Current Medical Research and Opinion最新文献

Background: COPD management and therapy have been periodically revised to support a more patient-specific approach. Several concerns remain in primary care, such as the proper choice of initial treatment, medication adherence, and missing values for spirometry investigations. These concerns may be exacerbated by inconsistencies between the GOLD23 report and reimbursement criteria, as per the Italian NOTA99, especially for what concerns the assessment of disease severity and related treatment choice. We therefore examined the perception and knowledge of general practitioners (GPs) on COPD management and treatment.

Methods: We conducted an exploratory e-Delphi study among 600 GPs. The study examined the COPD-related GP's access to spirometry evaluations in primary care clinics; knowledge on early recognition of COPD and related clinical concerns; perception of the clinical application of the NOTA99; the place in therapy of the triple LABA/LAMA/ICS combination.

Results: Among 466 participating GPs (response rate: 70.3%; mean age 52, SD: 14.2; mean years of experience: 21.3, SD: 15) had a good level of knowledge about the GOLD 2023 document and the reimbursement criteria for COPD medications. Nevertheless, a low (34%) direct access to spirometry was reported, along with absence of consensus on the proper choice of initial treatment (especially of use of LABA/LAMA combination), and the re-evaluation of free-triple therapy LABA/LAMA/ICS through specialist's referral.

Conclusions: This study captured the domains on which further training for GPs might be implemented to improve the management and treatment of COPD. An extension of this e-Delphi to a larger GPs' panel might further confirm these findings.

Objective: Talquetamab is the first-in-class GPRC5DxCD3 bispecific antibody for relapsed/refractory multiple myeloma. Given limited real-world data, this study was conducted with US healthcare providers (HCPs) to understand real-world talquetamab dosing and symptom management.

Methods: In February/March 2024, individual in-depth interviews (IDIs; n = 10) were conducted with HCPs administering talquetamab in real-world settings. A subsequent expert panel (n = 6) further discussed current practices.

Results: The IDIs reported a variety of settings for step-up dosing (SUD), including inpatient (n = 5), outpatient (n = 3), and hybrid models (n = 2), with a trend toward shorter SUD length to reduce healthcare resource utilization. Most HCPs used a biweekly (Q2W) schedule in SUD (n = 7) and treatment phases (n = 8). Six participants explored reducing dose frequency to every 4 weeks (Q4W) in patients following positive disease response to treatment, considering patient convenience and relieving GPRC5D-related symptoms. Panelists recommended symptom management and prophylactic strategies, such as dexamethasone and nystatin mouthwash or zinc and vitamin B complex for oral symptoms, and topical steroids and cosmetic products for skin and nail symptoms.

Conclusion: This study outlines current real-world practices for talquetamab. Findings indicate variation in the SUD care setting. The 0.8 mg/kg Q2W dosing schedule was most common, although switching to Q4W is a real-world symptom management strategy for some patients with responses to therapy. GPRC5D-related symptom management approaches are evolving; prophylactic use of dexamethasone and nystatin mouthwash or zinc and vitamin B complex may be effective strategies to alleviate oral symptoms. Further real-world evidence is needed to inform optimal dosing schedules while mitigating symptom impact.

Objective: To understand current practices and challenges for collecting author feedback for English-language, industry-sponsored publications in Asia-Pacific (APAC), and the implications for adherence to international publication guidelines.

Methods: A cross-sectional, internet-based survey of industry ('internal') authors (17 questions) and publication professionals (18 questions) supporting publications in APAC, conducted between November 18 and December 4, 2022.

Results: Overall, 142 survey responses were received, of which 94 (66%) were complete and included in the analysis (33 internal authors, 61 publication professionals). Almost half (45%) of internal authors preferred a non-English language for providing feedback on publications, and most (70%) would use this language whenever possible. Internal authors favored written (91%) versus spoken (73%) English, and email was the preferred mode of communication. Publication professionals said they have observed qualitative differences when authors provide feedback in a preferred non-English language versus English. Many agreed that authors tend to provide more substantive or critical feedback when they can respond in their preferred non-English language. Internal authors had low self-assessed familiarity with key publication guidelines, while most publication professionals had a moderate or high self-assessed familiarity. The main barriers to application of publication guidelines, as rated by publication professionals, were that external authors in APAC are not familiar with global publication guidelines and do not always provide feedback/responses in writing.

