A Comparative Study on the Safety and Efficacy of Tamsulosin And

S5254 575 Lapitan SW6 13/9/05 12:41 pm Page 562 The Journal of International Medical Research 2005; 33: 562 – 573 A Comparative Study on the Safety and Efficacy of Tamsulosin and Alfuzosin in the Management of Symptomatic Benign Prostatic Hyperplasia: a Randomized Controlled Clinical Trial MCM LAPITAN1,2, V ACEPCION2 AND J MANGUBAT2 1National Institutes of Health, University of the Philippines, Manila, Philippines; 2Division of Urology, Department of Surgery, University of the Philippines College of Medicine – Philippine General Hospital, Manila, Philippines This randomized, double-blind, parallel- There was a mean overall decrease in the design trial compared the efficacy and IPSS, with no significant difference safety of tamsulosin and alfuzosin in 76 between the treatment groups. There was men with symptomatic benign prostatic an overall increase in the Qmax, which hyperplasia. Patients were randomized to again was similar in the two groups. There receive 0.2 mg tamsulosin once daily was no significant change in the sexual orally (n = 40) or 10 mg alfuzosin once function scores in either group. The daily orally (n = 36), and changes in the incidence of adverse events was similar for International Prostate Symptom Score tamsulosin (25%) and alfuzosin (19.4%) (IPSS), maximal urinary flow rate (Qmax) therapy. In conclusion, both treatment and the Danish prostatic symptom sexual regimens similarly improved the IPSS and function score and morbidity rates were Qmax, did not alter sexual function and compared after 8 weeks of treatment. were well tolerated. KEY WORDS: TAMSULOSIN; ALFUZOSIN, LOWER URINARY TRACT SYMPTOMS; BENIGN PROSTATIC HYPERPLASIA; INTERNATIONAL PROSTATE SYMPTOM SCORE; URINARY FLOW RATE; DANISH PROSTATIC SYMPTOM SEXUAL FUNCTION SCORE Introduction One of the primary treatment options for symptomatic BPH is the use of α-adrenergic Benign prostatic hyperplasia (BPH) is one of blockers. These agents antagonize the effect α the most common diseases prompting of noradrenaline on the 1-adrenoceptors in medical consultation among elderly men. Its the bladder neck, prostatic urethra and the prevalence increases with age; by 80 years, prostate, resulting in the relaxation of almost 90% of men have symptoms prostatic smooth muscle and a reduction in attributable to prostatic obstruction. the dynamic component of bladder outlet 562 S5254 575 Lapitan SW6 13/9/05 12:41 pm Page 563 MCM Lapitan, V Acepcion, J Mangubat Tamsulosin and alfuzosin in symptomatic BPH obstruction. At least three types of between the two α-blockers. Tamsulosin had α 1-adrenoceptors have been described; the no statistically significant effect on blood α 1a-receptor appears to be the subtype pressure, but alfuzosin induced a considerable mainly responsible for mediating prostatic reduction in both standing and supine blood and bladder smooth-muscle tone. pressure compared with baseline. In the Philippines, currently available An unpublished randomized trial on α-blockers include terazosin, alfuzosin and tamsulosin and alfuzosin has been reported tamsulosin. Unlike alfuzosin and terazosin, on the US Food and Drug Administration α 9 tamsulosin possesses a high 1a-receptor website. This study was a four-arm trial affinity and, because of this ‘prostate comparing two doses of alfuzosin (10 mg selectivity’, has the theoretical advantage of and 15 mg), 0.4 mg tamsulosin and placebo. improving urinary symptoms and flow with Although statistical analysis to compare the fewer adverse effects.1 A systematic review by results of 10 mg and 15 mg alfuzosin with Wilt et al.2 assessing the effects of tamsulosin tamsulosin was not available, the data from in the treatment of lower urinary tract this report show similar reductions in symptoms suggestive of BPH showed its symptom score between the three active effectiveness was similar to that of other treatment groups and a modest advantage α-antagonists, with a slight increase in for tamsulosin in achieving a greater efficacy at higher doses. Long-term non- increase in the flow rate after 3 months. A comparative studies have shown that the higher adverse event rate of dizziness was improvements in efficacy parameters observed reported for alfuzosin, particularly with the during short-term treatment with tamsulosin 15 mg dose, while a slightly higher rate of were maintained for up to 6 years.3,4 impotence was reported for tamsulosin. In contrast, data from two clinical Alfuzosin 10 mg and tamsulosin had equally studies5,6 have shown that 10 mg alfuzosin low incidences of ejaculation failure. Twice once daily was effective at controlling the as many patients on 15 mg alfuzosin than symptoms associated with BPH over a on tamsulosin were withdrawn from the 3-month period, but that a higher dosage of study due to adverse events. 