1.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
2.Palliative Care and Hospice for Heart Failure Patients: Position Statement From the Korean Society of Heart Failure
Seung-Mok LEE ; Hae-Young LEE ; Shin Hye YOO ; Hyun-Jai CHO ; Jong-Chan YOUN ; Seong-Mi PARK ; Jin-Ok JEONG ; Min-Seok KIM ; Chi Young SHIM ; Jin Joo PARK ; Kye Hun KIM ; Eung Ju KIM ; Jeong Hoon YANG ; Jae Yeong CHO ; Sang-Ho JO ; Kyung-Kuk HWANG ; Ju-Hee LEE ; In-Cheol KIM ; Gi Beom KIM ; Jung Hyun CHOI ; Sung-Hee SHIN ; Wook-Jin CHUNG ; Seok-Min KANG ; Myeong Chan CHO ; Dae-Gyun PARK ; Byung-Su YOO
International Journal of Heart Failure 2025;7(1):32-46
Heart failure (HF) is a major cause of mortality and morbidity in South Korea, imposing substantial physical, emotional, and financial burdens on patients and society. Despite the high burden of symptom and complex care needs of HF patients, palliative care and hospice services remain underutilized in South Korea due to cultural, institutional, and knowledge-related barriers. This position statement from the Korean Society of Heart Failure emphasizes the need for integrating palliative and hospice care into HF management to improve quality of life and support holistic care for patients and their families. By clarifying the role of palliative care in HF and proposing practical referral criteria, this position statement aims to bridge the gap between HF and palliative care services in South Korea, ultimately improving patient-centered outcomes and aligning treatment with the goals and values of HF patients.
3.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
4.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
5.The epidemiology of male lower urinary tract symptoms associated with benign prostatic hyperplasia: Results of 20 years of Korean community care and surveys
Seonguk JEH ; Minsung CHOI ; Changseok KANG ; Daehyun KIM ; Jaehwi CHOI ; Seemin CHOI ; Jeongseok HWA ; Chunwoo LEE ; Sungchul KAM ; Seongwon KWON ; Saecheol KIM ; Jaeman SONG ; Dongdeuk KWON ; Tae Gyun KWON ; Kwangho KIM ; Younggon KIM ; Taehyung KIM ; Yong Gil NA ; Dong Soo PARK ; Hyun Jun PARK ; Rakhee SEONG ; Sangguk YANG ; Seongtae YOON ; Jinhan YUN ; Gyeongseop LEE ; Donghyun LEE ; Seonju LEE ; Byungyul JEON ; Hyunchul JUNG ; Seongjun HONG ; Nakkyu CHOI ; Yunsoo LEE ; Jaeseog HYUN
Investigative and Clinical Urology 2024;65(1):69-76
Purpose:
To investigate the prevalence of lower urinary tract symptoms/benign prostatic hyperplasia in a Korean population.
Materials and Methods:
The Korean Prostate & Voiding Health Association provided free prostate-related community health care and conducted surveys in all regions of Korea from 2001 to 2022 with the cooperation of local government public health centers. A total of 72,068 males older than 50 were surveyed and analyzed. History taking, International Prostate Symptom Score (IPSS), transrectal ultrasonography, prostate-specific antigen (PSA) testing, uroflowmetry, and urine volume testing were performed.
Results:
The mean prostate volumes in males in their 50s, 60s, 70s, and 80s or above were 24.7 g, 27.7 g, 31 g, and 33.7 g, respectively. The proportion of males with high PSA greater than 3 ng/mL was 3.8% among males in their 50s, 7.7% among males in their 60s, 13.1% among males in their 70s, and 17.9% among males 80 years of age or older. The mean IPSS total scores in males in their 50s, 60s, 70s, and 80s or above were 10.7, 12.7, 14.5, and 16, respectively. Severe symptoms were reported by 27.3% of males, whereas 51.7% reported moderate symptoms. The mean Qmax in males in their 50s, 60s, 70s, and 80s or above were 20 mL/s, 17.4 mL/s, 15.4 mL/s, and 13.8 mL/s, respectively.
Conclusions
In this population-based study, mean prostate volume, IPSS, PSA, and Qmax were 30.6±15.1 g, 14.8±8.2, 1.9±4.7 ng/mL, and 15.6±6.5 mL/s, respectively. Aging was significantly associated with increased prostate volume, PSA levels, and IPSS scores, and with decreased Qmax and urine volume.
