Dataset Information

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.

ABSTRACT:

Aims

This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.

Methods

A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population/regional differences were evaluated by the interaction term region-by-treatment using an analysis of covariance model after adjusting for background factors.

Results

Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population/regional differences were detected in the 3 drug categories examined (P > .05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (P = .0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.

Conclusions

This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.

SUBMITTER: Sai K

PROVIDER: S-EPMC6533431 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.

Sai Kimie K Yoshida Akiomi A Hanatani Tadaaki T Imatoh Takuya T Takeuchi Masahiro M Narukawa Mamoru M Watanabe Hiroshi H Uyama Yoshiaki Y Saito Yoshiro Y

British journal of clinical pharmacology 20190328 6

<h4>Aims</h4>This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.<h4>Methods</h4>A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in ...[more]

PMID: 30735569

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Project description:IntroductionCardiovascular benefits observed with new antidiabetic agents may not extend to chronic kidney disease (CKD) patients. This study performed a systematic review and meta-analysis of cardiovascular outcome trials (CVOTs) using new antidiabetic agents stratified by kidney function.MethodsMEDLINE (via PubMed) and the Cochrane Central Register of Controlled Trials were searched for eligible studies up to November 16, 2020. Data were stratified by the trial entry estimated glomerular filtration rate (eGFR) and albuminuria. Primary major cardiovascular event (MACE) outcomes were extracted, and a meta-analysis with a random effects model was performed to estimate overall risk ratios (RRs).ResultsOur search identified 16 studies for inclusion (glucagon-like peptide-1 [GLP-1] analogues, n = 6; dipeptidyl-peptidase 4 [DPP-4] inhibitors, n = 4; and sodium-glucose cotransporter-2 [SGLT-2] inhibitors, n = 6) with a combined total of 150,816 participants (28.2% with eGFR <60 ml/min per 1.73 m2, n = 42,534). The RR for MACE with GLP-1 analogues with an eGFR ≥60 ml/min per 1.73 m2 was 0.87 (95% confidence interval [CI], 0.77-0.98; P = 0.02) and 0.90 (95% CI, 0.78-1.04; P = 0.14) with an eGFR <60 ml/min per 1.73 m2. The RR for MACE with DPP-4 inhibitors with eGFR ≥60 ml/min per 1.73 m2 was 0.99 (95% CI, 0.92-1.07; P = 0.86) and 0.99 (95% CI, 0.91-1.08; P = 0.86) with an eGFR <60 ml/min per 1.73 m2. The RR for MACE with SGLT-2 inhibitors with an eGFR ≥60 ml/min per 1.73 m2 was 1.01 (95% CI, 0.92-1.10; P = 0.87) and 0.85 (95% CI, 0.75-0.95; P = 0.005) with an eGFR <60 ml/min per 1.73 m2. Most analyses had significant heterogeneity. Sufficient albuminuria data were unavailable to analyze empirically.ConclusionClear evidence for MACE prevention in diabetes patients with an eGFR <60 ml/min per 1.73 m2 currently exists for SGLT-2 inhibitors only. However, similar GLP-1 analogue effect sizes suggest a lack of sufficient power rather than a lack of effect.

Dataset Information

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.

Aims

Methods

Results

Conclusions

Publications

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials.

Similar Datasets

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