Changes in primary care management of atrial fibrillation patients following the shift from warfarin to non-vitamin K antagonist oral anticoagulants: a Norwegian population based study.

BACKGROUND: To assess baseline characteristics, drug utilisation and healthcare use for oral anticoagulants (OACs) following the introduction of non-vitamin K antagonist oral anticoagulants among patients with atrial fibrillation in primary care in Norway. METHODS: In this retrospective longitudinal cohort study, 92,936 patients with atrial fibrillation were identified from the Norwegian Primary Care Registry between 2010 and 2018. Linking to the Norwegian Prescription Database, we identified 64,112 patients (69.0%) treated with OACs and 28,824 (31%) who were untreated. Participants were followed until 15 May 2019, death, or loss to follow-up, whichever came first. For each OAC, predictors of initiation were assessed by modelling the probability of initiating the OAC using logistic regression, and predictors of the first switch after index date were assessed using multivariable Cox proportional hazards models. The numbers of primary care visits per quarter by index OAC were plotted and analysed with negative binomial regression analyses offset for the log of days at risk. RESULTS: Patients treated with OACs were older, had more comorbidities, and higher CHA2DS2-VASc scores than untreated patients. However, the mean CHA2DS2-VASc in the non-OAC group was 1.58 for men and 3.13 for women, suggesting an indication for OAC therapy. The percentage of patients with atrial fibrillation initiating OACs increased from 59% in 2010 to 79% in 2018. Non-vitamin K antagonist oral anticoagulant use increased throughout the study period to 95% of new OAC-treated patients in 2018, and switches from warfarin to non-vitamin K antagonist oral anticoagulants were common. The persistence of OAC treatment was > 60% after four years, with greatest persistence for apixaban. Patients treated with non-vitamin K antagonist oral anticoagulants had fewer primary care visits compared with those treated with warfarin (incidence rate ratio: 0.73, 95% confidence interval 0.71 to 0.75). CONCLUSION: In this Norwegian primary care study, we found that the shift from warfarin to non-vitamin K antagonist oral anticoagulants was successful with 95% use in patients initiating OACs in 2018, and associated with fewer general practitioner visits. Persistence with OACs was high, particularly for apixaban. However, many patients eligible for treatment with OACs remained untreated.

Health-related quality of life in diabetes: The associations of complications with EQ-5D scores.

BACKGROUND: The aim of this study was to describe how diabetes complications influence the health-related quality of life of individuals with diabetes using the individual EQ-5D dimensions and the EQ-5D index. METHODS: We mailed a questionnaire to 1,000 individuals with diabetes type 1 and 2 in Norway. The questionnaire had questions about socio-demographic characteristics, use of health care, diabetes complications and finally the EQ-5D descriptive system. Logistic regressions were used to explore determinants of responses in the EQ-5D dimensions, and robust linear regression was used to explore determinants of the EQ-5D index. RESULTS: In multivariate analyses the strongest determinants of reduced MOBILITY were neuropathy and ischemic heart disease. In the ANXIETY/DEPRESSION dimension of the EQ-5D, "fear of hypoglycaemia" was a strong determinant. For those without complications, the EQ-5D index was 0.90 (type 1 diabetes) and 0.85 (type 2 diabetes). For those with complications, the EQ-5D index was 0.68 (type 1 diabetes) and 0.73 (type 2 diabetes). In the linear regression the factors with the greatest negative impact on the EQ-5D index were ischemic heart disease (type 1 diabetes), stroke (both diabetes types), neuropathy (both diabetes types), and fear of hypoglycaemia (type 2 diabetes). CONCLUSIONS: The EQ-5D dimensions and the EQ-5D seem capable of capturing the consequences of diabetes-related complications, and such complications may have substantial impact on several dimensions of health-related quality of life (HRQoL). The strongest determinants of reduced HRQoL in people with diabetes were ischemic heart disease, stroke and neuropathy.

Diabetes: cost of illness in Norway.

BACKGROUND: Diabetes mellitus places a considerable burden on patients in terms of morbidity and mortality and on society in terms of costs. Costs related to diabetes are expected to increase due to increasing prevalence of type 2 diabetes. The aim of this study was to estimate the health care costs attributable to type 1 and type 2 diabetes in Norway in 2005. METHODS: Data on inpatient hospital services, outpatient clinic visits, physician services, drugs, medical equipment, nutrition guidance, physiotherapy, acupuncture, foot therapy and indirect costs were collected from national registers and responses to a survey of 584 patients with diabetes. The study was performed with a prevalence approach. Uncertainty was explored by means of bootstrapping. RESULTS: When hospital stays with diabetes as a secondary diagnosis were excluded, the total costs were €293 million, which represents about 1.4% of the total health care expenditure. Pharmaceuticals accounted for €95 million (32%), disability pensions €48 million (16%), medical devices €40 million (14%) and hospital admissions €21 million (7%). Patient expenditures for acupuncture, physiotherapy and foot therapy were many times higher than expenditure for nutritional guidance. Indirect costs (lost production from job absenteeism) accounted for €70.1 million (24% of the €293 million) and included sick leave (€16.7 million), disability support and disability pensions (€48.2 million) and other indirect costs (€5.3 million). If all diabetes related hospital stays are included (primary- and secondary diagnosis) total costs amounts to €535 million, about 2.6% of the total health care expenditure in Norway. CONCLUSIONS: Diabetes represents a considerable burden to society in terms of health care costs and productivity losses.

