Pharmacoepidemiology and Drug Safety最新文献

{"title":"Exploring the Complexity of Real-World Health Data Record Linkage-An Exemplary Study Linking Cancer Registry and Claims Data.","authors":"Nadja Lendle, Bianca Kollhorst, Timm Intemann","doi":"10.1002/pds.70120","DOIUrl":"10.1002/pds.70120","url":null,"abstract":"<p><strong>Purpose: </strong>Record linkage based on quasi-identifiers remains an important approach as not every data source provides a comprehensive unique identifier. In this study, the reasons for the failure of a linkage based on quasi-identifiers were examined. Furthermore, informed algorithms using information on gold standard links were developed to investigate the potentially achievable linkage quality based on quasi-identifiers.</p><p><strong>Methods: </strong>The study population includes patients from an antidiabetic cohort from German claims and colorectal cancer patients from two German cancer registries. Linkage algorithms were applied using information on gold standard links. Informed linkage algorithms based on deterministic linkage, logistic regression, random forests, gradient boosting, and neural networks were derived and compared. Descriptive analyses were performed to identify reasons for the failure of linkage, such as discrepancies between data sources.</p><p><strong>Results: </strong>A gradient boosting-based linkage approach performed best, achieving a precision (positive predictive value) of 77%, a recall (sensitivity) of 81%, and an F*-measure (combining precision and recall) of 64%. Of 641 patients in GePaRD, 8% were not uniquely identifiable using birth year, sex, area of residence, and year and quarter of diagnosis, whereas 33% of 42 817 cancer registry patients were not uniquely identifiable with these quasi-identifiers.</p><p><strong>Conclusions: </strong>Linkage of German claims and cancer registry data based on quasi-identifiers does result in insufficient linkage quality since subjects cannot be uniquely identified. It is advisable to use unique identifiers from a subsample, if available, to derive informed linkage algorithms for the entire sample. In this case, the machine learning technique gradient boosting has been found to outperform other methods.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70120"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Paroxetine Versus Non-Paroxetine Selective Serotonin Reuptake Inhibitors on Mortality and Heart Failure Following Myocardial Infarction: An Active Comparator Population-Based Cohort Study.","authors":"Thomas Ravn Lassen, Péter Szentkúti, Henrik Toft Sørensen, Hans Erik Bøtker, Jens Sundbøll","doi":"10.1002/pds.70141","DOIUrl":"10.1002/pds.70141","url":null,"abstract":"<p><strong>Background: </strong>Animal studies suggest that paroxetine, unlike other selective serotonin reuptake inhibitors (SSRIs), may attenuate post-myocardial infarction (MI) heart failure. We examine the effectiveness of paroxetine versus non-paroxetine SSRIs on the risk of post-MI mortality and heart failure in a clinical setting.</p><p><strong>Method: </strong>We conducted a nationwide population-based cohort study based on Danish medical registries. Using an active comparator design, we compared the effectiveness of paroxetine with non-paroxetine SSRI drugs on post-MI outcomes. This included all patients hospitalized for MI in Denmark during 1995-2020 who had redeemed an SSRI prescription within 90 days prior to admission and measured outcome variables after a 180-day follow-up period. We calculated cumulative incidences as a measure of risk and used Cox regression to compute hazard ratios (HRs) for all outcomes, adjusting for sex, age group, individual comorbidities, and comedications.</p><p><strong>Results: </strong>We identified 13 053 patients receiving treatment with an SSRI at the time of hospital admission for MI. Cumulative incidences were lower for paroxetine SSRI users compared with non-paroxetine SSRI users for all-cause mortality (24.7% versus 33.8% (difference: -9.1% [95% CI: -12.4; -5.8])) and cardiovascular death (15.9% versus 22.7% (-6.8% [95% CI: -9.6; -4.0])), but not for heart failure (11.0% versus 11.8% (-0.7% [95% CI: -3.13; 1.65])). Adjusted hazard ratios (aHRs) showed no substantial differences for all-cause mortality (aHR 0.9 [95% CI: 0.8-1.1]), cardiovascular death (aHR 0.9 [95% CI: 0.8-1.1]), or heart failure (aHR 1.0 [95% CI: 0.8-1.3]).