Current Medical Research and Opinion最新文献

Background: Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors were introduced for the treatment of anaemia in chronic kidney disease (CKD) in Japan in 2020; however, data on their use in clinical practice remain limited.

Methods: This retrospective cohort study used data from the Medical Data Vision database to assess treatment patterns and hemoglobin trends in non-dialysis-dependent (NDD)-CKD anaemia. Cohort 1 included patients starting HIF-PH inhibitors or erythropoiesis-stimulating agents (ESAs) between 2021 and 2024, while Cohort 2 included patients who had received ESAs in 2020. Sub-cohort 1, patients with iron repletion status in Cohort 1, were also examined.

Results: Cohort 1 included 9,253 patients. The patients starting HIF-PH inhibitors increased annually from 15.1% in 2021 to 54.8% in the first quarter of 2024. In Sub-cohort 1, prescriptions of HIF-PH inhibitors also annually increased. In these cohorts, initiation with HIF-PH inhibitors showed trends to maintain higher hemoglobin levels than ESAs. In patients with functional iron deficiency, the reduction in proportion with Hb <10 g/dL was more pronounced in HIF-PH inhibitors than ESAs. Cohort 2 (n = 1,998) had a low annual switch rate from ESAs to HIF-PH inhibitors (2.4%-3.9%), and improvement of anaemia was observed in the switched patients in whom ESAs do not sufficiently correct anaemia.

Conclusions: Real-world database analysis shows that initiation of HIF-PH inhibitors for renal anaemia in NDD-CKD increased to match that of ESAs by 2024, although switching from ESAs remained low. HIF-PH inhibitors showed a trend towards improvement in anaemia compared to ESAs, suggesting clinical benefit.

Pregnant women and newborns are historically underrepresented in clinical trials, creating critical gaps in evidence on the safety and effectiveness of medications used during pregnancy. Real-world data (RWD) sources offer a promising avenue to address these gaps. To fully realize this potential, it is essential to link maternal and infant records accurately within and across diverse datasets. High-quality mother--infant linkage enables the robust evaluation of maternal medication use and its short- and long-term effects on both maternal and infant health. However, linking maternal and infant healthcare data introduces complex methodological and practical challenges. Achieving accurate linkage is often hindered by factors such as inconsistent personal identifiers, discrepancies in insurance coverage between mother and infant, data incompleteness, algorithmic accuracy, and strict data privacy regulations. Commonly used proxies for linkage (e.g. shared address or healthcare provider) may also be unreliable and can introduce misclassification or duplication. This commentary synthesizes current knowledge on mother--infant data linkage in RWD. It also systematically outlines the key challenges, emerging opportunities, and strategic directions to improve linkage quality and address privacy concerns in the identification of mother--infant dyads to support rigorous pharmacoepidemiologic research on maternal and infant health outcomes. By improving linkage methods and leveraging innovative approaches such as tokenization and validated algorithms, researchers can enhance the reliability of real-world evidence on maternal and infant health outcomes, including long-term follow-up across diverse data sources. Advancing these methodological frontiers is essential to generate evidence that supports safer and more informed treatment decisions for pregnant women and their children.

Objectives: To quantify healthcare resource utilization (HCRU) and associated direct medical costs of migraine among adults in England compared with general population controls.

Methods: This retrospective cohort study used linked primary and secondary healthcare data (Clinical Practice Research Datalink Aurum [CPRD] and Hospital Episode Statistics [HES]) in England. Migraine cases (adults newly diagnosed with migraine between 1-Jan-2017 and 31-Mar-2019) and general population controls were matched on age, sex, ethnicity, practice region, Index of Multiple Deprivation 2019, and baseline depression and cardiovascular disease. All-cause HCRU and costs were estimated for cases and compared with controls using Fisher's Exact and Mann-Whitney U tests. Subgroup analyses were conducted by migraine treatment group (acute only, preventative only, acute and preventative, no treatment).

Results: A total of 62,143 migraine cases and matched controls were identified, of which 76.2% (n = 47,376) were female and the mean [SD] age at index was 39.8 [15.5] years. All-cause direct medical costs per-person per-year (pppy) were approximately 81% greater (p < 0.0001) in those with migraine (median [Q1, Q3]: £492 [£205, £1,149]) than controls (£272 [£101, £716]). The acute and preventative treatment subgroup had the highest all-cause direct costs pppy (£925 [£430, £2,046]).

Conclusion: Overall, patients diagnosed with migraine contribute a substantially larger cost burden on the healthcare system than their matched controls, with costs largely driven by interactions in secondary care. Costs varied depending on types of migraine treatment received and may reflect differences in migraine presentation, such as chronicity and patient needs, and potentially suboptimal management of migraine in primary care.

Chronic kidney disease affects over 36 million Americans, with more than 800,000 progressing to end-stage kidney disease (ESKD). Treatment with kidney transplantation offers superior survival, quality of life, and cost-effectiveness compared with dialysis, yet access remains limited. Hyperphosphatemia is a highly prevalent and modifiable complication of ESKD that contributes to cardiovascular disease, mineral bone disorder, and potential pulmonary dysfunction. Additionally, elevated serum phosphate has been linked to transplant graft failure and adverse post-transplant outcomes. Although normal phosphate levels are not formally required for transplant eligibility, they are frequently considered as part of transplant readiness assessments. Persistent gaps between clinical guideline recommendations and real-world serum phosphate control, despite dialysis, dietary restrictions, and phosphate binder therapy, underscore the need for individualized and more effective treatment strategies. Because transplant candidacy may be influenced by serum phosphate levels, phosphate management should be viewed not just as correction of a laboratory abnormality, but as a strategy to improve transplant access, promote health equity, and enhance long-term outcomes. Real-world tracking of transplant readiness metrics by serum phosphate levels will be essential to assessing the impact of new therapies and support transparent and equitable organ allocation. Effective phosphate management may reduce time on dialysis, improve graft and patient survival, and lower healthcare costs. In this context, managing hyperphosphatemia is a clinical and strategic imperative in advancing kidney health.

