Adults with a diagnosis of pulmonary arterial hypertension.
Intervention(s), exposure(s)
Approved and soon-to-be approved pharmaceutical interventions for pulmonary arterial hypertension (including mono or combination therapies; excluding calcium channel blockers) i.e. phosphodiesterase-5 inhibitors, prostacyclin-based therapies, endothelin receptor antagonists, tyrosine-kinase inhibitors.
Comparator(s)/ control
Active, placebo, or untreated, depending on the analysis.
Outcome(s)
Primary outcomes
Safety outcomes, focusing on oedema, blood pressure drop, syncope, bleeding, elevated liver enzymes, and line complications associated with treatment infusion.
Secondary outcomes
Treatment discontinuation rates.
Data extraction, (selection and coding)
Titles and abstracts of retrieved studies will be screened independently by two reviewers to identify studies for inclusion. Any disagreement over the eligibility of particular studies will be resolved through discussion with a third reviewer.
After initial title and abstract screens, other authors will be consulted to review the quality of remaining papers.
Data from the included studies will be tabulated. Extracted information will include: study population; details of the treatment and control; safety outcomes; data for assessing the risk of bias.
Risk of bias (quality) assessment
Authors will assess the risk of bias in included studies by considering any blinding of participants/evaluators and any selective reporting of outcomes, as well as noting any other sources of bias.
Strategy for data synthesis
Depending on the methodological heterogeneity of included studies, a narrative description of individual studies and/or summary statistics.
Analysis of subgroups or subsets
None planned
Dissemination plans
Publication in an appropriate peer-reviewed journal.
Contact details for further information
Vallerie McLaughlin
vmclaugh@med.umich.edu
Organisational affiliation of the review
None
Review team
Dr Lucy Bomphrey, Research Evaluation Unit at Oxford PharmaGenesisTM Professor Vallerie McLaughlin, University of Michigan Professor Nazzareno Galiè, University of Bologna Dr Anngret Mallick, Bayer Pharma AG Professor Mari-Ann Wallander, Uppsala University and Bayer AB
Anticipated or actual start date
01 August 2012
Anticipated completion date
31 December 2012
Funding sources/sponsors
Bayer Pharma AG
Conflicts of interest
VMcL has received honoraria/consulting fees from Actelion, Bayer, Gilead, United Therapeutics, and research grants (to the University of Michigan) from Actelion, Bayer, Novartis and United Therapeutics.
NG has been involved with Steering Committee activities for Eli Lilly and company, Actelion, Pfizer, Bayer-Schering, GlaxoSmithKline and Novartis; been a paid lecturer, for Actelion, Eli Lilly and company, Pfizer, Bayer-Schering and GlaxoSmithKline; and has done contract research for Actelion, Pfizer, United Therapeutics, Bayer-Schering, GlaxoSmithKline and Novartis.
M-AW and AM are employees of Bayer AB and Bayer Pharma AG, respectively.
LB is an employee of Oxford PharmaGenesisTM Ltd, which has received project funding from Bayer Pharma AG.
Formal screening of search results against eligibility criteria
Data extraction
Risk of bias (quality) assessment
Data analysis
Prospective meta-analysis
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.