6.Impact of pretreatment body mass index on clinical outcomes in patients with metastatic renal cell carcinoma receiving first-line immune checkpoint inhibitor-based therapy: A systematic review and meta-analysis
Kunwoo LEE ; Jiwoong YU ; Wan SONG ; Hyun Hwan SUNG ; Hwang Gyun JEON ; Byong Chang JEONG ; Seong Il SEO ; Seong Soo JEON ; Minyong KANG
Investigative and Clinical Urology 2024;65(5):423-434
This study aimed to assess the prognostic role of body mass index (BMI) in patients with metastatic renal cell carcinoma (mRCC) treated with first-line immune checkpoint inhibitor (ICI)-based therapy. We searched for relevant studies in the MEDLINE, Embase, and Cochrane Library databases. The initial search yielded 599 records, of which seven articles (2,517 patients) were selected for analysis. Patients with a high BMI had a favorable overall survival (OS) based on hazard ratio (HR) (crude HR 0.69, 95% confidence interval [CI] 0.57–0.83, p<0.0001; adjusted (a)HR 0.75, 95% CI 0.59–0.95, p=0.02), but not relative risk (RR 0.88, 95% CI 0.67–1.16, p=0.37). In the subgroup analysis, patients with a high BMI had better OS in the ICI with tyrosine kinase inhibitor (TKI) subgroup (aHR 0.71, 95% CI 0.55–0.92, p=0.01), while no significant difference was found in the ICI-only subgroup (aHR 1.02, 95% CI 0.56–1.87, p=0.95). Adjusted statistics for progression-free survival (PFS) were assessable in predominantly ICI-only studies and demonstrated a favorable outcome for patients with a low BMI (aHR 1.67, 95% CI 1.14–2.45, p=0.01). In conclusion, the impact of high BMI varies depending on the treatment type, exhibiting a favorable correlation with OS within ICI with TKI subgroup, but indicating an adverse association with PFS in the ICI-only subgroup. Further research is needed to clarify the influence of BMI by stratifying patients into ICI-only and ICI with TKI treatment to provide more insights.
7.Nomogram Using Prostate Health Index for Predicting Prostate Cancer in the Gray Zone:Prospective, Multicenter Study
Jae Hoon CHUNG ; Jeong Hyun KIM ; Sang Wook LEE ; Hongzoo PARK ; Geehyun SONG ; Wan SONG ; Minyong KANG ; Hyun Hwan SUNG ; Hwang Gyun JEON ; Byong Chang JEONG ; Seong IL SEO ; Hyun Moo LEE ; Seong Soo JEON
The World Journal of Men's Health 2024;42(1):168-177
Purpose:
To create a nomogram that can predict the probability of prostate cancer using prostate health index (PHI) and clinical parameters of patients. And the optimal cut-off value of PHI for prostate cancer was also assessed.
Materials and Methods:
A prospective, multi-center study was conducted. PHI was evaluated prior to biopsy in patients requiring prostate biopsy due to high prostate-specific antigen (PSA). Among screened 1,010 patients, 626 patients with clinically suspected prostate cancer with aged 40 to 85 years, and with PSA levels ranging from 2.5 to 10 ng/mL were analyzed.
Results:
Among 626 patients, 38.82% (243/626) and 22.52% (141/626) were diagnosed with prostate cancer and clinically significant prostate cancer, respectively. In the PSA 2.5 to 4 ng/mL group, the areas under the curve (AUCs) of the nomograms for overall prostate cancer and clinically significant prostate cancer were 0.796 (0.727–0.866; p<0.001), and 0.697 (0.598–0.795; p=0.001), respectively. In the PSA 4 to 10 ng/mL group, the AUCs of nomograms for overall prostate cancer and clinically significant prostate cancer were 0.812 (0.783–0.842; p<0.001), and 0.839 (0.810–0.869; p<0.001), respectively.
Conclusions
Even though external validations are necessary, a nomogram using PHI might improve the prediction of prostate cancer, reducing the need for prostate biopsies.
8.Comparison of Short-Term Outcomes and Safety Profiles between Androgen Deprivation Therapy+Abiraterone/Prednisone and Androgen Deprivation Therapy+Docetaxel in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer
Dong Jin PARK ; Tae Gyun KWON ; Jae Young PARK ; Jae Young JOUNG ; Hong Koo HA ; Seong Soo JEON ; Sung-Hoo HONG ; Sungchan PARK ; Seung Hwan LEE ; Jin Seon CHO ; Sung-Woo PARK ; Se Yun KWON ; Jung Ki JO ; Hong Seok PARK ; Sang-Cheol LEE ; Dong Deuk KWON ; Sun Il KIM ; Sang Hyun PARK ; Soodong KIM ; Chang Wook JEONG ; Cheol KWAK ; Seock Hwan CHOI ;
The World Journal of Men's Health 2024;42(3):620-629
Purpose:
This study aimed to compare the short-term outcomes and safety profiles of androgen-deprivation therapy (ADT)+abiraterone/prednisone with those of ADT+docetaxel in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Materials and Methods:
A web-based database system was established to collect prospective cohort data for patients with mHSPC in Korea. From May 2019 to November 2022, 928 patients with mHSPC from 15 institutions were enrolled. Among these patients, data from 122 patients who received ADT+abiraterone/prednisone or ADT+docetaxel as the primary systemic treatment for mHSPC were collected. The patients were divided into two groups: ADT+abiraterone/prednisone group (n=102) and ADT+docetaxel group (n=20). We compared the demographic characteristics, medical histories, baseline cancer status, initial laboratory tests, metastatic burden, oncological outcomes for mHSPC, progression after mHSPC treatment, adverse effects, follow-up, and survival data between the two groups.
