首页 > 最新文献

Pharmacoepidemiology and Drug Safety最新文献

英文 中文
Longitudinal Trends in Non-Insulin Pharmacotherapy for Type 2 Diabetes in Australian Women of Reproductive Age: Implications for Planned and Unplanned Pregnancies. 澳大利亚育龄妇女2型糖尿病非胰岛素药物治疗的纵向趋势:对计划和非计划妊娠的影响
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70320
Farah Hashmani, Kirsten I Black, Arianne Sweeting, Kelly Hall, Jenni Ilomaki, Luke E Grzeskowiak

Purpose: To (a) examine longitudinal trends in prescribing of first- and second-line non-insulin pharmacotherapies (NIPs) among reproductive-aged women in Australia between 2013 and 2021 and (b) explore concurrent use of highly effective long-acting reversible contraceptives (LARCs), as well as other hormonal contraceptives, at the time of first dispensing of NIP.

Methods: Using a 10% random sample of Australian women aged 18-44 years from dispensing claims from the Pharmaceutical Benefits Scheme (PBS), the annual prescription of at least one NIP was reported as a rate per 1000 women. Concurrent LARC use was identified where the date of contraceptive supply plus the likely duration of efficacy overlapped with the first dispensing date of NIP.

Results: The overall rate of NIP use has increased from 14.40 to 23.15/1000 women between 2013 and 2021, with increases observed in the rate of women prescribed the first-line agent metformin alone (11.94-18.41/1000), metformin and a second-line NIP (2.17-3.88/1000), and second-line NIP alone (0.29-0.85/1000). When compared with initiating treatment with metformin, the proportion of women considered concurrent LARC users or any contraceptive method was modestly higher for those commencing treatment with a second-line NIP (17.0% vs. 12.7% [aOR, 1.09, 95% CI: 1.02, 1.17] and 26.7% vs. 20.5% [aOR: 1.12, 95% CI: 1.05, 1.19], respectively).

Conclusion: There is increasing use of NIP amongst reproductive-aged women in Australia, with rates of use of second-line NIPs almost doubling between 2013 and 2021. While concurrent use of LARC appears higher among those prescribed second-line NIP, compared with metformin, rates of LARC use still appear low.

目的:(a)研究2013年至2021年期间澳大利亚育龄妇女一线和二线非胰岛素药物治疗(NIPs)处方的纵向趋势,(b)探索在首次分配NIP时同时使用高效长效可逆避孕药(LARCs)以及其他激素避孕药的情况。方法:从药品福利计划(PBS)配药索赔中随机抽取10%年龄在18-44岁的澳大利亚女性作为样本,报告每1000名女性每年至少开具一次NIP处方。在避孕药具供应日期加上可能的有效时间与NIP的首次配药日期重叠的地方,确定了LARC的同时使用。结果:2013年至2021年间,NIP的总体使用率从14.40 /1000女性增加到23.15/1000女性,其中单用一线药物二甲双胍(11.94-18.41/1000)、单用二线药物NIP(2.17-3.88/1000)和单用二线药物NIP(0.29-0.85/1000)的女性比例增加。与开始使用二甲双胍治疗相比,开始使用二线NIP治疗的女性认为同时使用LARC或任何避孕方法的比例略高(分别为17.0%对12.7% [aOR, 1.09, 95% CI: 1.02, 1.17]和26.7%对20.5% [aOR: 1.12, 95% CI: 1.05, 1.19])。结论:在澳大利亚育龄妇女中,NIP的使用越来越多,二线NIP的使用率在2013年至2021年间几乎翻了一番。虽然与二甲双胍相比,在处方的二线NIP中LARC的同时使用似乎更高,但LARC的使用率仍然很低。
{"title":"Longitudinal Trends in Non-Insulin Pharmacotherapy for Type 2 Diabetes in Australian Women of Reproductive Age: Implications for Planned and Unplanned Pregnancies.","authors":"Farah Hashmani, Kirsten I Black, Arianne Sweeting, Kelly Hall, Jenni Ilomaki, Luke E Grzeskowiak","doi":"10.1002/pds.70320","DOIUrl":"https://doi.org/10.1002/pds.70320","url":null,"abstract":"<p><strong>Purpose: </strong>To (a) examine longitudinal trends in prescribing of first- and second-line non-insulin pharmacotherapies (NIPs) among reproductive-aged women in Australia between 2013 and 2021 and (b) explore concurrent use of highly effective long-acting reversible contraceptives (LARCs), as well as other hormonal contraceptives, at the time of first dispensing of NIP.</p><p><strong>Methods: </strong>Using a 10% random sample of Australian women aged 18-44 years from dispensing claims from the Pharmaceutical Benefits Scheme (PBS), the annual prescription of at least one NIP was reported as a rate per 1000 women. Concurrent LARC use was identified where the date of contraceptive supply plus the likely duration of efficacy overlapped with the first dispensing date of NIP.</p><p><strong>Results: </strong>The overall rate of NIP use has increased from 14.40 to 23.15/1000 women between 2013 and 2021, with increases observed in the rate of women prescribed the first-line agent metformin alone (11.94-18.41/1000), metformin and a second-line NIP (2.17-3.88/1000), and second-line NIP alone (0.29-0.85/1000). When compared with initiating treatment with metformin, the proportion of women considered concurrent LARC users or any contraceptive method was modestly higher for those commencing treatment with a second-line NIP (17.0% vs. 12.7% [aOR, 1.09, 95% CI: 1.02, 1.17] and 26.7% vs. 20.5% [aOR: 1.12, 95% CI: 1.05, 1.19], respectively).</p><p><strong>Conclusion: </strong>There is increasing use of NIP amongst reproductive-aged women in Australia, with rates of use of second-line NIPs almost doubling between 2013 and 2021. While concurrent use of LARC appears higher among those prescribed second-line NIP, compared with metformin, rates of LARC use still appear low.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70320"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145990401","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}
引用次数: 0
Risk of Hospitalized COVID-19 in COPD: Single-Inhaler Triple Versus Dual Bronchodilator Therapy. COPD患者住院COVID-19的风险:单吸入器三联与双支气管扩张剂治疗
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70321
Simon Galmiche, Sophie Dell'Aniello, Samy Suissa

Purpose: Our objective was to estimate the effect of initiating an inhaled corticosteroids-containing single-inhaler triple agent (ICS-LABA-LAMA) compared with a single-inhaler LABA-LAMA dual bronchodilator in patients with COPD on the risk of severe COVID-19 prior to the roll-out of vaccines.

