Drugs - Real World Outcomes最新文献

Background and objective: Patients with heart failure or cardio/renal dysfunction (chronic kidney disease, end-stage kidney disease, or heart failure) are at increased risk of hyperkalemia. Sodium zirconium cyclosilicate (SZC) treats hyperkalemia, but the impact of SZC treatment duration on healthcare resource utilization in these populations is unclear. This study, GALVANIZE Outcome, assessed healthcare resource utilization associated with short-term versus long-term outpatient SZC use in matched cohorts of SZC users with heart failure and, separately, cardio/renal dysfunction.

Methods: Data from a large US claims database (7/2018-12/2022) were used to identify adults with heart failure or cardio/renal dysfunction initiating outpatient SZC (index date). Long-term (> 90 days) and short-term SZC users (≤ 30 days) were matched on key baseline characteristics using a two-step approach: exact matching followed by propensity score matching. Rates of hyperkalemia-related hospitalizations or emergency department visits and hyperkalemia-related hospitalizations were compared between long-term and short-term SZC users during the follow-up from index to the earliest of 6 months post-index, end of data availability, new potassium binder use, or reinitiation of SZC post-discontinuation.

Results: Among 942 matched heart failure pairs and 2892 matched cardio/renal pairs, long-term SZC users had fewer hyperkalemia-related hospitalizations or emergency department visits compared with short-term users, with reductions of 36% in the heart failure sample and 40% in the cardio/renal dysfunction sample; the respective reductions were 39% and 37% for hyperkalemia-related hospitalizations alone (all p < 0.001).

Conclusions: Long-term SZC use is associated with significant reductions in hyperkalemia-related hospitalizations or emergency department visits compared with short-term use among patients with heart failure or cardio/renal dysfunction.

Background: Hyperuricemia is a common comorbidity in patients with cardiovascular diseases and chronic kidney disease, often requiring long-term urate-lowering therapy. Febuxostat, a xanthine oxidase inhibitor, has raised cardiovascular safety concerns. Dotinurad, a selective urate reabsorption inhibitor, has emerged as a potential alternative, but clinical evidence in patients with Stage B/C heart failure remains limited.

Methods: This single-center retrospective study evaluated 30 patients with Stage B (n = 10) and C (n = 20) heart failure and hyperuricemia who were switched from febuxostat (10, 20, or 40 mg) to dotinurad (0.5, 1.0, or 2.0 mg, respectively), based on the prior febuxostat dose. Laboratory and urinary parameters were assessed at baseline and at follow-up (median 65 days [56-84] after switching).

Results: In Stage B heart failure, serum uric acid showed a non-significant trend toward reduction (5.8 [4.4-6.3] to 5.3 [4.8-7.5] mg/dL, p = 0.09), whereas in Stage C heart failure, serum uric acid increased significantly (5.1 [4.6-6.6] to 5.4 [4.8-6.8] mg/dL, p = 0.02). The proportion of patients achieving serum uric acid ≤ 6.0 mg/dL was maintained (Stage B: 60.0 to 50.0%; Stage C: 70.0 to 75.0%). Urinary uric acid excretion increased, while urinary pH remained stable in both groups. The uricosuric effect of dotinurad was evident with or without concomitant use of sodium-glucose cotransporter 2 inhibitors. No adverse events, including cardiovascular events, urolithiasis, or gout flares, were observed.

Conclusions: Switching from febuxostat to dotinurad may be effective and safe over the short term in patients with Stage B/C heart failure and hyperuricemia.

Background: Hyperthyroidism during pregnancy is associated with maternal, obstetric and fetal complications. Antithyroid drugs (ATDs) including carbimazole (CMZ), methimazole (MMI) and propylthiouracil (PTU) are the main pharmacotherapies for hyperthyroidism. Exposure to CMZ and MMI during the first trimester was associated with birth defects, while PTU is assumed to be the safer alternative.

Objective: To calculate the prescription prevalences of ATDs in women of childbearing age over time and to describe pregnancies occurring after or during ATD use.

Methods: Using the GePaRD database (claims data; 20% of the German population), we conducted year-wise cross-sectional studies for the period 2004-2020 to calculate prescription prevalences of CMZ, MMI and PTU in females aged 13-49 years. In longitudinal analyses, we included all women with any ATD dispensing between 2005 and 2020 aged 13-49 years at the first dispensing. We identified pregnancies occurring in this cohort and described ATD use before and during pregnancy.