Conclusion: It is important to consider the diverse language, cultural, and communication preferences of individuals involved in English-language publication development in APAC, and to ensure that authors are aware of current publication guidelines and best practices.

Background: Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors have emerged as a significant advancement in the treatment of HR+/HER2- metastatic breast cancer (MBC). Despite the clinical efficacy of CDK 4/6 inhibitors in HR+/HER2- metastatic breast cancer, there remains a significant gap in understanding their cost-effectiveness, particularly regarding the long-term economic impact and the key drivers of costs, when used in combination with endocrine therapy. This study aims to systematically review and conduct a meta-analysis of cost-effectiveness studies evaluating CDK4/6 inhibitors in treatment of HR+/HER2- advanced breast cancer and identify key drivers of costs of CDK4/6 inhibitors in combination with endocrine therapy.

Methods: A comprehensive search of PubMed and Embase was conducted to identify peer-reviewed studies from February 2015 to March 2022 reporting cost-effectiveness of CDK4/6 inhibitors in MBC treatment. Incremental net benefits (INBs) were estimated, and meta-analysis was conducted. This review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Results: We identified 120 articles, of which 18 were eligible for systematic review and 16 for meta-analysis. None of the three CDK4/6 inhibitors had positive INB compared to endocrine/aromatase inhibitors therapy alone. The pooled INB was estimated at -$149,266.87 (95% Confidence Interval (CI) = -$196,961.54, -$101,572.20).

Conclusion: The combination of CDK4/6 inhibitors and letrozole/endocrine therapy for the treatment of postmenopausal patients with advanced HR+/HER2 - MBC was not cost-effective.

Patient journey mapping, a novel method to visualize all the interactions a patient might have with the health system, is increasingly being adopted by the healthcare industry to identify challenges patients face, with the goal of improving health outcomes. However, patient journey maps are often used internally within pharma companies and are not published widely. Here, I conducted in-depth interviews with eight Indian patients/caregivers dealing with chronic and/or serious conditions; seven of the interviewees were living in India and spoke entirely from the perspective of the Indian health system, whereas one spoke from his experience of living in India, Ireland, and the UK. Using insights from these interviews, drawing on my own experience as a patient living with a rare disease and multiple comorbidities, and seeking feedback from several international patient advocates and industry professionals, I constructed a detailed map visualizing the collective journey of patients with serious/chronic conditions. Apart from showing the different stages in the patient journey, the map visualizes the associated stress levels, pain points (issues leading to a negative experience), emotions, and information-seeking behavior. One key insight that emerges is that along with a range of highly variable emotions patients experience, stress is a consistent factor throughout the patient journey. In many cases, the stress is caused or exacerbated by factors that can be avoided, such as long wait times, procedural hassles, inadequate or inaccurate information, and lack of empathy in interactions with healthcare professionals. The frustrations patients experience stem from a mix of underlying practical/tangible and emotional/aspirational needs. I have discussed these needs at length and provided suggestions for changes that could be implemented in the health system to meet these needs better. While my analysis presented here is generally framed from the context of the Indian health system, and some points discussed might have nuances in other health systems, the themes and insights provided are relevant to all patients and their journey, anywhere in the world. Pharmaceutical industry professionals, healthcare providers, and policymakers may benefit from these insights and may apply them to make strategic decisions and changes in their approach, with the goal of improving patient experience and health outcomes globally.

Objective: Atrial fibrillation (AF) is a common arrhythmia in patients at high cardiovascular risk. COVID-19 patients with underlying cardiovascular disease are at increased risk of poor clinical outcomes. In this study, we aimed to determine hospital outcomes among patients admitted with AF and COVID-19 infection.

Methods: We conducted a retrospective analysis using the 2020 California State Inpatient data, including all COVID-19 hospitalizations of individuals aged ≥18. Primary outcomes were in-hospital mortality, prolonged length of stay (above the 75th percentile), vasopressor use, mechanical ventilation, and ICU admission. We compared adverse hospital outcomes between those with and without AF and used multivariable logistic regression to adjust for confounders.

