PMID- 37451648
OWN - NLM
STAT- MEDLINE
DCOM- 20230822
LR  - 20230822
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 217
DP  - 2023 Oct
TI  - Prolonged-release pirfenidone in patients with pulmonary fibrosis as a phenotype 
      of post-acute sequelae of COVID-19 pneumonia. Safety and efficacy.
PG  - 107362
LID - S0954-6111(23)00250-0 [pii]
LID - 10.1016/j.rmed.2023.107362 [doi]
AB  - INTRODUCTION: One of the major concerns with post-acute sequelae of COVID-19 
      (PASC) is the development of pulmonary fibrosis, for which no approved 
      pharmacological treatment exists. Therefore, the primary aim of this open-label 
      study was to evaluate the safety and the potential clinical efficacy of a 
      prolonged-release pirfenidone formulation (PR-PFD) in patients having 
      PASC-pulmonary fibrosis. METHODS: Patients with PASC-pulmonary fibrosis received 
      PR-PFD 1800 mg/day (1200 mg in the morning after breakfast and 600 mg in the 
      evening after dinner) for three months. Blood samples were taken to confirm the 
      pharmacokinetics of PR-PFD, and adverse events (AEs) were evaluated monthly using 
      a short questionnaire. Symptoms, dyspnea, and pulmonary function tests 
      (spirometry, diffusing capacity for carbon monoxide, plethysmography, and 6-min 
      walk test [6MWT]) were evaluated at baseline, and one and three months after 
      having started the PR-PFD treatment. RESULTS: Seventy subjects with mild to 
      moderate lung restriction were included. The most common AEs were diarrhea (23%), 
      heartburn (23%), and headache (16%), for which no modifications in the drug study 
      were needed. Two patients died within the first 30 days of enrolment, and three 
      opted not to continue the study, events which were not associate with PR-PFD. 
      Pulmonary function testing, 6MWT, dyspnea, symptoms, and CT scan significantly 
      improved after three months of treatment with PR-PFD. CONCLUSION: In patients 
      with PASC pulmonary fibrosis, three months' treatment with PR-PFD was safe and 
      showed therapeutic efficacy. Still, it remains to be seen whether the pulmonary 
      fibrotic process remains stable, becomes progressive or will improve.
CI  - Copyright (c) 2023 Elsevier Ltd. All rights reserved.
FAU - Sansores, R H
AU  - Sansores RH
AD  - Respiratory Department, Hospital Medica Sur, Mexico City, Mexico.
FAU - Ramirez-Venegas, A
AU  - Ramirez-Venegas A
AD  - Centro Respiratorio de Mexico, Mexico City, Mexico; Tobacco and COPD Research 
      Department, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio 
      Villegas, Mexico City, Mexico.
FAU - Montiel-Lopez, F
AU  - Montiel-Lopez F
AD  - Centro Respiratorio de Mexico, Mexico City, Mexico; Tobacco and COPD Research 
      Department, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio 
      Villegas, Mexico City, Mexico.
FAU - Dominguez-Arellano, S
AU  - Dominguez-Arellano S
AD  - Centro Respiratorio de Mexico, Mexico City, Mexico.
FAU - Alva-Lopez, L F
AU  - Alva-Lopez LF
AD  - Radiology and Image Departament Hospital Medica Sur, Mexico City, Mexico.
FAU - Falfan-Valencia, R
AU  - Falfan-Valencia R
AD  - HLA Laboratory, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio 
      Villegas, Mexico City, Mexico.
FAU - Perez-Rubio, G
AU  - Perez-Rubio G
AD  - HLA Laboratory, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio 
      Villegas, Mexico City, Mexico.
FAU - Olaya-Lopez, E
AU  - Olaya-Lopez E
AD  - Pneumology Department, Hospital Espanol de Mexico, Mexico City, Mexico.
FAU - Zavaleta-Martinez, E O
AU  - Zavaleta-Martinez EO
AD  - Centro Medico Naval, Secretaria de Marina, Mexico City, Mexico.
FAU - Aguilar-Medina, S
AU  - Aguilar-Medina S
AD  - Respiratory Medicine Department, Hospital San Angel Inn Universidad, Mexico City, 
      Mexico.
FAU - Escobar-Alvarado, J C
AU  - Escobar-Alvarado JC
AD  - Sleep Laboratory, Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, 
      Mexico.
FAU - Poo, J L
AU  - Poo JL
AD  - Centro Respiratorio de Mexico, Mexico City, Mexico.
FAU - Matera, M G
AU  - Matera MG
AD  - Department of Experimental Medicine, Chair of Pharmacology, University of 
      Campania 'L. Vanvitelli', Naples, Italy.
FAU - Cazzola, M
AU  - Cazzola M
AD  - Department of Experimental Medicine, Chair of Respiratory Medicine, University of 
      Rome 'Tor Vergata', Rome, Italy. Electronic address: mario.cazzola@uniroma2.it.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20230713
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - D7NLD2JX7U (pirfenidone)
RN  - 0 (Pyridones)
SB  - IM
MH  - Humans
MH  - *COVID-19/complications
MH  - Disease Progression
MH  - Dyspnea/drug therapy/etiology
MH  - *Idiopathic Pulmonary Fibrosis/complications/drug therapy/diagnosis
MH  - Phenotype
MH  - *Pneumonia/drug therapy
MH  - Pyridones/adverse effects
COIS- Declaration of competing interest Nothing to declare. This was an independent 
      study. The Drug Company that markets the study drug only participated in it by 
      providing PR-PFD free of charge without having any involvement in the study 
      design and data collection and analysis.
EDAT- 2023/07/15 10:42
MHDA- 2023/08/16 06:43
CRDT- 2023/07/14 19:29
PHST- 2023/05/14 00:00 [received]
PHST- 2023/07/11 00:00 [revised]
PHST- 2023/07/11 00:00 [accepted]
PHST- 2023/08/16 06:43 [medline]
PHST- 2023/07/15 10:42 [pubmed]
PHST- 2023/07/14 19:29 [entrez]
AID - S0954-6111(23)00250-0 [pii]
AID - 10.1016/j.rmed.2023.107362 [doi]
PST - ppublish
SO  - Respir Med. 2023 Oct;217:107362. doi: 10.1016/j.rmed.2023.107362. Epub 2023 Jul 
      13.