Safety and Efficacy of Sustained&amp;ndash;Release Alfuzosin on Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in 3,095 Spanish Patients Evaluated during General Practice

Sánchez‐Chapado, Manuel; Guil, M; Alfaro, Verónica; Badiella, Llorenç; Fernández-Hernando, N.

doi:10.1159/000020163

Cited by 18 publications

(15 citation statements)

References 19 publications

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“…As for the safety of the treatment, all adverse events known to be potentially in¯uenced by a 1 -blocker therapy were recorded; 71 vasodilatory events were reported. In general, the safety pro®le in the present study is in accord with that shown by preliminary data [22] and in previous studies with SR-alfuzosin [11].…”

Section: Discussionsupporting

confidence: 92%

“…Alfuzosin is a selective a 1 -adrenoceptor antagonist with con®rmed ef®cacy and good cardiovascular tolerance in the treatment of BPO [10,11,19]. Besides improving LUTS, treatment with alfuzosin improves the quality of life of patients with BPO [21,22,28]. Moreover, the incidence and severity of orthostatic hypotension is lower with an a 1 -blocker administered as a modi®ed-release formulation than as an immediate-release formulation [16].…”

Section: Discussionmentioning

confidence: 99%

“…In all, 4018 outpatients with symptomatic BPH were enrolled into a national multicentre, non-interventional, open, and phase IV observational study (Shared-Care Study, the preliminary data for which was published recently [22]). The present investigation focused on the overall ®nal data, after including 923 new patients.…”

Section: Methodsmentioning

confidence: 99%

“…For this an of®cial version of the Spanish translation of the IPSS and QoL [27] was adopted; this validated IPSS has been successfully applied previously [8,22]. The IPSS questionnaire was completed in the GP's of®ce at baseline and at each follow-up visit.…”

Section: Methodsmentioning

confidence: 99%

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The clinical uroselectivity of alfuzosin is not significantly affected by the age of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

et al. 2000

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The clinical uroselectivity of alfuzosin is not signi®cantly affected by the age of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia i.e. <56, 56±65, 66±75 and >75 years. All groups of patients showed a mean IPSS decrease of 11±12 (55.8±65.4% from baseline) at the end of the study, while the QoL decreased by 2±3 points (55.6±63.6% from baseline). There were no relevant effects of age on the ef®cacy of the treatment. Moreover, alfuzosin was well tolerated independently of the age of the patient; 1.2% of the patients enrolled withdrew because of adverse events. The qualitative distribution of vasodilatory/nonvasodilatory adverse events was similar in all age groups. The incidence of asymptomatic orthostatic hypotension was low (0.58%) and not affected by the age of the patients. Conclusion This study con®rms that the clinical uroselectivity of SR-alfuzosin, already described in randomized controlled studies, is not signi®cantly affected in clinical practice by the age of the patients. This is considered particularly relevant to the characteristics of patients with BPH, as they are mostly elderly men.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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The clinical uroselectivity of alfuzosin is not significantly affected by the age of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

et al. 2000

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“…The overall total of patients surveyed is also limited, which could make it difficult to extrapolate to the general population. However, the clinical profile of the patients was similar to that described in other studies [23][24][25]. As for any observational study, the design can only generate hypotheses that need to be validated in future trials.…”

Section: Ipssmentioning

confidence: 71%

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Fourcade¹,

Théret²,

Taïeb³

2008

BJU International

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OBJECTIVETo describe the profile and management of patients medically treated for benign prostatic hyperplasia (BPH) in primary care in four European countries, as the diagnosis and management of BPH have developed dramatically in the last decade, and recent information from actual practice is insufficient.PATIENTS AND METHODSThis observational, cross‐sectional study was carried out by general practitioners in France (141 patients), Spain (127) and Portugal (50), and by office‐based urologists in Germany (162 patients) between July 2005 and June 2006. The physicians were unaware of the study sponsor. Patients aged ≥50 years were recruited if a decision for medical treatment of BPH was taken for the first time on that day. The patient and the investigator had to complete one questionnaire each.RESULTSThe physicians included 480 patients, with a mean (sd) age of 65.0 (7.8) years. The mean (sd) International Prostate Symptom Score (IPSS) was 16.0 (7.3). There were geographical differences in age (P = 0.009; patients in Germany being the youngest), IPSS (P = 0.017; patients in Spain having the highest score), quality of life (QoL; IPSS item 8, P < 0.001, the least altered being in Germany), and sexual activity (P = 0.010; the highest proportion of sexually active patients being in Portugal), but not for comorbidities and concomitant medication. The IPSS correlated poorly with age (r = 0.21) and moderately with QoL (r = 0.47). Severe symptoms (IPSS > 19) were not linked with sexual activity (age‐adjusted P = 0.378). Serum prostate specific antigen testing, although not recommended for BPH, was widely used (83.8% overall). All other examinations were carried out disparately depending on the country (P < 0.001 each). Digital rectal examination (DRE) and excluding urinary tract infection (urine culture) were used in ≈75% of study patients, but only half the patients in France had a urine culture, and 52% in Portugal had a DRE. A standardized assessment of symptoms and/or QoL was reported in 45% of study patients, with wide discrepancies among countries, i.e. 77.2% in Germany and 6.0% in Portugal. α‐blocker monotherapy was the most frequently prescribed treatment (62.5% overall, 87.1% in Germany, 46.1% in France), followed by phytotherapy (23.5%), and 5α‐reductase inhibitor monotherapy (3.75%); combinations were rare. Treatment varied according to the severity of the symptoms (P = 0.008), phytotherapy being given to patients with the lowest IPSS, and combinations to those with the highest IPSS.CONCLUSIONThere were geographical discrepancies that could be attributed to either different cultural habits or merely organisational differences, e.g. the presence of office urologists in Germany or diverse modes of access to phytotherapy (prescription vs ‘over the counter’) in the various countries.

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Benign Prostatic Hyperplasia

2006

Wiley Handbook of Current and Emerging Drug Therapies

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Safety and Efficacy of Sustained–Release Alfuzosin on Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in 3,095 Spanish Patients Evaluated during General Practice

Cited by 18 publications

References 19 publications

The clinical uroselectivity of alfuzosin is not significantly affected by the age of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

The clinical uroselectivity of alfuzosin is not significantly affected by the age of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Benign Prostatic Hyperplasia

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