Current Medical Research and Opinion最新文献

Objective: Infectious mononucleosis (IM) or mono is typically caused by primary infection with Epstein-Barr virus (EBV) and may have a months-long, complicated course. We utilized population-based data to add to the limited literature on health care utilization following EBV infection.

Methods: The Rochester Epidemiology Project includes medical records for ∼60% of residents living in 27 counties of Minnesota (MN) and Wisconsin (WI). Persons meeting a case definition of recent EBV infection from 1 January 1998 to 31 December 2021 were compared to three persons not meeting the definition, matched on case's sex, age, and index date. Emergency department (ED) visits and hospitalizations in the two groups were compared during 5-years' follow-up divided into three periods (short-term ≤3 months, mid-term >3 months-1 year, long-term >1-5 years). Adjusted hazard ratios (AHR) were estimated to account for the potential influence of confounding variables.

Results: In total, 6,423 persons had a recent EBV infection and were matched to 19,269 comparators. The risk of an ED visit was significantly higher among cases in the short-term period (24.3% vs referents: 7.6%, p <.001; AHR = 3.71, 95% CI = 3.41-4.03). Cases also had an increased risk of hospitalization in the short-term (5.2% vs 1.6%: referents, p <.001; AHR = 3.53, 95% CI = 2.94-4.24). For ED visits but not hospitalization, the excess risk persisted into the mid-term follow-up period. Persons without a concurrent clinical diagnosis of IM continued to have an increased risk of hospitalizations up to 1 year after index date (AHR = 1.45, 95% CI = 1.09-1.91) and an increased risk of ED visits up to 5 years after the index date (AHR = 1.29, 95% CI = 1.14-1.46).

Conclusion: There is a substantial short- and mid-term increased risk of serious health care encounters associated with recent EBV infection. Mid- and long-term risks are increased in patients who do not have a concomitant diagnosis of IM.

Objective: HIV molecular epidemiology (HIV ME) is a tool that aims to improve HIV research, surveillance, and cluster detection and response. HIV ME is a core pillar of the U.S. initiative to End the HIV Epidemic but faces some challenges and criticisms from stakeholders. We sought to assess user experience to identify the current needs for HIV ME.

Methods: Users of HIV ME, including researchers and public health practitioners, were engaged via a structured survey. Needs were assessed via open-ended questions about HIV ME. Data were analyzed using reflexive thematic analysis; the concordance of results was assessed semi-quantitatively.

Results: Of 90 possible HIV-ME end-users, 57 completed the survey (response rate = 63%), which included users engaged in research (n = 29) and public health (n = 28). Respondents identified current imperatives, challenges, and strategies to improve HIV ME. Imperatives included characterization of the virus, identification of HIV hotspots, and tailoring of HIV interventions. Challenges encompassed technological issues, ethical concerns, and implementation difficulties. Strategies to improve HIV ME involved improving data access and analysis, enhancing implementation guidance and resources, and fostering community engagement and support. Researchers and public health practitioners prioritized different imperatives, but similarly emphasized the ethical concerns with HIV ME.

Conclusion: The imperatives identified by users underscore the necessity of HIV ME, while the challenges highlight the hurdles to be overcome, including ethical concerns which emerged as a shared emphasis across user groups. The strategies outlined offer a roadmap for overcoming these challenges. These insights, drawn from user experience, present a valuable opportunity to inform the development of guidelines for the ethical application of HIV ME in research, surveillance, and cluster detection and response.

Objective: To assess tablet utilization patterns and describe pre-treatment characteristics among new users of rimegepant.

Background: Rimegepant is the only oral calcitonin gene-related peptide antagonist approved in the United States for both the acute and preventive treatment of migraine.

Methods: We conducted a retrospective cohort study of people with migraine who initiated treatment with rimegepant using two US commercial claims databases (MarketScan and Optum). Patients (≥18 years old) with migraine who newly initiated rimegepant were included. Patients were stratified into two groups representing acute (quantity = 8) and prevention (quantity = 15 or 16) use cohorts. Baseline characteristics and medication use history were assessed on index and during the 365-day pre-index period. Rimegepant utilization periods were calculated based on days supplied and varying approaches to define use periods. Tablet quantity per 30 days was reported separately for both acute and prevention cohorts.

Results: In MarketScan, a total of 14,037 rimegepant users were identified; 11,195 (79.8%) in the acute group and 1,880 (13.4%) in the prevention group. Rimegepant utilization for acute use was 4.9 ± 2.1 tablets per 30 days and for preventive use was 13.1 ± 7.7 tablets per 30 days. There was high baseline prevalence of triptan contraindications, warnings, and high cardiovascular risk, with a combined 46.2% meeting one or more of these criteria. Acute medication overuse was also common (25.1%) prior to rimegepant initiation. Results were consistent in the Optum database.

