Pharmacoepidemiology and Drug Safety最新文献

{"title":"Antihypertensive Medications and Risk of Heat-Related Illness During Heatwaves: Self-Controlled Case Series.","authors":"Mia Harley, Masao Iwagami, Chitose Kawamura, Elizabeth Williamson, Christopher T Rentsch, Rohini Mathur, Ian J Douglas, Dorothea Nitsch, Yuta Taniguchi, Yoko Hamasaki, Ai Suzuki, Naoaki Kuroda, Jun Komiyama, Angel Y S Wong, Nanako Tamiya","doi":"10.1002/pds.70447","DOIUrl":"10.1002/pds.70447","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate whether antihypertensive medications modify the risk of heat-related illness during heatwaves among adults with hypertension in Japan.</p><p><strong>Methods: </strong>We identified adults with hypertension in Tsukuba City administrative claims data between April 2014 and March 2019. Average daily temperature was derived from Japan Meteorological Agency data. We used a self-controlled case series (SCCS) design to estimate incidence rate ratios (IRRs) for heat-related illness during 5-day pre-heatwave, heatwave and 5-day post-heatwave periods compared to baseline within individuals. The main analysis was stratified by person-time prescribed antihypertensives (angiotensin-converting enzyme [ACE] inhibitors/angiotensin II receptor blockers [ARBs], calcium channel blockers [CCBs] or non-loop diuretics) and person-time not prescribed antihypertensives, with drug-temperature interaction assessed. Subgroup analyses were conducted for each antihypertensive class. All models were adjusted for age and season.</p><p><strong>Results: </strong>We observed a greater increase in the rate of heat-related illness during heatwaves versus baseline among person-time prescribed antihypertensives (IRR: 1.64, 95% CI: 1.53-1.75) than among person-time not prescribed antihypertensives (IRR: 1.42, 95% CI: 1.27-1.58), with evidence of drug-temperature interaction (p < 0.01). When examining individual drug classes, ACE inhibitors/ARBs and CCBs were associated with an increased risk of heat-related illness during heatwaves, whereas there was no evidence of an effect with diuretics.</p><p><strong>Conclusions: </strong>Our findings indicate that people taking antihypertensives are more vulnerable to heat-related illnesses during heatwaves. More research is required to explore whether this is a causal effect of the medication or due to differences between those who are treated and untreated with antihypertensives that are related to the outcome.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70447"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13553137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148912992","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":"Postpartum Psychotropic Treatment Patterns and Breastfeeding: Nationwide Clustering Study.","authors":"Anders Hviid, Anna Laksafoss, Elisabeth O'Regan, Poul Videbech, Ingrid Bech Svalgaard","doi":"10.1002/pds.70470","DOIUrl":"10.1002/pds.70470","url":null,"abstract":"<p><strong>Introduction: </strong>Postpartum psychotropic medication use is heterogeneous, comprising continuation of prenatal treatment, initiation, transient use and complex polypharmacy. Prior studies have reported the prevalence of potential infant exposure to psychotropics via breast milk, but characterisations better capturing the heterogeneity of this exposure are lacking. We aimed to identify distinct postpartum psychotropic treatment patterns using hierarchical clustering accounting for medication type, timing and polypharmacy, and to describe breastfeeding characteristics across these patterns.</p><p><strong>Methods: </strong>Population-based cohort study of mothers using psychotropics during the first postpartum year using linked Danish national registers 2012-2023. From a source population of 659 866 mother-child pairs with live-born singleton births, 38 528 mothers redeemed at least one psychotropic prescription during the first postpartum year and comprised the study cohort. Weekly psychotropic use was defined by redeemed prescriptions using prescribed daily dose assumptions. Hierarchical agglomerative clustering (tame R package) identified distinct treatment patterns based on medication type, timing and polypharmacy. The number of patterns was determined from interpretability, size and examination of the hierarchical dendrogram. Exclusive breastfeeding prevalence and duration were described across patterns among pairs with recorded breastfeeding habits (64%).