Drugs - Real World Outcomes

BACKGROUND: In Japan, daily, twice weekly, and weekly formulations of teriparatide (TPD) and monthly formulations of romosozumab (ROMO) are available as osteogenesis promoters for the treatment of osteoporosis with a high risk for fracture. OBJECTIVE: To compare the effects of three TPD preparations and ROMO on fracture healing and low back pain after a fresh vertebral fracture. METHODS: This was a retrospective observational study. Patients presenting with fresh osteoporotic vertebral fractures were treated subcutaneously with TPD daily (DTPD), twice weekly (2/WTPD), weekly (WTPD), or with ROMO monthly...

BACKGROUND: Approximately a decade has passed since the addition of venous thromboembolism to the list of significant adverse reactions of antipsychotic drugs. However, only a few studies have investigated the relationship between antipsychotic use and venous thromboembolism in the Japanese population. PURPOSE: We aimed to evaluate the risk of recurrent venous thromboembolism in users of antipsychotic drugs and update the evidence on venous thromboembolism in the Japanese population...

BACKGROUND: Adverse drug events among older adults result in significant mortality, morbidity and cost. This harm may be mitigated with appropriate prescribing and deprescribing. We sought to understand the prescribing outcomes of an interdisciplinary geriatric virtual consultation service. METHODS: We conducted a retrospective, before-and-after feasibility study to measure prescribing outcomes for a medication optimization virtual interdisciplinary geriatric specialist (MOVING) programme comprised of expertise from geriatric clinical pharmacology, pharmacy and psychiatry for older adults (aged ≥ 65 years) between June and December 2018, Ontario, Canada...

No abstract text is available yet for this article.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional disorder that leads to abdominal pain; its diagnosis is based on Rome IV criteria (recurrent abdominal pain at least 1 day per week in the last 3 months with more than two of the following: related to defecation, associated with a change in stool frequency and/or with a change in stool appearance). OBJECTIVE: To characterize an outpatient population diagnosed with IBS in Colombia during 2017-2018. METHODS: A cross-sectional study based on a review of clinical records of patients with a primary diagnosis of IBS...

INTRODUCTION: Traditional, complementary and alternative medicine (TCAM) are popular healthcare choices among consumers globally. The latest national data on the use of TCAM practitioners in New Zealand (NZ) were collected over a decade ago. Robust data on the use of natural health products (NHPs) and TCAM practices alongside conventional medicines are not yet available in NZ. OBJECTIVES: This study aimed to develop and test a bespoke questionnaire (All-MedsNZ) that included comprehensive data collection elements exploring NHPs' and conventional medicines' use...

OBJECTIVE: Drug non-adherence in primary preventive cardiovascular therapy is one of the most important modifiable drivers of cardiovascular events. The effect of deductibles in healthcare cost-sharing plans (the amount that has to be paid for healthcare services before the insurance company starts to pay) on such non-adherence in a European setting is unknown. Therefore, we estimated the association between deductibles and the adherence to primary preventive antihypertensive and antihyperlipidemic medication...

BACKGROUND: Immune checkpoint inhibitors (ICIs) can be commonly associated with the occurrence of immune-related adverse drug reactions (irADRs), which can involve any tissue and organ. ICI-induced skin toxicities are common irADRs and they can be a consequence of a rheumatologic ADR, such as in the case of scleroderma. A recent literature review reported that scleroderma and scleroderma mimics represent a group of disorders with significant morbidity that have been described during ICIs' use...

BACKGROUND: Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce. METHODS: An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed...

BACKGROUND: The antifibrotic drugs, nintedanib and pirfenidone, inhibit the decline in forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF). Nintedanib also inhibits the onset of acute exacerbation and reduces the risk of all-cause mortality. However, their effectiveness in real-world practice remains unclear. Our study aimed to investigate the changes in forced vital capacity, survival period, causes of death, and risk factors for mortality in patients with IPF receiving antifibrotic drugs...

INTRODUCTION: Numerous investigations on herbal medicine that have been undertaken in the past several years demonstrate the general acceptance of its safety. The Saudi Food and Drug Authority (SFDA) established the Herb-Drug Interaction (HDI) project to detect and assess potential HDIs to ensure safety. The aim is to detect safety signals and assess them based on available evidence. METHODS: First, SFDA-registered herbal products (n = 30) were selected and prioritized based on commonly used herbs...