Conclusion: Our analysis provides the first real-world data available on tablet utilization and characteristics of new users of rimegepant.

The development of therapies followed a generalized approach for a long time, assuming that a single treatment could effectively address various patient populations. However, recent breakthroughs have revealed the limitations of this one-size-fits-all paradigm. More recently, the field of therapeutics has witnessed a shift toward other modules, including cell therapies, high molecular weight remedies, personalized medicines, and gene therapies. Such advancements in therapeutic modules have the potential to revolutionize healthcare and pave the way for medicines that are more efficient and with minimal side effects. Cell therapies have gained considerable attention in regenerative medicine. Stem cell-based therapies, for instance, hold promise for tissue repair and regeneration, with ongoing research focusing on enhancing their efficacy and safety. High molecular weight drugs like peptides and proteins emerged as promising therapeutics because of their high specificity and diverse biological functions. Engineered peptides and proteins are developed for targeted drug delivery, immunotherapy, and disease-modulation. In personalized medicine, tailored treatments to individuals based on specific genetic profiling, lifestyle, biomarkers, and disease characteristics are all implemented. Clinicians have tailored treatments to optimize outcomes and minimize adverse effects, using targeted therapies based on specific mutations, yielding remarkable results. Gene therapies have revolutionized the treatment of genetic disorders by directly targeting the underlying genetic abnormalities. Innovative techniques, such as CRISPR-Cas9 have allowed precise gene editing, opening up possibilities for curing previously incurable conditions. In conclusion, advancements in therapeutic modules have the potential to revolutionize healthcare and pave the way for medicines that are more efficient and with minimal side effects.

Background and purpose: Public medical insurance data are increasingly used to study myasthenia gravis (MG); however, a validated case definition is lacking. We assessed the clinical characteristics of patients identified according to previously used case definitions.

Methods: Patients with diagnosis code G70.0 (myasthenia gravis) who visited Severance Hospital between January 2019 and December 2020 were retrospectively analyzed. Three case definitions used in previous epidemiologic studies were applied to the included patients, and their performance was evaluated based on sensitivity, specificity, and positive predictive value (PPV).

Results: A total of 843 patients with diagnosis code G70.0 were identified, and 796 (96.7%) met the clinical diagnostic criteria for MG. All three previously-used case definitions showed a PPV of >98% in identifying clinically diagnosed MG, with sensitivities ranging from 68.7 to 71.1%. Case definition #1 was unable to identify 230 patients with MG: 42.6% were in remission, 23.5% were lost to follow-up, and 25.2% were receiving prescriptions elsewhere. A similar pattern was observed for definitions #2 and #3: Patients with thymoma-associated MG who were followed-up by thoracic surgeons were frequently missed based on the previously used case definitions. A proposed case definition that additionally includes a history of thymoma enhanced the sensitivity to 77.9%, while maintaining a PPV of 99.4%.

Conclusion: The previously used case definitions showed a high PPV but were unable to identify patients in remission or followed-up elsewhere. These limitations can be overcome by utilizing a new case definition and expanding the study duration.

We conducted a scoping review of peer-reviewed literature published between January 1, 1990 and October 31, 2021, to identify socioeconomic determinants that contribute to higher burden and adverse outcomes in diseases for which self-care is an important modality of treatment and prevention. We identified these diseases using over-the-counter medicines sales data sourced from IQVIA. We searched Ovid Medline, PubMed, and EMBASE databases for articles published in English using inclusion/exclusion criteria. We analyzed articles covering 42 diseases that qualified as cardiovascular disorders (219 studies including ischemic heart disease, myocardial infarction, stroke, and related risk factors such as hypertension, dyslipidemia and atrial fibrillation), nutritional disorders (66 studies including malnutrition which encompasses undernutrition and micronutrient deficiencies, and anemia), digestive disorders (40 studies including gastroesophageal reflux disorder, inflammatory bowel disease, and dyspepsia), allergy disorders (40 studies including asthma and allergic rhinitis), pain disorders (14 studies including lower back pain, knee pain, generalized musculoskeletal pain and headaches), dermatological disorders (23 studies including atopic dermatitis [eczema], occupational dermatosis, and facial dermatitis), respiratory disorders (11 studies including chronic cough, pneumonia, chronic bronchitis, wheezing, and influenza), and gynecological disorders (29 studies including bacterial vaginosis and trichomoniasis vaginosis). We found that lifestyle factors were the commonly reported risk factors, and residential segregation, education, and income were the commonly reported socioeconomic determinants. A closer analysis of income within each disorder revealed that it is more often associated with health conditions that are self-limiting. Although we did not find any discernible relationship between the commonly reported socioeconomic factors and the prevalence of self-medication for the health conditions considered, income plays an important role in the burden and outcomes of conditions that require more self-care compared to those that require less self-care.

Objective: Proportion Of suboptimal Disease Control And Strategy of Treatment in IBD (PODCAST-IBD) was an international real-world study which aimed to quantify disease control in IBD using STRIDE-II recommendations.

