1.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
2.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
3.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
4.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
5.Contemporary Statistics of Acute Ischemic Stroke and Transient Ischemic Attack in 2021: Insights From the CRCS-K-NIH Registry
Do Yeon KIM ; Tai Hwan PARK ; Yong-Jin CHO ; Jong-Moo PARK ; Kyungbok LEE ; Minwoo LEE ; Juneyoung LEE ; Sang Yoon BAE ; Da Young HONG ; Hannah JUNG ; Eunvin KO ; Hyung Seok GUK ; Beom Joon KIM ; Jun Yup KIM ; Jihoon KANG ; Moon-Ku HAN ; Sang-Soon PARK ; Keun-Sik HONG ; Hong-Kyun PARK ; Jeong-Yoon LEE ; Byung-Chul LEE ; Kyung-Ho YU ; Mi Sun OH ; Dong-Eog KIM ; Dong-Seok GWAK ; Soo Joo LEE ; Jae Guk KIM ; Jun LEE ; Doo Hyuk KWON ; Jae-Kwan CHA ; Dae-Hyun KIM ; Joon-Tae KIM ; Kang-Ho CHOI ; Hyunsoo KIM ; Jay Chol CHOI ; Joong-Goo KIM ; Chul-Hoo KANG ; Sung-il SOHN ; Jeong-Ho HONG ; Hyungjong PARK ; Sang-Hwa LEE ; Chulho KIM ; Dong-Ick SHIN ; Kyu Sun YUM ; Kyusik KANG ; Kwang-Yeol PARK ; Hae-Bong JEONG ; Chan-Young PARK ; Keon-Joo LEE ; Jee Hyun KWON ; Wook-Joo KIM ; Ji Sung LEE ; Hee-Joon BAE ;
Journal of Korean Medical Science 2024;39(34):e278-
This report presents the latest statistics on the stroke population in South Korea, sourced from the Clinical Research Collaborations for Stroke in Korea-National Institute for Health (CRCS-K-NIH), a comprehensive, nationwide, multicenter stroke registry. The Korean cohort, unlike western populations, shows a male-to-female ratio of 1.5, attributed to lower risk factors in Korean women. The average ages for men and women are 67 and 73 years, respectively.Hypertension is the most common risk factor (67%), consistent with global trends, but there is a higher prevalence of diabetes (35%) and smoking (21%). The prevalence of atrial fibrillation (19%) is lower than in western populations, suggesting effective prevention strategies in the general population. A high incidence of large artery atherosclerosis (38%) is observed, likely due to prevalent intracranial arterial disease in East Asians and advanced imaging techniques.There has been a decrease in intravenous thrombolysis rates, from 12% in 2017–2019 to 10% in 2021, with no improvements in door-to-needle and door-to-puncture times, worsened by the coronavirus disease 2019 pandemic. While the use of aspirin plus clopidogrel for noncardioembolic stroke and direct oral anticoagulants for atrial fibrillation is well-established, the application of direct oral anticoagulants for non-atrial fibrillation cardioembolic strokes in the acute phase requires further research. The incidence of early neurological deterioration (13%) and the cumulative incidence of recurrent stroke at 3 months (3%) align with global figures. Favorable outcomes at 3 months (63%) are comparable internationally, yet the lack of improvement in dependency at 3 months highlights the need for advancements in acute stroke care.