</p><p><strong>Conclusion: </strong>Paroxetine was not associated with clinically significant improvement in post-MI outcomes compared with non-paroxetine SSRI drugs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70141"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11937423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Regulatory Interventions on Immediate Release Fentanyl and Alternatives Use in Spain: An Interrupted Time Series Analysis.","authors":"Elvira Rubio-Esparza, Diana González-Bermejo, Eva Angela Segovia-Muñoz, Edurne Lázaro-Bengoa","doi":"10.1002/pds.70145","DOIUrl":"https://doi.org/10.1002/pds.70145","url":null,"abstract":"<p><strong>Purpose: </strong>Immediate release fentanyl (IRF) is approved for breakthrough cancer pain. In February 2018, the Spanish Agency of Medicines and Medical Devices (AEMPS) issued a communication reminding the authorized conditions and risks. In July 2021, a prescription-controlled system was implemented to avoid use in non-cancer patients. We assessed the impact of these regulatory interventions on IRF use and alternatives such as immediate release morphine (IRM).</p><p><strong>Methods: </strong>Ecological study using national data of defined daily dose (DDD) dispensed per 100 000 inhabitants and day (DID). Segmented regression analysis was conducted to quantify the impact of the regulatory interventions. Furthermore, inflection points identified through sensitivity analysis using joinpoint regression were incorporated to capture potential trend changes more accurately and enhance the robustness of the analysis.</p><p><strong>Results: </strong>The AEMPS communication was associated with an immediate decrease in IRF use (-1.57 DID), although it did not influence the trend, which had previously stabilized since 2017. The prescription-controlled system was associated with a substantial decline in level (-5.01 DID) and slope (-1.64 DID per quarter). IRM use increased continuously throughout the study period. After the last intervention, a rise was observed (0.27 DID), but no trend changes.</p><p><strong>Conclusions: </strong>The prescription-controlled system was associated with a sharp decline in IRF use and a slight increase in IRM use, which can be attributed to restrictions applied to non-cancer patients. The increase in IRM use does not compensate for the decrease in IRF consumption, suggesting that other therapeutic strategies with opioids and non-opioid alternatives should be explored in these patients.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70145"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Receipt of Tdap or Influenza Vaccine During Pregnancy and Odds of Clinical Chorioamnionitis: A Nested Case-Control Study.","authors":"Clinton Hall, Sandra Maduforo, Celeste J Romano, Anna T Bukowinski, Gia R Gumbs, Ava Marie S Conlin","doi":"10.1002/pds.70147","DOIUrl":"https://doi.org/10.1002/pds.70147","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the odds of clinical chorioamnionitis following tetanus, diphtheria, and acellular pertussis (Tdap) or influenza vaccine receipt in pregnancy.</p><p><strong>Methods: </strong>In this nested case-control study, a cohort of live deliveries at two United States military hospitals, 2013-2018, was initially screened for chorioamnionitis using diagnosis codes. A sample of deliveries was selected for chart review and validation. Study cases (clinical chorioamnionitis) were defined by the presence of fever and at least one additional clinical symptom during the delivery hospitalization; controls were defined by the absence of these criteria. Descriptive statistics compared characteristics of validated cases and controls, and multivariable logistic regression models estimated adjusted odds ratios (aORs) and 95% confidence intervals (CIs) with receipt of Tdap or influenza vaccine during pregnancy; observations were weighted by the inverse probability of being sampled for validation.</p><p><strong>Results: </strong>Among 6931 deliveries, 1868 were sampled for validation and 1650 (n = 305 cases, n = 1345 controls) were included for analysis. At delivery, mean age was 25.0 years for cases and 25.9 years for controls; 88.4% of cases and 63.0% of controls were primipara. Tdap vaccine was recorded in 82.8% of cases and 82.0% of controls (aOR 0.94, 95% CI 0.72, 1.23) and influenza vaccine was recorded in 61.8% of cases and 63.0% of controls (aOR 0.97, 95% CI 0.78, 1.19). Analyses that considered timing and combinations of vaccine receipt yielded similar estimates.</p><p><strong>Conclusion: </strong>In this population, neither Tdap nor influenza vaccine receipt during pregnancy was associated with increased odds of clinical chorioamnionitis at delivery.