Introduction and Objectives
The lipidosterolic extract of Serenoa repens (LESR) is the most commonly used herbal preparation in the management of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Precise mechanisms of action, clinical benefit and pharmacoeconomic aspect of the treatment are still controversial. Objective: To evaluate the cost/effectiveness of LESR in the management of LUTS associated with BPH.
Material and Methods
This was an open-label, prospective clinical study which included 30 patients with mild/moderate uncomplicated symptomatic BPH (mean baseline IPSS = 12.30), aged 45–73 years who complied inclusion criteria. Patients have received LESR (320 mg/day) for three months. All patients filled the IPSS questionnaire before and after medication. In order to evaluate the cost/effectiveness of LESR, we used internationally accepted pharmacoepidemiologic/pharmacoecenomic methodology with defined daily dose (DDD) as a measuring unit. DDD of LESR is 320 mg and ATC code is G04CX02. After three months, we calculated both total consumption and cost of LESR in DDDs and EUROs and total IPSS reduction in questionnaire. Patients who reported adverse reactions to drug were excluded.
Twenty-two patients (73.33%) came to final assessment and filled the IPSS questionnaire. During 3 months, patients received 1980 DDDs of LESR. The price of one DDD was approximately 0.35 EUR, so the price of whole treatment was 693.00 EUR. Average values of the IPSS after 3 months were significantly reduced compared to baseline values (12.30+4.52/6.25+4.72)(p < 0.01). At the same time, total reduction of the IPSS was 109 points. So, the price of the lowering of the IPSS for one point with this herbal brand was 6.36 EUR.
This study could be a model more for the pharmacoeconomic evaluation of one aspect of the BPH management, such as LUTS. Similar methodology could be applied on other aspects of BPH, including reduction of prostate volume, improvement in urinary flow, improvement of quality of life, prevention of complications and so on.
© 2009 European Association of Urology. Published by Elsevier Inc. All rights reserved.