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Biomedical subjects

Luc Valiquette

Publications and source records attributed to Luc Valiquette.

24 records · Page 2Linked to original sources
PubMed2005

Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis.

OBJECTIVE: To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials. METHODS: In two randomized, double-blind studies, men with ED for > 6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment. RESULTS: Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from < or = 15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from < or = 15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%). CONCLUSION: In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).

Coitus↗
PubMed2005

Early symptom improvement of benign prostatic hyperplasia (BPH) treated with once daily alfuzosin.

INTRODUCTION AND OBJECTIVES: A novel slow release formulation of alfuzosin should improve compliance by reducing dosing to one 10 mg tablet per day. The current study examined efficacy, at 9 days and 3 months, and safety of this formulation of alfuzosin in BPH patients. METHODS: ALF-X was a 3-month, non-comparative, observational study of 353 BPH patients from 39 Canadian Urology centres. RESULTS: At baseline (BL), mean age was 63.1+/-9.01 years, 92.6% of patients were Caucasian, 3.4% had a history of acute urinary retention, mean duration of the micturition disorder was 48.6+/-54.15 months, and mean PSA was 3.3+/-6.65 ng/mL. Mean total International Prostate Symptom Score (I-PSS) decreased from 17.5 at BL to 10.4 at M3--an improvement of 7.1+/-6.82 points (40.6%, p < 0.001), mostly occurring (27.0%, p < 0.001)) during the first 9 days. Mean Quality of Life Assessment Index improved by 0.7+/-1.39 points between BL and D9 (17.5%, p < 0.001), and by 1.5+/-1.52 points between BL and M3 (37.5%, p < 0.001). The proportion of 'mild' I-PSS patients increased from 11.8% (BL) to 29.7% (D9) to 39.0% (M3); those with 'severe' I-PSS decreased from 37.8% (BL) to 14.5% (D9) to 9.4% (M3). Of 144 patients with nocturia (>2 nightly voidings) at D1, 51.4% improved to < or = 2 nightly voidings at D9, and 60.4% at M3. Adverse events related to alfuzosin occurred in 7.8% of patients; 2.0% experienced serious adverse events. There were no vasodilatory events related to alfuzosin or deaths. CONCLUSIONS: In routine clinical practice, slow-release alfuzosin is associated with a significant improvement in LUTS, and frequency of nocturia, and an excellent safety profile.

Adrenergic alpha-Antagonists↗
PubMed2005

Validation of prostate cancer index and SF-12 short forms.

BACKGROUND: Assessment of prostate cancer (PCa) specific and generic health-related quality-of-life (HRQOL) is frequently omitted due to several obstacles, such as respondent burden and infrastructure-related limitations. We attempted to reduce the number of items of two commonly used HRQOL assessment tools, namely the UCLA PCa Index (PCI) and the RAND SF-12, with the intent of generating the most parsimonious, yet psychometrically valid and reliable HRQOL assessment tool. METHODS: The PCI and SF-12 were administered to 2415 radical prostatectomy patients, and re-tested in a convenience sample of 35 men with PCa. Multivariate linear regression models defined the most predictive and item-reduced SF-12 and PCI item combinations. These were subjected to standard psychometric reliability and validity tests. RESULTS: The 8-item PCI sexual function (SF) scale was reduced to three items. The 5-item PCI urinary function (UF) scale was reduced to three items. The 6-item SF-12 mental health scale was reduced to three items, and the 6-item SF-12 physical scale was also reduced to three items. The total number of items was reduced from 27 to 12 (44%). The item-reduced scales accounted for over 85% of full-scale variance. All reliability and validity tests yielded highly satisfactory results. CONCLUSION: We developed SF-12 and PCI short-forms, which consist of 12 of 27 (44%) original items and can be completed by most men within 2 minutes. The short-forms represent a valid substitute for the full scales, as they provide over 85% of full-scale information and demonstrate excellent reliability statistics. The short forms have the potential for decreasing respondent burden and infrastructure-related requirements, which may in turn promote HRQOL assessment after radical prostatectomy.

Aged↗
PubMed2004

Vardenafil provides reliable efficacy over time in men with erectile dysfunction.

OBJECTIVES: To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED). METHODS: In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group. RESULTS: At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis. CONCLUSIONS: Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.

Clinical Trials, Phase III as Topic↗
PubMed2003

A historical review of erectile dysfunction.

Over the last three decades, there has been a significant increase in our understanding of the physiologic mechanisms responsible for erectile dysfunction. Erectile dysfunction has become a topic of considerable media and societal interest and acceptance. Paralleling the increase in knowledge has been an explosion in therapeutic options. This article will evaluate the therapeutic options, from a historical perspective of what has been available, and outline the progress that has been made.

Administration, Oral↗