Methods: We conducted a cohort study emulating a randomized trial, among patients with COPD aged 40 years or more in the UK, comparing those who initiated a triple inhaler with those who initiated a dual bronchodilator inhaler between March 1 and December 31, 2020. Weighting by fine stratification of the propensity score was used to account for confounders. The risk of hospitalized COVID-19 was compared with a Cox proportional hazards model in an as-treated analysis with a 30-day grace period.

Results: The study cohort included 876 patients initiating a triple inhaler and 5010 initiating a dual LABA-LAMA inhaler. The adjusted incidence rate of hospitalized COVID-19 was 5.6 per 100 person-years in the triple inhaler group and 2.9 per 100 person-years in the dual inhaler group, with a corresponding hazard ratio (HR) of 1.96 (95% confidence interval 1.01-3.77). Sensitivity analyses on the duration of the grace period, using an intent-to-treat exposure classification, or starting follow-up 14 days after treatment initiation (accounting for treatment initiation for an undocumented SARS-CoV-2 infection) were generally consistent with the main analysis.

Conclusions: Patients with COPD prescribed an ICS-containing triple inhaler were potentially exposed to an increased risk of severe COVID-19 prior to the vaccine era. As SARS-CoV-2 continues to cause significant burden, these findings should be considered when determining initiation of inhaled treatment in COPD.

目的:我们的目的是评估在COPD患者中,在疫苗推广之前,与单吸入剂LABA-LAMA双支气管扩张剂相比,开始使用含皮质类固醇的单吸入三联剂(ICS-LABA-LAMA)对严重COVID-19风险的影响。方法:我们进行了一项队列研究,模拟了一项随机试验,在英国40岁或以上的COPD患者中,比较了在2020年3月1日至12月31日期间使用三重吸入器和使用双支气管扩张剂吸入器的患者。使用倾向评分的精细分层加权来解释混杂因素。在30天宽限期的治疗分析中,将住院COVID-19的风险与Cox比例风险模型进行比较。结果:研究队列包括876名患者开始使用三重吸入器,5010名患者开始使用双LABA-LAMA吸入器。调整后的住院COVID-19发病率,三联吸入器组为5.6 / 100人-年,双联吸入器组为2.9 / 100人-年,相应的风险比(HR)为1.96(95%可信区间1.01-3.77)。使用意向治疗暴露分类或在治疗开始后14天开始随访(考虑到未记录的SARS-CoV-2感染的治疗开始)的宽限期持续时间的敏感性分析与主要分析基本一致。结论:在疫苗时代之前,COPD患者服用含ics的三重吸入器可能会增加患严重COVID-19的风险。由于SARS-CoV-2继续造成重大负担,在确定COPD患者开始吸入治疗时应考虑这些发现。
{"title":"Risk of Hospitalized COVID-19 in COPD: Single-Inhaler Triple Versus Dual Bronchodilator Therapy.","authors":"Simon Galmiche, Sophie Dell'Aniello, Samy Suissa","doi":"10.1002/pds.70321","DOIUrl":"10.1002/pds.70321","url":null,"abstract":"<p><strong>Purpose: </strong>Our objective was to estimate the effect of initiating an inhaled corticosteroids-containing single-inhaler triple agent (ICS-LABA-LAMA) compared with a single-inhaler LABA-LAMA dual bronchodilator in patients with COPD on the risk of severe COVID-19 prior to the roll-out of vaccines.</p><p><strong>Methods: </strong>We conducted a cohort study emulating a randomized trial, among patients with COPD aged 40 years or more in the UK, comparing those who initiated a triple inhaler with those who initiated a dual bronchodilator inhaler between March 1 and December 31, 2020. Weighting by fine stratification of the propensity score was used to account for confounders. The risk of hospitalized COVID-19 was compared with a Cox proportional hazards model in an as-treated analysis with a 30-day grace period.</p><p><strong>Results: </strong>The study cohort included 876 patients initiating a triple inhaler and 5010 initiating a dual LABA-LAMA inhaler. The adjusted incidence rate of hospitalized COVID-19 was 5.6 per 100 person-years in the triple inhaler group and 2.9 per 100 person-years in the dual inhaler group, with a corresponding hazard ratio (HR) of 1.96 (95% confidence interval 1.01-3.77). Sensitivity analyses on the duration of the grace period, using an intent-to-treat exposure classification, or starting follow-up 14 days after treatment initiation (accounting for treatment initiation for an undocumented SARS-CoV-2 infection) were generally consistent with the main analysis.</p><p><strong>Conclusions: </strong>Patients with COPD prescribed an ICS-containing triple inhaler were potentially exposed to an increased risk of severe COVID-19 prior to the vaccine era. As SARS-CoV-2 continues to cause significant burden, these findings should be considered when determining initiation of inhaled treatment in COPD.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70321"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12765584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145900781","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}
引用次数: 0
Emulating a Randomized Controlled Trial of Long-Acting Insulins and Cardiovascular Events Using Real-World Data for Patients With Type 2 Diabetes. 利用真实世界数据模拟2型糖尿病患者长效胰岛素与心血管事件的随机对照试验
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70313
Wanning Wang, Pauline Reynier, Michael Webster-Clark, Oriana H Y Yu, Vanessa Brunetti, Kristian B Filion

Aims: Randomized controlled trials (RCTs) have high internal validity but often have limited generalizability. To our knowledge, there have been no previous studies emulating RCTs using real-world data to evaluate the risk of major adverse cardiovascular events (MACE) among patients with type 2 diabetes mellitus (T2DM) treated with long-acting insulin analogues.

Methods: We emulated the DEVOTE trial of insulin degludec vs. glargine among patients with T2DM using data from the United Kingdom's Clinical Practice Research Datalink. DEVOTE eligible and ineligible subpopulations were created. Cox proportional hazards models with inverse probability of treatment weighting were used to estimate hazard ratios (HRs) and corresponding confidence intervals (CIs) for MACE comparing new users of insulin degludec to new users of insulin glargine overall and in the eligible/ineligible subpopulations.

Results: There were 10 430 patients in the overall population, 5280 in the DEVOTE eligible population, and 5150 in the DEVOTE ineligible population. The overall (HR: 1.36, 95% CI: 0.83, 1.86) and DEVOTE eligible populations (HR: 1.07, 95% CI: 0.63, 1.58) were compatible with findings from the DEVOTE trial (HR: 0.91, 95% CI: 0.78, 1.06) for the risk of MACE. Due to a low number of events, the DEVOTE ineligible population had deviations in point estimates and wider CIs (HR: 2.19, 95% CI: 0.30, 3.83).

