PMID- 32807645
OWN - NLM
STAT- MEDLINE
DCOM- 20220121
LR  - 20220121
IS  - 1873-5010 (Electronic)
IS  - 1569-1993 (Linking)
VI  - 20
IP  - 2
DP  - 2021 Mar
TI  - Long-term safety study of colistimethate sodium (Colobreathe(R)): Findings from the 
      UK Cystic Fibrosis Registry.
PG  - 324-329
LID - S1569-1993(20)30816-X [pii]
LID - 10.1016/j.jcf.2020.08.001 [doi]
AB  - BACKGROUND: As part of the risk management plan in Europe, a long-term 
      observational study was conducted to monitor the safety of colistimethate sodium 
      dry powder for inhalation (CMS-DPI) compared to other inhaled antibiotics. 
      METHODS: A cohort of CMS-DPI patients and a matched cohort were identified from 
      the UK Cystic Fibrosis Registry (UKCFR) from 2014-2018. The primary outcome was a 
      composite endpoint, defined as adverse events (AEs) or new cystic fibrosis (CF) 
      complications. Other outcomes included pulmonary exacerbations and treatment 
      discontinuations. RESULTS: Of 1466 and 3503 patients in the CMS-DPI and 
      comparator cohorts, respectively, 82.7% and 79.4% had AEs. Among the most common 
      new CF complications were osteopenia, CF-related diabetes, and increased liver 
      enzymes. The adjusted event rate ratio (ERR) for the primary outcome was 1.25 
      (95% confidence interval [CI]: 1.18-1.33, p<0.001). After excluding new CF 
      complications, there was no difference between cohorts (ERR=1.04, 95% CI: 
      0.79-1.38, p=0.785). Pulmonary exacerbations were common in CMS-DPI and 
      comparator cohorts (78.0% and 79.9% of patients, respectively), with adjusted ERR 
      of 1.02 (95% CI: 0.95-1.10, p=0.523). Rates of discontinuation were similar in 
      the CMS-DPI and Tobramycin inhalation powder comparator cohorts (37.8% and 39.8% 
      of patients, respectively). CONCLUSIONS: There was no difference in the rate of 
      adverse events between CMS-DPI and comparator cohorts. The safety profile of 
      CMS-DPI is similar to those of other inhaled antibiotics, supporting its 
      long-term safety in people with CF. The UKCFR has developed a successful model 
      for partnership with industry to conduct long-term studies aimed at assessing 
      drug safety.
CI  - Copyright (c) 2020. Published by Elsevier B.V.
FAU - Kaplan, Sigal
AU  - Kaplan S
AD  - Teva Pharmaceutical Industries Ltd., Netanya, Israel. Electronic address: 
      Sigalit.Kaplan@teva.co.il.
FAU - Lee, Andrew
AU  - Lee A
AD  - UK Cystic Fibrosis Trust (UKCFT), London, United Kingdom.
FAU - Caine, Noreen
AU  - Caine N
AD  - UK Cystic Fibrosis Trust (UKCFT), London, United Kingdom.
FAU - Charman, Susan C
AU  - Charman SC
AD  - UK Cystic Fibrosis Trust (UKCFT), London, United Kingdom.
FAU - Bilton, Diana
AU  - Bilton D
AD  - National Heart and Lung Institute, Imperial College, London & Royal Brompton 
      Hospital, London, United Kingdom.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200814
PL  - Netherlands
TA  - J Cyst Fibros
JT  - Journal of cystic fibrosis : official journal of the European Cystic Fibrosis 
      Society
JID - 101128966
RN  - 0 (Anti-Bacterial Agents)
RN  - DL2R53P963 (colistinmethanesulfonic acid)
RN  - Z67X93HJG1 (Colistin)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/administration & dosage/*therapeutic use
MH  - Child
MH  - Colistin/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Cystic Fibrosis/*complications
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pseudomonas Infections/*drug therapy
MH  - Registries
MH  - Respiratory Tract Infections/*drug therapy/microbiology
MH  - Symptom Flare Up
MH  - United Kingdom
OTO - NOTNLM
OT  - Colistimethate sodium dry powder for inhalation
OT  - Colobreathe
OT  - Long-term safety
OT  - UK Cystic Fibrosis Registry
COIS- Declaration of Competing Interest Sigal Kaplan is an employee of Teva 
      Pharmaceutical Industries Ltd. Diana Bilton has no conflicts of interest. Susan C 
      Charman, Andrew Lee, and Noreen Caine are employees of the UKCFT, which received 
      financial support from Teva Pharmaceuticals B.V. to conduct this study.
EDAT- 2020/08/19 06:00
MHDA- 2022/01/22 06:00
CRDT- 2020/08/19 06:00
PHST- 2020/05/16 00:00 [received]
PHST- 2020/07/17 00:00 [revised]
PHST- 2020/08/04 00:00 [accepted]
PHST- 2020/08/19 06:00 [pubmed]
PHST- 2022/01/22 06:00 [medline]
PHST- 2020/08/19 06:00 [entrez]
AID - S1569-1993(20)30816-X [pii]
AID - 10.1016/j.jcf.2020.08.001 [doi]
PST - ppublish
SO  - J Cyst Fibros. 2021 Mar;20(2):324-329. doi: 10.1016/j.jcf.2020.08.001. Epub 2020 
      Aug 14.