Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study

PURPOSE: The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. MATERIALS AND METHODS: This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. RESULTS: All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001), with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score. CONCLUSIONS: Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.

The Efficacy and Safety of Tadalafil 5 mg Once Daily in Korean Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: An Integrated Analysis

PURPOSE: This post hoc integrated analysis assessed the efficacy and safety of tadalafil 5 mg once daily in a large Korean population with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS). MATERIALS AND METHODS: Individual Korean participant data were integrated from three 12-week, randomized, double-blind, placebo-controlled studies in Asian men with BPH-LUTS, wherein 177 Korean men received placebo and 177 received tadalafil 5 mg once daily. The primary objective was to compare the change from baseline to week 12 in total International Prostate Symptom Score (IPSS) after treatment with tadalafil versus placebo. RESULTS: A significantly greater improvement (p<0.001) in total IPSS from baseline to week 12 was observed for tadalafil compared to placebo (least squares mean: tadalafil=-5.97; placebo=-3.94 ). Total IPSS at weeks 4 and 12, IPSS voiding and storage subscores at weeks 4, 8, and 12, and IPSS quality of life index at weeks 8 and 12 were also significantly improved (p<0.05) for tadalafil compared to placebo. There was significant improvement (p<0.001) in the patient global Impression of improvement responses and numerical improvement in the clinician global impression of improvement responses with tadalafil compared to placebo. There were no significant treatment differences for peak urine flow rate or postvoid residual volume . Few participants had treatment-emergent adverse events and there were no unexpected safety findings. CONCLUSIONS: This integrated analysis of three randomized, placebo-controlled Asian studies confirmed tadalafil 5 mg once daily as an efficacious and well-tolerated treatment for Korean men with BPH-LUTS.

The Effect of Antiviral Therapy on Serum Cholesterol Levels in Chronic Hepatitis C

BACKGROUND/AIMS: The aims of this study were to evaluate the effect of antiviral therapy on serum total cholesterol (TC) levels and to investigate the factors related to serum TC changes in chronic hepatitis C (CHC) patients. METHODS: A total of 94 CHC patients, the majority of whom were infected with genotype 1 or 2 and were receiving antiviral therapy, were consecutively enrolled. TC levels before treatment, at week 4, at the end of treatment (EOT), and at 24 weeks after the EOT were analyzed, along with factors related to pre- and post-treatment TC levels. RESULTS: Pretreatment TC levels in the sustained virologic response (SVR) group (167+/-3.6 mg/dL) and the non-SVR group (158+/-8.3 mg/dL) were similar, and both decreased during antiviral therapy. The TC levels at 24 weeks after the EOT significantly increased in the SVR group (183+/-4.7 mg/dL), but not in the non-SVR group (160+/-7.1 mg/dL, p=0.044) after adjusting for the pretreatment TC levels. The grade of hepatic fi brosis, as measured by the METAVIR score or the aspartate aminotransferase-platelet ratio index (APRI), but not viral load (p=0.119), was an independent variable associated with the pretreatment TC levels (METAVIR score, p=0.011; APRI, p=0.033). After adjusting for the presence of a SVR by longitudinal data analysis using generalized estimating equations, the independent variable APRI was associated with the serum TC level after antiviral therapy (p=0.014), whereas a SVR was associated with the serum TC level only with marginal statistical significance (p=0.084). CONCLUSIONS: Serum TC levels increased in the SVR group after antiviral therapy for CHC; however, this was probably due to an improvement in liver fi brosis rather than the eradication of virus.

A Case of Immunoglobulin Therapy for Pure Red Cell Aplasia Induced by Parvovirus B19 / 대한혈액학회지

Human parvovirus B19 infection could be manifested as pure red cell aplasia or chronic anemia in immunocompromised host. The patient was 35-year-old female who had been diagnosed as non-Hodgkin lymphoma, peripheral T-cell unspecified type and had been performed chemotherapy. She complained headache and dizziness that was found to a marked drop in hemoglobin (3.2g/dL). A bone marrow aspiration revealed findings consistent with erythroid hypoplasia with maturation arrest. Serum parvovirus B19 PCR and anti parvovirus B19 IgM were positive. After immunoglobulin therapy, it was leading to a marked increase in reticulocyte count and corresponding rise in hemoglobin. To our knowledge, this is the first report to use immunoglobulin in an adult cancer patient with pure red-cell aplasia. Human parvovirus B19 infection should be considered in immunocompromised cancer patients with red cell aplasia and early use of immunoglobulins would be helpful in resolution of anemia and not to delay planned chemotherapy.

A Case of Castleman's Disease with Kidney Involvement / 대한신장학회지

Castleman's disease is a rare disorder of unknown etiology that results in the unregulated growth of lymphoid tissue. It can be classified as unicentric and multicentric based on clinical and radiological findings, and also as hyaline vascular and plasma cell type based on histopathology. Castleman's disease may present as an asymptomatic involvement of one lymph node group or as a multicentric disease with systemic features. However, renal involvement is very rare. Here we report a 50-year old male patient with histopathologically proven multicentric plasma cell type of Castleman's disease who presented with weight loss, palpable cervical lymphadenopathy, azotemia and proteinuria. The finding of a percutaneous needle renal biopsy was compatible with plasma cell type of Castleman's disease. After treated with systemic corticosteroid, azotemia and proteinuria disappeared.

A Case of Clostridium sordellii Bacteremia in a Patient with Osteosarcoma

Clostridium sordellii is a gram-positive spore forming anaerobic bacillus, rarely encountered in human infection. It produces several exotoxins which contribute to myonecrosis, pulmonary infection, obstetric infection and bacteremia. C. sordellii bacteremia is very rare and has been reported in few patients with malignancy or immunosuppression. To date, there has been no report in Korea. Mortality is high when deep site infection exists regardless of underlying pathology and immune status. In contrast, superficial skin and subcutaneous tissue infection has a favorable prognosis. We present a case of C. sordellii bacteremia in a patient with osteosarcoma. The patient was admitted for the treatment of the infection at the ulcerative osteosarcoma lesions of the leg, and C. sordellii bacteremia was demonstrated. He was successfully treated with intravenous ampicillin/sulbactam for two weeks.

A Case of Clostridium sordellii Bacteremia in a Patient with Osteosarcoma

Clostridium sordellii is a gram-positive spore forming anaerobic bacillus, rarely encountered in human infection. It produces several exotoxins which contribute to myonecrosis, pulmonary infection, obstetric infection and bacteremia. C. sordellii bacteremia is very rare and has been reported in few patients with malignancy or immunosuppression. To date, there has been no report in Korea. Mortality is high when deep site infection exists regardless of underlying pathology and immune status. In contrast, superficial skin and subcutaneous tissue infection has a favorable prognosis. We present a case of C. sordellii bacteremia in a patient with osteosarcoma. The patient was admitted for the treatment of the infection at the ulcerative osteosarcoma lesions of the leg, and C. sordellii bacteremia was demonstrated. He was successfully treated with intravenous ampicillin/sulbactam for two weeks.