6.Prognostic Value of Alpha-Fetoprotein in Patients Who Achieve a Complete Response to Transarterial Chemoembolization for Hepatocellular Carcinoma
Jae Seung LEE ; Young Eun CHON ; Beom Kyung KIM ; Jun Yong PARK ; Do Young KIM ; Sang Hoon AHN ; Kwang-Hyub HAN ; Wonseok KANG ; Moon Seok CHOI ; Geum-Youn GWAK ; Yong-Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Hwi Young KIM ; Tae Hun KIM ; Kwon YOO ; Yeonjung HA ; Mi Na KIM ; Joo Ho LEE ; Seong Gyu HWANG ; Soon Sun KIM ; Hyo Jung CHO ; Jae Youn CHEONG ; Sung Won CHO ; Seung Ha PARK ; Nae-Yun HEO ; Young Mi HONG ; Ki Tae YOON ; Mong CHO ; Jung Gil PARK ; Min Kyu KANG ; Soo Young PARK ; Young Oh KWEON ; Won Young TAK ; Se Young JANG ; Dong Hyun SINN ; Seung Up KIM ;
Yonsei Medical Journal 2021;62(1):12-20
Purpose:
Alpha-fetoprotein (AFP) is a prognostic marker for hepatocellular carcinoma (HCC). We investigated the prognostic value of AFP levels in patients who achieved complete response (CR) to transarterial chemoembolization (TACE) for HCC.
Materials and Methods:
Between 2005 and 2018, 890 patients with HCC who achieved a CR to TACE were recruited. An AFP responder was defined as a patient who showed elevated levels of AFP (>10 ng/mL) during TACE, but showed normalization or a >50% reduction in AFP levels after achieving a CR.
Results:
Among the recruited patients, 569 (63.9%) with naïve HCC and 321 (36.1%) with recurrent HCC after complete resection were treated. Before TACE, 305 (34.3%) patients had multiple tumors, 219 (24.6%) had a maximal tumor size >3 cm, and 22 (2.5%) had portal vein tumor thrombosis. The median AFP level after achieving a CR was 6.36 ng/mL. After a CR, 473 (53.1%) patients experienced recurrence, and 417 (46.9%) died [median progression-free survival (PFS) and overall survival (OS) of 16.3 and 62.8 months, respectively]. High AFP levels at CR (>20 ng/mL) were independently associated with a shorter PFS [hazard ratio (HR)=1.403] and OS (HR=1.284), together with tumor multiplicity at TACE (HR=1.518 and 1.666, respectively). AFP non-responders at CR (76.2%, n=359 of 471) showed a shorter PFS (median 10.5 months vs. 15.5 months, HR=1.375) and OS (median 41.4 months vs. 61.8 months, HR=1.424) than AFP responders (all p=0.001).
Conclusion
High AFP levels and AFP non-responders were independently associated with poor outcomes after TACE. AFP holds clinical implications for detailed risk stratification upon achieving a CR after TACE.
7.Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006)
Sung Gwe AHN ; Seok Jin NAM ; Sei Hyun AHN ; Yongsik JUNG ; Heung Kyu PARK ; Soo Jung LEE ; Sung Soo KANG ; Wonshik HAN ; Kyong Hwa PARK ; Yong Lai PARK ; Jihyoun LEE ; Hyun Jo YOUN ; Jun Hyun KIM ; Youngbum YOO ; Jeong-Yoon SONG ; Byung Kyun KO ; Geumhee GWAK ; Min Sung CHUNG ; Sung Yong KIM ; Seo Heon CHO ; Doyil KIM ; Myung-Chul CHANG ; Byung In MOON ; Lee Su KIM ; Sei Joong KIM ; Min Ho PARK ; Tae Hyun KIM ; Jihyoung CHO ; Cheol Wan LIM ; Young Tae BAE ; Gyungyub GONG ; Young Kyung BAE ; Ahwon LEE ; Joon JEONG
Journal of Breast Cancer 2021;24(2):164-174
Purpose:
In this trial, we investigated the efficacy and safety of adjuvant letrozole for hormone receptor (HR)-positive breast cancer. Here, we report the clinical outcome in postmenopausal women with HR-positive breast cancer treated with adjuvant letrozole according to estrogen receptor (ER) expression levels.