Design/method: Cross-sectional assessment of IBD patients attending routine clinic appointments in four UK centers October 2022 to January 2023. Clinician-reported outcomes, patient-reported outcomes and retrospective data from medical chart review were used to assess IBD control against red flags aligned to STRIDE-II.

Results: Data were available from 198 UK patients. IBD was suboptimally controlled in 52.4% (54/103) of patients with Crohn's disease (CD) and 45.3% (43/95) with ulcerative colitis (UC). Impaired quality of life (QOL), defined as Short inflammatory bowel disease questionnaire (SIBDQ) score <50, was the main contributor to suboptimal disease control. Suboptimal disease control has a detrimental impact on fatigue and disability with significantly lower mean Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score in suboptimally controlled disease (CD: 81.5 vs 125, UC: 87.4 vs 122.8) and IBD Disk. Suboptimal disease control results in higher health care resource use (HCRU) (CD: £4,746 vs £1,924; UC: £2,428 vs £1,121) and higher rates of work productivity loss (CD: 41.7% vs 11.9%, UC: 38.0% vs 22.6%).

Conclusion: IBD was suboptimally controlled in around one-half of patients. Impaired QOL was the most common contributor (64%, 62/97) to suboptimal control. Suboptimal control had a considerable economic impact; HCRU more than doubled and productivity fell. Physicians could consider regular QOL assessments to prompt timely disease monitoring to enable identification of early active disease and appropriate treatment.

Objective: Tegoprazan represents a newly developed potassium-competitive acid blocker utilized for the treatment of acid-related disorders. The present study aimed to explore the therapeutic effectiveness of tegoprazan in Chinese individuals with duodenal ulcers (DU).

Methods: In the current multicenter, randomized, double-blind, double-dummy, parallel-group, non-inferiority, phase III clinical trial, individuals with DU underwent randomization 1:1 to be administered tegoprazan 50 mg or lansoprazole 30 mg once daily. The primary efficacy endpoint was the 6-week cumulative endoscopic ulcer healing rate. Secondary endpoints included 4-week endoscopic ulcer healing rate and relief of DU-related gastrointestinal symptoms at weeks 2, 4, and 6. Safety analysis encompassed adverse events (AEs) and laboratory indexes.

Results: The 6-week cumulative endoscopic ulcer healing rates were 96.9% (188/194) and 99.0% (189/191) in the tegoprazan and lansoprazole groups, respectively, indicating a difference of -2.0% (95% confidence interval (CI) = -4.9 to 0.8) in the full analysis set (FAS). The corresponding healing rates were 98.4% (185/188) and 99.5% (183/184) in the per-protocol set, respectively, indicating a difference of -1.1% (95% CI = -3.1 to 1.0). The 4-week healing rates in the tegoprazan and lansoprazole groups were 89.2% (173/194) and 88.5% (169/191) in the FAS, respectively, with a difference of 0.7% (95% CI = -5.6 to 7.0). Treatment-related AEs, all mild-to-moderate, were reported in 38.2% (78/204) and 48.2% (94/195) of participants in the tegoprazan and lansoprazole groups, respectively.

Conclusions: Tegoprazan 50 mg once daily is effective and non-inferior to lansoprazole 30 mg once daily in Chinese patients with DU, showing a promising safety and tolerability profile.

Clinicaltrials.gov registration number: NCT05010954.

Objective: We report patient-reported outcomes (PROs) measuring health-related quality of life (HRQoL) from the ROSEWOOD trial (NCT03332017), which demonstrated superior efficacy and a manageable safety profile with zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) in patients with heavily pretreated relapsed/refractory follicular lymphoma (R/R FL).

Methods: PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and EQ-5D-5L questionnaires at baseline and subsequently every 12 weeks. All QLQ-C30 domains and EQ-5D-5L visual analog scale (VAS) scores were analyzed descriptively. At the key clinical timepoints (weeks 12 and 24), a mixed model for repeated measures (MMRM) analysis was used to evaluate the key PRO endpoints, including global health status, physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting. Clinically meaningful change was defined as a ≥ 5-point mean difference from baseline and between the ZO and O arms.

Results: Patients were randomized to ZO (n = 145) or O (n = 72). By week 48, descriptive analysis results indicated that patients in the ZO arm demonstrated improved outcomes in role functioning and fatigue and nausea/vomiting symptoms, compared with those in the O arm. Both groups experienced improvements in pain symptoms. EQ-5D-5L VAS scores showed no observable differences between treatment arms through week 48. MMRM analysis revealed that the global health status/quality of life of patients treated with ZO improved, as did fatigue, at week 12. At week 24, patients in the ZO arm experienced a clinically meaningful improvement in role functioning, pain, and fatigue.

Conclusions: In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab.

Trial registration: The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).