Abstract
Background and purpose The ticlopidine/Ginkgo biloba ext. combination drug (Yuclid) is used as an antiplatelet agent for prevention of vascular events since its approval in 2008. The purpose of this study is to explore the safety of ticlopidine/Ginkgo biloba combination, mainly regarding the incidence of neutropenia, through a post-marketing surveillance study. Methods From March 2009 to October 2015, a total of 4839 subjects had been enrolled in this study. The enrollments were conducted by 152 doctors of 89 hospitals according to the regulations for post-marketing surveillance programs in Korea. If a subject was administered the drug once, he/she was included in the safety analysis set for any adverse events and bleedings, and the primary safety evaluation regarding neutropenia was conducted in subjects who completed 3-month blood test follow-up. We predefined that 1% reduction in neutropenia incidence by ticlopidine/Ginkgo biloba ext. combination from the previously reported incidence of ticlopidine of 2.3% was clinically meaningful. Results Among the safety analysis set of 4831 patients (99.8% of the enrolled subjects), 3150 (65.1%) completed evaluation for neutropenia at 3 months which is the primary safety endpoint. The major causes of dropout were no follow-up visit at 3 months (n = 1016) and violation of the follow-up period (n = 503). Nine patients experienced neutropenia (Absolute neutrophil count [ANC] 1200mm3) and the estimated cumulative incidence at 3 months is 0.29% (95% confidence interval, 0.13%– 0.54%). Severe neutropenia (ANC 450mm3) did not occur in any patients. Conclusions The incidence of neutropenia with addition of Ginkgo biloba ext. to ticlopidine may be lower than the previously reported incidence of neutropenia with ticlopidine, which needs to be confirmed in randomized controlled trials.
| Original language | English |
|---|---|
| Article number | e0217723 |
| Journal | PloS one |
| Volume | 14 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2019 Jun 1 |
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ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
- Agricultural and Biological Sciences(all)
Cite this
Incidence of neutropenia in patients with ticlopidine/Ginkgo biloba extract combination drug for vascular events : A post-marketing cohort study. / Jeong, Han Gil; Yoon, Jae Sun; Lee, Juneyoung; Bae, Hee Joon.
In: PloS one, Vol. 14, No. 6, e0217723, 01.06.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Incidence of neutropenia in patients with ticlopidine/Ginkgo biloba extract combination drug for vascular events
T2 - A post-marketing cohort study
AU - Jeong, Han Gil
AU - Yoon, Jae Sun
AU - Lee, Juneyoung
AU - Bae, Hee Joon
PY - 2019/6/1
Y1 - 2019/6/1
N2 - Background and purpose The ticlopidine/Ginkgo biloba ext. combination drug (Yuclid) is used as an antiplatelet agent for prevention of vascular events since its approval in 2008. The purpose of this study is to explore the safety of ticlopidine/Ginkgo biloba combination, mainly regarding the incidence of neutropenia, through a post-marketing surveillance study. Methods From March 2009 to October 2015, a total of 4839 subjects had been enrolled in this study. The enrollments were conducted by 152 doctors of 89 hospitals according to the regulations for post-marketing surveillance programs in Korea. If a subject was administered the drug once, he/she was included in the safety analysis set for any adverse events and bleedings, and the primary safety evaluation regarding neutropenia was conducted in subjects who completed 3-month blood test follow-up. We predefined that 1% reduction in neutropenia incidence by ticlopidine/Ginkgo biloba ext. combination from the previously reported incidence of ticlopidine of 2.3% was clinically meaningful. Results Among the safety analysis set of 4831 patients (99.8% of the enrolled subjects), 3150 (65.1%) completed evaluation for neutropenia at 3 months which is the primary safety endpoint. The major causes of dropout were no follow-up visit at 3 months (n = 1016) and violation of the follow-up period (n = 503). Nine patients experienced neutropenia (Absolute neutrophil count [ANC] 1200mm3) and the estimated cumulative incidence at 3 months is 0.29% (95% confidence interval, 0.13%– 0.54%). Severe neutropenia (ANC 450mm3) did not occur in any patients. Conclusions The incidence of neutropenia with addition of Ginkgo biloba ext. to ticlopidine may be lower than the previously reported incidence of neutropenia with ticlopidine, which needs to be confirmed in randomized controlled trials.
AB - Background and purpose The ticlopidine/Ginkgo biloba ext. combination drug (Yuclid) is used as an antiplatelet agent for prevention of vascular events since its approval in 2008. The purpose of this study is to explore the safety of ticlopidine/Ginkgo biloba combination, mainly regarding the incidence of neutropenia, through a post-marketing surveillance study. Methods From March 2009 to October 2015, a total of 4839 subjects had been enrolled in this study. The enrollments were conducted by 152 doctors of 89 hospitals according to the regulations for post-marketing surveillance programs in Korea. If a subject was administered the drug once, he/she was included in the safety analysis set for any adverse events and bleedings, and the primary safety evaluation regarding neutropenia was conducted in subjects who completed 3-month blood test follow-up. We predefined that 1% reduction in neutropenia incidence by ticlopidine/Ginkgo biloba ext. combination from the previously reported incidence of ticlopidine of 2.3% was clinically meaningful. Results Among the safety analysis set of 4831 patients (99.8% of the enrolled subjects), 3150 (65.1%) completed evaluation for neutropenia at 3 months which is the primary safety endpoint. The major causes of dropout were no follow-up visit at 3 months (n = 1016) and violation of the follow-up period (n = 503). Nine patients experienced neutropenia (Absolute neutrophil count [ANC] 1200mm3) and the estimated cumulative incidence at 3 months is 0.29% (95% confidence interval, 0.13%– 0.54%). Severe neutropenia (ANC 450mm3) did not occur in any patients. Conclusions The incidence of neutropenia with addition of Ginkgo biloba ext. to ticlopidine may be lower than the previously reported incidence of neutropenia with ticlopidine, which needs to be confirmed in randomized controlled trials.
UR - http://www.scopus.com/inward/record.url?scp=85066790328&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85066790328&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0217723
DO - 10.1371/journal.pone.0217723
M3 - Article
C2 - 31166961
AN - SCOPUS:85066790328
VL - 14
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 6
M1 - e0217723
ER -