Methods:
In this multi-institutional, open-label, observational study, postmenopausal patients with HR-positive breast cancer received adjuvant letrozole (2.5 mg/daily) for 5 years unless they experienced disease progression or unacceptable toxicity or withdrew their consent. The patients were stratified into the following 3 groups according to ER expression levels using a modified Allred score (AS): low, intermediate, and high (AS 3–4, 5–6, and 7–8, respectively). ER expression was centrally reviewed. The primary objective was the 5-year disease-free survival (DFS) rate.
Results:
Between April 25, 2010, and February 5, 2014, 440 patients were enrolled. With a median follow-up of 62.0 months, the 5-year DFS rate in all patients was 94.2% (95% confidence interval [CI], 91.8–96.6). The 5-year DFS and recurrence-free survival (RFS) rates did not differ according to ER expression; the 5-year DFS rates were 94.3% and 94.1%in the low-to-intermediate and high expression groups, respectively (p = 0.6), and the corresponding 5-year RFS rates were 95.7% and 95.4%, respectively (p = 0.7). Furthermore, 25 patients discontinued letrozole because of drug toxicity.
Conclusion
Treatment with adjuvant letrozole showed very favorable treatment outcomes and good tolerability among Korean postmenopausal women with ER-positive breast cancer, independent of ER expression.
8.Current Trends in the Treatment of Ankle Arthritis: Analysis of the Korean Foot and Ankle Society (KFAS) Member Survey
Byung-Ki CHO ; Jaeho CHO ; Heui-Chul GWAK ; Hak Jun KIM ; Su-Young BAE ;
Journal of Korean Foot and Ankle Society 2021;25(3):111-116
Purpose:
Variations in the preferred conservative and operative treatment methods for ankle arthritis may be observed in the practice of orthopedic surgeons. This study is based on the Korean Foot and Ankle Society (KFAS) member survey and aims to report the current trend and changes in the management of ankle arthritis over the last few decades.
Materials and Methods:
A web-based questionnaire containing 24 questions was sent to all KFAS members in July 2021. The questions were mainly related to the preferred techniques and clinical experience in osteotomy, arthrodesis, and total ankle arthroplasty (TAA) for patients with ankle arthritis.
Results:
Sixty-three out of 550 surgeons (11.5%) responded to the survey. The responses to 6 out of the total of 24 questions (25.0%) achieved the levels needed to reflect a tendency. Answers that showed a tendency were related to the following: a surgical approach for arthrodesis (anterior approach), use of auto-bone graft for arthrodesis (iliac bone), a nonunion rate of more than 10% following arthrodesis, main reason related to unsatisfactory results after arthrodesis (nonunion or delayed union), the main reason to change total ankle prosthesis (unstable supply of prosthesis), the unusualness of revision TAA and conversion of fusion to TAA. Diversity was found in several aspects of treatment (degree of experience and satisfaction in supramalleolar osteotomy, fixation method for arthrodesis, preferred TAA prosthesis and longevity, degree of experinece, annual number of TAA operation.
Conclusion
This study proposes updated information with regard to the current trends in the management of ankle arthritis in Korea. Both consensus and variations in the approach to patients with ankle arthritis were identified through this survey. With an increasing preference for TAA, the need for the development of a prosthesis optimized for Koreans and a stable supply of prostheses were the suggestions made by the study.
9.Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006)
Sung Gwe AHN ; Seok Jin NAM ; Sei Hyun AHN ; Yongsik JUNG ; Heung Kyu PARK ; Soo Jung LEE ; Sung Soo KANG ; Wonshik HAN ; Kyong Hwa PARK ; Yong Lai PARK ; Jihyoun LEE ; Hyun Jo YOUN ; Jun Hyun KIM ; Youngbum YOO ; Jeong-Yoon SONG ; Byung Kyun KO ; Geumhee GWAK ; Min Sung CHUNG ; Sung Yong KIM ; Seo Heon CHO ; Doyil KIM ; Myung-Chul CHANG ; Byung In MOON ; Lee Su KIM ; Sei Joong KIM ; Min Ho PARK ; Tae Hyun KIM ; Jihyoung CHO ; Cheol Wan LIM ; Young Tae BAE ; Gyungyub GONG ; Young Kyung BAE ; Ahwon LEE ; Joon JEONG
Journal of Breast Cancer 2021;24(2):164-174
Purpose:
In this trial, we investigated the efficacy and safety of adjuvant letrozole for hormone receptor (HR)-positive breast cancer. Here, we report the clinical outcome in postmenopausal women with HR-positive breast cancer treated with adjuvant letrozole according to estrogen receptor (ER) expression levels.
