scholarly journals Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source

Stroke ◽  
2021 ◽  
Vol 52 (3) ◽  
pp. 1069-1073
Author(s):  
Shinichiro Uchiyama ◽  
Kazunori Toyoda ◽  
Byung-Chul Lee ◽  
Chia-Wei Liou ◽  
Lawrence Ka Sing Wong ◽  
...  
Keyword(s):  
East Asia ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
East Asian ◽  
Hazard Ratio ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Asian Patients ◽  
Significant Difference ◽  
East Asian Patients

Background and Purpose: We assessed the outcomes of dabigatran versus aspirin in a prespecified subgroup analysis of East Asian patients with embolic stroke of undetermined source in the RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source). Methods: Patients with a recent embolic stroke of undetermined source were randomized to dabigatran (150 or 110 mg BID) or aspirin (100 mg QD). The primary efficacy outcome was recurrent stroke; the primary safety outcome was major bleeding. The East Asia cohort was compared with patients from all other countries (non-East Asia cohort). Results: Overall, 988 of 5390 patients (18%) were randomized in East Asia. During a median follow-up of 18.8 months, there was no statistically significant difference in recurrent stroke (hazard ratio, 0.65 [95% CI, 0.41–1.03]) or major bleeding (hazard ratio, 1.04 [95% CI, 0.57–1.91]) in East Asian patients receiving dabigatran versus aspirin. Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32–12.01]). Conclusions: The treatment effect of dabigatran versus aspirin was consistent between cohorts, with no apparent superiority for dabigatran over aspirin in preventing recurrent stroke in patients with embolic stroke of undetermined source. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239120.

scholarly journals Antithrombotic Treatment of Embolic Stroke of Undetermined Source

Stroke ◽  
2020 ◽  
Vol 51 (6) ◽  
pp. 1758-1765 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Ralph L. Sacco ◽  
J. Donald Easton ◽  
Christopher B. Granger ◽  
Michal Bar ◽  
...  
Keyword(s):  
Renal Function ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
Dabigatran Etexilate ◽  
Hazard Ratio ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Antithrombotic Treatment ◽  
Double Blind ◽  
The Impact

Background and Purpose— The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods— RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results— The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39–0.82]; interaction P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43–0.94]; interaction P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions— In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02239120.

Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale

Stroke ◽  
2021 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Aurauma Chutinet ◽  
J. Donald Easton ◽  
Christopher B. Granger ◽  
Eva Kleine ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Dabigatran Etexilate ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Foramen Ovale ◽  
Significant Difference

Background and Purpose: Patent foramen ovale (PFO) may increase the risk of embolic stroke of undetermined source (ESUS). Guidelines suggest anticoagulation may be more effective than antiplatelets in preventing stroke in patients with ESUS and PFO when interventional closure is not performed. Methods: Patients with ESUS randomized to dabigatran (150/110 mg BID) or aspirin (100 mg QD) from the RE-SPECT ESUS study (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) were included. The rate of recurrent stroke (primary end point) and ischemic stroke was reported for patients with and without baseline PFO. A meta-analysis comparing the effects of anticoagulant and antiplatelet therapy on ischemic stroke in patients with PFO was updated to include RE-SPECT ESUS. Results: PFO was present in 680 of 5388 (12.6%) patients with documented PFO status. The risk of recurrent stroke with dabigatran versus aspirin was similar in patients with and without PFO ( P for interaction, 0.8290). In patients with PFO, the meta-analysis found no statistically significant difference between anticoagulant and antiplatelet therapy (odds ratio, 0.70 [95% CI, 0.43–1.14]) for ischemic stroke. Conclusions: There is insufficient evidence to recommend anticoagulation over antiplatelet therapy for patients with ESUS and a PFO. More data are needed to guide antithrombotic therapy in this population. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239120.

