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Oh, M.J.,Hwang, H.H.,Kim, H.G.,Lee, G.H.,Cho, Y.S.,Lee, S.Y.,Kang, S.Y.,Cho, K.H.,Lee, Y.Y.,Lee, Y.J.,Jang, C.G.,Lee, S.Y. Excerpta Medica] ; Elsevier Science Ltd 2017 Clinical therapeutics Vol.39 No.7
Purpose: A fixed-dose combination (FDC) pill of amlodipine (relatively old calcium channel blocker as dihydropyridine) and olmesartan (relatively new angiotensin II receptor blocker) is used for hypertension that is not adequately controlled with a single-formulation drug. Because the FDC is a one-pill formulation, and amlodipine and olmesartan have different mechanisms of action, it is expected to improve patients' medication compliance and have an increased blood pressure-lowering efficacy. The purpose of this study was to assess the safety profile and the bioequivalence of two different FDC formulations [amlodipine besylate/olmesartan medoxomil 10/40 mg (reference product) and S-amlodipine nicotinate/olmesartan medoxomil 5/40 mg (test product)]. Methods: A randomized, open-label, single-dose, 2-treatment, 2-way, and 2-period crossover study, including a 3-week washout period, was performed in 32 healthy Korean male volunteers. To analyze the concentration of S-amlodipine or olmesartan, plasma samples were collected up to 144 hours after the dose for S-amlodipine and 48 hours after the dose for olmesartan. Pharmacokinetic parameters, including the C<SUB>max</SUB> and the area under the curve from time 0 to the last measurable concentration (AUC<SUB>0-last</SUB>) for the time versus concentration plot, were calculated. Analysis of variance for bioequivalence was conducted using C<SUB>max</SUB> and AUC<SUB>0-last</SUB> converted to log scale, and the mean ratios and 90% CIs were determined. Safety data included analysis of adverse events (AEs), vital signs, physical examinations, clinical laboratory test, and 12-lead ECGs. Findings: Of the 32 enrolled participants, 29 healthy volunteers completed the study. For both S-amlodipine and olmesartan, the main pharmacokinetic parameters were all within the acceptable range for regulatory bioequivalence. The 90% CIs for the geometric mean ratios of C<SUB>max</SUB> and AUC<SUB>0-last</SUB> were 0.8766 to 0.9760 and 0.8288 to 0.9224, respectively, for S-amlodipine and 0.9097 to 1.1229 and 0.8904 to 1.0407, respectively, for olmesartan. Hypotension was the most frequent AE, and it was observed in 4 volunteers with the test product and 7 volunteers with the reference product. Both the test and reference formulations were well tolerated. Implications: The present study demonstrates that the newly developed FDC product (test drug) and the conventional FDC product (reference drug) have comparable pharmacokinetic characteristics in healthy adult male volunteers. Both the test and reference products indicated good tolerance in this population, and no serious AEs were observed.
Cho, S.Y.,Park, J.,Yoo, S.,Cho, M.C.,Jeong, H.,Son, H. Excerpta Medica, etc.] ; Elsevier Science Ltd 2017 Urology Vol.108 No.-
Objective: To evaluate surgical outcomes of patients who underwent complete or incomplete enucleation technique during a short-term postoperative period. Materials and Methods: Patients having intractable lower urinary tract symptoms/benign prostatic hyperplasia and prostates >30 g with obstructed pattern in the urodynamic examinations were included. They underwent transurethral resection of prostate (TUR-P), 120 W GreenLight laser high power system-photoselective vapoenucleation of prostate (HPS-PVEP), or holmium laser enucleation of prostate (HoLEP). Patients with the size of remnant prostates minus surgical defects <25 g were grouped into the completely enucleated group (group C), and others were grouped into the partially enucleated group (group P). Results: Mean prostate-specific antigen value was 3.5@?+/-@?4.5@?ng/mL, and mean prostate volume was 58.4@?+/-@?31.0@?mL. Complete enucleation rates in TUR-P, HPS-PVEP, and HoLEP groups were 39% (37 out of 95), 54.6% (83 out of 152), and 54.4% (31 out of 57), respectively. Complete enucleation rate of the TUR-P was significantly lower than those of the other 2 groups. Compared with group C, group P had lower maximal flow rate, higher bladder outlet obstruction index, and higher overactive bladder symptom scores. Multivariate logistic regression analyses showed that smaller prostate, presence of intravesical prostatic protrusion, HoLEP operation, and surgeons' experience were significant predictors for achieving complete enucleation of prostate. Voiding subscores of group C were significantly higher than those of group P at postoperative 12 months. Conclusion: The performance of HoLEP was superior to other surgical techniques. However, HPS-PVEP with vapoenucleation showed the comparable enucleation rate with that of HoLEP. Complete enucleation was effective in maintaining outcomes of prostate resection, especially voiding subscores.