Methods:
In this multi-institutional, open-label, observational study, postmenopausal patients with HR-positive breast cancer received adjuvant letrozole (2.5 mg/daily) for 5 years unless they experienced disease progression or unacceptable toxicity or withdrew their consent. The patients were stratified into the following 3 groups according to ER expression levels using a modified Allred score (AS): low, intermediate, and high (AS 3–4, 5–6, and 7–8, respectively). ER expression was centrally reviewed. The primary objective was the 5-year disease-free survival (DFS) rate.
Results:
Between April 25, 2010, and February 5, 2014, 440 patients were enrolled. With a median follow-up of 62.0 months, the 5-year DFS rate in all patients was 94.2% (95% confidence interval [CI], 91.8–96.6). The 5-year DFS and recurrence-free survival (RFS) rates did not differ according to ER expression; the 5-year DFS rates were 94.3% and 94.1%in the low-to-intermediate and high expression groups, respectively (p = 0.6), and the corresponding 5-year RFS rates were 95.7% and 95.4%, respectively (p = 0.7). Furthermore, 25 patients discontinued letrozole because of drug toxicity.
Conclusion
Treatment with adjuvant letrozole showed very favorable treatment outcomes and good tolerability among Korean postmenopausal women with ER-positive breast cancer, independent of ER expression.
10.Current Trends in the Treatment of Ankle Arthritis: Analysis of the Korean Foot and Ankle Society (KFAS) Member Survey
Byung-Ki CHO ; Jaeho CHO ; Heui-Chul GWAK ; Hak Jun KIM ; Su-Young BAE ;
Journal of Korean Foot and Ankle Society 2021;25(3):111-116
Purpose:
Variations in the preferred conservative and operative treatment methods for ankle arthritis may be observed in the practice of orthopedic surgeons. This study is based on the Korean Foot and Ankle Society (KFAS) member survey and aims to report the current trend and changes in the management of ankle arthritis over the last few decades.
Materials and Methods:
A web-based questionnaire containing 24 questions was sent to all KFAS members in July 2021. The questions were mainly related to the preferred techniques and clinical experience in osteotomy, arthrodesis, and total ankle arthroplasty (TAA) for patients with ankle arthritis.
Results:
Sixty-three out of 550 surgeons (11.5%) responded to the survey. The responses to 6 out of the total of 24 questions (25.0%) achieved the levels needed to reflect a tendency. Answers that showed a tendency were related to the following: a surgical approach for arthrodesis (anterior approach), use of auto-bone graft for arthrodesis (iliac bone), a nonunion rate of more than 10% following arthrodesis, main reason related to unsatisfactory results after arthrodesis (nonunion or delayed union), the main reason to change total ankle prosthesis (unstable supply of prosthesis), the unusualness of revision TAA and conversion of fusion to TAA. Diversity was found in several aspects of treatment (degree of experience and satisfaction in supramalleolar osteotomy, fixation method for arthrodesis, preferred TAA prosthesis and longevity, degree of experinece, annual number of TAA operation.
Conclusion
This study proposes updated information with regard to the current trends in the management of ankle arthritis in Korea. Both consensus and variations in the approach to patients with ankle arthritis were identified through this survey. With an increasing preference for TAA, the need for the development of a prosthesis optimized for Koreans and a stable supply of prostheses were the suggestions made by the study.

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