Efficacy and safety of tadalafil when used in monoand initial combination therapy regimens in patients with pulmonary arterial hypertension
Abstract
Objective
. To evaluate the efficacy and safety of tadalafil in 24-week mono- and initial combination therapy in newly diagnosed patients with pulmonary arterial hypertension (PAH).
Material and Methods
. A single-center, open-label, prospective study at the E.I. Chazov National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation in 2024-2025 enrolled patients over 18 years of age with newly diagnosed idiopathic pulmonary arterial hypertension (IPAH) and PAH associated with systemic sclerosis (PAH-SSc) in functional class II-III (WHO) who were prescribed tadalafil-based therapy (Tadacardil Canon, Canonpharma Production, Russia). A total of 47 pts aged 43.8 [37.5; 53.6] yrs were enrolled (28 IPAH pts, 19 PAH-SSD pts). The dose of tadalafil 20 mg once daily, if well tolerated and without hypotension, was increased to 40 mg once in all patients after 4 weeks. Starting monotherapy with tadalafil was prescribed to 11 low-risk patients, combination therapy with tadalafil and macitentan 10 mg/day – to 36 intermediate risk patients. Clinical and instrumental data [functional class, 6-minute walk test (6MWT) with determination of the degree of dyspnea according to Borg, capillary blood oxygen saturation (SpO2); NT-proBNP assessment, echocardiography (Echo), right heart catheterization (RHC)] were assessed at baseline and after 24±2 wks of therapy.
Results.
After 24 wks of treatment, the 6MWT distance in IPAH and PAH-SSD groups increased by 49.9 m…
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