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70147"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antidepressant Use Trajectories and Risk of Discontinuation After Adolescents and Young Adult Cancer Diagnosis.","authors":"Oluwadamilola Onasanya, Udim Damachi, Susan dosReis, Wendy Camelo Castillo","doi":"10.1002/pds.70131","DOIUrl":"10.1002/pds.70131","url":null,"abstract":"<p><strong>Background: </strong>Little is known about the continuity of antidepressant treatment after adolescent and young adult (AYA) cancer diagnosis. Clinical guidelines recommend that past antidepressant use trajectories should inform decisions on discontinuation after cancer diagnosis. We characterized AYAs' antidepressant adherence trajectories before incident cancer diagnosis and assessed any association between their past adherence trajectory and the risk of antidepressant discontinuation up to 1 year afterward.</p><p><strong>Methods: </strong>We conducted a retrospective, longitudinal cohort study of AYAs receiving ≥ 2 antidepressant fills 9 months before incident cancer diagnosis (index date). Group-based trajectory modeling was used to estimate latent subgroups of antidepressant adherence before cancer diagnosis, using monthly proportions of days covered (PDC) over the nine-month baseline; IQVIA PharMetrics Plus for Academics US claims, 2006-2020. Discontinuation was defined as ≥ 60-days gap without antidepressants within 1 year post-index date.</p><p><strong>Results: </strong>We observed three distinct antidepressant adherence trajectory groups before cancer diagnosis: recent start (17% of cohort, mean PDC [range]: 0.25 [0.03-0.49]); gradually increasing (36%, mean PDC [range]: 0.57 [0.22-0.81]); and consistently high (47%, mean PDC [range]: 0.90 [0.62-1.00]). Compared with AYAs exhibiting prior consistently high adherence trajectories, those with recent start (HR, [95% CI] 1.96, [1.46-2.63]) and gradually increasing (HR, [95% CI] 1.52, [1.20-1.93]) trajectories experienced about 2 times the higher risk of antidepressant discontinuation over the year following cancer diagnosis.</p><p><strong>Conclusion: </strong>Past antidepressant trajectory is associated with antidepressant discontinuation after AYA cancer diagnosis. Attention is needed in the psycho-oncologic care of AYAs who recently started antidepressants before cancer diagnosis.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70131"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in the Cost and Utilization of Publicly Dispensed Respiratory Inhalers in Ontario, Canada: A Repeated Cross-Sectional Study.","authors":"Ria Garg, Tianru Wang, Mina Tadrous, Tony Antoniou, Tara Gomes","doi":"10.1002/pds.70125","DOIUrl":"10.1002/pds.70125","url":null,"abstract":"<p><strong>Purpose: </strong>Several new respiratory inhalers have recently entered the market, including combination therapy products and generic alternatives. Therefore, we examined the cost and utilization of publicly dispensed respiratory inhalers in Ontario, Canada, and the impact of new market entrants on these trends.</p><p><strong>Methods: </strong>We conducted a repeated cross-sectional study among provincial drug program beneficiaries dispensed a respiratory inhaler between January 1, 2003, and March 31, 2023. We estimated per-beneficiary spending on respiratory inhalers per quarter, defined as the cost (2022 Canadian dollars) of respiratory inhalers reimbursement divided by the number of beneficiaries dispensed a respiratory inhaler. Joinpoint regression models were used to characterize changes in the trend.</p><p><strong>Results: </strong>Between Q1 of 2003 and Q1 of 2023, public payer spending rose 160% ($26 206 322 to $68 054 816), while the number of beneficiaries dispensed a respiratory inhaler increased 92% (155 893 to 299 418). Reimbursement of ICS/LABA inhalers accounted for half the cost ($33 844 484 in Q1 of 2023). The trend for per-beneficiary spending was marked by six joinpoints, with periods of increasing and decreasing quarterly costs. Between 2003 and 2015, per-beneficiary spending increased, reaching $248/beneficiary in Q1 of 2015. In Q2 of 2015, the trend decreased for the first time and continued to decline until Q2 of 2018 ($206/beneficiary). The trend increased again after Q3 of 2018 and reached a plateau in Q3 of 2019 ($216/beneficiary).</p><p><strong>Conclusions: </strong>Public formulary listing of combination therapy inhalers, namely LAMA/LABA in Q2 of 2015, coincided with a significant decline in per-beneficiary spending on respiratory inhalers.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70125"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11977044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in the Dispensing of Oral Anti-Cancer Medications Across Australia Over 10 Years.","authors":"Michael James Leach, Emily Griffin, Sinead Hickmott, Holly Atkinson, Louise Bettiol, Eli Ristevski","doi":"10.1002/pds.70126","DOIUrl":"10.1002/pds.70126","url":null,"abstract":"<p><strong>Purpose: </strong>Oral anti-cancer medications (OAMs) are easily administered yet high-risk treatments. Few studies have investigated national and subnational trends in OAM dispensing. We aimed to examine 10-year trends in Australia's OAM dispensing at the national level as well as by state/territory and medication type/class.