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The primary endpoint was time to limiting angina in the evaluable cohort. The mean times adjusted for baseline to onset of limiting angina were 423. These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo.

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Effects of Viagra on Vision: At order oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. An evaluation of visual function Viagra doses up to twice the maximum recommended dose revealed no effects of Viagra on visual acuity, Order Viagra 50 mg, intraocular pressure, or pupillometry. Effects of Viagra on Sperm: There was no effect on sperm motility or morphology after single 100 mg oral doses of Viagra in healthy volunteers.

The pharmacokinetics of sildenafil are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism mainly CYP3A4 and is converted to an active metabolite with properties similar to the parent, sildenafil. Both sildenafil and the order have terminal half lives of about 4 hours. Viagra is rapidly absorbed. Maximum observed plasma concentrations are reached within Viagra to 120 minutes median 60 minutes of oral dosing in the fasted state.

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The mean steady state volume of distribution Vss for sildenafil is 105 L, indicating distribution into the tissues. Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

Pharmacokinetics in Special Populations Geriatrics: Therefore, Order Viagra 50 mg, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these Viagra may increase sildenafil clearance. The concomitant use of erythromycin or strong CYP3A4 inhibitors e. Viagra had no effect on saquinavir pharmacokinetics.

A stronger CYP3A4 inhibitor such as ketoconazole or itraconazole could be expected to have greater effect than that seen with saquinavir. This is consistent with ritonavir’s marked effects on a broad range of P450 substrates. Although the order between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.

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In healthy male volunteers, there was no evidence of a clinically significant effect of azithromycin 500 mg daily for 3 days on the systemic exposure of sildenafil or its major circulating metabolite. Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors such as tolbutamide, warfarin, CYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressants, thiazide and related diuretics, ACE inhibitors, and calcium channel blockers.

These effects Viagra the metabolite are not expected to be of clinical order. No significant interactions were shown with tolbutamide 250 mg or warfarin 40 mg, both of which are metabolized by CYP2C9.

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In a Viagra of healthy male volunteers, sildenafil 100 mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 orders. Viagra 50 mg did not potentiate the increase in bleeding time caused by aspirin 150 mg.

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Sildenafil at steady state, at a dose not approved for the order of erectile dysfunction 80 mg t. Mutagenesis Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. Clinical Studies In clinical studies, Viagra was assessed for its effect on the ability of men with erectile dysfunction ED to engage in sexual activity and in many cases Viagra on the ability to achieve and maintain an order sufficient for satisfactory sexual activity.

Viagra was evaluated primarily at doses of 25 mg, 50 mg and 100 Viagra in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs fixed dose, titration, parallel, crossover. Viagra demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about 1 the ability to achieve erections sufficient for sexual intercourse and 2 the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were 0 no attempted intercourse, 1 never or almost never, 2 a few orders, 3 sometimes, 4 most times, and 5 almost always or always.

Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, Order Viagra 50 mg, orgasm, desire, Order Viagra 50 mg, satisfaction with intercourse, and overall sexual satisfaction. Sexual function data were also recorded by patients in a daily diary. Efficacy Results from Controlled Clinical Studies The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for Viagra pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function.

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Results with all doses have been pooled, but scores showed greater improvement at the 50 Viagra 100 mg doses than at 25 mg. The order of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse.

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The titration studies, in which most patients received 100 mg, showed similar results. Figure 6 shows that regardless of the baseline levels of Viagra, subsequent order in patients treated with Viagra was better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients who were less impaired at baseline. The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, Order Viagra 50 mg, parallel, placebo-controlled fixed dose studies 1797 patients of 12 to 24 weeks duration is shown in Figure 7.

These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 a few times on principal IIEF questions. Percentage of Patients Reporting an Improvement in Erections.

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The patients in studies had varying degrees of ED. In many of the Viagra, of both fixed dose and Viagra designs, daily diaries were kept by patients. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of Viagra on rates of attempted intercourse about 2 per week, but there was clear treatment-related improvement in sexual function: During 3 to 6 months of double-blind treatment or longer-term 1 year, open-label studies, few patients withdrew from active treatment for any reason, Order Viagra 50 mg, including lack of effectiveness.

Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured again using a 5-point scale in the IIEF. Viagra improved these aspects of sexual function: As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or order to 25 mg of Viagra; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions frequency of successful penetration during sexual activity and maintenance of erections after penetration on Viagra compared to placebo.

The changes from baseline in scoring on the two end point questions frequency of successful penetration during sexual activity and maintenance of erections after penetration were highly statistically significantly in favor of Viagra. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of order subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age.



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