Sulphonylureas monotherapy and risk of hospitalization for heart failure in patients with type 2 diabetes mellitus: A population‐based cohort study in China

Xu, Yang; Wang, Tiansheng; Yang, Zhirong; Lin, Hongbo; Shen, Peng; Zhan, Siyan

doi:10.1002/pds.5024

Cited by 9 publications

(10 citation statements)

References 46 publications

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“…This was further supported by subsequently published studies (in progress at the time of our assessment) reporting on the capacity to record a broad range of outcomes in the large resident population captured in the YRHIP. 38,45,[47][48][49][50][51] These include studies evaluating vaccine uptake and safety, either as a discrete platform, 45,56 or when contributing to the broader Ningbo City Regional Health Care Information Platform. [52][53][54][55] However, there is some uncertainty to which extent more recent and future data may vary, which could hinder robust evidence generation on HPV vaccine safety and effectiveness.…”

Section: Discussionmentioning

confidence: 99%

“…20 A number of studies in progress at the time of this assessment are now published, confirming the capability to generate RWE from large populations in the YRHIP (Table 1). 38,45,[47][48][49][50][51][52][53][54][55][56] The CHERRY 38,47 and CK-NET studies 49,50 each performed analyses in cohorts of approximately 1 million adults, with a wide range of outcomes identified via ICD-10 codes over prolonged time frames. Other large-scale studies include a diabetes study, 48 a herpes zoster incidence study conducted to generate baseline data in view of the introduction of the zoster vaccine in China, 51 and rheumatoid arthritis epidemiology.…”

Section: Disease Area Reference Study Period Key Observationsmentioning

confidence: 99%

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A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Welby

Feng

Tang

et al. 2023

Pharmacoepidemiology and Drug

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BackgroundReal‐world data (RWD) are increasingly used to generate real‐world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a use case, we described the process and findings of a feasibility assessment to identify reliable and relevant data sources for monitoring the safety and effectiveness of the AS04‐HPV‐16/18 human papillomavirus (HPV) vaccine in China.MethodsIterative multi‐step process: (1) targeted literature review and data source mapping; (2) expert opinion from national RWD experts; (3) survey to evaluate the identified data source operational infrastructure; and (4) continuous appraisal of published studies using the identified data source.ResultsThe Yinzhou Regional Health Information Platform (YRHIP) was identified as a data source of main interest, based on its large population coverage, high cervical cancer screening rates, and availability of adult electronic immunization records. Field meetings with national RWD experts confirmed its suitability for post‐authorization vaccine studies. Survey results showed that exposure data and relevant safety and effectiveness endpoints were recorded and linkable at the individual level across the platform. Iterative appraisal of emerging evidence from the literature corroborated these findings.ConclusionsThis feasibility assessment indicates that the YRHIP has the capacity to capture demographic, exposure, outcome and other data required to generate RWE on HPV vaccine safety and effectiveness in China. Studies using the YRHIP to monitor the AS04‐HPV‐16/18 vaccine in routine use building on this feasibility assessment are ongoing.

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Section: Discussionmentioning

confidence: 99%

Section: Disease Area Reference Study Period Key Observationsmentioning

confidence: 99%

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Welby

Feng

Tang

et al. 2023

Pharmacoepidemiology and Drug

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“…We conducted a retrospective new-user active-comparator cohort study using the Yinzhou Regional Health Care Database (YRHCD). The YRHCD integrated longitudinal information of population census, electronic medical records, disease surveillance and management, health check, death registry, and other healthcare services in the Yinzhou District, Ningbo City of China ( 14 , 15 ). Since 2009, the YRHCD has covered nearly all health-related activities of all residents in this region, from birth to death ( 14 ).…”