</p><p><strong>Methods: </strong>Aggregate data on Australia's OAM dispensing and population for 2014-2023 were sourced from Services Australia and the Australian Bureau of Statistics, respectively. Annual OAM dispensing rates (counts per 100 000 population) were calculated overall as well as by state/territory and medication type/class. Percentage change (Δ) in dispensing rates from 2014 to 2023 was determined. Where valid, Mann-Kendall trend tests were performed.</p><p><strong>Results: </strong>Australia-wide from 2014 to 2023, dispensing counts per 100 000 population for any OAMs increased nonlinearly from 3 475 to 3 930 (+Δ13%), hormonal OAMs decreased nonlinearly from 2 659 to 2 225 (-Δ16%), and non-hormonal OAMs exhibited a significant (p < 0.05) near-linear upward trend from 816 to 1 705 (+Δ109%). This coincided with a significant upward trend in the number of unique non-hormonal OAMs dispensed Australia-wide (+Δ187%). Percentage changes in non-hormonal OAM dispensing rates were greatest for protein kinase inhibitor (PKI) dispensing Australia-wide (+Δ232%), with a significant, near-linear upward trend from 286 to 950, and non-hormonal OAM dispensing in South Australia (+Δ141%), with a significant, near-linear upward trend from 820 to 1972.</p><p><strong>Conclusions: </strong>Australia's non-hormonal OAM dispensing increased over 2014-2023, mostly for PKIs. This likely reflects rising availability of and prescriber/patient demand for these medications, suggesting scope to pilot and expand OAM adherence and safety initiatives.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70126"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of State Policies on Opioid Prescribing Among Surgery and Injury Patients: Controlled Interrupted Time-Series Study, North Carolina, 2014-2019.","authors":"Theo G Beltran, Brian W Pence, Naoko Fulcher, Nabarun Dasgupta, Courtney N Maierhofer, Bethany L DiPrete, Stephen W Marshall, Maryalice Nocera, Scott K Proescholdbell, Li-Tzy Wu, David A Edwards, Timothy S Carey, Paul R Chelminski, Juan M Hincapie-Castillo, Joacy G Mathias, Shabbar I Ranapurwala","doi":"10.1002/pds.70144","DOIUrl":"10.1002/pds.70144","url":null,"abstract":"<p><strong>Purpose: </strong>Impact of policies limiting opioid prescribing for acute and post-surgical pain among racially minoritized populations is not well understood. We evaluated the impact of two North Carolina (NC) policies on outpatient opioid prescribing among injury and surgical patients by race, ethnicity, age, and sex.</p><p><strong>Methods: </strong>We conducted controlled and single series interrupted time series using electronic health data from two integrated healthcare systems in NC, among > 11 years-old patients having acute injuries and surgery between April 2014 and December 2019. The policy interventions were safe opioid prescribing investigative initiative (SOPI, May 2016) and NC law limiting opioid days' supply (STOP Act, January 2018). Outcomes included, proportion of patients receiving index opioid prescription after surgery or injury event, receipt of subsequent opioid prescriptions, days' supply, and milligrams of morphine equivalents (MME).</p><p><strong>Results: </strong>Of the 621 997 surgical and 864 061 injury patients, 69.4% and 19.7%, respectively, received an index opioid analgesic prescription. There were sustained declines in index opioid prescription among post-surgical patients after SOPI [-2.7% per year (-4.6, -0.9)] and STOP act [-4.1% (-5.9, -2.2)], but no change among injury patients. Policy-related opioid prescribing declines were larger among black, native American, and Hispanic post-surgical patients than whites and Asians. Index and subsequent opioid days' supply showed sustained declines after SOPI and STOP Act among post-surgical patients. There was no policy impact on MME.</p><p><strong>Conclusions: </strong>Policies were associated with reductions in opioid prescribing, particularly in post-surgical patients; however, racialized inequities likely reflect implicit and explicit racialized biases in pain management practices.