Results:
No significant differences in the demographic characteristics, medical histories, metastatic burden, and baseline cancer status were observed between the two groups. The ADT+abiraterone/prednisone group had a lower prostate-specific antigen (PSA) progression rate (7.8% vs. 30.0%; p=0.011) and lower systemic treatment discontinuation rate (22.5% vs. 45.0%; p=0.037). No significant differences in adverse effects, oncological outcomes, and total follow-up period were observed between the two groups.
Conclusions
ADT+abiraterone/prednisone had lower PSA progression and systemic treatment discontinuation rates than ADT+docetaxel. In conclusion, further studies involving larger, double-blinded randomized trials with extended follow-up periods are necessary.
9.Hypofractionated radiation therapy combined with androgen deprivation therapy for clinically node-positive prostate cancer
Tae Hoon LEE ; Hongryull PYO ; Gyu Sang YOO ; Seong Soo JEON ; Seong Il SEO ; Byong Chang JEONG ; Hwang Gyun JEON ; Hyun Hwan SUNG ; Minyong KANG ; Wan SONG ; Jae Hoon CHUNG ; Bong Kyung BAE ; Won PARK
Radiation Oncology Journal 2024;42(2):139-147
Purpose:
This study aimed to analyze the treatment outcomes of combined definitive radiation therapy (RT) and androgen deprivation therapy (ADT) for clinically node-positive prostate cancer.
Materials and Methods:
Medical records of 60 patients with clinically suspected metastatic lymph nodes on radiological examination were retrospectively analyzed. Eight patients (13.3%) were suspected to have metastatic common iliac or para-aortic lymph nodes. All patients underwent definitive RT with a dose fractionation of 70 Gy in 28 fractions. ADT was initiated 2–3 months before RT and continued for at least 2 years. Biochemical failure rate (BFR), clinical failure rate (CFR), overall survival (OS), and prostate cancer-specific survival (PCSS) were calculated, and genitourinary and gastrointestinal adverse events were recorded.
Results:
The median follow-up period was 5.47 years. The 5-year BFR, CFR, OS, and PCSS rates were 19.1%, 11.3%, 89.0%, and 98.2%, respectively. The median duration of ADT was 2.30 years. BFR and CFR increased after 3 years, and 11 out of 14 biochemical failures occurred after the cessation of ADT. Grade 2 and beyond late genitourinary and gastrointestinal toxicity rates were 5.0% and 13.3%, respectively. However, only two grade 3 adverse events were reported, and no grade 4–5 adverse events were reported. Patients with non-regional lymph node metastases did not have worse BFR, CFR, or adverse event rates.
Conclusion
This study reported the efficacy and tolerable toxicity of hypofractionated definitive RT combined with ADT for clinically node-positive prostate cancer. Additionally, selected patients with adjacent non-regional lymph node metastases might be able to undergo definitive RT combined with ADT.
10.Bilateral Seminal Vesicle Invasion as a Strong Prognostic Indicator in T3b Prostate Cancer Patients Following Radical Prostatectomy: A Comprehensive, Multicenter, Long-term Follow-up Study
Jungyo SUH ; In Gab JEONG ; Hwang Gyun JEON ; Chang Wook JEONG ; Sangchul LEE ; Seong Soo JEON ; Seok-Soo BYUN ; Cheol KWAK ; Hanjong AHN
Cancer Research and Treatment 2024;56(3):885-892
Purpose:
Pathologic T3b (pT3b) prostate cancer, characterized by seminal vesicle invasion (SVI), exhibits variable oncological outcomes post–radical prostatectomy (RP). Identifying prognostic factors is crucial for patient-specific management. This study investigates the impact of bilateral SVI on prognosis in pT3b prostate cancer.
Materials and Methods:
We evaluated the medical records of a multi-institutional cohort of men who underwent RP for prostate cancer with SVI between 2000 and 2012. Univariate and multivariable analyses were performed using Kaplan-Meier analysis and covariate-adjusted Cox proportional hazard regression for biochemical recurrence (BCR), clinical progression (CP), and cancer-specific survival (CSS).
Results:
Among 770 men who underwent RP without neo-adjuvant treatment, median follow-up was 85.7 months. Patients with bilateral SVI had higher preoperative prostate-specific antigen levels and clinical T category (all p < 0.001). Extracapsular extension, tumor volume, lymph node metastasis (p < 0.001), pathologic Gleason grade group (p < 0.001), and resection margin positivity (p < 0.001) were also higher in patients with bilateral SVI. The 5-, 10-, and 15-year BCR-free survival rates were 23.9%, 11.7%, and 8.5%; CP-free survival rates were 82.8%, 62.5%, and 33.4%; and CSS rates were 96.4%, 88.1%, and 69.5%, respectively. The bilateral SVI group demonstrated significantly lower BCR-free survival rates, CP-free survival rates, and CSS rates (all p < 0.001). Bilateral SVI was independently associated with BCR (hazard ratio, 1.197; 95% confidence interval, p=0.049), CP (p=0.022), and CSS (p=0.038) in covariate-adjusted Cox regression.
Conclusion
Bilateral SVI is a robust, independent prognostic factor for poor oncological outcomes in pT3b prostate cancer.

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