</p><p><strong>Results: </strong>Eight distinct treatment patterns were identified, differing in psychotropic type, timing and polypharmacy. Three SSRI-dominated patterns (24 225 pairs, 63%) ranged from increasing SSRI use (Pattern I; n = 11 731), through continued SSRI use with high persistence (Pattern II; n = 7167), to mixed use involving SSRIs and other psychotropics (Pattern III; n = 5327; 48% using three or more medications). The remaining five patterns (14 303 pairs, 37%) were dominated by benzodiazepine-related drugs, other antidepressants, centrally acting sympathomimetics, antipsychotics or complex mixed use, ranging from late-initiated benzodiazepine-related use (Pattern IV; median initiation Week 27; persistence 13%) to early-initiated, highly persistent mixed use (Pattern VIII; median initiation Week 4; persistence 94%). Exclusive breastfeeding duration varied across patterns, with long-duration exclusive breastfeeding (181 days or more) highest in the SSRI-continued pattern (Pattern II, 10.6%) and lowest in the mixed-use-increasing and antipsychotics-sporadic patterns (Patterns III and VII, 5.1% and 5.2%).</p><p><strong>Conclusion: </strong>Postpartum psychotropic treatment patterns are clinically heterogeneous and exclusive breastfeeding practices differ across treatment patterns.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70470"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13526646/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148860600","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":"Risk of Heart Failure Hospitalization Associated With Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors Versus Erythropoiesis-Stimulating Agents: A Nationwide Claims-Based Cohort Study.","authors":"Yuki Kunitsu, Keiko Ikuta, Daiki Hira, Shunsaku Nakagawa, Tomohiro Terada","doi":"10.1002/pds.70453","DOIUrl":"10.1002/pds.70453","url":null,"abstract":"<p><strong>Purpose: </strong>Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are increasingly used to treat renal anemia in patients with chronic kidney disease (CKD). We evaluated the risk of heart failure associated with HIF-PHIs compared with erythropoiesis-stimulating agents (ESAs) in routine clinical practice.</p><p><strong>Methods: </strong>We conducted a nationwide, retrospective, active-comparator cohort study using a Japanese claims database. We included adults with non-dialysis CKD and heart failure initiating HIF-PHIs or ESAs alongside diuretic therapy between August 2020 and March 2025. The primary outcome was heart failure hospitalization. Secondary outcomes included emergency heart failure hospitalization and hospitalization requiring intravenous diuretics. Baseline characteristics were balanced using inverse probability of treatment weighting (IPTW) based on propensity scores. Hazard ratios (HRs), 95% confidence intervals (CIs), and sensitivity analyses were evaluated in predefined subgroups using Cox proportional hazards models.</p><p><strong>Results: </strong>The cohorts comprised 14 995 HIF-PHI and 22 889 ESA users with baseline characteristics well balanced after IPTW adjustment. Heart failure hospitalization incidence rates per 1000 person-years (PY) were 157.8 for HIF-PHIs and 177.0 for ESAs. HRs were 0.93 [95% CI 0.87-1.01] for heart failure hospitalization, 0.94 [95% CI 0.84-1.03] for emergency heart failure, and 0.87 [95% CI 0.81-0.94] for intravenous diuretic administration. Results were generally consistent across subgroup and sensitivity analyses.</p><p><strong>Conclusions: </strong>Although residual confounding cannot be excluded because of the observational study design, HIF-PHIs were not associated with evidence of an increased risk of heart failure hospitalization in patients with heart failure.