Incremental cost effectiveness of proton pump inhibitors for the prevention of non-steroidal anti-inflammatory drug ulcers: a pharmacoeconomic analysis linked to a case-control study

Introduction We estimated the cost effectiveness of concomitant proton pump inhibitors (PPIs) in relation to the occurrence of non-steroidal anti-inflammatory drug (NSAID) ulcer complications. Methods This study was linked to a nested case-control study. Patients with NSAID ulcer complications were compared with matched controls. Only direct medical costs were reported. For the calculation of the incremental cost effectiveness ratio we extrapolated the data to 1,000 patients using concomitant PPIs and 1,000 patients not using PPIs for 1 year. Sensitivity analysis was performed by 'worst case' and 'best case' scenarios in which the 95% confidence interval (Cl) of the odds ratio (OR) and the 95% Cl of the cost estimate of a NSAID ulcer complication were varied. Costs of PPIs was varied separately. Results In all, 104 incident cases and 284 matched controls were identified from a cohort of 51,903 NSAID users with 10,402 NSAID exposition years. Use of PPIs was associated with an adjusted OR of 0.33 (95% Cl 0.17 to 0.67; p = 0.002) for NSAID ulcer complications. In the extrapolation the estimated number of NSAID ulcer complications was 13.8 for non-PPI users and 3.6 for PPI users. The incremental total costs were (sic) 50,094 higher for concomitant PPIs use. The incremental cost effectiveness ratio was (sic) 4,907 per NSAID ulcer complication prevented when using the least costly PPIs. Conclusions Concomitant use of PPIs for the prevention of NSAID ulcer complications costs (sic) 4,907 per NSAID ulcer complication prevented when using the least costly PPIs. The price of PPIs highly influenced the robustness of the results

Prospective evaluation of a computerized algorithm for Vitamin K antagonist drug dose calculation

Introduction: In an earlier study, we described and validated a VKA dose-finding algorithm (B2A), based on a novel bidirectional factor (BF). We designed a prospective study to evaluate the B2A in a daily care setting. Methods: In this open-label prospective study, we compared the outcomes of the B2A over the year 2020 with the outcomes of the previous year (2019), using regular algorithms. The outcomes were the duration of Time in the Therapeutic Range (TTR), the percentage of automated dose proposals (PAuP) and the percentage of accepted dose proposals (PAcP). The data were obtained from three anticoagulation centers in the Netherlands, in four locations. The outcomes of this study were based on a non-inferiority level.Results: The TTR over the year 2020 was at least non-inferior compared with the standard of care treatment. The percentage of automated proposals increased in all centers to approximately 96% of all dosages. Conclusion: The B2A performs non-inferior compared with the existing algorithms and in some aspects even better

Thromboprophylaxis in total hip-replacement surgery in Europe:Acenocoumarol, fondaparinux, dabigatran and rivaroxban

This paper reviews the clinical and pharmacoeconomic studies that have been conducted within Europe for patients undergoing elective hip-replacement surgery. Additionally, we offer a perspective on the possible future clinical use of new agents in orthopedic surgery, such as dabigatran and BAY 59-7939 (rivaroxban). Low-molecular weight heparins are standard therapy for patients requiring thromboprophylaxis and, therefore, we compare these with the other agents: vitamin K antagonists, fondaparinux and the direct oral inhibitors (thrombin or factor Xa inhibitors). The most evidence on the cost-effectiveness and efficacy is available for the low-molecular weight heparins and fondaparinux. Their major limitation is that they require parenteral administration. Only fondaparinux has undergone an extensive pharmacoeconomic evaluation. The direct thrombin inhibitors and direct factor Xa inhibitors are possibly the drugs of the future, but it must be borne in mind that they are still in Phase III clinical trials and, therefore,their safety and efficacy profile is not completely understood, neither are the pharmacoeconomic aspects

Pharmacoeconomics of quetiapine for the management of acute mania in bipolar I disorder

Bipolar disorder (or manic depression) is a lifelong, severe and complex psychiatric illness characterized by recurrent episodes of depression and mania. The aim of this study is to explore the cost-effectiveness of quetiapine compared with other alternatives for the treatment of acute manic episodes in bipolar I disorder, with a specific focus on serious side effects. Four trials investigating quetiapine monotherapy and adjunctive therapy were performed to investigate the efficacy of quetiapine in patients with bipolar I disorder. Data were derived from The Netherlands Mental Health Survey and Incidence Study and used to construct a study population for the model. To assess the cost-effectiveness of quetiapine in the management of acute mania in bipolar I disorders, a discrete event simulation model of seven monotherapy and combination treatment options was developed. A comparison of the total costs demonstrates that all of the monotherapy options and placebo are more costly than the combination therapy options. The combinations of lithium with risperidone (euro2365) and with olanzapine (euro2429) are estimated to be less costly per patient than the combination of lithium with quetiapine (euro2555). A group of 10,000 patients switching from olanzepine/lithium to quetiapine/lithium would involve extra costs of euro1,260,000, but would prevent an estimated number of 362 serious side effects. Switching from risperidone/lithium to quetiapine/lithium would cost an additional euro1,900,000 and would prevent 1580 serious side effects. In terms of serious side effects, the combination of lithium/quetiapine was superior to the combination of lithium with olanzapine or risperidone. It must be considered whether the decreased likelihood of developing a severe side effect is worth the extra costs incurred with the combination of quetiapine/lithium

Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome

BACKGROUND & AIMS: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. METHODS: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. RESULTS: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005). CONCLUSIONS: In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.status: publishe