15 mg alfuzosin once daily did not provide Although 0.4 mg tamsulosin is widely any additional benefit in terms of efficacy used in the USA and European countries, the compared with the 10 mg dose. The clinical standard government-approved dosage in benefits of 10 mg alfuzosin were maintained the Philippines and other Asian countries is for up to 12 months in a 3-month double- 0.2 mg once daily. The efficacy and blind study followed by a 9-month non- tolerability of 0.2 mg tamsulosin in blinded extension phase.7 This dose of symptomatic BPH were demonstrated in a alfuzosin was well tolerated during both double-blind, placebo-controlled study in short- and long-term treatment. 244 Japanese patients,10 in a 6-week non- Only one randomized controlled trial has blinded study in 505 Chinese patients11 and been published that compared tamsulosin in a 1-year non-blinded long-term study in and alfuzosin.8 This study, using 0.4 mg 211 Korean patients.12 In studies comparing tamsulosin once daily and 2.5 mg alfuzosin tamsulosin with 2 mg terazosin13 or 5 mg three times daily, showed a similar finasteride,13 0.2 mg tamsulosin had a magnitude of improvement in terms of comparable or better efficacy and symptom score and urinary flow rates tolerability profile. 563 S5254 575 Lapitan SW6 13/9/05 12:41 pm Page 564 MCM Lapitan, V Acepcion, J Mangubat Tamsulosin and alfuzosin in symptomatic BPH It should be noted that only the 10 mg (iv) A history of prostatectomy during the dose of alfuzosin is currently available; the 3 months prior to presentation; 2.5 mg and the 5 mg formulations are being (v) Active, untreated, urinary tract phased out worldwide. infection; The present study was conducted to (vi) Significant, untreated or uncontrolled contribute to the evidence base on the efficacy medical disease such as diabetes, and safety of tamsulosin, particularly in hypertension, renal failure, hepatic comparison with alfuzosin, using form- dysfunction, cardiac failure or senile ulations available in the Philippines and at dementia; doses commonly used in clinical practice. (vii) Intake of any medication for the treatment of BPH (α-blockers, 5α-reductase Patients and methods inhibitors, plant extracts) in the PATIENTS preceding 2 weeks; All adult male patients presenting with (viii)Intake of α-blockers (e.g. doxazosin, difficulty in urination and lower urinary tract terazosin, prazosin), α/β-blockers (e.g. symptoms at the out-patient clinic of the labetalol), 5α-reductase inhibitors, Division of Urology, University of the cholinergic agents, anticholinergics, Philippines Philippine General Hospital, antispasmodics for any other reason. Manila, Philippines (a tertiary government The protocol for this trial was reviewed medical centre), were screened for eligibility and approved by the Ethics Review Board of to the study. the Research Implementation and Dis- The inclusion criteria for the study were: semination Office (RIDO) of the College of (i) Adult males aged 40 years or over Medicine of the University of the Philippines. presenting with voiding difficulty; The trial was conducted in accordance with (ii) A clinical diagnosis of BPH; the Good Clinical Practice guidelines and (iii) Able to read and comprehend English or was monitored by the RIDO. All the patients Tagalog; who participated in this trial were given full (iv) An International Prostate Symptom information on the purpose, procedures, Score (IPSS) of at least 13; advantages and disadvantages, and other (v) A maximal urinary flow rate (Qmax) matters associated with the conduct of the between 4 ml/s and 15 ml/s after two trial. Written informed consent was obtained uroflowmetry determinations with voided from all the study participants. urine volumes of at least 120 ml using a Bonito urodynamic system (Laborie BASELINE ASSESSMENTS Medical Technologies, Ontario, Canada). Baseline assessments included a review of Exclusion criteria included: the patient’s medical history and intake of (i) Suspicion of, or proven, prostatic medication, a physical examination including malignancy; a digital rectal examination, the IPSS and (ii) Urinary retention, defined as a post- Danish prostatic symptom sexual function void residual volume of at least 100 ml score (DAN-PSS) questionnaires, uroflow- as measured on a bladder scan metry, and post-void residual volume (BladderScan™, Diagnostic Ultrasound, determination by bladder scan. The IPSS Bothell, WA, USA); questionnaire used was a previously validated (iii) An indwelling Foley catheter; Filipino translation of the original. The 564 S5254 575 Lapitan SW6 13/9/05 12:41 pm Page 565 MCM Lapitan, V Acepcion, J Mangubat Tamsulosin and alfuzosin in symptomatic BPH DAN-PSS sexual scoring questionnaire used FOLLOW-UP was a non-validated Filipino translation. All patients were followed up every 2 weeks Both questionnaires were self-administered, for a total of 8 weeks of active treatment. although aid and guidance by a research During this period, patients were seen by an assistant was given when requested. urologist who assessed the progress of treatment according to standard clinical practice. TREATMENT SCHEDULE In addition, the IPSS and DAN-PSS sexual Patients underwent a 1-week run-in period function questionnaires were completed and during which they were given a packet of the occurrence of adverse events was medication each morning and evening, both recorded at each visit.

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