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 9","pages":"e70453"},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849924","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":"Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy Algorithm.","authors":"Giorgio Limoncella, Anna Girardi, Claudia Bartolini, Giulia Hyeraci, Giuseppe Roberto, Olga Paoletti, Davide Messina, Felipe Villalobos, Carlo Alberto Bisacco, Jesse van den Berg, Eline Houben, Katia Santacà, Ylenia Ingrasciotta, Gianluca Trifirò, Giorgia Pellegrini, Valentina Ientile, Vjola Hoxhaj, Carlos Durán, Judit Riera-Arnau, Patricia García-Poza, Mar Martín-Pérez, Ana Llorente-García, Lucia Cea-Soriano, Consuelo Huerta-Álvarez, Francisco Sánchez-Sáez, Gabriel Sanfélix-Gimeno, Clara L Rodríguez-Bernal, Jérémy Jové, Marie-Agnès Bernard, Nicolas H Thurin, Sue Jordan, Daniel Thayer, Hywel Turner Evans, Alex-Ioan Coldea, Marco Manfrini, Marleen van Gelder, Michele Tari, Romin Pajouheshnia, Ana Sofia Afonso Maciel, Maryline Le Noan-Lainé, Ditte Mølgaard-Nielsen, Marianne Cunnington, Caitlin Dodd, Leonardo Grilli, Constanza L Andaur Navarro, Miriam Sturkenboom, Hedvig Nordeng, Rosa Gini","doi":"10.1002/pds.70438","DOIUrl":"10.1002/pds.70438","url":null,"abstract":"<p><strong>Purpose: </strong>In 2019, the Innovative Medicines Initiative funded the ConcePTION project to enhance monitoring of medication safety in pregnancy and breastfeeding. This paper describes how the ConcePTION Pregnancy Algorithm (PA) identified pregnancies in 10 diverse European electronic healthcare data sources and estimated their duration.</p><p><strong>Methods: </strong>Data sources from six European countries were mapped to the ConcePTION Common Data Model. Any pregnancy-related record was retrieved from various available data banks, including birth register, primary care records, and hospital records, and reconciled into episodes of pregnancy (starting between 01/2015 and 12/2019), each with start date, end date, and type of end. A random forest model was used to estimate missing gestational ages for incomplete records. Parameters were tailored to data sources to address local variations in data availability, collection, and governance. Model performance was evaluated using cross-validated Root Mean Squared Error (RMSE).</p><p><strong>Results: </strong>The PA identified ~2.7 million pregnancies, in over 2.2 million individuals. Most ended in live births (50%-83%), 1%-15% in elective terminations, and 4%-10% in spontaneous abortions, depending on data sources. Pregnancies with unknown type of end were also retrieved (2%-34%). Gestational age was predicted for 6%-89% of records (RMSE: 17-50 days). The median gestational age at first identified pregnancy record ranged from 47 to 280 days.</p><p><strong>Conclusions: </strong>We developed an open-source algorithm to identify and date pregnancies, including early-stage pregnancies with unknown end and/or ongoing at the time of data extraction. This algorithm may facilitate multinational studies, improving generation of timely real-world evidence about use and safety of medicinal products in pregnancy.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70438"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13453551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701911","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":"Abstracts of ISPEs 2026, 42nd International Conference, August 29-September 2, 2026, Milan.","authors":"","doi":"10.1002/pds.70409","DOIUrl":"10.1002/pds.70409","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 Suppl 3 ","pages":"e70409"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850664","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":"Prenatal Exposure to Modafinil and the Risk of Major Congenital Anomalies and Other Adverse Neonatal and Pediatric Outcomes.","authors":"Melinda Kanoun, Naïm Bouazza, Jean-Marc Treluyer, Mathis Collier","doi":"10.1002/pds.70448","DOIUrl":"10.1002/pds.70448","url":null,"abstract":"<p><strong>Objective: </strong>To assess the risk of major congenital anomalies (MCAs) and other adverse outcomes following prenatal exposure to modafinil.</p><p><strong>Methods: </strong>This retrospective cohort study used the French national healthcare database (SNDS) to include singleton children born between January 2009 and September 2024 of women aged 15-55 years. Prenatal exposure to psychostimulants was defined as maternal dispensation during pregnancy. Children prenatally exposed to modafinil were compared with two control groups: children prenatally exposed to methylphenidate and children prenatally unexposed to any psychostimulant matched to the exposed group using propensity-score matching (PSM). Outcomes included MCAs, neurodevelopmental disorders (NDs), and specialized consultations. Analyses included descriptive statistics, survival analysis, regression models, and dose-response analyses.