Order real viagra

In March 1998, the US Food and Drug Administration (FDA) approved sildenafil citrate (Viagra ® , Pfizer Inc, New York, NY, USA) for the treatment of erectile dysfunction (ED) (FDA 1998).

As of December 2005, more than 27 million men worldwide had received sildenafil for treatment of ED, including an estimated 17 million men in the US (Data on file, Pfizer Inc, New York, NY). Thus, the long-term safety and effectiveness of sildenafil can now be evaluated in men who have been taking the drug for several years. The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less.

For example, 1,358 men with ED completed 1 of 4 double-blind trials and continued with open-label sildenafil treatment in extension studies for a total treatment duration of approximately 1 year (Morales et al 1998; Steers et al 2001).

In the current study, 979 of these men subsequently received up to 4 more years of open-label, flexible-dose (25, 50, and 100 mg) sildenafil.

Preliminary (3-year) results were reported previously (Carson et al 2002; Padma-Nathan et al 2002), and we now present the final data. The population included patients with ED of organic and psychogenic etiology and typical concomitant medical conditions for this population (ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease). Our objective was to assess the long-term safety and effectiveness of sildenafil treatment in men with ED.

This was a 4-year, open-label, flexible-dose (25, 50, and 100 mg) study of sildenafil. Men who previously completed and were compliant with sildenafil or placebo treatment in 1 of 4 double-blind, placebo-controlled trials, and subsequently completed and were compliant with sildenafil treatment in initial open-label extension, were eligible for inclusion in this long-term extension study. Compliance was assessed by medication diaries and by continued study participation. A total of 1,545 men were originally enrolled in the double-blind trials, with 1,358 of these men continuing in the initial open-label extension studies.

The current study includes 979 of the original patients, who agreed to participate in the long-term extension ( Figure 1 ). The procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional).

Number of patients and treatment duration in the original double-blind trials and the initial open-label extensions and disposition throughout 4 years of open-label, flexible-dose (25, 50, and 100 mg) sildenafil long-term extension study. Of the 979 participants who entered the sildenafil long-term extension study, 584 (60%) completed all 4 years.

Reasons for discontinuation, other than insufficient clinical response and treatment-related adverse event (AE), included AE unrelated to treatment, protocol violation, loss to follow-up, and other (eg, loss of interest in participation in a clinical study, loss of sexual partner, and ability to afford sildenafil after approval [thus, no longer needing to participate in a clinical study to obtain the medication]).

N for the satisfaction question (“Are you satisfied with the effect of treatment on your erections?”) is equal to the number of men who answered.

*Some of the discontinued subjects supplied satisfaction data. At the time order real viagra the study started, the FDA stated that there were sufficient routine safety data on sildenafil to make collection of standard adverse event data unnecessary. Therefore, only serious adverse events and adverse events leading to changes in dosing or to temporary or permanent discontinuation were recorded and evaluated by the investigators for relatedness to sildenafil treatment. Because the major focus of this study was safety, and it was designed before the development and validation of patient-reported outcomes to assess satisfaction with the quality of erection (eg, Quality of Erection Questionnaire (Porst et al 2007)) or satisfaction with ED treatment (eg, the Erectile Dysfunction Inventory of Treatment Satisfaction (Althof et al 1999)), effectiveness was assessed by asking, at yearly intervals or at discontinuation, simple, unvalidated general efficacy questions, “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?” The

second

Overall, 979 men initially agreed to participate in the study, most of whom were white (89%) and whose mean age was 58 years ( Table 1 ). The duration of the double-blind trials plus initial open-label extension was 0.9 to 1.2 years (48–60 weeks). Median duration of participation in the open-label, long-term extension study was 4 years, the median number of doses taken was 420 (range, 1–1469) ( Figure 2 ), and the preferred dose was 100 mg in more than 88% of the men. The retention rate was 84% (818/979) the first year, 75% (731/979) the second year, and 66% (648/979) the third year; the entire 4-year extension study was completed by 584 of the initial 979 men (60%) ( Figure 1 ). Reasons for discontinuation included loss of interest in participation in a clinical study, loss of sexual partner, loss to follow-up, ability to afford sildenafil after approval (thus, no longer needing to participate in a clinical study to obtain the medication), insufficient clinical response, and adverse events.

