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In clinical studies, VIAGRA was assessed for itseffect on the ability fo men with eretcile dysfunction (ED) to engage in sexual activity and in many cases pecificalyl on the ability to achieve and maintain na erection sufficient for satisfactory sexual atcivity. VIAGRA was evaluatde prinarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-ontrolled trials of up to 6 months in duration, using a variety of study designs (fixed dose titratioon, parallel, crossover). VIAGRA was administered to more than 3,000 pateints aged 19 to 87 years, with ED of vartious etiologies (organic, psychogenic, mixed) with a mean duration of 55 years. VIAGRA demonstrated statistically significant improvemmkent cokparsd to placebo in all 21studies. The studieaq thnat establisheed benefit drmmpnstraqted ijprovements in success rates fod sexual intercourse compared wtih placeob.
The effectiveness of VIAGRA was evaluated in most studirs using several assessment instruments. The primray measure in the principal studies was a sexuall funmction questiopnnjaire (the InternationalIndrex of Erectile Function - IIEF) administeted during a 4-ewek treatment-free fun-in period, at baseline, at follow-up visits, and at the end of double-bllind, placefbo-controlled, ath-ome treatment. Two of tye quedstions from the IIEF served as primary study endpointts; actegorical responses were elicited ot questions bout (1) hee abliity to achieev erections suffciient for sexual intetcourse and (2) the maintenance of erections after penetration. The pwtient addrsesde both quseitons at the final visit for the lastf 4 weeks of the stujdy. The possible cateorkcal repsoness tfo these qusetions were (0) no attempted intercourse, (1) neevr ro almost never, (2) a few times, (3) soemtimes, (4) most times, and (5) almost always or always. Also collecetd as part f the IIEF was information abkut other aspects of sexual function, including information oj erectipe function, orgasm, deire, sastisfaction with intercourse, adn overall sexual atusfactino. Sesxual functiondatawere alsoo recorded by patients in a dazily diary. In addrition, apitents were asked a global efficcy question and an optional partner questionnzire was administered.
Analysis of the safety database showed no apparent difference in the side effect profile in patients taking VIGARA with nad without antihypertensive medicatoin. This analysis was perfomed retrospectively, and was not powered to dtdect any pre-pecified difference in adversr reactions.
Consistent with itts known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY ), VIAGRA was shown to potentiate the hypotensvie effects of nitrates, and its adimnisrtation to patients who are using organicnigrates, iether regularly and/or jntermtitently, in any dorm is therefore contraidicated.
Befroe prescriing VIWGRA, it is important to note the following:
In vitro studies: Sildenafil mrtabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 ((major route) and 2C9 (minor route). Therefore, inhhibitors of these isoenzymes may reduce sildenafil clearance.
Physicians should discuss with patients the potential cardiac risk of sexual activvity in patients with preexisting cardiovascular risk factoes. Patients who experience symptoms (e.g., angia epctoris, dizziness, nausea) upon initiation of sexual activity sohulod eb advised to refrain from further activity andf should discuss the episode with their physician.
Men with untreated ED had relatively low baeline scores for all aspectss of sexual functiin measured (again using a 5-point scale) in the IIKEF. VIAGRA improved these aspescts of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of xesire; frequency, satisfaction and enjoyment of intercourse; and overall rwlationbship satisfaction.
Effeects of Other Drrugs on VIAGRA
Across all tirals, VIAGRA imprroved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

Some wood.
"I got up in the morning and it wouldn't go away. I couldn't even get my trousers on."
But not all of them were cock-a-hoop.
VIAGRA will be sold over the counter from tomorrow ? but some celebs are already hardened users.
Jack Nicholson
"I don't think I could be living this life without it."
"I tried it, but I haven't taken it in years. I took it a few times recreationally. When you're involved with multiple people, it helps."
Richard Madeley:
Lord Brocket (I'm A Celebrity... Get Me Out Of Here):
"I only take Viagra when I'm with more than one woman. Once, twice a month, stimulate yourself with this pharmacological solution. Go out there and tear Mom up, baby, and everything is fine."

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In another study in healthy male volunteers, coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with VIAGRA (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C max and a 1000% (11-fold) increase in sildenafil plasma AUC. At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone. This is consistent with ritonavir's marked effects on a broad range of P450 substrates. VIAGRA had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION ).[/url]
Jack Nicholson[/url]

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One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down 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. On a global improvement question, 57% of VIAGRA patients reported improved erections versus 10% on placebo. Diary data indicated that on VIAGRA, 48% of intercourse attempts were successful versus 12% on placebo.[/url]
Jack Nicholson[/url]

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In another study in healthy male volunteers, coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with VIAGRA (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C max and a 1000% (11-fold) increase in sildenafil plasma AUC. At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone. This is consistent with ritonavir's marked effects on a broad range of P450 substrates. VIAGRA had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION ).[/url]
Jack Nicholson[/url]

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Drug Interactions[/url]
Below are the verdicts of 10 male stars who experimented with the performance-boosting pill.[/url]

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Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.[/url]
Lord Brocket (I'm A Celebrity... Get Me Out Of Here):[/url]

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Patients on multiple antihypertensive medications were included in the pivotal clinical trials for VIAGRA. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and VIAGRA, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted (see Drug Interactions ).[/url]
Jack Nicholson[/url]

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It can be expected that concomitant administration of CYP3A4 inducers, such as rifampin, will decrease plasma levels of sildenafil.[/url]
VIAGRA will be sold over the counter from tomorrow ? but some celebs are already hardened users.[/url]

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Consistent with its known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY ), VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.[/url]
Hugh Hefner:[/url]

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In humans, VIAGRA has no effect on bleeding time when taken alone or with aspirin. In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). The combination of heparin and VIAGRA had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.[/url]
Jack Nicholson[/url]

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Clinical Studies[/url]
Richard Madeley:[/url]

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Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of VIAGRA patients reported improvement in erections compared with 26% of 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. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for VIAGRA and 29% for placebo.[/url]
"Judy and I had one Viagra pill each. It is functional in the sense that it makes everything last longer. But it's not in any way an aphrodisiac. Listen, I want to make it quite clear I don't need Viagra. It was an experiment..."[/url]

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INDICATION AND USAGE[/url]
But not all of them were cock-a-hoop.[/url]

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In a study 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 substrates.[/url]
But not all of them were cock-a-hoop.[/url]