Kombinationstherapie bei pulmonaler arterieller Hypertonie – Switch von Selexipag zu intravenösem Treprostinil

Zusammenfassung

Aktuell ist ein breites Spektrum von Substanzen zur Behandlung von Patienten mit pulmonaler arterieller Hypertonie verfügbar. Die aktuellen Empfehlungen orientieren sich bei der initialen medikamentösen Therapie an dem Risiko der Patienten. Bei Patienten mit hohem Risiko wird schon initial eine Triple-Kombination verschiedener Substanzen unter Einbeziehung von Prostanoiden empfohlen.

In der prospektiven, einarmigen, unverblindeten Studie sollte geklärt werden, ob PAH-Patienten unter einer Triple-Therapie von der Umstellung von Selexipag auf intravenöses Treprostinil profitieren. Primärer Endpunkt war das Erreichen eines „Low-Risk“-Status nach 6 (12) Monaten.

Es wurden 27 PAH-Patienten (45 [37; 61] Jahre, 77,8% Frauen) eingeschlossen. Bei Studienbeginn wurden sie einem „Low-Risk“- (n=1), „Intermediate“- (n=12) oder „High-Risk“-Status (n=14) zugeordnet. Eine Verlaufsbeobachtung erfolgte im Mittel über 8 (Spanne 5–11) Monate bei 22 Patienten. Ein Patient wurde nach 4 Monaten erfolgreich transplantiert, weitere 4 Patienten verstarben (in 1 Fall septische Komplikationen unklarer Genese; in 3 Fällen progredientes Rechtsherzversagen). Der primäre Endpunkt (Erreichen des „Low-Risk“-Status) wurde von 12/21 (57,1%) Patienten erreicht (ein weiterer Patient verblieb im „Low-Risk“-Status).

Diese Daten geben (trotz der geringen Zahl von Patienten) einen Hinweis darauf, dass auch bei etablierter Triple-Therapie durch den Wechsel von Selexipag auf intravenöses Treprostinil eine klinische Verbesserung einzelner Patienten möglich ist.

Abstract

A wide range of substances is currently available for the treatment of patients with pulmonary arterial hypertension. The current recommendations for initial drug therapy are based on the patient’s risk profile. For patients at high risk, an initial triple combination therapy with different substances including prostanoids is recommended.

The aim of the prospective, single-arm, unblinded study was to clarify whether PAH patients on triple therapy benefit from switching from selexipag to intravenous treprostinil. The primary endpoint was the achievement of a “low-risk” status after 6 (12) months.

27 PAH patients (45 (37; 61) years, 77.8% women) were included. At study entry they were assigned to low-risk (n=1), intermediate (n=12) or high-risk status (n=14). On average, 22 patients were followed for 8 (range 5–11) months. One patient was successfully transplanted after four months, another four patients died (in one case septic complications of unknown origin; in three cases progressive right heart failure). The primary endpoint (reaching “low-risk” status) was achieved in 12/21 (57.1%) patients (one further patient remained in “low-risk” status).

These data indicate (despite the small number of patients) that even with established triple therapy, clinical improvement in individual patients is possible by switching from selexipag to intravenous treprostinil.

Schlüsselwörter

pulmonal arterielle Hypertonie - Risikostratifizierung - Selexipag - intravenöses Treprostil - Medikamentenpumpe

Keywords

pulmonary hypertension - risk stratification - elexipaq - intravenous trepostinil - drug pump

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