21 Oct OPTIMA Trial: Macitentan +Tadalafil Improves Hemodynamics in Pulmonary Artery Hypertension
MedicalResearch.com Interview with:
Olivier Sitbon, MD, PhD
MedicalResearch.com: What is the background for this study? How does this treatment competition differ from other treatments for PAH?
Response: Pulmonary arterial hypertension (PAH) is a complex, progressive and potentially fatal disease with no cure. Over the past decades, advances in understanding the pathophysiology of PAH have led to major prognostic improvement and developments of new treatment guidelines and therapies. Current treatment guidelines recommend initial combination therapy for these patients to target multiple PAH-associated pathways in parallel.
OPTIMA was a prospective, multicenter, single-arm, open-label, Phase IV trial designed to evaluate the efficacy, safety and tolerability of initial oral combination therapy with macitentan and tadalafil in patients with newly diagnosed PAH. Treatment with macitentan 10 mg once-daily and tadalafil 20 mg once-daily was initiated on the same day. After 8±3 days, tadalafil dose was increased to 40 mg once-daily.
Safety and tolerability findings were consistent with previous clinical trials that supported the approval and use of macitentan 10 mg once-daily. Efficacy outcomes were assessed at Week 16 and safety continued to be monitored until study closure.
The results from the OPTIMA analysis suggest that initial treatment with macitentan in combination with tadalafil is associated with hemodynamic improvement in newly diagnosed patients with pulmonary arterial hypertension
MedicalResearch.com: What are the outcomes of this study?
Response: OPTIMA is the first clinical trial that demonstrates a marked hemodynamic improvement with initial oral double combination therapy in PAH. In this study, macitentan plus tadalafil met its primary endpoint, achieving a 47% reduction in pulmonary vascular resistance (PVR) at week 16 compared with baseline in newly diagnosed patients with PAH. These data are meaningful as PVR is a key marker of disease severity in PAH.
MedicalResearch.com: What should readers take away from your report?
Response: Results from the OPTIMA study showed that initial macitentan and tadalafil combination therapy was well tolerated in newly diagnosed patients with PAH, achieving improved hemodynamic and functional parameters. These data support the use of macitentan as part of a combination regime in patients with PAH, and add to the body of evidence supporting initial combination therapy as the standard of care.
MedicalResearch.com: What future research is planned?
Response: All patients from the OPTIMA trial were enrolled in an open-label extension study (UMBRELLA study) to follow patients for safety.
This study was supported by Actelion Pharmaceuticals.
Citation: Study findings presented at the CHEST Annual Meeting 2019 in New Orleans
Combination drug therapy using macitentan and tadalafil for pulmonary arterial hypertension provides clear benefits
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