PMID- 29101500
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2001-1326 (Print)
IS  - 2001-1326 (Electronic)
IS  - 2001-1326 (Linking)
VI  - 6
IP  - 1
DP  - 2017 Nov 3
TI  - Early clinical experiences with nintedanib in three UK tertiary interstitial lung 
      disease centres.
PG  - 41
LID - 10.1186/s40169-017-0172-3 [doi]
LID - 41
AB  - BACKGROUND: Nintedanib has been shown to slow disease progression in patients 
      with idiopathic pulmonary fibrosis (IPF). It was approved by the National 
      Institute for Health and Care Excellence (NICE) in January 2016 for IPF patients 
      with a forced vital capacity (FVC) of 50-80% in the United Kingdom (UK). AIM: To 
      report real world data about our early clinical experience using nintedanib in 
      187 patients with a multi-disciplinary (MDT) diagnosis of IPF in a manufacturer 
      funded patient in need scheme (three UK centres) prior to NICE approval. METHODS: 
      All patients with a MDT diagnosis of IPF from December 2014 to January 2016 
      commenced on nintedanib were included. Demographic details, adverse events (AEs) 
      and where available lung function results were retrospectively collected from 
      clinical letters. RESULTS: 187 patients (76% males) with a median age of 72 years 
      (49-89) were treated with nintedanib. The average pre-treatment FVC was 
      81.1 +/- 19.8% and diffusion capacity of the lungs for carbon monoxide was 
      43.9 +/- 15% (n = 82). Fifty percent of patients started nintedanib because they 
      were ineligible for pirfenidone due to an FVC > 80%. The median treatment course 
      was 8 +/- 4 months. The majority of patients experienced 1-3 AEs with nintedanib 
      (52%, n = 97). The most frequent AEs were diarrhoea (50%), nausea (36%), reduced 
      appetite (24%), tiredness (20%) and gastro-oesophageal reflux (18%). The majority 
      of AEs resulted in no change in treatment (64%, n = 461). 21% (n = 150) of AEs 
      resulted in a dose reduction and 13% (n = 94) necessitated discontinuation of 
      treatment. 1 in 5 patients discontinued treatment either temporarily or on a 
      permanent basis during the monitoring period. In a select cohort of patients, a 
      statistically significant greater proportion of patients remained stable or 
      improved and a lower proportion declined, as depicted by FVC changes of > 5% 
      after nintedanib commencement (P < 0.05 using Chi squared test). CONCLUSIONS: 
      Nintedanib is well tolerated and has an acceptable safety profile. Only 8% of 
      those reporting diarrhoea discontinued treatment either on a temporary or 
      permanent basis. There were no signals with respect to increased cardiovascular 
      morbidity or major bleeding risk. This is in keeping with the INPULSIS clinical 
      trial findings but in a real world cohort.
FAU - Toellner, Hannah
AU  - Toellner H
AUID- ORCID: 0000-0001-6316-4617
AD  - Manchester Medical School, University of Manchester, Stopford Building, Oxford 
      Rd, Manchester, M13 9PT, UK. hannah.toellner@doctors.org.uk.
FAU - Hughes, G
AU  - Hughes G
AD  - Manchester University NHS Foundation Trust, Wythenshawe Hospital, Southmoor Rd, 
      Wythenshawe, Manchester, M23 9LT, UK.
FAU - Beswick, W
AU  - Beswick W
AD  - Hull and East Yorkshire Hospitals NHS Trust, Castle Road, Cottingham, HU16 5JQ, 
      UK.
FAU - Crooks, M G
AU  - Crooks MG
AD  - Hull and East Yorkshire Hospitals NHS Trust, Castle Road, Cottingham, HU16 5JQ, 
      UK.
FAU - Donaldson, C
AU  - Donaldson C
AD  - Newcastle Upon Tyne Hospitals NHS Trust, Queen Victoria Rd, Newcastle upon Tyne, 
      NE1 4LP, UK.
FAU - Forrest, I
AU  - Forrest I
AD  - Newcastle Upon Tyne Hospitals NHS Trust, Queen Victoria Rd, Newcastle upon Tyne, 
      NE1 4LP, UK.
FAU - Hart, S P
AU  - Hart SP
AD  - Hull and East Yorkshire Hospitals NHS Trust, Castle Road, Cottingham, HU16 5JQ, 
      UK.
FAU - Leonard, C
AU  - Leonard C
AD  - Manchester University NHS Foundation Trust, Wythenshawe Hospital, Southmoor Rd, 
      Wythenshawe, Manchester, M23 9LT, UK.
FAU - Major, M
AU  - Major M
AD  - Hull and East Yorkshire Hospitals NHS Trust, Castle Road, Cottingham, HU16 5JQ, 
      UK.
FAU - Simpson, A J
AU  - Simpson AJ
AD  - Newcastle Upon Tyne Hospitals NHS Trust, Queen Victoria Rd, Newcastle upon Tyne, 
      NE1 4LP, UK.
FAU - Chaudhuri, N
AU  - Chaudhuri N
AD  - Manchester University NHS Foundation Trust, Wythenshawe Hospital, Southmoor Rd, 
      Wythenshawe, Manchester, M23 9LT, UK.
LA  - eng
PT  - Journal Article
DEP - 20171103
PL  - United States
TA  - Clin Transl Med
JT  - Clinical and translational medicine
JID - 101597971
PMC - PMC5670096
OTO - NOTNLM
OT  - Idiopathic pulmonary fibrosis
OT  - Nintedanib
OT  - Real world
OT  - Treatment
EDAT- 2017/11/05 06:00
MHDA- 2017/11/05 06:01
PMCR- 2017/11/03
CRDT- 2017/11/05 06:00
PHST- 2017/08/15 00:00 [received]
PHST- 2017/10/22 00:00 [accepted]
PHST- 2017/11/05 06:00 [entrez]
PHST- 2017/11/05 06:00 [pubmed]
PHST- 2017/11/05 06:01 [medline]
PHST- 2017/11/03 00:00 [pmc-release]
AID - 10.1186/s40169-017-0172-3 [pii]
AID - 172 [pii]
AID - 10.1186/s40169-017-0172-3 [doi]
PST - epublish
SO  - Clin Transl Med. 2017 Nov 3;6(1):41. doi: 10.1186/s40169-017-0172-3.