Information de reference pour ce titreAccession Number: | 00126418-200511001-00006.
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Author: | Hareendran, Asha MA,PhD; Abraham, Lucy BSc,MSc,CPsychol
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Institution: | Worldwide Outcomes Research, Pfizer Global Pharmaceuticals, Sandwich, UK
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Title: | Using a Treatment Satisfaction Measure in an Early Trial to Inform the Evaluation of a New Treatment for Benign Prostatic Hyperplasia.[Article]
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Source: | Value in Health. 8 (Supplement I):S35-S40, November/December 2005.
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Abstract: | Objective: This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia (BPH).
Methods: The study was a randomized, placebo-controlled, double blind trial comparing three doses (low, medium, and high) of a new uro-selective alpha-blocker with an active comparator. A total of 536 men aged 40 years and older with lower urinary tract symptoms (LUTS) resulting from BPH were randomized into the study. Patients' perceptions of satisfaction with efficacy, dosing, and side effects were explored using a validated disease-specific instrument, the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia (TSS-BPH). The TSS-BPH was administered at the end of the study or at withdrawal.
Results: Compared with placebo, the medium and high doses showed the greatest efficacy on the primary endpoint, the International Prostate Symptom Score (IPSS). Patient satisfaction with efficacy at these doses was significantly better than that for placebo. Nevertheless, adverse events were most frequent in the high dose group. Satisfaction with side effects was significantly worse than placebo for this group, and this was reflected in the total scores on the TSS-BPH, with patients being most satisfied overall with the medium dose.
Conclusions: Exploring patients' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects, and can be used to inform the selection of doses for later trials. This is especially useful for products that require adherence with medication over long periods of time.
Copyright (C) 2005 Blackwell Publishing Ltd.
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Author Keywords: | BPH; clinical trials; treatment satisfaction; urinary symptoms.
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Language: | English.
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Document Type: | ORIGINAL ARTICLE.
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Journal Subset: | Clinical Medicine. Behavioral & Social Sciences.
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ISSN: | 1098-3015
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NLM Journal Code: | 100883818
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