Conclusion: The risk of MACE among patients with T2DM newly prescribed insulin degludec compared to insulin glargine was consistent between the overall population and the DEVOTE eligible subpopulation, while the DEVOTE ineligible population had discrepant point estimates.

目的:随机对照试验(RCTs)具有较高的内部效度,但通常具有有限的推广能力。据我们所知,之前还没有研究模拟使用真实世界数据的随机对照试验来评估接受长效胰岛素类似物治疗的2型糖尿病(T2DM)患者的主要不良心血管事件(MACE)风险。方法:我们使用英国临床实践研究数据链的数据,模拟了在T2DM患者中使用去糖精胰岛素与甘精胰岛素的试验。分别创建了符合条件和不符合条件的亚种群。采用治疗加权逆概率的Cox比例风险模型来估计MACE的风险比(hr)和相应的置信区间(ci),比较总体上和符合条件/不符合条件的亚人群中新使用胰岛素的人与新使用甘精胰岛素的人。结果:总人群中有10430例患者,其中有5280例为符合条件的人群,5150例为不符合条件的人群。总体(HR: 1.36, 95% CI: 0.83, 1.86)和符合条件的人群(HR: 1.07, 95% CI: 0.63, 1.58)在MACE风险方面与尽心试验(HR: 0.91, 95% CI: 0.78, 1.06)的结果一致。由于事件数量较少,不符合条件的人群在点估计和更宽的CI上存在偏差(HR: 2.19, 95% CI: 0.30, 3.83)。结论:T2DM患者新开降糖糖胰岛素与甘精胰岛素发生MACE的风险在总体人群和符合用药条件的亚人群中是一致的,而在不符合用药条件的人群中存在点估计差异。
{"title":"Emulating a Randomized Controlled Trial of Long-Acting Insulins and Cardiovascular Events Using Real-World Data for Patients With Type 2 Diabetes.","authors":"Wanning Wang, Pauline Reynier, Michael Webster-Clark, Oriana H Y Yu, Vanessa Brunetti, Kristian B Filion","doi":"10.1002/pds.70313","DOIUrl":"10.1002/pds.70313","url":null,"abstract":"<p><strong>Aims: </strong>Randomized controlled trials (RCTs) have high internal validity but often have limited generalizability. To our knowledge, there have been no previous studies emulating RCTs using real-world data to evaluate the risk of major adverse cardiovascular events (MACE) among patients with type 2 diabetes mellitus (T2DM) treated with long-acting insulin analogues.</p><p><strong>Methods: </strong>We emulated the DEVOTE trial of insulin degludec vs. glargine among patients with T2DM using data from the United Kingdom's Clinical Practice Research Datalink. DEVOTE eligible and ineligible subpopulations were created. Cox proportional hazards models with inverse probability of treatment weighting were used to estimate hazard ratios (HRs) and corresponding confidence intervals (CIs) for MACE comparing new users of insulin degludec to new users of insulin glargine overall and in the eligible/ineligible subpopulations.</p><p><strong>Results: </strong>There were 10 430 patients in the overall population, 5280 in the DEVOTE eligible population, and 5150 in the DEVOTE ineligible population. The overall (HR: 1.36, 95% CI: 0.83, 1.86) and DEVOTE eligible populations (HR: 1.07, 95% CI: 0.63, 1.58) were compatible with findings from the DEVOTE trial (HR: 0.91, 95% CI: 0.78, 1.06) for the risk of MACE. Due to a low number of events, the DEVOTE ineligible population had deviations in point estimates and wider CIs (HR: 2.19, 95% CI: 0.30, 3.83).</p><p><strong>Conclusion: </strong>The risk of MACE among patients with T2DM newly prescribed insulin degludec compared to insulin glargine was consistent between the overall population and the DEVOTE eligible subpopulation, while the DEVOTE ineligible population had discrepant point estimates.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70313"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12768564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906468","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}
引用次数: 0
The Risk of Hypothyroidism With the Use of GLP-1 Receptor Agonists in Saudi Arabia. 在沙特阿拉伯使用GLP-1受体激动剂导致甲状腺功能减退的风险
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70315
Almaha Alfakhri, Ohoud Almadani, Raseel Alroba, Adel Alrwisan, Omar Alshaya, Yasser Albogami

Aim: Preclinical studies have suggested that glucagon-like peptide-1 receptor agonists (GLP-1RAs) may induce thyroid gland hyperplasia, raising concerns about potential thyroid-related risks. Given their increasing use and the limited evidence on thyroid safety, this study assessed the association between GLP-1RA use and the incidence of hypothyroidism using real-world data.

Methods: We conducted an active-comparator, new-user cohort study using the Real-World Evidence Research Network (SRWEN) (2016-2023). Adults (≥ 18 years) initiating GLP-1RAs or dipeptidyl peptidase-4 inhibitors (DPP-4is) were followed from first prescription until hypothyroidism, treatment discontinuation, switching, death, or study end. Hypothyroidism was identified through ICD-10 codes or levothyroxine prescriptions. Inverse probability of treatment weighting was applied to adjust for confounding, and weighted Cox proportional hazards models were used to estimate hazard ratios (HRs). RStudio 4.4.0 was used for analyses.

Results: A total of 47 017 patients were included (6800 GLP-1RA users; 40 217 DPP-4i users). GLP-1RA users were younger (mean age 50 vs. 58 years) and more often female. The incidence rate of hypothyroidism was 128 per 10 000 person-years in GLP-1RA users compared to 150 per 10 000 person-years in DPP-4i users. GLP-1RA use was not associated with a statistically significant risk of hypothyroidism (adjusted HR 1.04, 95% CI 0.69-1.57). Sensitivity analyses extending follow-up by 30 and 60 days yielded consistent findings.

Conclusion: In this real-world analysis, GLP-1RA use was not associated with an increased incidence of hypothyroidism compared to DPP-4is. Findings were consistent across sensitivity and subgroup analyses. Although findings do not suggest a short-term risk, longer-term studies are warranted to further evaluate thyroid safety.