A cost-utility analysis of phosphodiesterase type 5 inhibitors in the treatment of erectile dysfunction.

INTRODUCTION: Patent expiration for erectile dysfunction (ED) treatments like sildenafil means loss of exclusivity (LOE), and other manufacturers may bring generics to the market. This has resulted in price reductions, which influences the cost-effectiveness. In Norway, this development has led to a discussion on whether reimbursement should be granted. Cost-effectiveness analysis in this treatment area is scarce and more research is demanded. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of three separate phosphodiesterase type 5 (PDE5) inhibitors in ED therapy in a Norwegian setting. METHODS: The cost-effectiveness was analyzed using two patient populations: (1) 55-year-old patients diagnosed with ED and with no specific underlying illness, and (2) 55-year-old patients diagnosed with ED and with diabetes as an underlying illness. Using a state-transition Markov model with a 10-year time horizon, a "no-treatment" option was compared with three treatment strategies: (1) treatment using 50/100 mg sildenafil; (2) treatment using 10/20 mg tadalafil; (3) treatment using 10 mg vardenafil. A societal perspective was applied. RESULTS: All PDE5 inhibitor treatment strategies were cost-effective compared to a "no-treatment" option, with cost per additional quality-adjusted life-year of less than €15,000. With a willingness-to-pay threshold greater than €13,500, sildenafil was estimated as the dominant treatment strategy. The probabilistic sensitivity analysis indicated robust results. However, as the expected value of information was considerable, the cost-effectiveness of conducting further research to reduce uncertainty should be considered. Treating a diabetic population was less cost-effective for all PDE5 inhibitors and was associated with greater uncertainty with regard to choosing the optimal strategy. CONCLUSIONS: Sildenafil treatment of erectile dysfunction was a cost-effective alternative compared to tadalafil and vardenafil, as well as compared to a "no-treatment" option. Treating a diabetic population is less cost-effective for all PDE5 inhibitors and was associated with greater uncertainty.

A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants.

AIMS: We aimed to evaluate bleeding risk in clinical practice in patients with atrial fibrillation (AF) being prescribed dabigatran, rivaroxaban, or apixaban compared with warfarin. METHODS: Using nationwide registries (Norwegian Patient Registry and Norwegian Prescription Database), we identified AF patients with a first prescription of oral anticoagulants between January 2013 and June 2015. Patients were followed until discontinuation or switching of oral anticoagulants, death, or end of follow-up. The primary endpoint was major or clinically relevant non-major (CRNM) bleeding. RESULTS: In total 32 675 AF patients were identified (58% men, median age 74 years): 11 427 patients used warfarin, 7925 dabigatran, 6817 rivaroxaban, and 6506 apixaban. After a median follow-up of 173 days (25th, 75th percentile 84, 340), 2081 (6.37%) patients experienced a first major or CRNM bleeding. Using a Cox proportional hazard model adjusting for baseline characteristics, use of apixaban [hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.61-0.80, P < 0.001] and dabigatran (HR 0.74, 95% CI 0.66-0.84, P < 0.001) were associated with a lower risk of major or CRNM bleeding compared with warfarin whereas use of rivaroxaban was not (HR: 1.05, 95% CI 0.94-1.17, P = 0.400). Use of dabigatran and rivaroxaban were associated with higher risk of gastrointestinal bleeding, whereas use of apixaban and dabigatran were associated with lower risk of intracranial bleeding, compared with warfarin. CONCLUSION: In this nationwide cohort study in AF patients, apixaban and dabigatran were associated with a lower risk of major or CRNM bleeding compared with warfarin. The risk of gastrointestinal bleeding was higher with rivaroxaban and dabigatran compared with warfarin.

Overall survival in renal cell carcinoma after introduction of targeted therapies: a Norwegian population-based study.

BACKGROUND: This population-wide retrospective, non-interventional registry study assessed changes in overall survival (OS) and factors influencing OS in Norwegian patients with renal cell carcinoma (RCC). METHODS: Two population-wide health registries were used to identify all RCC patients with (mRCC) or without metastases diagnosed before (2002-2005) and after (2006-2008 and 2009-2011) introduction of targeted therapies. Median OS was estimated using Kaplan-Meier method. Cox proportional hazards regression modeling was used to identify prognostic factors. RESULTS: Overall, 5,463 patients were diagnosed with RCC during 2002-2005 (n=1,898), 2006-2008 (n=1,631), and 2009-2011 (n=1,934); of these, 1,678 (31%) had mRCC. Patients diagnosed in 2009-2011 and 2006-2008 had significant (P<0.001) improvements in OS versus those diagnosed in 2002-2005: median OS, not reached and not reached versus 82.0 months in RCC; 14.0 and 12.0 months versus 9.0 months in mRCC. Similarly, OS improvements were seen in the primary and elderly (≥75 years) mRCC populations. Median OS was comparable (12 months) between clear cell and papillary mRCC, but it was longer (24.0 months) for chromophobe mRCC. Multivariate regression analyses showed that younger age, previous nephrectomy, and 1 or more prescriptions of targeted therapy were significantly associated with longer OS in mRCC patients. CONCLUSION: OS increased in RCC and mRCC patients in Norway between 2002 and 2011 following introduction of targeted therapies.