BackgroundFew post-marketing surveillance studies have examined the safety and efficacy of Rapamune® (Sirolimus) in Asian countries. This study aimed to better understand safety and efficacy of Rapamune for kidney transplant recipients in the routine clinical practice setting in Korea.MethodsThis was an open-label, non-comparative, observational, prospective, multi-center, post-marketing surveillance study conducted at 15 Korean transplant centers between 31 August 2009 and 24 September 2015. The subjects were administered Rapamune as part of routine practice. The safety was monitored based on reporting of adverse events (AEs). Efficacy endpoints included acute rejection, graft function, graft survival, and patient survival.ResultsRapamune was most commonly used for late conversion therapy after post-transplant 1 year and was substituted for anti-metabolites (63.6%) or calcineurin inhibitors (28.7%). The median treatment duration of Rapamune was 182 days. Among 209 subjects enrolled, AEs and adverse drug reactions (ADRs) were reported in 54.07% and 43.06% of subjects, respectively, in the safety analysis set. Most of the AEs were expected (96.21%), mild (75.83%), did not result in any action taken with regard to the study drug (72.99%), and resolved by the end of the study (75.36%). The most frequently reported AEs/ADRs were pharyngitis and diarrhea. Most of the serious AEs/ADRs occurred in one or two subjects. Unexpected ADRs of renal artery occlusion and cholangitis were reported by one subject each. The incidence of biopsy-proven acute rejection was 2.87%. At the end of the study, 99.51% of the subjects and their grafts had survived. The mean eGFR was 64.72 ± 19.56 mL/min.ConclusionsRapamune had an acceptable safety profile in prevention of kidney allograft rejection in Korea.

Objectives To understand the natural history of patients with prostate specific antigen (PSA) elevation receiving Holmium Laser Enucleation of the Prostate (HoLEP) for benign prostatic hyperplasia (BPH), and to understand clinical factors correlated with PSA elevation. Subjects and Methods: Patients in the prospective database registry from our institution who underwent HoLEP between January 2010 and May 2020 were analyzed. The patients were classified into low (< 3.0ng/mL) and high ( > = 3.0ng/mL) PSA groups at baseline. Intraoperative and early postoperative outcomes were evaluated. Postoperative evaluation was performed, with PSA being evaluated at the postoperative sixth month. Factors showing correlation with PSA elevation were analyzed. Results A total of 1297 patients with a mean age of 69.7 (± 6.8 SD) years were analyzed. The baseline PSA was 4.0 (± 4.2) ng/mL, with 713 (55.0%) patients in the low PSA group (1.6 (± 0.8) ng/mL), and 584 (45.0%) patients in the high PSA group (6.9 (± 4.7) ng/mL). The PSA level decreased postoperatively by 66.6 (± 23.6)% in all patients, and 54.3 (± 23.9)% in the low PSA group, and 79.6 (± 14.7)% in the high PSA group. Conclusions In patients with LUTS and elevated PSA, significant PSA reduction and symptom improvement was observed after HoLEP.

Purpose: This study investigated functional outcomes in lower urinary tract symptoms (LUTS), the incidence of incidental prostate cancer (PCa), and changes in prostate-specific antigen (PSA) levels after holmium laser enucleation of the prostate (HoLEP) in patients with elevated PSA and benign prostatic hyperplasia (BPH).Methods: A retrospective review of a prospectively designed protocol for patients who underwent HoLEP at our institution from January 2010 to May 2020 was conducted. Patients were classified into low-PSA (<3.0 ng/mL) and high-PSA (≥3.0 ng/mL) groups at baseline. Follow-up for PSA was performed at the sixth postoperative month. Baseline and postoperative clinical parameters, functional parameters, PCa incidence, and postoperative changes in PSA were compared between the lowand high-PSA groups.Results: The baseline PSA of 1,296 patients (mean age, 69.7±6.8 years) was 4.0±4.1 ng/mL, with 712 patients (55.0%) in the low-PSA group (1.6±0.8 ng/mL), and 584 patients (45.0%) in the high-PSA group (6.9±4.7 ng/mL). Incidental PCa was detected in 82 patients (6.3%), with a similar incidence in the low-PSA (41 patients, 5.9%) and high-PSA (41 patients, 7.0%) groups (P>0.05). At 6 months postoperatively, both groups showed significant improvements in the maximum flow rate, postvoid residual volume, and all domains of the International Prostate Symptom Score (P<0.05). At postoperative 6 months, the PSA level significantly decreased by 66.6%±23.6% in all patients (54.3%±23.9% in the low-PSA group; 79.6%±14.7% in the high-PSA group) (P<0.05), and the PSA levels of 1,264 patients (97.6%) had normalized.Conclusions: In patients with elevated PSA presenting with LUTS/BPH, our study demonstrated significant improvements in functional parameters and decreased PSA after HoLEP. The incidental PCa detection rate did not show a statistically significant difference between the low- and high-PSA groups. Timely surgery for LUTS/BPH without delay due to PSA monitoring should be considered.