目的:临床前研究表明,胰高血糖素样肽-1受体激动剂(GLP-1RAs)可能诱导甲状腺增生,引起对潜在甲状腺相关风险的担忧。鉴于GLP-1RA的使用越来越多,而甲状腺安全性的证据有限,本研究利用真实世界的数据评估了GLP-1RA的使用与甲状腺功能减退的发病率之间的关系。方法:我们使用真实世界证据研究网络(SRWEN)(2016-2023)进行了一项主动比较,新用户队列研究。开始GLP-1RAs或二肽基肽酶-4抑制剂(DPP-4is)的成人(≥18岁)从第一次处方开始随访,直到甲状腺功能减退、停止治疗、切换、死亡或研究结束。通过ICD-10代码或左旋甲状腺素处方诊断甲状腺功能减退。应用处理加权的逆概率来调整混杂因素,并使用加权Cox比例风险模型来估计风险比(hr)。使用RStudio 4.4.0进行分析。结果:共纳入47 017例患者(6800例GLP-1RA使用者;40 217例DPP-4i使用者)。GLP-1RA使用者较年轻(平均年龄50岁vs. 58岁),且多为女性。GLP-1RA服用者甲状腺功能减退的发病率为128 / 10000人年,而DPP-4i服用者为150 / 10000人年。GLP-1RA的使用与甲状腺功能减退的风险无统计学意义(调整后HR 1.04, 95% CI 0.69-1.57)。敏感性分析延长随访30天和60天,得出一致的结果。结论:在这个现实世界的分析中,与dpp -4相比,GLP-1RA的使用与甲状腺功能减退的发病率增加无关。结果在敏感性和亚组分析中是一致的。虽然研究结果不表明短期风险,但长期研究需要进一步评估甲状腺安全性。
{"title":"The Risk of Hypothyroidism With the Use of GLP-1 Receptor Agonists in Saudi Arabia.","authors":"Almaha Alfakhri, Ohoud Almadani, Raseel Alroba, Adel Alrwisan, Omar Alshaya, Yasser Albogami","doi":"10.1002/pds.70315","DOIUrl":"https://doi.org/10.1002/pds.70315","url":null,"abstract":"<p><strong>Aim: </strong>Preclinical studies have suggested that glucagon-like peptide-1 receptor agonists (GLP-1RAs) may induce thyroid gland hyperplasia, raising concerns about potential thyroid-related risks. Given their increasing use and the limited evidence on thyroid safety, this study assessed the association between GLP-1RA use and the incidence of hypothyroidism using real-world data.</p><p><strong>Methods: </strong>We conducted an active-comparator, new-user cohort study using the Real-World Evidence Research Network (SRWEN) (2016-2023). Adults (≥ 18 years) initiating GLP-1RAs or dipeptidyl peptidase-4 inhibitors (DPP-4is) were followed from first prescription until hypothyroidism, treatment discontinuation, switching, death, or study end. Hypothyroidism was identified through ICD-10 codes or levothyroxine prescriptions. Inverse probability of treatment weighting was applied to adjust for confounding, and weighted Cox proportional hazards models were used to estimate hazard ratios (HRs). RStudio 4.4.0 was used for analyses.</p><p><strong>Results: </strong>A total of 47 017 patients were included (6800 GLP-1RA users; 40 217 DPP-4i users). GLP-1RA users were younger (mean age 50 vs. 58 years) and more often female. The incidence rate of hypothyroidism was 128 per 10 000 person-years in GLP-1RA users compared to 150 per 10 000 person-years in DPP-4i users. GLP-1RA use was not associated with a statistically significant risk of hypothyroidism (adjusted HR 1.04, 95% CI 0.69-1.57). Sensitivity analyses extending follow-up by 30 and 60 days yielded consistent findings.</p><p><strong>Conclusion: </strong>In this real-world analysis, GLP-1RA use was not associated with an increased incidence of hypothyroidism compared to DPP-4is. Findings were consistent across sensitivity and subgroup analyses. Although findings do not suggest a short-term risk, longer-term studies are warranted to further evaluate thyroid safety.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70315"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906478","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}
引用次数: 0
Development and Validation of Case-Finding Algorithms to Identify Periprosthetic Joint Infections After Total Hip Arthroplasty in Veterans Health Administration Data. 在退伍军人健康管理数据中识别全髋关节置换术后假体周围关节感染的病例查找算法的开发和验证。
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70311
Jessica C O'Neil, Yixuan Pei, Craig Newcomb, Randi Silibovsky, Judith A O'Donnell, Charles L Nelson, Evelyn Hsieh, Joseph King, Stephen Crystal, Jennifer S Hanberg, Vincent Lo Re, Erica J Weinstein

Purpose: To determine the positive predictive values (PPVs) of ICD-9- and ICD-10-based diagnostic coding algorithms to identify periprosthetic joint infection (PJI) following total hip arthroplasty (THA) within the United States (US) Veterans Health Administration (VHA).

Methods: We selected patients with: (1) any position hospital discharge ICD-9 or ICD-10 diagnosis of PJI, (2) ICD-9, ICD-10, or current procedural terminology (CPT) procedure codes for THA any time prior to PJI diagnosis, (3) CPT code for hip X-ray within ±90 days of the PJI diagnosis, and (4) 1 or more CPT codes for arthrocentesis, arthrotomy, or revision arthroplasty all occurring within ±90 days of the PJI diagnosis date. We obtained separate samples of patients for ICD-9 and ICD-10-based PJI diagnoses. These samples were stratified by THA medical center volume. Infectious disease physicians adjudicated each identified PJI event. The PPV (95% confidence interval [CI]) for the ICD-9 and ICD-10 PJI algorithms were calculated.

Results: Among the 90 sampled hip PJI events for the ICD-9 era, 79 were confirmed PJIs (PPV 87.8%, 95% CI 79.2%-93.7%). For the 90 sampled hip PJI events for the ICD-10 era, 72 were confirmed PJIs (PPV 80.0%, 95% CI 70.3%-87.7%).

Conclusion: These algorithms yielded a PPV of 87.8% (ICD-9) and 80.0% (ICD-10), for confirmed PJI events and could be considered for use in future pharmacoepidemiologic studies.

