The cost-effectiveness of oral semaglutide versus empagliflozin in Type 2 diabetes in Denmark.

Aim: To evaluate the cost-effectiveness of oral semaglutide+metformin versus empagliflozin+metformin in people with Type 2 diabetes uncontrolled on msetformin alone. Materials and methods: The IQVIA Core Diabetes Model was populated with efficacy data from a head-to-head study between oral semaglutide+metformin and empagliflozin+metformin. Danish costs and quality-of-life data were sourced from literature. Price per day was Danish Krone (DKK) 25.53 for oral semaglutide and DKK11.40 for empagliflozin. Discounting was fixed at 4%. Scenario and sensitivity analyses were performed. Results: Over a lifetime, Core Diabetes Model projected 8.78 and 8.75 quality-adjusted life-years and a total cost of DKK 447,633 and DKK 387,786, thereby generating an incremental cost-effectiveness ratio of DKK 1,930,548 for oral semaglutide+metformin versus empagliflozin+metformin. Scenario and sensitivity analyses showed the robustness of the outcomes. Duration of treatment with oral semaglutide is the key driver of the analyses. Conclusion: Oral semaglutide+metformin seems not cost effective versus empagliflozin+metformin in patients uncontrolled on metformin in Denmark.

The Cost-Effectiveness of Empagliflozin Versus Liraglutide Treatment in People with Type 2 Diabetes and Established Cardiovascular Disease.

INTRODUCTION: The increasing financial burden associated with diabetes treatment presents a challenge to healthcare systems worldwide. Recently, clinical guidelines have focussed on patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD) and recommend a sodium-glucose co-transporter 2 (SGLT2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist as second-line treatment after metformin or independently of baseline glycated haemogloblin A1c (HbA1c). In Danish clinical guidelines, empagliflozin and liraglutide are highlighted owing to their positive impact on mortality. Thus, this study aimed to assess the cost-effectiveness of empagliflozin plus standard of care (SoC) versus liraglutide plus SoC in Danish patients with T2D and established CVD using a lifetime and 5-year horizon. METHODS: The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the clinical event rates observed in the cardiovascular outcome trial EMPA-REG OUTCOME. Network meta-analysis provided the relative risks for cardiovascular outcomes with empagliflozin versus liraglutide. Microvascular outcomes were predicted by standard CDM risk equations. The relative treatment effect was assumed for 9 years after which treatment was switched to basal-bolus therapy. The CDM was populated with Danish costs of events and drug costs at price-level 2019. Discounting of 4% was applied. RESULTS: Over a lifetime horizon, CDM projected 9.858 and 9.667 life years, 6.162 and 5.976 quality-adjusted life years (QALY) and DKK 478,026 (€64,079) and DKK 500,025 (€67,027) in total costs for empagliflozin plus SoC and liraglutide plus SoC, respectively. For a 5-year horizon, the results were 4.189 and 4.140 life years, 2.746 and 2.655 QALY, as well as DKK 123,413 (€16,543) and DKK 161,783 (€21,687), respectively. Empagliflozin was the dominant treatment alternative. Sensitivity analyses showed the robustness of these results. CONCLUSION: The cost-effectiveness analysis suggests that empagliflozin plus SoC is dominant compared to liraglutide plus SoC in Denmark over both lifetime and 5-year horizons.