</p><p><strong>Results: </strong>Of 10 955 766 included children, 865 were prenatally exposed to modafinil and 950 to methylphenidate. Exposure to modafinil during the first trimester of pregnancy was statistically associated with increased risk of MCA compared to methylphenidate, although the confidence interval was wide and close to the null (aRR = 1.77 [1.01-3.07]). Comparison with PS-matched unexposed population indicated a possible modest increase in risk, albeit with a wide confidence interval crossing the null (aRR = 1.23 [0.76-1.99]), showing no clear association. Occurrence of NDs (aHR = 0.96 [0.56-1.65]), and specialized consultations (aHR = 1.08 [0.91-1.28]) were similar in the modafinil and PSM unexposed groups but were higher in the methylphenidate group (NDs: aHR = 0.48 [0.29-0.80]; specialized consultations: aHR = 0.71 [0.59-0.85]).</p><p><strong>Conclusion: </strong>This study shows no increase in neurodevelopmental risk, while a moderate MCA risk cannot be excluded.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70448"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13429282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148664307","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":"Pharmacological Therapy in Patients With Gender Dysphoria: A Cohort Study in the Lazio Region, Italy.","authors":"Valeria Belleudi, Sara Lopes, Michela Servadio, Arianna Bellini, Antonio Addis","doi":"10.1002/pds.70445","DOIUrl":"10.1002/pds.70445","url":null,"abstract":"<p><strong>Purpose: </strong>Individuals with gender dysphoria (GD) experience discomfort or distress related to gender incongruence. Management often requires pharmacological support for hormonal and psychological needs. This study aimed to identify a cohort of GD patients in the Lazio Region and analyze their medication use compared with the general population.</p><p><strong>Methods: </strong>Using regional health information systems, we identified individuals with incident hospitalizations for GD between 2011 and 2021. We assessed medication use in the year following discharge and compared it with an age- and sex-matched population sample (1:10 ratio). We calculated the proportion of individuals with at least one dispensed prescription in selected therapeutic classes, with 95% confidence intervals.</p><p><strong>Results: </strong>We identified 365 individuals with GD (median age 26 years), of whom 52.9% were assigned male at birth (AMAB) and 47.1% were assigned female at birth (AFAB). Within one year, 72.1% (67.5%-76.7%) of GD individuals received at least one medication, compared to 43.1% (41.5%-44.7%) in the general population. Medicine use was higher among AMAB (83.9%) than AFAB (58.7%). The most prescribed drug classes were anti-infectives (35%), sex hormones (35%), gastrointestinal/metabolic agents (28%), and nervous system drugs (18%). Patterns differed by sex assigned at birth: estrogens, anti-androgens, and vitamins were common in AMAB, while acid-related disorder drugs, psychotropics, and testosterone were more frequent in AFAB.</p><p><strong>Conclusions: </strong>GD patients showed higher medication use than the general population, with distinct patterns by sex assigned at birth. These findings highlight the importance of monitoring and evaluating long-term safety of pharmacological therapies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70445"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13426041/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148631098","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":"Comment on 'Comparative Effectiveness and Safety of Three Oral Antihypertensive Therapies on Maternal and Infant Outcomes in a California Medicaid Population, 2016-2020'.","authors":"Maajid Mohi Ud Din Malik, Rajesh Prasad Jayaswal","doi":"10.1002/pds.70444","DOIUrl":"10.1002/pds.70444","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70444"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13406910/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148606157","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":"Population-Based Trends in Antidepressant Dispensing Among Children and Adolescents in Manitoba, Canada.","authors":"Amani F Hamad, Kevin J Friesen, Yejin Cha, Cara Katz, Abdullah Maruf","doi":"10.1002/pds.70455","DOIUrl":"10.1002/pds.70455","url":null,"abstract":"<p><strong>Purpose: </strong>This study quantified temporal trends in antidepressant dispensing among children and adolescents and described patterns by antidepressant class, drug, and demographic subgroups.