目的:在美国退伍军人健康管理局(VHA)内确定基于ICD-9和icd -10的诊断编码算法识别全髋关节置换术(THA)后假体周围关节感染(PJI)的阳性预测值(PPVs)。方法:我们选择以下患者:(1)在PJI诊断前任何时间的任何位置出院ICD-9或ICD-10诊断PJI, (2) ICD-9, ICD-10或现行手术术语(CPT)程序代码为THA,(3)在PJI诊断后±90天内髋关节x线检查CPT代码,(4)在PJI诊断后±90天内进行关节穿刺,关节切开术或关节置换术的1个或多个CPT代码。我们分别获得了基于ICD-9和icd -10的PJI诊断的患者样本。这些样本按THA医疗中心容积分层。传染病医生判定每一个确定的PJI事件。计算ICD-9和ICD-10 PJI算法的PPV(95%置信区间[CI])。结果:在ICD-9时代的90例髋关节PJI事件中,79例确诊为PJI (PPV为87.8%,95% CI为79.2%-93.7%)。在ICD-10时代的90例髋关节PJI事件中,72例确诊为PJI (PPV为80.0%,95% CI为70.3%-87.7%)。结论:对于确诊的PJI事件,这些算法的PPV分别为87.8% (ICD-9)和80.0% (ICD-10),可考虑在未来的药物流行病学研究中使用。
{"title":"Development and Validation of Case-Finding Algorithms to Identify Periprosthetic Joint Infections After Total Hip Arthroplasty in Veterans Health Administration Data.","authors":"Jessica C O'Neil, Yixuan Pei, Craig Newcomb, Randi Silibovsky, Judith A O'Donnell, Charles L Nelson, Evelyn Hsieh, Joseph King, Stephen Crystal, Jennifer S Hanberg, Vincent Lo Re, Erica J Weinstein","doi":"10.1002/pds.70311","DOIUrl":"10.1002/pds.70311","url":null,"abstract":"<p><strong>Purpose: </strong>To determine the positive predictive values (PPVs) of ICD-9- and ICD-10-based diagnostic coding algorithms to identify periprosthetic joint infection (PJI) following total hip arthroplasty (THA) within the United States (US) Veterans Health Administration (VHA).</p><p><strong>Methods: </strong>We selected patients with: (1) any position hospital discharge ICD-9 or ICD-10 diagnosis of PJI, (2) ICD-9, ICD-10, or current procedural terminology (CPT) procedure codes for THA any time prior to PJI diagnosis, (3) CPT code for hip X-ray within ±90 days of the PJI diagnosis, and (4) 1 or more CPT codes for arthrocentesis, arthrotomy, or revision arthroplasty all occurring within ±90 days of the PJI diagnosis date. We obtained separate samples of patients for ICD-9 and ICD-10-based PJI diagnoses. These samples were stratified by THA medical center volume. Infectious disease physicians adjudicated each identified PJI event. The PPV (95% confidence interval [CI]) for the ICD-9 and ICD-10 PJI algorithms were calculated.</p><p><strong>Results: </strong>Among the 90 sampled hip PJI events for the ICD-9 era, 79 were confirmed PJIs (PPV 87.8%, 95% CI 79.2%-93.7%). For the 90 sampled hip PJI events for the ICD-10 era, 72 were confirmed PJIs (PPV 80.0%, 95% CI 70.3%-87.7%).</p><p><strong>Conclusion: </strong>These algorithms yielded a PPV of 87.8% (ICD-9) and 80.0% (ICD-10), for confirmed PJI events and could be considered for use in future pharmacoepidemiologic studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70311"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12768563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906395","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}
引用次数: 0
Concordance of Lung Cancer, Melanoma, and Renal Cell Cancer Diagnosis Information Recorded in Health Care Databases in England: Analysis of Linkage Between Primary Care, Hospital Care, and Cancer Registry Data. 英国卫生保健数据库中记录的肺癌、黑色素瘤和肾细胞癌诊断信息的一致性:初级保健、医院护理和癌症登记数据之间的联系分析
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 DOI: 10.1002/pds.70299
Paul D Kruithof, Patrick C Souverein, Johanna H M Driessen, Lizza E L Hendriks, Sander Croes, Robin M J M van Geel

Purpose: Real-world evidence (RWE) addresses clinical trial limitations by capturing more representative patient populations and improves evaluation of anticancer treatments, although it becomes available only years after market authorization. As many RWE sources capture only parts of the healthcare continuum, dataset linkage is necessary to enhance data richness. Linkage quality must be assessed to prevent information bias due to incomplete data linkage.

Methods: We evaluated diagnosis concordance for lung cancer (LC), melanoma, and renal cell cancer (RCC) in England. Patients were matched based on national health service (NHS) number, sex and date of birth. Eligible patients were drawn from the National Cancer Registry and Analysis Service (NCRAS), and matched with three other datasets: Clinical Research Practice Database Aurum (CPRD Aurum), Hospital Episode Statistics Admitted Patient Care (HES-APC), and systemic anticancer treatment (SACT). Concordance was evaluated for cancer diagnosis and date of diagnosis. Determinants of non-concordance were investigated to assess representativeness.

Results: In total, 89 797 patients with LC, melanoma or RCC were identified, and concordance of cancer diagnosis records between NCRAS, CPRD Aurum and HES-APC exceeded 70%. Because patients are only registered in SACT upon receiving systemic anticancer treatment, matched numbers in SACT were significantly lower (3.0%-21.1%), as anticipated, particularly among patients over 80 years of age. However, differences in patient characteristics across datasets were limited. Concordance analyses showed that the majority of cases with LC diagnoses were registered within 3 months of the initial diagnosis within all data sources, whereas melanoma and RCC showed longer delays.

Conclusions: Given the high concordance, NCRAS data can be enriched with HES-APC and CPRD Aurum, and further complemented by SACT for systemic therapy. Provided that SACT undergoes further validation, linkage between NCRAS, CPRD Aurum, HES-APC, and SACT may be a promising resource for RWE generation in oncology research.

