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Marie Fisk

University of Cambridge & Cambridge University Hospitals NHS Foundation Trust

01 January 0001

There is an urgent need to improve the survival and health of people living with chronic obstructive pulmonary disease (COPD). COPD is a lung condition that causes breathlessness and cough and often people living with the condition have sudden worsening of symptoms called exacerbations or flare-ups. Theseexacerbations are very debilitating and frightening for people living with COPD and can shorten life expectancy. Inhalers are the main type of medicines used to treat COPD and can improve symptoms and breathing capacity and reduce the risk of these exacerbations. Despite the benefits of inhalers, there remains an important unmet need to improve survival and improve the health of people living with COPD. COPD is a leading cause of death worldwide, and COPD exacerbations are the 2nd leading cause of hospital admission in the UK. People living with COPD, in addition to their lung disease, also often have an increased risk of heart attacks and stroke. Whether medicines prescribed to treat cardiovascular disease (CVD) can be of benefit to improve survival and reduce exacerbations is an area of special interest. People living with COPD and who have a diagnosis of CVD too; often don't receive the same recommended treatments as people with CVD, but without COPD. This may be because of concern of undertaking interventional procedures in patients with lung disease. It is therefore imperative that pharmacological therapies (i.e drugs) that may benefit, are more widely considered whether appropriate to prescribe in people living with COPD. Data from a large observational general population study showed that aspirin use was associated with less progression of lung damage in people with COPD. A separate analysis also suggested aspirin use was associated with a reduced number of exacerbations. A smaller COPD study found that aspirin use vs not having a prescription for it, was associated with reduced 1-year mortality following a hospital admission for an exacerbation. Data from studies also suggest benefits of other types of cardiovascular medicines in people with COPD. For example, cardiovascular drugs called beta blockers which reduce heart rate and statins which reduce cholesterol are also thought to be potentially beneficial in reducing the risk of COPD exacerbations, besides their established cardiovascular benefits. Indeed, a randomised placebo-controlled trial is currently underway in the UK to see if a beta blocker called bisoprolol can help reduce risk of exacerbations. The aim of our research proposal is to utilise the uniquely large trial dataset of the SUMMIT COPD trial to find out if we can estimate the effects of cardiovascular medicines on survival and exacerbations. Objectives are: 1.   To determine individual and cumulative effects of cardiovascular medicines on survival in people with COPD.2.   Estimate individual and cumulative effects of cardiovascular medicines on exacerbations.3.   Evaluate the possible benefit vs risk of antiplatelets (i.e aspirin) in COPD.4.   Evaluate the effect of aspirin vs none on decline in breathing capacity over time in people with COPD. The SUMMIT COPD trial is a unique study to utilise to answer these objectives. It is a large trial, and has good quality data in terms of outcomes recorded. Given that eligibility for taking part in the trial meant being at higher risk of CVD, means the cohort has a reasonable proportion of participants prescribed such cardiovascular medicines, which is helpful for analyses. We also hope to evaluate our objectives in a second separate trial population that is different from the SUMMIT trial to see if we get similar results. We will use varied statistical methods to answer our questions. It is very efficient to analyse existing trial data to assess these research objectives and avoids cost and waste of doing further large studies at this stage.

[{ "PostingID": 4109, "Title": "GSK-HZC113782", "Description": "A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease" },{ "PostingID": 16073, "Title": "GSK-CTT116855", "Description": "A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease" }]

Statistical Analysis Plan