Results: The age-standardized prescription prevalence of ATDs decreased by 32.1% between 2004 (2.71 per 1000) and 2020 (1.84 per 1000). This decrease was attributable to CMZ (2004: 1.40 per 1000; 2020: 0.76 per 1000; relative decrease: 45.7%) and MMI (2004: 1.25 per 1000; 2020: 0.99 per 1000; relative decrease: 20.8%). In the cohort including 9723 women, 13,586 pregnancies were observed, of which 67% (n = 9140) occurred after ATD use. In 16.2% of the pregnancies (n = 2203), ATD use overlapped with pregnancy onset. The proportion exposed to CMZ/MMI at pregnancy onset decreased from 30.7% in 2005 to 10.9% in 2020. In 16.5% of pregnancies (n = 2243), ATD use was started during pregnancy.

Conclusion: The prescription prevalence of ATD overall and specifically of CMZ/MMI in girls and women of childbearing age decreased between 2005 and 2020 in Germany. The decrease in exposure to CMZ/MMI at pregnancy onset indicates that physicians became increasingly aware of the potential risks of CMZ/MMI to the unborn child.

Background: Vaso-occlusive crises (VOCs) are a hallmark of sickle cell disease (SCD). Individuals with SCD often report stigma and negative healthcare provider (HCP) attitudes when seeking treatment. This study examines health equity concerns and perceived barriers to care among adults with recurrent VOCs.

Methods: A prospective survey was conducted from May to November 2022 in the US, UK, France, Germany, and Italy. Adults (≥ 18 years) with recurrent VOCs completed a health equity survey and patient-reported outcome measures (PROMs) at month 6. Participants were categorized as experiencing either unfair or fair treatment based on their response to whether they reported ever having been treated unfairly by an HCP due to their race or ethnicity. PROMs were scored, and analyses included Pearson's Chi-squared test and two-sample t-tests.

Results: Among 110 participants, most were female (75.5%), Black/African American (93.5%), and US residents (59.1%). In the past year, 66.7% had ≥ 4 VOCs, and 85.3% used opioids. Most (68.6%) believed they would receive better care if they were of a different race/ethnicity, and 64.7% felt HCPs did not believe their symptoms. About 30% waited > 60 min for emergency department check-in, with additional delays before treatment. Key barriers included reported HCP lack of empathy (58.9%) and SCD knowledge (55.9%). Pain significantly impacted daily activities, with all outcomes worse in the Unfair treatment group.

Conclusions: Findings highlight significant health equity concerns and barriers to care for adults with SCD and recurrent VOCs, underscoring unmet needs and the humanistic burden in this population.

Background: In an ageing population, drug-related problems, including potentially inappropriate medications (PIMs), are increasingly relevant. PIM lists are important tools for improving medication safety in older adults.

Objective: As part of the POLAR_MI (POLypharmacy, drug interActions, Risks) project, this study aimed to assess the prevalence of PIM and its association with falls in patients aged ≥ 65 years, based on the methods and processes of the Medical Informatics Initiative Germany.

Methods: A retrospective, distributed analysis of electronic health records (EHRs) (2018-2021) was conducted at ten German university hospitals. PIMs were defined using PRISCUS and EU(7)-PIM lists. Falls were identified using documented fractures as a surrogate. Multivariable logistic regression modelling was applied, adjusting for confounders including age, gender, Charlson Comorbidity Index (CCI) and fall-risk-increasing drugs (FRIDs).

Results: A total of 166,126 cases (median age: 76 years; 45.8% women) were analysed. According to PRISCUS, 12.8% of cases had at least one PIM, with amitriptyline most common (1.1% of all cases). According to EU(7)-PIM, 45.6% of cases were affected, with apixaban most frequent (8.6%). An association between falls and at least one PIM (PRISCUS: adjusted odds ratio [aOR] 1.21, 95% confidence interval [CI] 0.94-1.55; EU(7)-PIM: aOR 1.01, 95% CI 0.83-1.22) could not be observed. However, FRIDs were associated with falls (PRISCUS: aOR 2.31, 95% CI 1.64-3.27; EU(7)-PIM: aOR 2.43, 95% CI 1.69-3.48).

Conclusions: In this large multicentre EHR analysis, PIMs were common in older patients, but an association with an increased likelihood of falls could not be observed. In contrast, the well-known association with FRIDs was confirmed. The ongoing digitalisation of German hospitals enables such large-scale data analyses for risk assessment and supports improvements in patient safety.

Background: Oral mucositis (OM) is a frequent and debilitating complication of chemotherapy, yet little is known about its burden and management in Sudan. Therefore, this study aimed to determine the prevalence, characteristics, management, and factors associated with OM.

Methods: A hospital-based cross-sectional study was conducted from April to June 2022 at Khartoum Oncology Hospital, Sudan, among chemotherapy patients, with OM severity graded per the World Health Organization criteria. The data were analyzed using SPSS version 27.

