Objective To evaluate the eÃcacy and safety in a dosereductions in total symptom score were obtained with tamsulosin 0.4 mg and 0.6 mg (4.1, −28.7%, and ranging study of tamsulosin (once-daily) as a modifiedrelease formulation compared with placebo in patients 4.4 points, −28.2%, respectively) compared with reductions of 3.4 (−20.1%) in the tamsulosin with lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO), and to estab-(0.2 mg) and 2.9 points (−17.7%) in the placebo groups. The diÂerence in eÂects on total symptom lish the optimum dosage for phase III clinical studies. Patients and methods Of 169 patients with LUTS associscore between treatment groups was not statistically significant, which can be attributed to the small ated with BPO enrolled in a 3 week placebo run-in period, 126 were subsequently randomized to receive sample size. Tamsulosin was well tolerated; at least one adverse event was reported by 29%, 23%, 27% placebo (28), or 0.2 mg (35), 0.4 mg (30), or 0.6 mg (33) of tamsulosin once daily for 4 weeks. Free-flow and 36% of patients in the placebo and tamsulosin 0.2 mg, 0.4 mg and 0.6 mg groups, respectively. There and pressure-flow measurements, and modified Boyarsky symptom scores were used to determine were no apparent tamsulosin dose-dependent changes in vital signs from baseline to the end of 4 weeks of eÃcacy. Safety was evaluated by monitoring adverse events and vital signs (including 8 h after the first randomized treatment. Tamsulosin caused no statistically significantly greater changes in blood pressure dose), and by laboratory determinations. Results Tamsulosin 0.4 mg and 0.6 mg produced sigthan placebo during the initial 8 h after the first dose. There were no clinically significant changes in laboranificantly greater improvements in maximum urinary flow rate (Q max ) (2.2 mL/s, 22.6%, and 1.8 mL/s, tory variables. Conclusion Tamsulosin is well tolerated and eÂective in 20.2%, respectively) than did placebo (−0.1 mL/s, −0.9%). The results from the pressure-flow studies improving urinary flow and relieving LUTS associated with BPO. Optimal eÂects are achieved with tamsuloconfirmed the results for Q max in the free flow studies, with optimum and significant eÂects for tamsin 0.4 mg administered once daily. Keywords Benign prostatic obstruction, tamsulosin, a 1 -sulosin 0.4 mg. This also applied for detrusor pressure at maximum flow, which decreased by 26.6 cmH 2 O adrenoceptor antagonists, a 1A -adrenergic receptor, lower urinary tract symptoms (−28.2%) on 0.4 mg tamsulosin whereas it increased by 4.9 cm H 2 O (5.7%) on placebo. Patients and methods [5][6][7]. This provides the rationale for using a 1 -adrenoceptor antagonists; they relax the bladder neck and This was a multicentre, double-blind, placebo-controlled, randomized phase II study involving 10 centres in the prostate smooth muscle and relieve the dynamic component of BPO, thereby increasing urinary flow and improv-UK. The study was approved by the local ethics committees and was performed in ...
Ketorolac can be considered a viable alternative to pethidine for the treatment of renal colic.
An open randomised Phase III trial was conducted of the depot GnRH analogue goserelin (Zoladex) versus stilboestrol (3 mg/day) in patients with advanced or metastatic prostate cancer. The study included 250 patients and the median follow-up was 43 months. In the Zoladex arm the time to first response was achieved earlier and more patients reported an improvement in symptoms. There was no statistically significant difference between the Zoladex and the stilboestrol arms with regard to survival and time to treatment failure. A major reason for treatment failure was the preponderance of adverse events in patients receiving stilboestrol. It is suggested that stilboestrol should no longer be used for prostate cancer when equally effective alternative treatments are available.
A radioimmunoassay is described for D-Ser (tBu)6 AZA Gly10 GnRH (ICI 118630) in serum of prostate cancer patients treated chronically with this peptide to produce a medical castration. With 125I-118630 as the label, and an anti-GnRH serum, the specificity of the assay is directed to the N-terminal end of the peptide, and putative degradation products have less than 6% cross-reactivity. The assay appears specific for intact 118630 which, after subcutaneous administration of 250 micrograms, has a half-time of disappearance from the serum of 4.9 +/- 0.4 h and a volume of distribution of 13.7 +/- 0.8 litres. Continuous subcutaneous infusion of 120 micrograms 118630/d gave stable serum concentrations of between 2-3 ng/ml for up to 63 d which were very similar to values predicted from pharmacokinetic analysis of the analogue clearance rate. This contrasts with the "peak and trough' pattern of serum 118630 levels measured in two subjects after 118630 administration from a subcutaneous implant containing 3.6 mg of peptide in a biodegradable formulation. Serum 118630 levels peaked at between 6-8 ng/ml 15 d after the implant and fell to less than 1 ng/ml at 29 d, immediately before the next implant. Serum 118630 levels following a second 3.6 mg implant were almost identical with respect to absolute concentration and time to peak value as after the first implant. This assay will be of value not only for evaluation of the pharmacokinetics of GnRH analogue release from new long-acting formulations, but also for correlation of serum peptide concentrations with pituitary gonadotroph desensitization.
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