18F-fluoro-deoxy-glucose positron emission tomography combined with computed tomography can reliably rule-out infection and cancer in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis suspected of disease relapse.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of autoimmune diseases characterized by systemic inflammation in small- to medium-sized blood vessels. Although immunosuppressive therapy has greatly improved the prognosis for these patients, there are still significant comorbidities, such as cancer and infection, associated with AAV. These comorbidities are often indistinguishable from an underlying AAV disease relapse, and create a clinical conundrum, as these conditions are normally contraindications for immunosuppressive treatment. Thus, it is important to be able to rule out these comorbidities before initiation of immunosuppressive treatment. We examined F-fluoro-deoxy-glucose positron emission tomography combined with computed tomography (FDG-PET/CT)'s value in ruling out cancer or infection in patients with AAV.Data were obtained retrospectively for a clinically based cohort of AAV patients who underwent FDG-PET/CT during 2009 to 2014 owing to a suspicion of cancer, infection, or both cancer and infection indistinguishable from disease relapse. FDG-PET/CT conclusions were compared to the final diagnoses after follow-up analysis (mean 43 months).A total of 19 patients were included who underwent a total of 26 scans. The results of FDG-PET/CT outcome compared to final diagnosis were: 9 true positives, 3 false positives, 13 true negatives, and 1 false negative. The diagnostic probabilities for FDG-PET/CT with respect to overall comorbidity (i.e., cancer or infection) were: sensitivity 90% ( 95% confidence interval [CI] 60%-98%), specificity 81% ( 95% CI 57%-93%), positive predictive value 75% (95% CI 47%-91%), negative predictive value 93% (95% CI 68%-99%), and accuracy 84% (95% CI 66%-94%).FDG-PET/CT had a high negative predictive value and ruled out the comorbidities correctly in all but one case of urinary tract infection, a well-known limitation. Our study showed FGD-PET/CT's promise as an effective tool for ruling out cancer or infection in patients with AAV albeit in a limited population.

State-of-the-Art Imaging in Pulmonary Embolism: Ventilation/Perfusion Single-Photon Emission Computed Tomography versus Computed Tomography Angiography - Controversies, Results, and Recommendations from a Systematic Review.

Pulmonary embolism (PE) is a common, ubiquitous, and potentially lethal disease. As symptoms and clinical findings are notoriously nonspecific, diagnostic imaging is essential to avoid undertreatment as well as overtreatment. Controversies remain regarding first-line imaging in suspected PE. The two main contemporary contenders are ventilation/perfusion scintigraphy with single-photon emission computed tomography (V/Q SPECT) with or without additional low-dose CT (SPECT/CT) and CT angiography (CTA). We present our results from a systematic review and meta-analysis of the diagnostic performances of these modalities: V/Q SPECT, V/Q SPECT/CT, and CTA are all viable options, but we consider V/Q SPECT/CT to be superior in most clinical settings with better overall diagnostic performance, that is, pooled sensitivities (97.6 vs. 82.0%), specificities (95.9 vs. 94.9%), positive predictive values (93.0 vs. 93.8%), negative predictive values (98.6 vs. 84.7%), and accuracies (96.5 vs. 88.6%). We further address some of the ongoing controversies regarding the various modalities, that is, radiation exposure, the issues of subsegmental PE, nondiagnostic studies, and various challenges in specific patient populations.

The role of FDG-PET/CT in preoperative staging of sentinel lymph node biopsy-positive melanoma patients.

BACKGROUND: On April 1, 2015, Odense University Hospital (OUH) began a new diagnostic strategy, wherein all malignant melanoma (MM) patients in the Region of Southern Denmark with a positive sentinel lymph node biopsy (SLNB) underwent FDG-PET/CT preoperatively prior to lymph node dissection (LND). The purpose of this study is to determine FDG-PET/CT's efficacy in finding distant metastasis in the first year after the implementation of this new strategy, and to what extent these findings influence subsequent diagnostic testing and treatment in this patient group. We conducted a retrospective multicenter cohort study which included all patients with MM from all hospitals in the Region of Southern Denmark from April 1, 2015 to April 1, 2016 found to be SLNB-positive who subsequently underwent FDG-PET/CT. Patient information was acquired from the Danish Melanoma Database and was cross-referenced with OUH's patient records. The data was analyzed for a number of parameters including FDG-PET/CT findings and treatment strategy. Median follow-up time was 7 months. RESULTS: A total of 47 patients were eligible from the first year of this new diagnostic strategy. One patient was excluded due to undergoing LND prior to FDG-PET/CT. Thus, 46 patients were included in this study. Ultimately, preoperative FDG-PET/CT neither uncovered any distant metastases nor led to any alterations in treatment strategy in this patient group. CONCLUSIONS: Surprisingly, this new diagnostic strategy did not find any MM metastases or uncover anything else of relevance. FDG-PET/CT did, however, provide false positive findings in 13 % (6/46) of these patients. These scans triggered additional, predominantly invasive, procedures, which did not ultimately have an impact on the therapeutic strategy. Thus, these findings indicate a need for re-evaluation of this new diagnostic strategy as well as the necessity for further clinical trials evaluating FDG-PET/CT's utility in this clinical setting.