Patients were randomized to placebo or sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.At baseline patients had PPH (80%) or PAH secondary to CTD (20%);WHO functional class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil group compared with the placebo group. Only thing is make sure you use the right dosage that works best for you . San Diego: Academic Press.Adeyeye, Moji Christianah; Brittain Harry, G. (2008). Adverse reactions were generally transient and mild to moderate in nature.At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Sildenafil is also available in other brands and strengths for high blood pressure in the lungs (pulmonary hypertension). Commonly reported It works great . Both sildenafil and the active metabolite have terminal half-lives of about 4 hours.After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).Age, gender, race, and renal and hepatic function were included as factors assessed in the population pharmacokinetic model to evaluate sildenafil pharmacokinetics in patients with PAH. No patients died during the 16-week controlled study.After completing the 16-week controlled study, a patient originally randomized to sildenafil remained on his/her dose of sildenafil or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil. Drug or placebo was administered three times a day.The primary objective of the study was to assess the effect of sildenafil on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. The delay in clinical worsening was demonstrated when Sildenafil for oral suspension, 10 mg/ mL was added to background epoprostenol therapy [see Clinical Studies (14)].
Subjects who had failed to respond to bosentan were also excluded. Turn the bottle back upright with the oral syringe still in place. Start here for a quick overview of the site
This site is provided for educational and informational purposes only, in accordance with our Table 1: Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in-Treated Patients than Placebo-Treated Patients and Incidence ≥ 3% inTable 2: Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Sildenafil + Epoprostenol group at least 6% greater than Epoprostenol group)Disease-Associated Maternal and/or Embryo/Fetal RiskFigure 6: Kaplan-Meier Plot of Mortality by Sildenafil DoseTable 3: Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI)] for the Sildenafil 20 mg Three Times a Day and Placebo GroupStudies of Adults with Pulmonary Arterial Hypertensionmonotherapy (20 mg, 40 mg, and 80 mg three times a day))Figure 9: Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10: Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 1: Mean (95% Confidence Interval)Figure 11: Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Study 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))Figure 12: Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244Sildenafil added to bosentan therapy – lack of effect on exercise capacity)What is the most important information I should know aboutwith any nitrate or guanylate cyclase stimulator medicines.