Title of article :
Prulifloxacin Effectiveness in Moderate-to-Severe Acute Exacerbations of Chronic Bronchitis: A Noninterventional, Multicentre, Prospective Study in Real-Life Clinical Practice—The “AIOLOS” Study
Author/Authors :
Gourgoulianis, Konstantinos University Respiratory Clinic - University General Hospital of Larissa, Larissa, Greece , Ruggieri, Alessandro Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , del Vecchio, Alessandra Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , Calisti, Fabrizio Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , Comandini, Alessandro Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , Esposito, Giovanna Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , Di Loreto, Giorgio Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy , Tzanakis, Nikolaos University Respiratory Clinic - University General Hospital of Heraklion (PE.PA.GNI), Heraklion, Greece
Abstract :
Real-world evidence regarding the effectiveness of prulifloxacin in the treatment of acute exacerbations of chronic bronchitis
(AECB) is limited. Therefore, this study aimed to assess the rates and time to symptom improvement and resolution in patients
with moderate-to-severe AECB who were given prulifloxacin in the routine care in Greece. This observational, prospective study,
conducted in 15 hospital-based clinics across Greece, enrolled outpatients >40 years old, with moderate-to-severe AECB, for
whom the physician had decided to initiate treatment with prulifloxacin. Data were collected at prulifloxacin onset (baseline),
7–10 days after baseline, and at least 28 days after therapy completion. Between 23 November 2015 and 27 January 2018, 305
patients (males: 76.4%; mean (standard deviation) (SD) age: 69.7 (9.8) years; Anthonisen type I/II: 94.8%; chronic bronchitis
duration >10 years: 24.9%) were consecutively enrolled. At baseline, >80% had increased sputum volume, cough, dyspnoea, and
sputum purulence. Prulifloxacin improved symptoms in 99.7% of the patients after a mean (SD) of 5.47 (3.57) days, while
symptoms fully recovered after a mean (SD) of 10.22 (5.00) days in 95.4%. &e rate of adverse events related to prulifloxacin was
1.3% (serious: 0.7%). In the routine care in Greece, prulifloxacin was highly effective in moderate-to-severe AECB, while
displaying a predictable safety profile.