Introduction: Colorectal cancer (CRC) screening is recommended for average-risk adults, yet completion of the screening process requires follow-up colonoscopy after a positive stool-based test (SBT). Until recently, patients frequently faced out-of-pocket costs for follow-up colonoscopy, which was classified as a diagnostic procedure. In November 2022, coordinated federal policies were issued to eliminate patient cost-sharing for this procedure across commercial and Medicare insurance, effective January 2023. This study evaluated changes in follow-up colonoscopy utilization before and after implementation of these policies.

Methods: We conducted a retrospective cohort study using a large, nationally representative health care claims resource linked with laboratory data from January 1, 2022, to December 1, 2023. Adults aged 45-75 years who underwent colonoscopy were included. Follow-up colonoscopy (a diagnostic colonoscopy performed within six months of a positive SBT) was the primary endpoint. An interrupted time series design with a seasonally adjusted segmented autoregressive model estimated changes before (January-December 2022) and after (January-November 2023) cost-sharing elimination.

Results: Among 10,841,411 individuals undergoing colonoscopy, follow-up procedures comprised 3.59% (95% CI, 3.18-3.99) before implementation. Following policy enactment, there was an immediate 41.2% relative increase (absolute increase 1.48% [95% CI, 1.25-1.71]; p < .001), sustained through November 2023.

Conclusion: Elimination of patient cost-sharing for follow-up colonoscopy was associated with an immediate and sustained increase in utilization after positive stool-based tests. While other contextual factors may have contributed, these findings suggest that financial policy interventions can improve completion of the CRC screening process.

Background: Hyperkalemia is a common and clinically significant complication among patients receiving renin-angiotensin-aldosterone system inhibitors (RAASi). Despite their well-established cardiovascular and renal benefits, RAASi use is often limited by hyperkalemia, leading to treatment modification or discontinuation. Real-world adherence to potassium management strategies remains inconsistent, particularly in high-risk populations.

Objective: This study aimed to determine the incidence and severity of hyperkalemia among RAASi users, identify associated risk groups, and assess its influence on clinical decisions and patient outcomes.

Methods: We conducted a retrospective cohort study involving 905 adult patients attending outpatient clinics at King Abdulaziz Medical City, Jeddah. All patients were on RAASi therapy and followed for a mean duration of 29.8 months.

Results: Hyperkalemia (K⁺ ≥5.1 mmol/L) was observed in 295 patients, yielding an overall incidence of 32.8% (95% CI: 30-36%). Most cases were mild (74.6%), with moderate and severe hyperkalemia accounting for 19.0% and 6.4%, respectively. Recurrence occurred in over half of the affected patients, with decreasing intervals between successive episodes. Risk factors significantly associated with hyperkalemia included age ≥75 years, diabetes, congestive heart failure, and reduced eGFR. RAASi therapy was discontinued in 6.2%, and down-titrated in 4.5% of patients due to hyperkalemia. Adverse clinical events included emergency visits (2.1%), hospitalizations (1.7%), arrhythmias (0.3%), and dialysis (0.2%).

Conclusion: Hyperkalemia affects nearly one-third of RAASi users, often prompting de-escalation of therapy. Proactive monitoring and management strategies are necessary to maintain the benefits of RAAS inhibition, especially in high-risk groups.

Introduction: A positive result from a multi-target stool DNA (mt-sDNA) test, fecal immunochemical test (FIT), or fecal occult blood test (FOBT) requires a timely follow-up colonoscopy (FU-CY) to minimize colorectal cancer (CRC) incidence and reduce CRC-related mortality. This study aimed to assess differences in FU-CY adherence between patients who received a positive mt-sDNA or FIT/FOBT result by payer type.

Methods: This retrospective analysis utilized a large national claims database linked to the Exact Sciences Laboratories database, covering over 20 million individuals. Eligible patients were 45-75 years old with a positive result between 1 January 2017 and 30 June 2022, with the first test result serving as the index date. Primary outcomes included FU-CY adherence and time to colonoscopy completion.

Results: A total of 362,646 (mt-sDNA n = 292,300; FIT/FOBT n = 70,346) patients were identified. Overall adherence to FU-CY was significantly (p < .001) higher for the mt-sDNA test cohort (77.1%) compared to the FIT/FOBT cohort (45.1%). Among payer types, mt-sDNA test adherence was highest for commercial insurance (80.7%) and lowest for Medicaid (69.8%); for FIT/FOBT, adherence among commercially insured patients (42.3%) was lower than other payer types (47.4-47.9%). Regression analyses confirmed significantly higher FU-CY adherence (p < .001) for mt-sDNA across payer types, sex, and race/ethnicity. Within 180 days, FU-CY rates ranged from 62.7%-74.9% for mt-sDNA versus 36.1%-42.5% for FIT/FOBT.

Conclusion: In this large national study, adherence to FU-CY was substantially higher following mt-sDNA versus FIT/FOBT across payer types, with notably higher completion within 180 days for mt-sDNA test.