Section: Methodsmentioning

confidence: 99%

Sulfonylurea and Cancer Risk Among Patients With Type 2 Diabetes: A Population-Based Cohort Study

et al. 2022

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BackgroundCurrent evidence of the association between the use of sulfonylurea and cancer risk is highly conflicting and little evidence of this association is from the mainland Chinese population. This study aimed to evaluate the potential effects of sulfonylurea use on cancer risk among patients with type 2 diabetes mellitus (T2DM).MethodsA retrospective cohort study of T2DM patients who were new users of sulfonylurea or metformin was conducted using the Yinzhou Regional Health Care Database. A marginal structural Cox model was used to estimate the hazard ratio (HR) of cancer associated with the use of sulfonylurea compared with metformin, with time-varying confounders controlled by inverse probability weighting. Secondary analyses using different glucose-lowering drugs (GLDs) as comparator and sensitivity analyses for potential bias due to latency period, model misspecification, missing data, analyses strategy (intention-to-treat and per-protocol), and diagnosis validation were performed to examine the robustness of the results.ResultsAfter fully controlling for time-varying confounding, baseline confounding, and competing risk, the use of sulfonylurea was not associated with the risk of any cancer (HR 1.09; 95% CI, 0.93–1.27), compared with the use of metformin. In the secondary analyses, compared with α - glucosidase inhibitors, thiazolidinediones, glinides, other GLDs except sulfonylure and insulin, and T2DM patients not treated with sulfonylureas, the HRs of the association between sulfonylurea use and cancer risk were 0.92 (95% CI; 0.78–1.08), 0.89 (95% CI; 0.66–1.19), 0.85 (95% CI; 0.71–1.02), 1.04 (95% CI; 0.89–1.22), and 1.07 (95% CI; 0.99–1.16), respectively. The results of analyses for various subgroups, risk of site-specific cancers, cumulative duration, dose-response relationship, and sensitivity analyses of different latency periods and missing data were generally consistent with the findings of the primary analyses.ConclusionNo association between sulfonylurea use and cancer risk was found in this study after properly controlling biases due to time-varying confounders and other sources. Further studies on the association between sulfonylurea use and the risk of cancer by using data from a Chinese population with higher representativeness are needed.

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“…In contrast to the neutral outcome of the UKPDS, another study demonstrated an increased risk of heart failure associated with sulfonylurea derivates. This recent retrospective population-based cohort study by Xu et al included 15,752 patients with diabetes mellitus type 2 from the Yinzhou district in China and observed a significantly increased risk of hospitalisation for heart failure in patients treated with sulfonylurea derivate monotherapy compared to acarbose monotherapy (an alpha-glucosidase inhibitor preventing intestinal glucose absorption with neutral effects on heart failure that is not commonly prescribed in the Netherlands) (HR 1.61 (95% CI 1.14-2.27)) [14].…”

Section: Sulfonylurea Derivatesmentioning

confidence: 99%

The effects of antidiabetic agents on heart failure

et al. 2021

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In the Netherlands, approximately 250,000 people are living with heart failure. About one-third of them have comorbid diabetes mellitus type 2. Until recently, the effects of antidiabetic agents on heart failure were largely unknown. This changed after an observed increased risk of heart failure and ischaemic heart disease associated with thiazolidinediones that prompted the requirement for cardiovascular outcome trials for new glucose-lowering drugs. In the past decade, three new classes of antidiabetic agents have become available (i.e. dipeptidyl peptidase‑4 inhibitors, glucagon-like peptide‑1 receptor agonists and sodium-glucose cotransporter‑2 (SGLT2) inhibitors). Although the first two classes demonstrated no beneficial effects on heart failure compared to placebo in patients with diabetes mellitus type 2, SGLT2 inhibitors significantly and consistently lowered the risk of incident and worsening heart failure. Two recent trials indicated that these favourable effects were also present in non-diabetic patients with heart failure with reduced ejection fraction, resulting in significantly lower risks of hospitalisation for heart failure and presumably also cardiovascular and all-cause mortality. SGLT2 inhibitors have been shown to be benefit on top of recommended heart failure therapy including sacubitril/valsartan and may also prove beneficial for heart failure with preserved ejection fraction. In this review, we discuss the effects of antidiabetic agents on heart failure.

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Sulphonylureas monotherapy and risk of hospitalization for heart failure in patients with type 2 diabetes mellitus: A population‐based cohort study in China

Cited by 9 publications

References 46 publications

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case

Sulfonylurea and Cancer Risk Among Patients With Type 2 Diabetes: A Population-Based Cohort Study

The effects of antidiabetic agents on heart failure

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