Abstract

Gout flares have been challenging to identify in retrospective databases due to gout flares not being well documented by diagnosis codes, making it difficult to conduct accurate database studies. Previous studies have used different algorithms, and in this study, we used a computer-based method to identify gout flares. The objectives of this study were to identify gout flares in gout patients newly initiated on urate-lowering therapy and evaluate factors associated with a patient experiencing gout flares after starting drug treatment. This was a retrospective cohort study identifying gout patients newly initiated on a urate-lowering therapy (ULT) during the study time period of January 1, 2007–December 31, 2010. The index date was the first dispensed ULT prescription during the study time period. Patients had to be ≥18 years of age on index date, have no history of prior ULT prescription during 12 months before index date, and were required to have 12 months of continuous membership with drug benefit during pre-/post-index. Electronic chart notes were reviewed to identify gout flares; these reviews helped create a validated computer-based method to further identify patients with gout flares and were categorized into 0 gout flares, 1–2 gout flares, and ≥3 gout flares during the 12 months post-index period. Multivariable logistic regression was used to examine patient and clinical factors associated with gout flares during the 12-month follow-up period. There were 8905 patients identified as the final cohort and 68 % of these patients had one or more gout flares during the 12-month follow-up: 2797 patients (31 %) had 0 gout flares, 4836 (54 %) had 1–2 gout flares, and 1272 patients (14 %) had ≥3 gout flares. Using a multivariate regression analyses, factors independently associated with 1–2 gout flares and ≥3 gout flares versus no gout flares were similar, however, with slight differences, such as younger patients were more likely to have 1–2 gout flares and patients ≥65 years of age had ≥3 gout flares. Factors such as male gender, not attaining sUA goal, having ≥3 comorbidities, diuretics use, no changes in initial ULT dose, and not adhering to ULT all were associated with gout flares versus no gout flares. Using a new method to identify gout flares, we had the opportunity to compare our findings with the previous studies. Our study findings echo other previous studies where older patients, male, diuretics, having a greater number of comorbidities, and non-adherence are more likely to have more gout flares during the first year of newly initiating ULT. There is an unmet need for patients with gout to be educated and managed more closely, especially during the first year.

Highlights

  • Acute gout flare is the most common manifestation of gout and has been described as an acute inflammatory reaction with red, swollen, and painful joints [1, 2]

  • The refined computer methodology was applied to a final ‘gold standard’ set of progress notes. This method achieved a 82.1 % sensitivity, 91.5 % specificity, 77.9 % positive predictive value (PPV), and 93.4 % negative predictive value (NPV) for identifying gout flares at the note level [20]

  • There were 8828 gout patients identified as newly initiated on a urate-lowering therapy (ULT), using our selection criteria (Fig. 1); 68 % of these patients had one or more gout flares during the 12-month follow-up

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Summary

Introduction

Acute gout flare is the most common manifestation of gout and has been described as an acute inflammatory reaction with red, swollen, and painful joints [1, 2]. Gout flares are a common finding in gout patients, and it is important to identify them in clinical trials and observational studies so there is a better understanding on how to manage these patients appropriately [10]. Patients with gout flares have greater healthcare resource utilization, decreased quality of life, and loss of work productivity, leading to an increased economic burden for the patient as well as the healthcare system [6, 11,12,13,14,15,16]. It is important to learn how to better manage these patients, to decrease the economic burden, and to help reduce the frequency of gout flares to improve their quality of life

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