目的:真实世界证据(RWE)通过捕获更具代表性的患者群体来解决临床试验的局限性,并改善抗癌治疗的评估,尽管它在市场授权后几年才可用。由于许多RWE源仅捕获医疗保健连续体的一部分,因此需要数据集链接来增强数据的丰富性。必须评估链接质量,以防止由于数据链接不完整而导致的信息偏差。方法:我们评估了英国肺癌(LC)、黑色素瘤和肾细胞癌(RCC)的诊断一致性。患者根据国民健康服务(NHS)号码、性别和出生日期进行匹配。符合条件的患者从国家癌症登记和分析服务(NCRAS)中抽取,并与其他三个数据集相匹配:临床研究实践数据库Aurum (CPRD Aurum)、住院患者护理(HES-APC)和全身抗癌治疗(SACT)。评估癌症诊断和诊断日期的一致性。不一致的决定因素进行了调查,以评估代表性。结果:共发现LC、黑色素瘤或RCC患者89 797例,NCRAS、CPRD Aurum与HES-APC的肿瘤诊断记录一致性超过70%。由于患者仅在接受全身抗癌治疗后才在SACT中登记,因此SACT中的匹配数明显较低(3.0%-21.1%),正如预期的那样,特别是在80岁以上的患者中。然而,不同数据集的患者特征差异有限。一致性分析显示,在所有数据源中,LC诊断的大多数病例都是在初始诊断后3个月内登记的,而黑色素瘤和RCC的延迟时间更长。结论:鉴于NCRAS数据的高一致性,可以通过HES-APC和CPRD Aurum来丰富NCRAS数据,并进一步辅以SACT进行全身治疗。如果SACT经过进一步验证,NCRAS、CPRD Aurum、HES-APC和SACT之间的联系可能是肿瘤研究中RWE生成的一个有前途的资源。
{"title":"Concordance of Lung Cancer, Melanoma, and Renal Cell Cancer Diagnosis Information Recorded in Health Care Databases in England: Analysis of Linkage Between Primary Care, Hospital Care, and Cancer Registry Data.","authors":"Paul D Kruithof, Patrick C Souverein, Johanna H M Driessen, Lizza E L Hendriks, Sander Croes, Robin M J M van Geel","doi":"10.1002/pds.70299","DOIUrl":"10.1002/pds.70299","url":null,"abstract":"<p><strong>Purpose: </strong>Real-world evidence (RWE) addresses clinical trial limitations by capturing more representative patient populations and improves evaluation of anticancer treatments, although it becomes available only years after market authorization. As many RWE sources capture only parts of the healthcare continuum, dataset linkage is necessary to enhance data richness. Linkage quality must be assessed to prevent information bias due to incomplete data linkage.</p><p><strong>Methods: </strong>We evaluated diagnosis concordance for lung cancer (LC), melanoma, and renal cell cancer (RCC) in England. Patients were matched based on national health service (NHS) number, sex and date of birth. Eligible patients were drawn from the National Cancer Registry and Analysis Service (NCRAS), and matched with three other datasets: Clinical Research Practice Database Aurum (CPRD Aurum), Hospital Episode Statistics Admitted Patient Care (HES-APC), and systemic anticancer treatment (SACT). Concordance was evaluated for cancer diagnosis and date of diagnosis. Determinants of non-concordance were investigated to assess representativeness.</p><p><strong>Results: </strong>In total, 89 797 patients with LC, melanoma or RCC were identified, and concordance of cancer diagnosis records between NCRAS, CPRD Aurum and HES-APC exceeded 70%. Because patients are only registered in SACT upon receiving systemic anticancer treatment, matched numbers in SACT were significantly lower (3.0%-21.1%), as anticipated, particularly among patients over 80 years of age. However, differences in patient characteristics across datasets were limited. Concordance analyses showed that the majority of cases with LC diagnoses were registered within 3 months of the initial diagnosis within all data sources, whereas melanoma and RCC showed longer delays.</p><p><strong>Conclusions: </strong>Given the high concordance, NCRAS data can be enriched with HES-APC and CPRD Aurum, and further complemented by SACT for systemic therapy. Provided that SACT undergoes further validation, linkage between NCRAS, CPRD Aurum, HES-APC, and SACT may be a promising resource for RWE generation in oncology research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 1","pages":"e70299"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12803871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145985361","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}
引用次数: 0
The Challenges for Pharmacoepidemiologists Identifying Migraine in Electronic Healthcare Data Sources: A Systematic Literature Review. 药物流行病学家在电子医疗数据来源中识别偏头痛的挑战:系统的文献综述。
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 DOI: 10.1002/pds.70278
Joan Forns, Alicia Abellan, Nuria Riera-Guàrdia, Andrea V Margulis, Elena Rivero-Ferrer

Purpose: Ascertaining migraine in electronic healthcare data is challenging because of likely diagnosis underrecording and treatment with over-the-counter analgesics, which cannot be used as disease proxies. Algorithm-identified migraine prevalence may depend on algorithm characteristics and target population.

Methods: To describe migraine-identifying algorithms implemented in electronic healthcare data sources and summarize validation results and observed migraine prevalence, we searched PubMed for peer-reviewed, English-language, original research articles that identified migraine in adults using electronic algorithms in electronic healthcare data. We summarized algorithms, validation results, and migraine prevalence (PROSPERO: CRD42023491279).

Results: Of 360 unique titles and abstracts, 50 articles (14%) were selected for full-text review; of them, 41 articles (82%) were finally included: 16 were studies conducted in Europe, 13 in North America, and 12 in Asia. Sixteen studies (39%) identified migraine only using diagnosis codes, 5 (12%) only treatments, 9 (22%) diagnosis and/or treatment codes, and 11 (27%) diagnosis codes, treatments, and setting (e.g., primary care, specialist consultation). Reported migraine prevalence in the general population ranged between 4% and 17%. Only two studies reported validation results: one identified prevention-eligible patients with migraine (positive predictive value [PPV] = 97%), and one identified migraine on the basis of calculated probabilities with PPVs between 74% and 92%.

Conclusion: Finding patients with migraine is feasible in various types of data sources; preferred algorithms vary; algorithm performance is mostly unknown. Identifying chronic migraine or other complex types of migraine requires combining diagnosis codes, treatments, and care settings, which is possible in only some data sources.

