Systematic review of randomised, double‐blind clinical trials of oral agents conducted in patients with pulmonary arterial hypertension

@article{Torres2007SystematicRO,
  title={Systematic review of randomised, double‐blind clinical trials of oral agents conducted in patients with pulmonary arterial hypertension},
  author={Fernando Torres},
  journal={International Journal of Clinical Practice},
  year={2007},
  volume={61}
}
  • F. Torres
  • Published 1 October 2007
  • Medicine
  • International Journal of Clinical Practice
Background:  Therapies have become available in the last decade that may provide more than symptomatic benefit in patients with pulmonary arterial hypertension (PAH). With choices for possible therapy, it is important to compare the results observed in randomised, double‐blind clinical trials. The objective of this systematic review was to compare the published results for the different oral therapeutic agents for the treatment of PAH. 
Oral therapies for the treatment of pulmonary arterial hypertension
TLDR
The data suggested similar clinical efficacy over 12–16 weeks between agents, as indicated by the identical magnitude of the SMD between the active agent and placebo and the non-significant differences between drugs as determined by the meta-regression analysis. Expand
Meta-analysis of randomized controlled trials on treatment of pulmonary arterial hypertension.
TLDR
Inhaled Iloprost and oral bosentan and sildenafil are effective and safe in treating PAH and iloprost had the highest incidence of serious adverse events among the 3 drugs. Expand
Endothelin receptor antagonists for pulmonary arterial hypertension.
TLDR
Endothelin receptor antagonists can increase exercise capacity, improve World Health Organization/New York Heart Association functional class, prevent WHO/NYHA functional class deterioration, reduce dyspnoea and improve cardiopulmonary haemodynamic variables in patients with pulmonary arterial hypertension. Expand
Sitaxentan for the Oral Treatment of Pulmonary Arterial Hypertension: Benefits from Endothelin Receptor Subtype Selectivity?
TLDR
In clinical trials of up to one year duration the propensity of sitaxentan to induce elevation of liver transaminases and hepatic failure was signifi cantly lower than that of bosentan. Expand
Cardiopulmonary exercise testing in patients with pulmonary hypertension: clinical recommendations based on a review of the evidence
TLDR
Class-based recommendations with associated levels of evidence for the use of CPX in the PH patient population are given and additional research is needed to better define optimal CPX measures and associated cutoff values. Expand
Treatment of pediatric pulmonary hypertension
TLDR
The basic physiology behind pulmonary hypertension and pulmonary vascular disease is explained, the histopathologic process and the various diagnostic tools are described and are followed by the current and future therapy at the disposal. Expand
Inhaled tyrosine kinase inhibitors for pulmonary hypertension: a possible future treatment
TLDR
It is indicated that imatinib is superior to erlotinib with regard to small droplet size formation using both inhaled technologies and ultrasound technologies, and further in vivo experimentation is necessary to investigate the positive effects of these drugs in the treatment of pulmonary hypertension. Expand
Ambrisentan for the treatment of pulmonary arterial hypertension
TLDR
Its once daily dosing and lower incidence of serum aminotransferase elevation offer potential advantages over other ERAs, but further experience with this agent is needed to fully understand its long-term efficacy and safety. Expand
PDE5 inhibitors and pulmonary hypertension
TLDR
Future studies are required to assess the potential use of other PDE5 antagonists and combination therapy on pulmonary hemodynamics, functional capacity, and long-term prognosis in the treatment of pulmonary arterial hypertension. Expand
Effectiveness, safety and costs of orphan drugs: an evidence-based review
TLDR
Evaluating the clinical effectiveness of orphan drugs that have been granted marketing licenses in Europe, determining the annual costs of each drug, compare the costs of branded orphan drugs against their generic equivalents, and explore any relationships between orphan drug disease prevalence and annual costs suggest there is inconsistency in the quality of evidence. Expand
...
1
2
...

References

SHOWING 1-10 OF 28 REFERENCES
Clinical efficacy of sildenafil in primary pulmonary hypertension: a randomized, placebo-controlled, double-blind, crossover study.
TLDR
Sildenafil significantly improves exercise tolerance, cardiac index, and QOL in patients with PPH in a randomized, double-blind, crossover design. Expand
A randomized, placebo-controlled, double-blind, crossover study to evaluate the efficacy of oral sildenafil therapy in severe pulmonary artery hypertension.
TLDR
Sildenafil significantly improved the symptomatic status, exercise capacity, NYHA class, and hemodynamic parameters of patients with severe PAH and can be safely used as a primary or adjunctive treatment of the same. Expand
End points and clinical trial designs in pulmonary arterial hypertension: clinical and regulatory perspectives.
TLDR
Quality of life will become a very important issue; however, appropriate quality-of-life questionnaires for PAH have yet to be developed, and hemodynamics will likely remain valuable as secondary end points, but future clinical trials should include hemodynamics obtained both during exercise and at rest. Expand
Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension.
TLDR
Results of this study demonstrate that the addition of inhaled iloprost in patients with PAH with reduced exercise capacity on bosentan monotherapy is safe and efficacious. Expand
Effects of the dual endothelin receptor antagonist bosentan in patients with pulmonary arterial hypertension: a 1-year follow-up study.
TLDR
Long-term treatment with bosentan is safe and has sustained benefits on exercise capacity and hemodynamics in patients with PAH and was associated with an improvement in hemodynamic parameters and modified NYHA functional class. Expand
Bosentan Therapy in Patients With Eisenmenger Syndrome: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study
TLDR
In this first placebo-controlled trial in patients with Eisenmenger syndrome, bosentan was well tolerated and improved exercise capacity and hemodynamics without compromising peripheral oxygen saturation. Expand
Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebocontrolled study
TLDR
Bosentan increases exercise capacity and improves haemodynamics in patients with pulmonary hypertension, suggesting that endothelin has an important role in pulmonary hypertension. Expand
Ambrisentan therapy for pulmonary arterial hypertension.
TLDR
Ambrisentan appears to improve exercise capacity, symptoms, and hemodynamics in patients with PAH, and the incidence and severity of liver enzyme abnormalities appear to be low. Expand
Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan.
TLDR
Treatment with the selective ET(A) receptor antagonist sitaxsentan, orally once daily at a dose of 100 mg, improves exercise capacity and WHO FC in PAH patients, with a low incidence of hepatic toxicity. Expand
Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHE-2
TLDR
This study showed a trend but no statistical significance towards haemodynamics or clinical improvement due to the combination of bosentan and epoprostenol therapy in patients with pulmonary arterial hypertension. Expand
...
1
2
3
...