Single-tablet combination therapy of Macitentan/Tadalafil for patients with pulmonary arterial hypertension: qualitative interview study of the A DUE phase 3 trial
INTRODUCTION: This study explored patient and clinician perspectives on a new fixed-dose combination of macitentan and tadalafil (M/T FDC) in a once-daily single tablet for treatment of pulmonary arterial hypertension (PAH). - METHODS: Qualitative semi-structured interviews were conducted during the...
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| Hauptverfasser: | , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
18 March 2025
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| In: |
Advances in therapy
Year: 2025, Jahrgang: 42, Heft: 5, Pages: 2298-2313 |
| ISSN: | 1865-8652 |
| DOI: | 10.1007/s12325-025-03159-x |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1007/s12325-025-03159-x
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| Verfasserangaben: | Fenling Fan, Stacy Davis, Claire Burbridge, Kelly Chin, Michael Friberg, Ekkehard Grünig, Melanie Hughes, Pavel Jansa, Jörg Linder, Jennifer Rafalski, Alvaro Agustin Rodriguez, Jason A. Randall |
MARC
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| 245 | 1 | 0 | |a Single-tablet combination therapy of Macitentan/Tadalafil for patients with pulmonary arterial hypertension |b qualitative interview study of the A DUE phase 3 trial |c Fenling Fan, Stacy Davis, Claire Burbridge, Kelly Chin, Michael Friberg, Ekkehard Grünig, Melanie Hughes, Pavel Jansa, Jörg Linder, Jennifer Rafalski, Alvaro Agustin Rodriguez, Jason A. Randall |
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| 520 | |a INTRODUCTION: This study explored patient and clinician perspectives on a new fixed-dose combination of macitentan and tadalafil (M/T FDC) in a once-daily single tablet for treatment of pulmonary arterial hypertension (PAH). - METHODS: Qualitative semi-structured interviews were conducted during the open-label period of the global, phase 3 A DUE clinical trial that evaluated M/T FDC. A subset of enrolled patients (N = 26) and site investigators (N = 18 clinicians) were interviewed. Patients received four tablets during double-blind treatment and could be in one of three arms (macitentan + placebo; tadalafil + placebo; M/T FDC + placebo) followed by M/T FDC (one tablet) during the open-label period. Patients and clinicians were asked to share their experience of pre-trial PAH medication, double-blind treatment, and open-label M/T FDC. Thematic analysis was conducted on blinded data. - RESULTS: Patients preferred the M/T FDC tablet (open-label) over the four tablets during double-blind treatment. Patients were satisfied with M/T FDC, highlighting its positive impact on their psychological well-being, through reducing stress associated with managing multiple pills. All patients indicated that having a single, once-a-day pill for PAH was more convenient and associated with greater treatment adherence. Clinicians highlighted that their patients have a high daily pill burden for PAH and other comorbidities, and prefer treatments with an oral mode of administration that reduce the number of daily pills required. Clinicians felt that M/T FDC would be well received in clinical practice and potentially assist in implementing guideline-recommended combination treatment of PAH. - CONCLUSIONS: In this qualitative analysis, all 26 patients and 18 clinicians provided positive feedback on M/T FDC treatment, which was consistent across countries. Reducing the number of pills needed to treat PAH, through use of single-tablet M/T FDC, is highly valued by patients and endorsed by clinicians, who both felt the single-tablet combination therapy could have a positive effect on patients' well-being and increase treatment adherence. | ||
| 650 | 4 | |a Adaptive Clinical Trials as Topic | |
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Antihypertensive Agents | |
| 650 | 4 | |a Clinical Trials, Phase III as Topic | |
| 650 | 4 | |a Clinician interview | |
| 650 | 4 | |a Double-Blind Method | |
| 650 | 4 | |a Drug Combinations | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Fixed-dose combination | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Hypertension, Pulmonary | |
| 650 | 4 | |a Interviews as Topic | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Multicenter Studies as Topic | |
| 650 | 4 | |a Patient interview | |
| 650 | 4 | |a Patient perspective | |
| 650 | 4 | |a Patient Satisfaction | |
| 650 | 4 | |a Phosphodiesterase 5 Inhibitors | |
| 650 | 4 | |a Polypharmacy | |
| 650 | 4 | |a Pulmonary arterial hypertension | |
| 650 | 4 | |a Pulmonary Arterial Hypertension | |
| 650 | 4 | |a Pyrimidines | |
| 650 | 4 | |a Qualitative Research | |
| 650 | 4 | |a Randomized Controlled Trials as Topic | |
| 650 | 4 | |a Sulfonamides | |
| 650 | 4 | |a Tablets | |
| 650 | 4 | |a Tadalafil | |
| 650 | 4 | |a Treatment adherence | |
| 700 | 1 | |a Davis, Stacy |e VerfasserIn |4 aut | |
| 700 | 1 | |a Burbridge, Claire |e VerfasserIn |4 aut | |
| 700 | 1 | |a Chin, Kelly |e VerfasserIn |4 aut | |
| 700 | 1 | |a Friberg, Michael |e VerfasserIn |4 aut | |
| 700 | 1 | |a Grünig, Ekkehard |e VerfasserIn |0 (DE-588)112535801 |0 (DE-627)618892605 |0 (DE-576)31856694X |4 aut | |
| 700 | 1 | |a Hughes, Melanie |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jansa, Pavel |e VerfasserIn |4 aut | |
| 700 | 1 | |a Linder, Jörg |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rafalski, Jennifer |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rodriguez, Alvaro Agustin |e VerfasserIn |4 aut | |
| 700 | 1 | |a Randall, Jason A. |e VerfasserIn |4 aut | |
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