Trial reportBMC cardiovascular disorders2017
Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial.
Trial report in BMC cardiovascular disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00323297 (A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension), which is not on this map. Cited by 23 papers, 7 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, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
Who cites it
23 citing papers in PubMed, 7 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Phosphodiesterase type 5 inhibitor plus endothelin receptor antagonist compared to either alone for group 1 pulmonary arterial hypertension.The Cochrane database of systematic reviews · 2025Pooled it
- Treatment of pulmonary arterial hypertension in patients with connective tissue diseases: a systematic review and meta-analysis.Internal and emergency medicine · 2024Pooled it
- Medications for the treatment of pulmonary arterial hypertension: a systematic review and network meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2022Pooled it
- Effects of oral targeted treatments in pulmonary arterial hypertension: A systematic review and meta-analysis.Frontiers in cardiovascular medicine · 2022Pooled it
- Effect of Combination Therapy of Endothelin Receptor Antagonist and Phosphodiesterase-5 Inhibitor on Clinical Outcome and Pulmonary Haemodynamics in Patients with Pulmonary Arterial Hypertension: A Meta-Analysis.Clinical drug investigation · 2019Pooled it
- Phosphodiesterase 5 inhibitors for pulmonary hypertension.The Cochrane database of systematic reviews · 2019Pooled it
- A Systematic Literature Review Exploring the Efficacy and Safety of Tadalafil and Sildenafil in Pulmonary Arterial Hypertension.Pulmonary circulation · 2025Article
- Future Perspectives of Pulmonary Arterial Hypertension: A Review of Novel Pipeline Treatments and Indications.Drugs in R&D · 2024Review
- 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
- Role of Cytochrome P450 2C9 in COVID-19 Treatment: Current Status and Future Directions.European journal of drug metabolism and pharmacokinetics · 2023Review
- Review
- Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review.Journal of personalized medicine · 2022Review
- Efficacy and safety of novel-targeted drugs in the treatment of pulmonary arterial hypertension: a Bayesian network meta-analysis.Drug delivery · 2021Article
- Therapy for Pulmonary Arterial Hypertension: Glance on Nitric Oxide Pathway.Frontiers in pharmacology · 2021Review
- Management of Pulmonary Arterial Hypertension.Current cardiovascular risk reports · 2021Review
- Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.BMC pulmonary medicine · 2020Article
- A meta-analysis of the safety and efficacy of bosentan therapy combined with prostacyclin analogues or phosphodiesterase type-5 inhibitors for pulmonary arterial hypertension.Experimental and therapeutic medicine · 2019Article
- EXPRESS: Switching to riociguat: A potential treatment strategy for the management of CTEPH and PAH.Pulmonary circulation · 2019Article
- A Bayesian network meta-analysis on the efficacy and safety of eighteen targeted drugs or drug combinations for pulmonary arterial hypertension.Drug delivery · 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
5 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFew controlled clinical trials exist to support oral combination therapy in pulmonary arterial hypertension (PAH).
methodsPatients with PAH (idiopathic [IPAH] or associated with connective tissue disease [APAH-CTD]) taking bosentan (62.5 or 125 mg twice daily at a stable dose for ≥3 months) were randomized (1:1) to sildenafil (20 mg, 3 times daily; n = 50) or placebo (n = 53). The primary endpoint was change from baseline in 6-min walk distance (6MWD) at week 12, assessed using analysis of covariance. Patients could continue in a 52-week extension study. An analysis of covariance main-effects model was used, which included categorical terms for treatment, baseline 6MWD (<325 m; ≥325 m), and baseline aetiology; sensitivity analyses were subsequently performed.
resultsIn sildenafil versus placebo arms, week-12 6MWD increases were similar (least squares mean difference [sildenafil-placebo], -2.4 m [90% CI: -21.8 to 17.1 m]; P = 0.6); mean ± SD changes from baseline were 26.4 ± 45.7 versus 11.8 ± 57.4 m, respectively, in IPAH (65% of population) and -18.3 ± 82.0 versus 17.5 ± 59.1 m in APAH-CTD (35% of population). One-year survival was 96%; patients maintained modest 6MWD improvements. Changes in WHO functional class and Borg dyspnoea score and incidence of clinical worsening did not differ. Headache, diarrhoea, and flushing were more common with sildenafil.
conclusionsSildenafil, in addition to stable (≥3 months) bosentan therapy, had no benefit over placebo for 12-week change from baseline in 6MWD. The influence of PAH aetiology warrants future study.
trial registrationClinicalTrials.gov NCT00323297 (registration date: May 5, 2006).
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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 Socratic graph.