Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia.

INTRODUCTION: Lost productivity accounts for a significant part of the costs caused by gastrointestinal symptoms. We aimed to describe selfreported productivity in patients presenting with dyspepsia. MATERIAL AND METHODS: Data were sourced from a randomized, double-blinded study of two weeks of esomeprazole 40 mg or placebo in 805 primary-care patients with uninvestigated dyspepsia. Work productivity was tested using the Work Productivity and Activity Impairment questionnaire. Treatment effect on work productivity loss was tested according to the likelihood of treatment response. RESULTS: A total of 401/805 employed patients were included in the analysis. The average work productivity loss in the past seven days was 10.5 working hours/week. The productivity loss grew with increasing severity of symptoms at baseline. Following two weeks of treatment, the mean improvement in work productivity was significantly higher for both absenteeism (1 hour versus 0.1 hour, p < 0.05) and presenteeism (5.3 hours versus 4.3 hours, p < 0.05) in patients treated with esomeprazole versus placebo. The most substantial improvement was seen in patients who, based on baseline symptoms, were assessed to be likely treatment responders. CONCLUSION: Dyspepsia symptoms represent a significant economic burden in terms of lost productivity. The RESPONSE algorithm is successful in determining which patients will benefit from acid suppression in terms of enhanced productivity.

Cost-effectiveness of dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation. Applying RE-LY to clinical practice in Denmark.

OBJECTIVE: To estimate the economic implications of introducing dabigatran etexilate ('dabigatran') for anti-coagulation therapy in Danish patients with non-valvular atrial fibrillation based on results of the RE-LY trial. METHODS: The lifetime cost and outcomes of dabigatran and warfarin were estimated using a previously published cost-effectiveness model. The model utilizes the data from the RE-LY study to estimate the costs and outcomes of stroke prevention in atrial fibrillation. Cost estimates were based on official Danish tariffs and prices, and published literature on the cost of stroke. In the base-case analysis a conservative approach was adopted applying tariffs from the lowest range for the cost of International Normalized Ratio (INR) monitoring associated with warfarin. The effectiveness measure of the analysis was quality-adjusted life-years (QALY). RESULTS: The model estimated that the mean cost per patient for the remaining life-time is euro 16,886 treated with warfarin and euro 18,752 treated with dabigatran. This was associated with mean QALYs per patient of 8.32 with warfarin and 8.59 with dabigatran. The resulting incremental cost-effectiveness ratio (ICER) of ∼ euro 7000 per QALY gained is regarded as cost-effective by Danish standards. This conclusion was seen to be robust to realistic variations in input parameters, including adjustment for the RE-LY centres achieving the best INR monitoring quality. Threshold analysis revealed that dabigatran would be cost-saving in settings where the cost of warfarin monitoring exceeds euro 744 per year. LIMITATIONS: The analysis does not include all aspects of Danish clinical practice anti-coagulation that will influence cost-effectiveness of dabigatran, e.g., this study did not attempt to model quality of anticoagulation monitoring and under-utilization in clinical practice. CONCLUSIONS: Based on the outcomes observed in the RE-LY trial, dabigatran represents a cost-effective alternative to warfarin in Denmark for all patients with atrial fibrillation within the licensed indication of dabigatran.

INR variability in atrial fibrillation: a risk model for cerebrovascular events.

BACKGROUND: Use of vitamin K antagonists (VKAs) for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) necessitates frequent monitoring of the international normalized ratio (INR) to avoid the increased risk of hemorrhage associated with excess anticoagulation, or ischemic stroke due to insufficient anticoagulation. We therefore developed a model to estimate the excess morbidity attributable to inadequate INR control in NVAF populations. METHODS: Equations expressing the risk of cerebrovascular events as a function of INR were generated using published data. Additional functions were developed to estimate the excess risk attributable to inferior INR control, using the clinical trial setting as the reference. RESULTS: The derived risk functions were applied to French NVAF patients receiving anticoagulation in routine medical practice. This population achieved a time in therapeutic range (INR 2.0-3.0) of 59%, compared with 68% time in therapeutic range (TTR) in the SPORTIF III and V clinical trials. However, there was considerable variation in the TTR among patients in routine care, of whom 36% were in range for less than 50% of the time. Among this latter group, the relative risk, compared with the clinical trial setting, was 1.47 for ischemic stroke and 2.68 for intracranial hemorrhage. Conversely, for patients achieving a TTR greater than 50%, the relative risks for ischemic stroke and intracranial hemorrhage were 0.99 and 1.16, respectively. CONCLUSIONS: This model permits estimation of the excess risk attributable to inferior INR control in NVAF populations receiving VKA anticoagulation, and has implications for public health planning and management.