Clinical characteristics of a large cohort of patients with narcolepsy candidate for pitolisant: a cross-sectional study from the Italian PASS Wakix® Cohort

Mutti, Carlotta;Brunetti, Valerio;Figorilli, Michela;Liguori, Claudio;Pizza, Fabio;Proserpio, Paola;Sacco, Tommaso;Pedrazzi, Giuseppe;Lecomte, Isabelle;Blanchard, Nora;Agostoni, Elio Clemente;Bonanni, Enrica;Centonze, Diego;Cicolin, Alessandro;Della Marca, Giacomo;Ferini-Strambi, Luigi;Ferri, Raffaele;Gigli, Gian Luigi;Izzi, Francesca;Liguori, Rocco;Lodi, Raffaele;Nobili, Lino;Parrino, Liborio;Placidi, Fabio;Puligheddu, Monica;Romigi, Andrea;Savarese, Maria Antonietta;Terzaghi, Michele;Plazzi, Giuseppe

2022-01-01

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Abstract

Introduction: Narcolepsy is a chronic and rare hypersomnia of central origin characterized by excessive daytime sleepiness and a complex array of symptoms as well as by several medical comorbidities. With growing pharmacological options, polytherapy may increase the possibility of a patient-centered management of narcolepsy symptoms. The aims of our study are to describe a large cohort of Italian patients with narcolepsy who were candidates for pitolisant treatment and to compare patients' subgroups based on current drug prescription (drug-naïve patients in whom pitolisant was the first-choice treatment, switching to pitolisant from other monotherapy treatments, and adding on in polytherapy). Methods: We conducted a cross-sectional survey based on Italian data from the inclusion visits of the Post Authorization Safety Study of pitolisant, a 5-year observational, multicenter, international study. Results: One hundred ninety-one patients were enrolled (76.4% with narcolepsy type 1 and 23.6% with narcolepsy type 2). Most patients (63.4%) presented at least one comorbidity, mainly cardiovascular and psychiatric. Pitolisant was prescribed as an add-on treatment in 120/191 patients (62.8%), as switch from other therapies in 42/191 (22.0%), and as a first-line treatment in 29/191 (15.2%). Drug-naive patients presented more severe sleepiness, lower functional status, and a higher incidence of depressive symptoms. Conclusion: Our study presents the picture of a large cohort of Italian patients with narcolepsy who were prescribed with pitolisant, suggesting that polytherapy is highly frequent to tailor a patient-centered approach.