Results: This analysis included 94,114 COVID-19 hospitalizations, of which 9391 (10.0%) had AF. Patients with COVID-19 and AF had higher rates of adverse outcomes, including mortality (27.2% vs. 9.6%, p < .001), prolonged length of stay (40.0% vs. 27.1%, p < .001), vasopressor use (4.4% vs. 1.9%, p < .001), mechanical ventilation (19.0% vs. 9.1%, p < .001), and ICU admission (18.4% vs. 8.8%, p < .001) After multivariable adjustment, the odds of adverse outcomes remained significantly higher, including mortality adjusted odds ratio [OR], 2.04, 95% CI: 1.92-2.16), prolonged length of stay (aOR, 1.37, 95% CI: 1.31-1.44), vasopressor use (aOR, 1.98, 95% CI: 1.86-2.11), mechanical ventilation (aOR, 1.95, 95% CI: 1.72-2.20), and ICU admission (aOR, 2.01, 95% CI: 1.88-2.15).

Conclusion: COVID-19 hospitalized patients frequently have underlying AF, which confers a higher risk of adverse hospital outcomes and mortality, even after adjusting for baseline comorbidities. Heightened awareness is needed in the treatment of hospitalized COVID-19 patients with AF.

Objectives: To describe and compare healthcare resource utilization (HRU) among advanced therapy-naïve and advanced therapy-experienced patients with ulcerative colitis (UC) initiating ustekinumab or vedolizumab in the United States.

Methods: Claims data from IQVIA PharMetrics Plus de-identified database (01/01/2015-06/30/2022) were used to identify adult patients with UC initiating ustekinumab or vedolizumab (index date) after 10/21/2019. Baseline characteristics were balanced using inverse probability of treatment weighting. All-cause and UC-related HRU (number of inpatient admissions, inpatient days, emergency department visits, and outpatient visits) were described during the post-index period, and Poisson regression models were used to evaluate associations between index therapy and HRU outcomes. Analyses were performed separately among advanced therapy-naïve or advanced therapy-experienced patients.

Results: A total of 444 (ustekinumab) and 1,917 (vedolizumab) advanced therapy-naïve patients, and 647 (ustekinumab) and 1,152 (vedolizumab) advanced therapy-experienced patients were identified. In advanced therapy-naïve patients, higher rates of UC-related inpatient days (rate ratio [95% confidence interval] = 1.84 [1.15, 3.58]; p = 0.004), emergency department visits (1.39 [1.01, 2.17]; p = 0.044), and outpatient visits (1.81 [1.61, 2.04]; p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. In advanced therapy-experienced patients, higher rates of UC-related inpatient admissions (1.47 [1.06, 2.12]; p = 0.012), inpatient days (2.18 (1.44, 3.71); p < 0.001), and outpatient visits (1.50 (1.19, 1.82); p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. Results were similar when all-cause HRU was examined.

Conclusions: Among patients with UC with and without advanced therapy experience, higher rates of all-cause and UC-related HRU were observed among those treated with vedolizumab relative to ustekinumab.

Objective: This retrospective study using claims data compared demographics, clinical characteristics, treatment patterns, healthcare resource utilization, and clinical outcomes in Black and White patients with pulmonary arterial hypertension (PAH) in the United States.

Methods: Patients (aged ≥18 years) had ≥1 pharmacy claim for PAH medication, ≥6 months' continuous healthcare plan enrollment, ≥1 inpatient/outpatient medical claim with a pulmonary hypertension diagnosis ≤6 months before first PAH medication, and race recorded.

Results: This analysis included 836 Black and 2896 White patients. Black patients were younger, with lower levels of education and annual household income, and higher comorbidity scores versus White patients. Only ∼14% of Black and White patients received index combination therapy. Lower adherence to index treatment was observed in Black patients. Although adjusted regression analysis in the overall population showed no differences in outcomes between groups, Black patients <65 years were 36% less likely to receive index combination therapy (odds ratio [OR] 0.64; 95% confidence interval [CI] 0.41-0.99), and 46% less likely to adhere to index treatment (OR 0.54; 95% CI 0.33-0.90). Other disparities included 24% higher all-cause health care resource utilization, 75% higher all-cause costs, and higher risk of clinical composite outcome. Social determinants of health (education, income, health insurance plan) partially mediated these race effects.

Conclusions: Differences in demographics, clinical characteristics, and treatment patterns between Black and White patients with PAH were observed. Disparities between Black and White patients <65 years were only partially mediated through social determinants of health variables, suggesting other factors may be involved.