Results: Among the 340 patients, 258 (75.9%) were female, and 128 (37.6%) were aged 45-59 years. OM occurred in 127 (37.4%) patients, mostly with generalized lesions (96; 75.6%) and Grade 3 severity (76; 59.8%). Common complications included inability to eat (75; 59.1%) and taste changes (69; 54.3%). Only 36 (28.3%) patients received prescription medication, mainly miconazole gel (17; 47.2%); pain management was provided to 12 (11.5%) patients, and dental interventions were provided to two (0.6%) patients. In multivariable logistic regression, age (p = 0.035) and number of chemotherapy doses (p < 0.001) remained independent predictors, with lower odds for four to six doses (aOR (adjusted odds ratio) 0.152; 95% CI (confidence interval) 0.087-0.268), seven to ten doses (aOR 0.033; 95% CI 0.009-0.121), and more than ten doses (aOR 0.045; 95% CI 0.004-0.484) than for one to three doses.

Conclusion: OM is moderately prevalent but often severe among Sudanese chemotherapy patients, with inadequate management and poor adherence to evidence-based practice. Implementing standardized oral care, clinician training, and patient education could reduce its burden and improve outcomes.

Introduction: People with Lewy body dementia (LBD) experience pronounced psychotic symptoms but are extremely sensitive to side effects from antipsychotic treatment. In comparison, acetylcholinesterase inhibitors (AChEIs) are a safer treatment option for managing cognitive and neuropsychiatric symptoms and should ideally be the first-line treatment according to review literature. This study described the pharmacological treatment of LBD-associated neuropsychiatric symptoms among older people by comparing dispensing records of antipsychotic drugs and AChEIs.

Methods: This study included people with records of antipsychotic drugs dispensed in 2019 according to the Swedish Prescribed Drug Register, which functioned as an indicator of neuropsychiatric symptoms, who had been registered with LBD in the Swedish registry for cognitive/dementia disorders according to basal registrations from 2007 to 2020. We then determined the proportions of individuals with and without dispensing records of AChEIs prescribed before their index antipsychotic prescription fill of 2019, by comparing prescribing dates. Age, sex and nursing home residency were included as independent variables in a multiple logistic regression model to analyse associations between demographic factors and first-line treatment with AChEIs.

Results: In total, 362 individuals with symptoms of LBD had filled at least one prescription for any antipsychotic drug in 2019. There were 114 people (31.5%) who had been prescribed antipsychotics as first-line treatment instead of AChEIs, and among them, 60 individuals had been diagnosed with LBD after the index antipsychotic prescribing date. First-line treatment with AChEIs was more common among males (odds ratio, OR, 1.65 [95% CI 1.03-2.62]) and nursing home residents (2.51 [1.59-3.96]).

Conclusions: Antipsychotics were utilized as first-line treatment instead of AChEIs among almost one-third of antipsychotic users with symptoms of LBD. It is important to consider emerging psychotic symptoms among older people as possible manifestations of LBD to ensure early and appropriate pharmacological treatment.

Background: Topical ketoprofen gel (Fastum gel) is used for the treatment of rheumatic and traumatic musculoskeletal pain. Following reports of photosensitivity reactions, additional risk minimisation measures have been implemented in Europe to inform healthcare professionals (HCPs) and patients about this risk.

Objective: The main objectives of our survey were to assess both HCPs' awareness of the risk of photosensitivity associated with Fastum gel and their opinion on the usefulness of an annual direct healthcare professional communication (DHPC) in Belgium and Luxembourg.

Methods: A cross-sectional online survey was conducted between June and July 2023, approximately 1 month after the annual distribution of the DHPC. Targeted HCPs were asked about their awareness of the photosensitivity risk associated with Fastum gel, as well as their opinion on the usefulness of the annual DHPC. The study also explored the channels through which the information was received, along with awareness and use of educational materials. Frequencies and percentages were calculated both overall and by HCP category for each country.

Results: In Belgium, 569 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (99%). More than half of pharmacists (58%) and half of physicians (50%) indicated that an annual DHPC is necessary. Around half of the respondents (49%) recalled receiving information about the risk in 2023, primarily through the DHPC (68%) while outlining other channels such as the logo on the packaging (42%) and the Summary of Product Characteristics (40%). Awareness of the patient card (32%) and the checklist (5%) was overall low, with very limited use in 2023. In Luxembourg, 190 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (97%). The majority of pharmacists (70%) and more than half of physicians (52%) supported the annual DHPC distribution. Over two thirds of the respondents (68%) recalled receiving relevant information in 2023, mainly through the DHPC (70%) but also through the SmPC (30%). Awareness of the patient card (22%) and the checklist (13%) was overall low, with very limited use in 2023.

Conclusions: The results indicate a high level of awareness of the photosensitivity risk of Fastum gel among participating HCPs. Notably, a majority of HCPs expressed the need for an annual DHPC. This study also underscores the importance of using multiple channels of information to increase the opportunities for reaching HCPs. Nevertheless, the survey revealed limited use of the checklist and the patient card among HCPs.