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January 6, 2018American Journal of Cardiovascular DrugsOpen Access

The addition of selexipag to background double combination therapy reduced the risk of morbidity or mortality by 37% (HR 0.63) compared with placebo in patients with pulmonary arterial hypertension.

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Why the study?

Does the addition of selexipag reduce morbidity/mortality in patients with pulmonary arterial hypertension already receiving double combination therapy (ERA and PDE-5i)?

Population

376 patients with pulmonary arterial hypertension receiving background double combination therapy, including…

Comparison

Selexipag added to background double combination… vs Placebo added to background double combination…

Design

RCT, Randomized, Placebo-controlled

Key result

The addition of selexipag to background double combination therapy reduced the risk of morbidity or mortality by 37% (HR 0.63) compared with placebo in patients with pulmonary arterial hypertension.

Authors

GCGerry CoghlanRCRichard N. ChannickKCKelly Chin

Discussion

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Overview

Supports adding selexipag to double oral therapy in PAH; extends RCT evidence for sequential triple combination.

Study Design

Type

RCT (n=376)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Does the addition of selexipag reduce morbidity/mortality in patients with pulmonary arterial hypertension already receiving double combination therapy (ERA and PDE-5i)?

P
Population
376 adult patients (aged 18-75 years) with pulmonary arterial hypertension receiving background double combination therapy (ERA and PDE-5i), followed for a median of approximately 63 weeks.
I
Intervention
Selexipag added to background double combination therapy (ERA and PDE-5i)
C
Comparator
Placebo added to background double combination therapy (ERA and PDE-5i)
O
Outcome
Composite primary endpoint of morbidity/mortalitycomposite

Main Result

Hazard Ratio: 0.63 (95% CI 0.44–0.9)

Absolute Event Rate: 26.3% vs 40.6%

Adding selexipag to background double combination therapy with an ERA and PDE-5i provides incremental morbidity and mortality benefits in patients with pulmonary arterial hypertension.

Limitations

  • Exploratory post hoc analysis
  • Subgroups analyzed and number of events were smaller than in the overall study
  • Trial was not powered to demonstrate treatment effects in these specific subgroups
  • Potential influence of cross-over, as patients who experienced a non-fatal primary endpoint event could receive open-label selexipag
  • WHO functional class is a subjective measure
  • post hoc analysis

Cite This Study

Coghlan et al. (2018) conducted an RCT in Pulmonary arterial hypertension (PAH) (n=376). Selexipag vs. Placebo was evaluated on Composite of morbidity or mortality (time to first event) (HR 0.63, 95% CI 0.44-0.90). The addition of selexipag to background double combination therapy reduced the risk of morbidity or mortality by 37% (HR 0.63) compared with placebo in patients with pulmonary arterial hypertension.

synapsesocial.com/papers/6aae32b2b01005587e84c412https://doi.org/10.1007/s40256-017-0262-z
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