PURPOSE: There are only limited data on drug utilization patterns in pediatric inpatients, especially on general wards. The aim of the study was to describe prescribing patterns and their associations with prescribing errors in a university children's hospital in the German-speaking part of Switzerland. METHOD: This was a subanalysis of a retrospective single-center observational study. Patient characteristics and drug use of 489 patients with 2693 drug prescriptions were associated with prescribing errors...

BACKGROUND: Safe and appropriate use of medicines is essential to improve health outcomes in cirrhosis. However, little is known about the number and type of medicines dispensed to people with cirrhosis in Australia, as this predominantly occurs in the community. We aimed to characterise the prescriptions dispensed to people with cirrhosis and explore changes in the use of medication groups over time. METHODS: Pharmaceutical Benefits Scheme data between 1 January 2016 and 30 June 2020 was extracted for consenting CirCare participants (multi-site, prospective, observational study)...

BACKGROUND: A relevant safety concern for the use of valproate (VPA) in women of reproductive age is its teratogenicity. In 2014 European Medicines Agency (EMA) introduced risk minimisation measures (RMMs) to reduce the VPA use by women of reproductive age, where the impact on VPA use was not as large as expected. In 2018, the EMA introduced additional RMMs, and it is essential to assess impact of these interventions. OBJECTIVE: The objective of this study was to evaluate the impact of the EMA-published RMMs in 2014 and 2018 on the prevalence of VPA use and to describe trends in the prevalence rate and incidence proportion of VPA use in epilepsy, bipolar disorder and off-label indications in Latvia...

BACKGROUND: Rearrangements in the anaplastic lymphoma kinase (ALK) gene define a molecular subgroup of non-small-cell lung carcinoma (NSCLC) that should be treated with ALK-targeting tyrosine kinase inhibitors (TKIs). OBJECTIVE: This study aimed to portray the Portuguese reality about the diagnosis and treatment of stage IV ALK-positive NSCLC. METHODS: Institutions that treat lung cancer in Portugal were invited to participate in an anonymous electronic questionnaire...

INTRODUCTION: Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) is the most frequently diagnosed metastatic breast cancer (mBC) subtype. Combinations of endocrine therapy (ET) with cyclin-dependent kinase 4/6 inhibitors (CDK4 & 6is) improve outcomes compared with ET alone. The efficacy and safety of abemaciclib among patients with HR+/HER2- mBC has been demonstrated in the MONARCH clinical trials; however, there is a paucity of real-world evidence, particularly in older patients...

BACKGROUND AND OBJECTIVES: There is a lack of well-controlled US studies of intramuscular (IM) interferon beta (IFNβ)-1a use in pregnant women with multiple sclerosis; however, in the European Medicines Agency region, IFNβ formulations may be considered during pregnancy if clinically needed based on data from European Union cohort registries. The AVONEX Pregnancy Exposure Registry was established to prospectively study the effects of IM IFNβ-1a on the risk of birth defects and spontaneous pregnancy loss in a US population...

BACKGROUND: Non-Hispanic Black and Hispanic persons with MS (pwMS) are more likely to experience rapid disease progression and severe disability than non-Hispanic White pwMS; however, it is unknown how the initiation of high-efficacy disease-modifying therapies (DMTs) differs by race/ethnicity. This real-world study describes DMT treatment patterns in newly diagnosed pwMS in the United States (US) overall and by race/ethnicity. METHODS: This retrospective analysis used the US Optum Market Clarity claims/electronic health records database (January 2015-September 2020)...

BACKGROUND: Patients with inflammatory bowel diseases (IBDs) are at increased risk of pancreatitis. Data from a global safety database (GSD) were queried to identify risk factors for pancreatitis in vedolizumab-treated patients with IBD. METHODS: Takeda's GSD was retrospectively queried for case reports (CRs) of adverse events (AEs) following vedolizumab treatment, from licensure (May 20, 2014) through March 31, 2021. Unsolicited and solicited CRs of pancreatitis were coded using the Medical Dictionary for Regulatory Activities (MedDRA) High-Level Term "Acute and chronic pancreatitis...

BACKGROUND: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR TKIs) are established first-line treatments among patients with metastatic non-small cell lung cancer harboring EGFR-sensitizing mutations. Upon EGFR TKI resistance, there are scant data supporting a standard of care in subsequent lines of therapy. OBJECTIVE: We aimed to characterize real-world treatment patterns and adverse events associated with hospitalization in later lines of therapy...