Michael Baldwin

The inevitable drift to triple therapy in COPD: an analysis of prescribing pathways in the UK

Background Real-world prescription pathways leading to triple therapy (TT) (inhaled corticosteroid [ICS] plus long-acting β2-agonist bronchodilator [LABA] plus long-acting muscarinic antagonist) differ from Global initiative for chronic Obstructive Lung Disease [GOLD] and National Institute for Health and Care Excellence treatment recommendations. This study sets out to identify COPD patients without asthma receiving TT, and determine the pathways taken from diagnosis to the first prescription of TT. Methods This was a historical analysis of COPD patients without asthma from the Optimum Patient Care Research Database (387 primary-care practices across the UK) from 2002 to 2010. Patient disease severity was classified using GOLD 2013 criteria. Data were analyzed to determine prescribing of TT before, at, and after COPD diagnosis; the average time taken to receive TT; and the impact of lung function grade, modified Medical Research Council dyspnea score, and exacerbation history on the pathway to TT. Results During the study period, 32% of patients received TT. Of these, 19%, 28%, 37%, and 46% of patients classified as GOLD A, B, C, and D, respectively, progressed to TT after diagnosis (P<0.001). Of all patients prescribed TT, 25% were prescribed TT within 1 year of diagnosis, irrespective of GOLD classification (P=0.065). The most common prescription pathway to TT was LABA plus ICS. It was observed that exacerbation history did influence the pathway of LABA plus ICS to TT. Conclusion Real life UK prescription data demonstrates the inappropriate prescribing of TT and confirms that starting patients on ICS plus LABA results in the inevitable drift to overuse of TT. This study highlights the need for dissemination and implementation of COPD guidelines to physicians, ensuring that patients receive the recommended therapy.

Improving Clinical Reality in Chronic Obstructive Pulmonary Disease Economic Modelling: Development and Validation of a Micro-Simulation Approach

BackgroundChronic obstructive pulmonary disease (COPD) is a progressive and irreversible disease responsible for the deaths of 3 million people worldwide in 2005, and predicted to be the third leading cause of death worldwide by 2030. Many COPD models developed to date have followed a Markov structure, in which patients or populations can move between defined health states over successive time periods or cycles. In COPD, health states are typically based on disease severity defined solely by lung function, as described by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. These current modelling methods may restrict the ability to reflect the disease progression/clinical pathway or clinical practice.ObjectivesGiven these limitations in previous COPD models, the authors aimed to develop a more flexible model that could improve on the description of the clinical disease pathway. The overall objective of this model was to inform the development of policies, guidelines or cost-effectiveness analyses. A second objective was to validate the model in relation to existing epidemiology studies of COPD.MethodsA patient simulation model was developed in Microsoft Excel™. The predictability of the model was tested by populating it with data from natural history of disease studies as well as with clinical trial data. Each patient moves through the model with demographic characteristics randomly generated from a set distribution. These characteristics determine the risk of clinical events occurring in the model.ResultsThe validation with these studies found the model to have generally good predictive ability, yielding in this way a good degree of external validity.ConclusionsThe micro-simulation model is a flexible approach for modelling COPD that allows consideration of complex COPD treatment pathways. The model was found to be generally robust in terms of predicting clinical outcomes of published studies when tested against other studies. It has significant potential as a tool for supporting future COPD treatment positioning decisions as well as to inform the development of policies, guidelines or cost-effectiveness analyses.

Changes in initial COPD treatment choice over time and factors influencing prescribing decisions in UK primary care : a real-world study

Prescribing patterns in chronic obstructive pulmonary disease (COPD) are often inconsistent with published guidelines. This retrospective, observational study utilised data from the Optimum Patient Care Research Database to examine the changes in COPD prescribing patterns over time and to identify predictors of physician treatment choice for patients newly diagnosed with COPD. Initial therapy was defined as the treatment(s) prescribed at or within 1 year before COPD diagnosis. Changes over time were assessed in three cohorts based on the date of diagnosis: (1) 1997–2001; (2) 2002–2006; and (3) 2007–2010. Factors affecting the odds of being prescribed any initial therapy or any initial maintenance therapy were identified by univariable and multivariable logistic regression. The analysis included 20,154 patients, 45% of whom were prescribed an initial regimen containing an inhaled corticosteroid (ICS), whereas 28% received no initial pharmacological treatment. Prescribing of ICS monotherapy decreased over time, as did the proportion of patients receiving no therapy at or within 1 year before diagnosis. Comorbid asthma, a high exacerbation rate, increased symptoms and poor lung function each increased the likelihood of being prescribed any initial therapy or initial maintenance therapy; comorbid asthma and an annual rate of ⩾3 exacerbations were the strongest predictors. In conclusion, our analyses revealed major differences between actual prescribing behaviour and guideline recommendations for patients with newly diagnosed COPD, with many patients receiving no treatment and large numbers of patients receiving ICS-containing regimens. Predictors of initial therapy were identified.