Usage of flexible-dose (25, 50, and 100 mg) sildenafil over 2–1561 days by the 979 participants who entered the study. Age, mean (range) years 58.2 (27–82) Weight, mean (range) kg 89.2 (53.5–158.8) Race, n (%) White 873 (89.2) Black 68 (6.9) Asian 8 (0.8) Other 30 (3.1) ED duration, mean (range) years 4.5 (0.1–35.8) ED etiology, % organic/mixed/psychogenic 72/17/11 Common concomitant medical conditions, n (%) Hypertension 272 (27.8) Diabetes mellitus 213 (21.8) Hyperlipidemia 139 (14.2) History of ischemic heart disease 83 (8.5) Tolerability. Over the 4-year study period, 37 (3.8%) of the men had 1 or more adverse events that led to changes in dosing or to temporary or permanent discontinuation and were determined by the investigators to be treatment-related ( Table 2 ).

Of the 47 events, headache and dyspepsia were most common (n = 10 each), followed by rhinitis (n = 6), flushing (n = 5), abnormal vision (n = 4), dizziness (n = 3), and 1 report each of mild palpitations, moderate tachycardia, diarrhea, nausea, myalgia, hypertonia, respiratory disorder, conjunctivitis, and photophobia. Of the few cardiovascular events determined by the investigator to be treatment related (4 cases of mild flushing and 1 each of moderate flushing, mild palpitations, and moderate tachycardia), only 1 led to permanent discontinuation. In this case the man experienced mild flushing with the first dose of sildenafil 100 mg but continued therapy after a dose reduction.

After 629 days of therapy, at which time his dosage was once again 100 mg, he permanently discontinued sildenafil because of the flushing.

Two other cardiovascular events led to temporary discontinuation (mild flushing and moderate tachycardia), and the remainder were addressed with a change in dosing.

Of the 149 serious adverse events that occurred during the 4 years of the study, including 18 acute myocardial infarctions, none were considered by order real viagra the investigator to be treatment related.

Adverse events that led to changes in dosing or to temporary or permanent discontinuation. Adverse events (AEs) in 979 men Treatment-related a All causality Patients with AEs, n (%) 37 (3.8) 210 (21.5) Discontinued because of AEs, n (%) 11 (1.1) 55 (5.6) Most frequent (?0.5%) AEs, n (%) Headache 10 (1.0) 10 (1.0) Dyspepsia 10 (1.0) 12 (1.2) Rhinitis 6 (0.6) 6 (0.6) Flushing 5 (0.5) 5 (0.5) Coronary artery disorder 0 24 (2.5) Prostatic disorder 0 16 (1.6) Carcinoma 0 14 (1.4) Myocardial infarction 0 11 (1.1) b Arthritis 0 9 (0.9) Bone fracture accidental 0 9 (0.9) Accidental injury 0 7 (0.7) Cerebrovascular disorder 0 7 (0.7) Atrial fibrillation 0 6 (0.6) Cholecystitis 0 6 (0.6) Sepsis 0 5 (0.5) Heart failure 0 5 (0.5) Gastrointestinal carcinoma 0 5 (0.5) Bone disorder 0 5 (0.5) Each treatment year, less than 1% of the men who started the year discontinued sildenafil because of treatment-related adverse events, for a total of only 11 (1.1%) of the original 979 participants over the 4 years of the study ( Table 3 ). Discontinuations were caused by dyspepsia (n = 4), rhinitis (n = 2), abnormal vision plus headache (n = 1), dyspepsia plus rhinitis (n = 1), and flushing, dizziness, and myalgia (n = 1 each). Percentage of participants who discontinued, (n/N) a Study year Treatment-related adverse event Insufficient response Other reasons (not treatment related) 1 0.5 (5/979) 2.2 (22/979) 13.7 (134/979) 2 0.2 (2/818) 2.3 (19/818) 8.1 (66/818) 3 0.1 (1/731) 1.9 (14/731) 9.3 (68/731) 4 0.5 (3/648) 1.1 (7/648) 8.3 (54/648) Effectiveness.

Of the 979 men who participated in the study, 932 (95%) were analyzed for efficacy.

At the completion of each year, at least 94% of the annually decreasing number of participants reported satisfaction with the effect of sildenafil treatment on their erections, with only a 3.3 percentage point variation across the 4 yearly assessments ( Table 4 ). Almost all of these men reported improved ability to engage in sexual activity. Percentage of participants (n/N) a Study year Satisfied with treatment effect on erections Improved ability to have sexual activity End of year End of year 1 98.1 (806/822) 99.6 (803/806) 2 96.6 (672/696) 99.9 (671/672) 3 94.8 (551/581) 99.6 (549/551) 4 96.3 (550/571) 100 (550/550) Each treatment year, less than 3% of the men who started the year discontinued sildenafil treatment because of insufficient clinical response.

Over the 4 years of the study, only 62 (6.3%) of the original 979 participants discontinued because of insufficient response ( Table 3 ).

There are numerous data published on the efficacy and safety of sildenafil treatment for ED.