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70144"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discontinuation Categories Underlying Gaps in Dispensing for Six Medication Groups.","authors":"Elizabeth A Bayliss, Glenn K Goodrich, Jennifer C Barrow, Bill Harding, Courtney A Ripley, Courtney R Kraus, Valerie Paolino, Jonathan D Norton, Orla C Sheehan, Linda A Weffald, Ariel R Green, Ted E Palen, Emily Reeve, Matthew L Maciejewski, Cynthia M Boyd","doi":"10.1002/pds.70142","DOIUrl":"10.1002/pds.70142","url":null,"abstract":"<p><strong>Purpose: </strong>Accurately identifying medication discontinuations at scale is important for developing evidence about deprescribing. Gaps in dispensing often serve as proxies for discontinuation but are imprecise. We categorize reasons for gaps in dispensing to inform data-based methods to accurately identify medication discontinuations.</p><p><strong>Methods: </strong>Using pharmacy dispensing data, we purposively sampled from a population of adults age 65+ with 2+ chronic conditions who experienced a 90-day gap in dispensing-with and without subsequent fills-of oral diabetes drugs, statins, proton pump inhibitors, drugs with anticholinergic properties, anticoagulants and antiplatelet drugs, or antihypertensives. We reviewed clinical documentation (e.g., visit notes, communications, medication orders) from last dispensing through the 90-day gap plus 120 days to classify dispensing gaps as true discontinuations (clinically intended) or non-discontinuations (no evidence of intent to discontinue), and then into subcategories. Medications with no documented explanation for the gap in dispensing and continued listing on the patient's medication list were classified as non-discontinuations.</p><p><strong>Results: </strong>Of N = 1906 records reviewed, there were 1068 (56%) true discontinuations and 838 (44%) non-discontinuations. Subcategories within true discontinuations included provider intent to discontinue, provider substitutions, intentional stops followed by restarts, and agreeing with a colleague's or patient's decision to discontinue. Non-discontinuations included documented low adherence, changes in dose, changes in pharmacy formulary, and changes in drug formulation. Proportions of drugs in categories and subcategories varied by medication group.</p><p><strong>Conclusion: </strong>Using gaps in dispensing as proxy measures for medication discontinuation may introduce bias through misclassification, and varied reasons for discontinuation may complicate causal interpretations.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70142"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dipeptidyl Peptidase-4 Inhibitors and Risk of Heart Failure in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Requiring Dialysis.","authors":"Tzu-Han Lin, Tung-Ying Hung, Liang-Yu Lin, Tzu-Chieh Lin, Ying-Jay Liou, Yu-Juei Hsu, Meng-Ting Wang","doi":"10.1002/pds.70138","DOIUrl":"https://doi.org/10.1002/pds.70138","url":null,"abstract":"<p><strong>Introduction: </strong>Evidence on the safety of antidiabetic agents in end-stage renal disease (ESRD) patients requiring dialysis, a group often excluded from randomized controlled trials, is scant. Dipeptidyl peptidase-4 inhibitors (DPP-4i), widely used for type 2 diabetes mellitus (T2DM) management in this group, have raised concerns regarding the risk of heart failure (HF). However, real-world evidence on HF risk with DPP-4i in dialysis-dependent diabetic patients is limited. We aimed to assess HF safety of DPP-4i compared with sulfonylureas (SU)/meglitinides in a nationwide T2DM population with ESRD requiring dialysis.</p><p><strong>Methods: </strong>A new user, active comparator cohort study employing propensity score-inverse probability of treatment weighting was conducted utilizing Taiwan's nationwide healthcare claims database (2012-2020). Evaluated outcomes included hospitalizations for HF or cardiovascular death as the primary outcome, with major adverse cardiovascular events (MACEs), all-cause mortality, and severe hypoglycemia as secondary outcomes, using weighted Cox proportional hazards models.</p><p><strong>Results: </strong>The study included 6882 patients initiating DPP-4i and 6174 starting SU/meglitinides, with a mean age of 66.4 years and 53.1% male. Initiation of DPP-4i versus SU/meglitinide was not associated with increased risks of HF hospitalizations, cardiovascular death, MACEs, or all-cause mortality, but was significantly tied to a 44% reduced risk of severe hypoglycemia.</p><p><strong>Conclusions: </strong>This study's findings indicate that in T2DM patients with ESRD requiring dialysis, DPP-4i do not elevate the risk of hospitalizations for HF, cardiovascular death, or all-cause mortality, but significantly lower the risk of severe hypoglycemia compared with SUs/meglitinides. This supports the preference for DPP-4i over SUs or meglitinides for managing T2DM in dialysis patients.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70138"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}