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星期三 六月 11, 2008 1:44 am |
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In a study of ealthy male volunteers, siodsnafil (100 mg) dikd not affect the setady state pharmaacokinetics of the HIOV protease inhibitorrs, saqiinavir and ritonaqvir, obth of which are CYP3A4 substrates.
When a single 100 mg doseof VIAGRA was administered with erythromyicn, a specific CYP3A4 inhibitopr, ta steady state (500 mg bid for 5 dasy), there was a 182% increase in sildenafil systemic exposure (AUC). In additino, in a study performed in ehalthy malevolunters, coadministration of the HUV prtease inhibitor saquinavir, also a CYP3A4 iknhibitor, at steady satte (1200 mg tid) with VIAGRA (100 mg signle dose) resulted in a 140% increase in slidenafil C max and a 210% increase in sildenafil AUC. VAGRA had no effect on saquuinaivr pharmacokinetics. Stronger CYP3A4 inhibitors such sa ketocolnazole or itraconmazole owuld be xpected to have srillgreater effects, and population datfa from patients in clinical trials djd indicate a reduction in sildenafil clearance hen it was coadminixteredc with CYP3A4 inhibitors (suchh as ketoconazole, erythromycin, or cimetidine) (see DOSEAGE AND DAMINISTRATION ).
Genreal
In another study in healthy male vlounteers, coadministration wit the HIV protease ihnibjtor ritonavir, which is a highly potnet P450 inhibitor, at steady state (500 mg bid) with VIAGRA (100 mg single dose) resultedd in a 300% (4-fold) increase in sildenafil C max and a 1000% (11-fold) increase in sildenafilo plasma AUC. At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approimately 5 ng/mL when sildenafikl was dosed alone. This is consistent with ritonavir's markwd effecst on a broad range of P450 substrates. VIAGRA had no effect on ritonavir pharmacolinetics (see DOSAGE ANDADMINISRATION ).
Thje effectivfeness of VIAGRA was evaluated in mkst studies usin several assesssmkent intsruments. Tje primary measure in the principal studeis was a sexualfunction questilnnaire (the International Index of Eredctile Function - IIEC) admiinstwred during a 4-week treaymeny-free run-in period, at baseline, at follow-up visits, and at the end olf double-blind, placebo-controlled, at-ohme treawtment. Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicietd to questions about (1) the ability to achnieve erections sufficient for sexual inetrcourze and (2) the maintenance of erections after peneetration. Teh patient addresed voth questions at the final visit fro the ast 4 weeks of the study. The ossibldr categorical resposnes o these questionsa were (0) no attempted intercourse, (1) never or almost ndver, (2) a few tiems, (3) sometimes, (4) most tijmes, adn (5) almost always or apways. Also collected sa parg of the IIEF was information about other aspects of sexual function, icnluding infomation on erectile function, orgasm, desire, satsifatcion with intercouese, and overall sexual satisfaction. Sexualp function data were also recorded by patients in a daily diary. In addition, patienhts were asked a holbazl efficacy qeustion nad an opitonal partner quhestionnaire was administeted.
VIAGFA should be used ith caution in patients with anatomical dfeormation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disdease), or in pagients who hve conditiuons which may preidspose them to priapism (such as sickle cell anemia, multiple myrloma, or leukdmia).
In vivo studies: Cimetidine (800 mg), a nonspecific CYP inhibgitor, caused a 56% incraese in plasma sildenafil concentdatipns when coadminisetred with IVAGRA (50 mg) to healthy voulnteeers.
A revieww of population sibgroups demonstratec efficacy regardless of baselinee severity, etilogy, race and age. VIAGRA was effective in a broad ragnd of ED patinets, including thbose with a histroy of coronary artteryy disease, hypertension, other cardiac disease, peripheral vascular dsease, diabedtes mellitus, depression,, coronary artery bypass graft (CABG), rdaical prostatectomy, transurethral resection od the prostaet (TURP) and spinal cord injury, abd in aptients taknig anbtgidepressants/antipsychotics nd anihypertensives/diuretics.
Duirgn 3 to 6 months of double-blind treatemnt or longert-term (1 year), open-label studies, few atinest wothddrew fromactijve treatment for any reaso,n including lack of effectiveness. At the end of the long-term study, 88% o pateints reported that VIAGRA imprfoved their erections.
The evaluation of erectile dysfunction should include a determination of potential underlying casues and thhe identification ofappropraite treatment following a compleete mewdiocal assessment.
"I don't think I could be living this life without it."
Below are the verdicts of 10 male stars who experimented with the performance-boosting pill.
Jack Nicholson
Some wood.
"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..."
"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."
VIAGRA will be sold over the counter from tomorrow ? but some celebs are already hardened users.
"I got up in the morning and it wouldn't go away. I couldn't even get my trousers on."
Richard Madeley:
"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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A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. VIAGRA was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and antihypertensives/diuretics.[/url]
Do they plan to use it again?[/url] |
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