</p><p><strong>Methods: </strong>This population-based cohort study used administrative health data from Manitoba, Canada and included individuals aged 6-18 years between 2000 and 2024. Antidepressant dispensing was identified in prescription dispensing records using the Anatomical Therapeutic Chemical code N06A. Annual prevalence was defined as the proportion of individuals dispensed antidepressants in a given year; annual incidence rate was defined as the rate of new antidepressant dispensing following a 2-year washout period. Analyses were stratified by antidepressant class, drug, age group (6-12, 13-18), sex and neighborhood income quintiles.</p><p><strong>Results: </strong>The cohort included 699 526 individuals; 66 895 (9.6%) had an antidepressant dispensing, of which most were dispensed selective serotonin reuptake inhibitors (n = 49 219, 73.6%). The prevalence of antidepressant dispensing increased from 14.9 (95% confidence interval [CI] 14.5-15.5) to 48.7 (95% CI 47.9-49.6) per 1000 individuals in 2000 and 2024, respectively. The incidence increased from 9.2 (95% CI 8.8-9.6) to 17.4 (95% CI 16.8-17.9) per 1000 person-years. A decline in dispensing between 2003 and 2005, and a sharp rise beginning in 2020, were observed. Subgroup analyses showed a temporal increase in antidepressant dispensing across all subgroups, particularly among females and adolescents aged 13-18 years.</p><p><strong>Conclusions: </strong>This study found a marked increase in antidepressant dispensing in children and adolescents over time, particularly in females and adolescents. Future studies are needed to evaluate appropriateness, clinical outcomes and long-term safety of antidepressant use in this population.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70455"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13459037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148707391","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":"A Pharmaco-Epidemiological Research Program Leveraging a Nationwide Database of Kidney Transplantation.","authors":"Pierre Marquet, Antoine Humeau, Sabrina Crépin, Clément Benoist, Sylvain Couderc, Caroline Monchaud, Marc Labriffe, Franck Saint-Marcoux","doi":"10.1002/pds.70442","DOIUrl":"10.1002/pds.70442","url":null,"abstract":"<p><strong>Objectives: </strong>The pharmaco-epidemiological research program in kidney transplantation (PERP-KT) aims to evaluate, for the principal maintenance immunosuppressive drugs (MISDs): the influence of model-informed precision dosing on graft and patient survival; long-term exposure-effects relationships; and the benefit-harm balance of their combinations and time sequences in patient groups or clinical settings not adequately evaluated in comparative randomized clinical trials. It also aims to develop a hybrid, dynamic, deep learning model capable of predicting the rate of renal graft function decline, thereby providing a platform for individualized prediction of the benefits and risks associated with MISDs.</p><p><strong>Patients and methods: </strong>After obtaining all regulatory andd ethical approvals, de-identified extracts of three national databases were linked to create the nationwide PERP-KT dataset, which is hosted within the highly secure environment of the French Health Data Hub.</p><p><strong>Results: </strong>CRISTAL (the exhaustive registry of the French Agence de la Biomédecine) comprises data from 49 886 kidney donors and the corresponding 47 842 transplant recipients between 2005 and 2020. Following iterative deterministic matching and extensive quality control procedures, CRISTAL data were successfully linked to: the French national Health Data System (SNDS), which records reimbursed healthcare utilization, for 30 782 kidney transplant recipients; and to ISBA, a web-based platform for Bayesian dose adjustment of MISDs that contains pharmacological data, for 17 700 kidney grafts and 17 576 recipients.</p><p><strong>Perspectives: </strong>More than 20 pharmaco-epidemiological studies will leverage the database's extensive follow-up, large population size and richness of clinical, healtcare-utilization, and pharmacological data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 8","pages":"e70442"},"PeriodicalIF":2.6,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13396964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148579600","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}