South-East Asia study alliance guidelines on the management of acne vulgaris in South-East Asian patients

2015 ◽  
Vol 42 (10) ◽  
pp. 945-953 ◽  
Author(s):  
Chee Leok Goh ◽  
Flordeliz Abad-Casintahan ◽  
Derrick Chen Wee Aw ◽  
Roshidah Baba ◽  
Lee Chin Chan ◽  
...  
Keyword(s):  
East Asia ◽  
Acne Vulgaris ◽  
East Asian ◽  
South East Asia ◽  
Asian Patients ◽  
East Asian Patients

Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

2008 ◽  
Vol 26 (13) ◽  
pp. 2118-2123 ◽  
Author(s):  
Daniel G. Haller ◽  
Jim Cassidy ◽  
Stephen J. Clarke ◽  
David Cunningham ◽  
Eric Van Cutsem ◽  
...  
Keyword(s):  
Colon Cancer ◽  
East Asia ◽  
Regional Differences ◽  
East Asian ◽  
Safety Data ◽  
Phase Iii ◽  
Asian Patients ◽  
The World ◽  
Grade 3 ◽  
East Asian Patients

PurposeWe conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability.MethodsTreatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study).ResultsIn the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR.ConclusionRegional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.

scholarly journals High prevalence of APOA1/C3/A4/A5 alterations in luminal breast cancers among young women in East Asia

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ching-Hung Lin ◽  
Ruby Yun-Ju Huang ◽  
Tzu-Pin Lu ◽  
Kuan-Ting Kuo ◽  
Ko-Yun Lo ◽  
...  
Keyword(s):  
East Asia ◽  
Copy Number ◽  
East Asian ◽  
Breast Tumors ◽  
Genetic Alterations ◽  
Gene Copy ◽  
Copy Number Loss ◽  
Asian Patients ◽  
High Prevalence ◽  
East Asian Patients

AbstractIn East Asia, the breast cancer incidence rate among women aged <50 years has rapidly increased. Emerging tumors are distinctly characterized by a high prevalence of estrogen receptor (ER)–positive/human epidermal growth factor receptor (HER2)–negative cancer. In the present study, we identified unique genetic alterations in these emerging tumors. We analyzed gene copy number variations (CNVs) in breast tumors from 120 Taiwanese patients, and obtained public datasets of CNV and gene expression (GE). The data regarding CNV and GE were separately compared between East Asian and Western patients, and the overlapping genes identified in the comparisons were explored to identify the gene–gene interaction networks. In the age <50 years/ER + /HER2– subgroup, tumors of East Asian patients exhibited a higher frequency of copy number loss in APOA1/C3/A4/A5, a lipid-metabolizing gene cluster (33 vs. 10%, P < .001) and lower APOA1/C3/A4/A5 expressions than tumors of Western patients. These copy number loss related– and GE–related results were validated in another Taiwanese cohort and in two GE datasets, respectively. The copy number loss was significantly associated with poor survival among Western patients, but not among East Asian patients. Lower APOA1, APOC3, and APOA5 expressions were associated with higher ESTIMATE immune scores, indicating an abundance of tumor-infiltrating immune cells. In conclusion, APOA1/C3/A4/A5 copy number loss was more prevalent in luminal breast tumors among East Asian women aged <50 years, and its immunomodulatory effect on the tumor microenvironment possibly plays various roles in the tumor biology of East Asian patients.

scholarly journals P70.01 Distribution of CCND1 Mutations in East Asian Patients With Non-Small Cell Lung Cancer

2021 ◽  
Vol 16 (3) ◽  
pp. S562-S563
Author(s):  
H. Feng ◽  
C. Xu ◽  
W. Wang ◽  
D. Wang ◽  
Y. Zhu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
East Asian ◽  
Small Cell ◽  
Small Cell Lung ◽  
Asian Patients ◽  
East Asian Patients

A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies

2021 ◽  
Author(s):  
Toshio Shimizu ◽  
Yasutoshi Kuboki ◽  
Chia-Chi Lin ◽  
Kan Yonemori ◽  
Tomoko Yanai ◽  
...  
Keyword(s):  
Phase 1 ◽  
East Asian ◽  
Phase 1 Study ◽  
Asian Patients ◽  
East Asian Patients

scholarly journals Phase 1 Study of MLN8237 (Alisertib) in Adult East Asian Patients (PTS) with Advanced Solid Tumors or Lymphomas

2013 ◽  
Vol 24 ◽  
pp. ix48
Author(s):  
W.S. Kim ◽  
K. Venkatakrishnan ◽  
T.M. Kim ◽  
C.-C. Lin ◽  
L.S. Thye ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase 1 ◽  
East Asian ◽  
Advanced Solid Tumors ◽  
Phase 1 Study ◽  
Asian Patients ◽  
East Asian Patients
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