Trial reportBMC pulmonary medicine2017
Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension.
Trial report in BMC pulmonary medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00430716 (A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A multinational, multicentre, randomized, parallel group, double-blind study to assess the efficacy and safety of 1mg, 5mg and 20 mg tid of oral sildenafil in the treatment of subjects aged 18 years and over with pulmonary arterial hypertension (pah)
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Pharmacology Management in Improving Exercise Capacity of Patients with Fontan Circulation: A Systematic Review and Meta-analysis.Current cardiology reviews · 2022Pooled it
- Combined Methods (Formal Adjusted Indirect Comparison, Meta-Analysis and Principal Component Analysis) Comparisons of the Safety and Efficacy of Ambrisentan, Bosentan, and Sildenafil in the Patients With Pulmonary Arterial Hypertension.Frontiers in pharmacology · 2020Pooled it
- Phosphodiesterase 5 inhibitors for pulmonary hypertension.The Cochrane database of systematic reviews · 2019Pooled it
- Contemporary Treatment Strategies in Pulmonary Hypertension: A Clinician's Guide.Annual review of medicine · 2026Review
- A Systematic Literature Review Exploring the Efficacy and Safety of Tadalafil and Sildenafil in Pulmonary Arterial Hypertension.Pulmonary circulation · 2025Article
- Platelet Membrane-Encapsulated Poly(lactic-International journal of pharmaceutics: X · 2024Article
- The nitric oxide-soluble guanylate cyclase-cGMP pathway in pulmonary hypertension: from PDE5 to soluble guanylate cyclase.European respiratory review : an official journal of the European Respiratory Society · 2024Review
- Contribution of pressure and flow changes to resistance reduction after pulmonary arterial hypertension treatment: a meta-analysis of 3898 patients.ERJ open research · 2024Article
- Article
- Inadequate Dosage May Lead to the Recurrence of Postoperative Pulmonary Hypertension in Patients With Congenital Heart Disease.Frontiers in pharmacology · 2021Article
- Clinical efficacy of tadalafil compared to sildenafil in treatment of moderate to severe canine pulmonary hypertension: a pilot study.Journal of veterinary cardiology : the official journal of the European Society of Veterinary Cardiology · 2019Article
- Betaine Attenuates Monocrotaline-Induced Pulmonary Arterial Hypertension in Rats via Inhibiting Inflammatory Response.Molecules (Basel, Switzerland) · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn a previous study, 6-minute walk distance (6MWD) improvement with sildenafil was not dose dependent at the 3 doses tested (20, 40, and 80 mg 3 times daily [TID]). This study assessed whether lower doses were less effective than the approved 20-mg TID dosage.
methodsTreatment-naive patients with pulmonary arterial hypertension were randomized to 12 weeks of double-blind sildenafil 1, 5, or 20 mg TID; 12 weeks of open-label sildenafil 20 mg TID followed. Changes from baseline in 6-minute walk distance (6MWD) for sildenafil 1 or 5 mg versus 20 mg TID were compared using a Williams test. Hemodynamics, functional class, and biomarkers were assessed.
resultsThe study was prematurely terminated for non-safety reasons, with 129 of 219 planned patients treated. At week 12, 6MWD change from baseline was significantly greater for sildenafil 20 versus 1 mg (P = 0.011) but not versus 5 mg. At week 24, 6MWD increases from baseline were larger in those initially randomized to 20 versus 5 or 1 mg (74 vs 50 and 47 m, respectively). At week 12, changes in hemodynamic parameters were generally small and variable between treatment groups; odds ratios for improvement in functional class were not statistically significantly different. Improvements in B-type natriuretic peptide levels were significantly greater with sildenafil 20 versus 1 but not 5 mg.
conclusionsSildenafil 20 mg TID appeared to be more effective than 1 mg TID for improving 6MWD; sildenafil 5 mg TID appeared to have similar clinical and hemodynamic effects as 20 mg TID.
trial registrationClinicalTrials.gov NCT00430716 (Registration date: January 31, 2007).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.