Evaluation of Hytrin (terazosin hydrochloride) efficacy in treatment of prostatic benign hyperplasia
basing on the multicentre clinical test
Article published in Urologia Polska 2001/54/4.
Eugeniusz Miękoś, Zbigniew Trzepizur, Waldemar Różański, Radosław Boniecki, Janusz Kuśnierz, Cezary Zydek, Zbigniew Jabłonowski
- Klinika Urologii Instytutu Chirurgii Wojskowej Akademii Medycznej w Łodzi Kierownik kliniki: prof, dr hab. med. Eugeniusz Miękoś
prostate, benign prostatic hyperplasia, pharmacological treatment-terazosine-alpha 1 blockers
- Aim of study: The aim of this study was to evaluate efficacy and safety of Hytrin (terazosin) in treatment patients with prostatic benign hyperplasia.
- Material and method: Examinations were conducted in five clinical centres in Poland on 117 patients treated because of prostatic benign hyperplasia. Mean value of patients age was 64,43. Patients qualified to treatment were treated with Hytrin. Initially patients took the drug al the dose of 1 mg a day during 7 days and then 2 nig during the next 7 days. In case of good lole-rance towards the medicine by the patient, dose of the drug was increased to 5 mg a day. Treatment lasted 84 days. Follow-up examinations were carried out during the first visit, at 14™, 42n\" and 84ln day of treatment. During the first and the last visit patients had laboratory examinations conducted: urine analysis, urine culture, APTT, PT, ionorgam (Na, K, CI, Ca, Mg, P), PSA, morphology, level of urea, creatinine, uric acid, alkaline phosphatase, transaminases, bilirubin and bicarbonates in blood serum. During each visit patients had the blood pressure pulse, number of breaths per minute measured. Each lime the patient filled in the IPSS questionnaire and the quality of life according to AUA form. Each patient during the first and last visit had ultrasonography with evaluation of kidneys, urinary bladder, capacity of prostatic adenoma, urine retention in bladder after miction, also urodynamic examination (uriflowmetry) and DRE were conducted.
- Results: From the whole group of 117 patients qualified to treatment with Hytrin, two of them were excluded (1,70%) because of the diagnosis of prostatic cancer. 115 patients underwent statistic analysis. Side effects were stated at 8 patients (6,95%), 7 of those patients (6,08%) because of increasing of side effects were excluded from this study at varous levels of examination. Advisable therapeutic effect was observed after the first two weeks of taking the drug in single dose initially per 1 mg through 7 days and then per 2 mg during the next 7 days. Increasing the single dose up to 5 mg a day caused more efficient therapeutic effect. Statistically significant improvement concerning the decrease of complaints from lower urinary tracts evaluated according to IPSS and in the quality of life estimated according to AUA form (QoL) and using urodynamic examination (uro-flowmetry) was obtained.
- Conclusions: Treatment patients suffering from prostatic benign hyperplasia with Hytrin is effective and safe. Risk of occurring side effects as the result of taking terazosin is insignificant and amounts in material examined to 6,95%. Both treatment with terazosin at therapeutic doses 5 mg, results in advisable therapeutic effect expressed as the significant decrease of complaints concerning miction, improvement of quality of life and urodynamic parameters and low diminution of urine retention in bladder.
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