Effects of safety warnings and risk management plan for Thiazolidinediones in Taiwan

Hsu, Jason C.; Cheng, Ching Lan; Ross‐Degnan, Dennis; Wagner, Anita K.; Zhang, Fang; Yang, Yea Huei Kao; Liu, Li Ling; Tai, Hsueh Yung; Chen, Ke Hsin; Yang, Po Wen; Lu, Christine Y.

doi:10.1002/pds.3834

Cited by 8 publications

(6 citation statements)

References 39 publications

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“…Nevertheless, few reports and studies have mentioned the possible association of pioglitazone with bladder cancer, and this topic warrants further examination. [ 14 – 16 ]…”

Section: Discussionmentioning

confidence: 99%

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The prescribing trend of oral antidiabetic agents for type 2 diabetes in Taiwan

Chu

Huang

et al. 2017

Medicine

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The purpose of this study was to evaluate the prescription trend and pattern of oral antidiabetic (OAD) medications, which are extensively used worldwide for treating type 2 diabetes, in 2 age groups.In this population-based study, data obtained from the National Health Insurance Research Database, Taiwan, were analyzed to investigate the prescription trend of all types of OAD medications during 2005 to 2012. We used descriptive statistics to demonstrate the trend of prescription patterns stratified by age (aged 65 years and above or younger than 65).Sulfonylurea (SU) was once the most commonly used drug, but the proportion of its prescription had declined gradually (76.83% in 2005 to 63.70% in 2012). Consequently, biguanide (BG) became the most commonly used drug since 2010 (64.31% in 2005 to 74.41% in 2012). In addition, the prescriptions of thiazolidinedione decreased significantly (9.20% in 2005 to 2.86% in 2012), whereas the usage of DPP-4 inhibitor increased with time (3.73% in 2009 to 19.64% in 2012). The treatment choice of SU and α-glucosidase inhibitor (AGI) was higher in elderly patients compared with the younger population (SU: 62.70% in 2012, AGI: 12.78% in 2012). Two-drug combination therapies were the prevalent treatment choices for patients with type 2 diabetes (44.77% in 2012), particularly in the elderly group; however, ≥3 drug combination therapies increased gradually during the study period, particularly in the younger group.This descriptive study presents the change in the prescription of OAD medication for different age groups during 2005 to 2012.

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“…Nevertheless, few reports and studies have mentioned the possible association of pioglitazone with bladder cancer, and this topic warrants further examination. [ 14 – 16 ]…”

Section: Discussionmentioning

confidence: 99%

“…[ 13 ] In addition, a study examining pioglitazone usage and the associated risk of bladder cancer was published in the British Medical Journal and received extensive attention. [ 14 – 16 ]…”

Section: Introductionmentioning

confidence: 99%

The prescribing trend of oral antidiabetic agents for type 2 diabetes in Taiwan

Chu

Huang

et al. 2017

Medicine

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“…Impact evaluation on prescribing practices or on the occurrence of health outcomes is generally carried out for different types of interventions such as black-box warnings and contraindications included in the label, as well as RCs, educational materials and for more stringent interventions such as controlled distribution programmes [23,[61][62][63][64][65][66][67][68]. While there has been an increase in the number of publicly available studies assessing effectiveness of various types of health interventions, there is marked heterogeneity noted in study conduct stemming from variations in study design, data choice, methods used for evaluation, in addition to main outcomes evaluated and study reporting [20,26].…”

Section: Evaluating the Effectiveness Of Rmm(s)mentioning

confidence: 99%

Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

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Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidencebased approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

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“…Several studies have investigated the effectiveness of rosiglitazone advisories in a number of countries. [43][44][45][46][47][48][49] All of these studies found that there was a decrease in use following an advisory.…”

Section: Discussionmentioning

confidence: 99%