目的:在电子医疗数据中确定偏头痛是具有挑战性的,因为可能存在诊断记录不足和使用非处方止痛药治疗的情况,而非处方止痛药不能作为疾病的替代指标。算法确定的偏头痛患病率可能取决于算法特征和目标人群。方法:为了描述在电子医疗保健数据源中实现的偏头痛识别算法,并总结验证结果和观察到的偏头痛患病率,我们在PubMed检索了同行评审的、英语的、原始的研究文章,这些文章使用电子医疗保健数据中的电子算法识别成人偏头痛。我们总结了算法、验证结果和偏头痛患病率(PROSPERO: CRD42023491279)。结果:360篇独特的题目和摘要中,有50篇(14%)入选全文综述;最终纳入41篇(82%),其中16篇为欧洲研究,13篇为北美研究,12篇为亚洲研究。16项研究(39%)仅使用诊断代码识别偏头痛,5项(12%)仅使用治疗代码,9项(22%)诊断和/或治疗代码,11项(27%)诊断代码、治疗和设置(例如,初级保健、专家咨询)。据报道,偏头痛在普通人群中的患病率在4%到17%之间。只有两项研究报告了验证结果:一项研究确定了符合预防条件的偏头痛患者(阳性预测值[PPV] = 97%),另一项研究根据PPV在74%至92%之间的计算概率确定了偏头痛。结论:在各种类型的数据来源中发现偏头痛患者是可行的;首选算法各不相同;算法的性能大多是未知的。识别慢性偏头痛或其他复杂类型的偏头痛需要结合诊断代码、治疗和护理设置,这仅在某些数据源中是可能的。
{"title":"The Challenges for Pharmacoepidemiologists Identifying Migraine in Electronic Healthcare Data Sources: A Systematic Literature Review.","authors":"Joan Forns, Alicia Abellan, Nuria Riera-Guàrdia, Andrea V Margulis, Elena Rivero-Ferrer","doi":"10.1002/pds.70278","DOIUrl":"https://doi.org/10.1002/pds.70278","url":null,"abstract":"<p><strong>Purpose: </strong>Ascertaining migraine in electronic healthcare data is challenging because of likely diagnosis underrecording and treatment with over-the-counter analgesics, which cannot be used as disease proxies. Algorithm-identified migraine prevalence may depend on algorithm characteristics and target population.</p><p><strong>Methods: </strong>To describe migraine-identifying algorithms implemented in electronic healthcare data sources and summarize validation results and observed migraine prevalence, we searched PubMed for peer-reviewed, English-language, original research articles that identified migraine in adults using electronic algorithms in electronic healthcare data. We summarized algorithms, validation results, and migraine prevalence (PROSPERO: CRD42023491279).</p><p><strong>Results: </strong>Of 360 unique titles and abstracts, 50 articles (14%) were selected for full-text review; of them, 41 articles (82%) were finally included: 16 were studies conducted in Europe, 13 in North America, and 12 in Asia. Sixteen studies (39%) identified migraine only using diagnosis codes, 5 (12%) only treatments, 9 (22%) diagnosis and/or treatment codes, and 11 (27%) diagnosis codes, treatments, and setting (e.g., primary care, specialist consultation). Reported migraine prevalence in the general population ranged between 4% and 17%. Only two studies reported validation results: one identified prevention-eligible patients with migraine (positive predictive value [PPV] = 97%), and one identified migraine on the basis of calculated probabilities with PPVs between 74% and 92%.</p><p><strong>Conclusion: </strong>Finding patients with migraine is feasible in various types of data sources; preferred algorithms vary; algorithm performance is mostly unknown. Identifying chronic migraine or other complex types of migraine requires combining diagnosis codes, treatments, and care settings, which is possible in only some data sources.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70278"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145661326","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}
引用次数: 0
National Trends and Disparities in Herpes Zoster Vaccination Among US Older Adults With Diabetes, 2008-2023. 2008-2023年美国老年糖尿病患者带状疱疹疫苗接种的全国趋势和差异
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 DOI: 10.1002/pds.70301
Chun-Tse Hung, Li-Min Wang, Ding-Cheng Liu, Yu-Chien Hung

Purpose: To evaluate trends and disparities in herpes zoster vaccination among US older adults with diabetes.

Methods: Data from the 2008 to 2023 National Health Interview Survey were used. Joinpoint regression analysis was performed to analyze trends in herpes zoster vaccination. A multivariable logistic regression model was used to identify factors associated with herpes zoster vaccination.

Results: A total of 42 377 participants with diabetes were included, representing approximately 18 million US older adults with diabetes. From 2008 to 2023, the prevalence of herpes zoster vaccination increased nearly tenfold, from 4.2% in 2008 to 42.2% in 2023 (average annual percent change = 14.09, p < 0.01), with similar overall trends observed in adults without diabetes (p = 0.08). Upward trends were also observed across age groups and diabetes types. Several factors, including age, race/ethnicity, region, educational level, health insurance, income, perceived health status, flu and pneumococcal vaccination, comorbid atherosclerotic cardiovascular disease and cancer, were associated with herpes zoster vaccination.

Conclusion: Herpes zoster vaccine coverage has surged among US older adults with diabetes over the past 16 years. However, disparities in vaccination remain, underscoring the need for targeted policies and interventions to improve coverage.

目的:评估美国老年糖尿病患者带状疱疹疫苗接种的趋势和差异。方法:采用2008 ~ 2023年全国健康访谈调查数据。采用联合点回归分析分析带状疱疹疫苗接种趋势。采用多变量logistic回归模型确定与带状疱疹疫苗接种相关的因素。结果:共纳入42 377名糖尿病患者,代表约1800万美国老年糖尿病患者。从2008年到2023年,带状疱疹疫苗接种的流行率增加了近10倍,从2008年的4.2%增加到2023年的42.2%(平均年百分比变化= 14.09,p)。结论:在过去16年中,美国老年糖尿病患者的带状疱疹疫苗覆盖率激增。然而,疫苗接种方面的差距仍然存在,强调需要有针对性的政策和干预措施来提高覆盖率。
{"title":"National Trends and Disparities in Herpes Zoster Vaccination Among US Older Adults With Diabetes, 2008-2023.","authors":"Chun-Tse Hung, Li-Min Wang, Ding-Cheng Liu, Yu-Chien Hung","doi":"10.1002/pds.70301","DOIUrl":"10.1002/pds.70301","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate trends and disparities in herpes zoster vaccination among US older adults with diabetes.</p><p><strong>Methods: </strong>Data from the 2008 to 2023 National Health Interview Survey were used. Joinpoint regression analysis was performed to analyze trends in herpes zoster vaccination. A multivariable logistic regression model was used to identify factors associated with herpes zoster vaccination.</p><p><strong>Results: </strong>A total of 42 377 participants with diabetes were included, representing approximately 18 million US older adults with diabetes. From 2008 to 2023, the prevalence of herpes zoster vaccination increased nearly tenfold, from 4.2% in 2008 to 42.2% in 2023 (average annual percent change = 14.09, p < 0.01), with similar overall trends observed in adults without diabetes (p = 0.08). Upward trends were also observed across age groups and diabetes types. Several factors, including age, race/ethnicity, region, educational level, health insurance, income, perceived health status, flu and pneumococcal vaccination, comorbid atherosclerotic cardiovascular disease and cancer, were associated with herpes zoster vaccination.</p><p><strong>Conclusion: </strong>Herpes zoster vaccine coverage has surged among US older adults with diabetes over the past 16 years. However, disparities in vaccination remain, underscoring the need for targeted policies and interventions to improve coverage.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70301"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12701292/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145743330","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}
引用次数: 0
All Lines Is the Right Approach: Selecting Patient Lines of Therapy for an External Comparator Arm. 所有方法都是正确的:选择外部比较臂的患者治疗方法。
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 DOI: 10.1002/pds.70262
Daniel Backenroth, Laura Hester, Stijn Vansteelandt

Purpose: To identify the best method for selecting index dates when constructing external comparator arms (ECAs) from real-world data for comparison with single-arm trials (SATs).

Methods: We evaluated four approaches for index date selection-first eligible line, last eligible line, random eligible line, and all eligible lines-using causal inference reasoning, numerical examples and a simulation study. Simulations modeled survival across multiple lines of therapy under scenarios with varying eligibility patterns and treatment effects. Overall survival (OS) estimates comparing SAT and ECA populations were obtained using stratified Cox models and propensity-weighted Cox models, adjusted for line of therapy and patient state.

