal cord injury (83), depression (75). The safety and efficacy of sildenafil was maintained in long term studies. The European Medicines Agency has waived the obligation to submit the results of studies with VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction. See section 4. 2 for information on paediatric use.

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