Characterise the natural history of patients with alpha-1 antitrypsin deficiency in routine care patients with/without COPD

 

COPD is a major cause of death worldwide and few treatments improve survival. Recent research suggests that, in patients with COPD ischaemic heart disease treatments — statins and beta blockers – can improve overall survival. COPD and ischaemic heart disease commonly co-exist and it may be that the beneficial effect of statins and beta blockers is due to improvements in heart disease rather than effects on the COPD disease course. At this time, it is not known if the apparent effects of statins and beta blockers on COPD exacerbation frequency and overall survival are independent of COPD severity.

The study aims to investigate the effect of statins and beta blockers on COPD exacerbation frequency and survival in an observational primary care population stratified by COPD severity (i.e. by lung function and DOSE Index Score).

There will be five core study objectives evaluated for the following patient groups, those treated with:

  • Statins
  • Beta blockers
  • Statins and beta blockers
  • Neither statins nor beta blockers (“control patients”)

Objective 1: Determine the difference in COPD exacerbation frequency in COPD patients
Objective 2: Determine the difference in COPD exacerbation frequency in COPD patients with an apparent “frequent exacerbation phenotype” (defined as ≥2 COPD exacerbations in the prior 12 months)
Objective 3: Determine the difference in all-cause mortality rate (if there are sufficient data available)
Objective 4: Stratify patients according to GOLD classifications and DOSE Index and explore potential differential prescribing levels for statins and beta blockers for different COPD severities.
Objective 5: Evaluate whether lone or combination use of beta blockers and statins results in a greater benefit, in terms of exacerbation frequency or survival.

Dataset: The study will be a retrospective observational study using data from the Optimum Patient Care Research Database (OPCRD). The OPCRD is a UK respiratory dataset containing anonymized, longitudinal, research-quality clinical records and patient-reported outcome data from practices that subscribe to OPC for respiratory review services; the database includes in excess of 341,000 patients at 176 practices. It has Multicentre Research Ethics Committee (MREC) approval for medical research.
Population: All the patients aged ≥18years with a COPD diagnosis.
Index date: the date for a patient’s first prescription for a statins and/or beta blocker (following the date of their first COPD diagnosis).
Duration: 3 year study periodcomprising 1 baseline year for patient characterisation prior to the index date and a 2-year period immediately following the index date.
Primary Outcomes: COPD Exacerbations, defined as: hospitalisation, out of hours medical attendance or accident and emergency attendance for COPD, or treatment with oral corticosteroids and/or antibiotics in patients diagnosed with COPD, or primary care consultation for lower respiratory tract infection/exacerbation.
Secondary Outcomes: All-cause mortality

Recommended Reading
Blamoun AI, Batty GN, DeBari VA, Rashid AO, Sheikh M, Khan MA. Statins may reduce episodes of exacerbation and the requirement for intubation in patients with COPD: evidence from a retrospective cohort study. Int. J. Clin. Pract. 2008 Sep;62(9):1373–8.
Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova H, Tal-Singer R, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N. Engl. J. Med. 2010 Sep 16;363(12):1128–38.
Salpeter SR, Ormiston TM, Salpeter EE. Cardioselective beta-blockers in patients with reactive airway disease: a meta-analysis. Ann. Intern. Med. 2002 Nov 5;137(9):715–25.
Short PM, Lipworth SIW, Elder DHJ, Schembri S, Lipworth BJ. Effect of beta blockers in treatment of chronic obstructive pulmonary disease: a retrospective cohort study. BMJ. 2011;342:d2549.
Rutten FH, Zuithoff NPA, Hak E, Grobbee DE, Hoes AW. Beta-blockers may reduce mortality and risk of exacerbations in patients with chronic obstructive pulmonary disease. Arch. Intern. Med. 2010 May 24;170(10):880–7.

Lead Investigator:
Andrew Wilson, Clinical Senior Lecturer in Respiratory Health, University of East Anglia, Norwich and Honorary Consultant Physician in Respiratory Medicine, Norfolk and Norwich University Hospital, Colney Lane, Norwich, UK
Research Team:
The research team is made up of researchers working at the University of East Anglia, Norwich, UK:
Katie Hawkins, UK
Phyo Myint, UK
Erika Sims, UK

Status: Completed Study
Support: Respiratory Effectiveness Group
Registration:
Documents and Publications:
Protocol
Abstracts
Presentations
Final Publications
Additional Material