Results: Including all eligible lines produced unbiased OS estimates across scenarios. Selecting the last eligible line introduced substantial bias, while random selection led to moderate bias.

Conclusions: Using all eligible lines of therapy for each patient when constructing ECAs minimizes bias and preserves the SAT target population. Alternative methods can lead to biased estimates or, in the case of the first eligible line method, require changes to the clinical question that may shrink the SAT population. We recommend adopting the all eligible lines method with variance correction and adjustment for line of therapy to ensure valid comparative effectiveness analyses.

目的:从真实世界数据构建外部比较臂(ECAs)与单臂试验(SATs)进行比较时,确定选择指标日期的最佳方法。方法:采用因果推理推理、数值示例和模拟研究,评估了四种索引日期选择方法——第一合格线、最后合格线、随机合格线和所有合格线。模拟了在不同资格模式和治疗效果的情况下,多种治疗方案的生存。使用分层Cox模型和倾向加权Cox模型获得比较SAT和ECA人群的总生存(OS)估计值,并根据治疗线和患者状态进行调整。结果:包括所有符合条件的线产生了跨场景的无偏OS估计。选择最后一条符合条件的线引入了大量偏倚,而随机选择导致了中度偏倚。结论:在构建ECAs时,对每位患者使用所有符合条件的治疗线可以最大限度地减少偏倚并保留SAT目标人群。替代方法可能导致有偏差的估计,或者,在第一个符合条件的线方法的情况下,需要改变临床问题,这可能会缩小SAT人群。我们建议采用所有符合条件的线方法,并对治疗线进行方差校正和调整,以确保有效的比较有效性分析。
{"title":"All Lines Is the Right Approach: Selecting Patient Lines of Therapy for an External Comparator Arm.","authors":"Daniel Backenroth, Laura Hester, Stijn Vansteelandt","doi":"10.1002/pds.70262","DOIUrl":"10.1002/pds.70262","url":null,"abstract":"<p><strong>Purpose: </strong>To identify the best method for selecting index dates when constructing external comparator arms (ECAs) from real-world data for comparison with single-arm trials (SATs).</p><p><strong>Methods: </strong>We evaluated four approaches for index date selection-first eligible line, last eligible line, random eligible line, and all eligible lines-using causal inference reasoning, numerical examples and a simulation study. Simulations modeled survival across multiple lines of therapy under scenarios with varying eligibility patterns and treatment effects. Overall survival (OS) estimates comparing SAT and ECA populations were obtained using stratified Cox models and propensity-weighted Cox models, adjusted for line of therapy and patient state.</p><p><strong>Results: </strong>Including all eligible lines produced unbiased OS estimates across scenarios. Selecting the last eligible line introduced substantial bias, while random selection led to moderate bias.</p><p><strong>Conclusions: </strong>Using all eligible lines of therapy for each patient when constructing ECAs minimizes bias and preserves the SAT target population. Alternative methods can lead to biased estimates or, in the case of the first eligible line method, require changes to the clinical question that may shrink the SAT population. We recommend adopting the all eligible lines method with variance correction and adjustment for line of therapy to ensure valid comparative effectiveness analyses.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70262"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145637202","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}
引用次数: 0
Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. 所有单克隆抗体治疗中重度特应性皮炎的疗效和安全性:系统综述和网络荟萃分析。
IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 DOI: 10.1002/pds.70268
Wenting Cai, Linlin Fu, Yan Wu, Yao Yao, Jinping Zhang

Objective: The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD).

Methods: The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate-to-severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables.

Results: This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI-50 (RRs ranging between 1.31 and 22.65), EASI-75(RRs ranging between 1.51 and 36.58), EASI-90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30-0.63). Other safety analysis results showed no statistical difference.

Conclusions: Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety.

目的:本研究的目的是比较单克隆抗体(mAb)治疗中重度特应性皮炎(AD)的疗效和安全性。方法:检索截至2024年11月PubMed、Embase、Web of Science和Cochrane Library数据库中有关单克隆抗体治疗中重度AD的随机对照试验(RCTs)。对照组采用安慰剂。疗效指标为:从基线至疗效观察时间,湿疹面积和严重程度指数评分(EASI-50、EASI-75、EASI-90)改善50%、75%、90%的患者百分比,以及研究者总体评估(IGA)评分为0或1的患者百分比,以及瘙痒症数值评定量表(NRS)、EASI评分、特应性皮炎评分(SCORAD)和体表面积百分比(BSA)变化的百分比。皮肤科生活质量指数(DLQI)。采用Stata14和RevMan5.4进行统计分析。生成数据处理、网络证据图、累积排序曲线下曲面(SUCRA)排序图、联盟图和漏斗图。采用风险比(RR)和95%置信区间(95% CI)作为效应量来分析二元分类变量。结果:本研究纳入32项随机对照试验,共7588例患者。Spesolimab, Rademikibart, Dupilumab, Amlitelimab在EASI-50 (RRs范围为1.31 - 22.65),EASI-75(RRs范围为1.51 - 36.58),EASI-90(RRs范围为3.72 - 5.49)和IGA评分为0或1的患者百分比(RRs范围为1.78 - 13.36)方面优于安慰剂。根据SUCRA对NRS、EASI、SCORAD变化百分比的排名,Dupilumab显示出相对较好的疗效。Dupilumab的严重不良事件发生率低于安慰剂,差异有统计学意义(RR = 0.43, 95% CI 0.30-0.63)。其他安全性分析结果无统计学差异。结论:通过对主要疗效指标的分析,本网络meta分析(NMA)研究表明,所有单克隆抗体的疗效均优于安慰剂。基于本研究结果,Spesolimab、Rademikibart、Dupilumab、Amlitelimab被推荐为疗效和安全性相对较好的治疗方案。
{"title":"Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis.","authors":"Wenting Cai, Linlin Fu, Yan Wu, Yao Yao, Jinping Zhang","doi":"10.1002/pds.70268","DOIUrl":"10.1002/pds.70268","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD).</p><p><strong>Methods: </strong>The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate-to-severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables.</p><p><strong>Results: </strong>This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI-50 (RRs ranging between 1.31 and 22.65), EASI-75(RRs ranging between 1.51 and 36.58), EASI-90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30-0.63). Other safety analysis results showed no statistical difference.</p><p><strong>Conclusions: </strong>Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70268"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145678436","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}
引用次数: 0
期刊
Pharmacoepidemiology and Drug Safety
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1