Improved quality of life in patients with overactive bladder symptoms treated with solifenacin
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Notice bibliographique
Résumé
OBJECTIVE: To assess the effect of solifenacin succinate treatment on quality of life (QoL) measured in clinical trials in patients with overactive bladder (OAB). PATIENTS AND METHODS: QoL data using the King's Health Questionnaire (KHQ) were analysed from two phase-3, 12-week studies (1984 patients) and a long-term extension of these studies (1637 patients) where patients received solifenacin for up to an additional 40 weeks (i.e. a 52-week exposure to solifenacin). The 12-week studies were multinational, multicentre, randomized, double-blind, and placebo-controlled. The 10 domains from the KHQ evaluated were general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity. Changes from baseline to endpoint in QoL variables were assessed by analysis of variance, and from pooled outcomes of the 12-week studies by analysis of covariance. Descriptive statistics were used to evaluate data in the extension study. RESULTS: In the two 12-week studies (1033 and 857 patients), those receiving once-daily solifenacin had statistically significantly better QoL than those on placebo. Changes in the KHQ were statistically significantly (P < 0.05) different from placebo for both solifenacin 5 and 10 mg once daily on five of the 10 KHQ domains in each of the studies. Pooled data from the two 12-week studies showed statistically significant (P < 0.05) differences from placebo for both solifenacin doses in nine of the 10 domains. Improvements in QoL scores for solifenacin were 35-48% in nine of the 10 domains for the 1347 patients providing QoL data in the extension study. About two-thirds of this overall improvement occurred during the original 12-week study, with an additional third reported during the extension, with an improvement in QoL over time in patients treated with solifenacin. CONCLUSIONS: Results from the KHQ in study participants in the two double-blind studies showed that solifenacin significantly improved the QoL in patients with OAB symptoms after 12 weeks of treatment, with further improvements during long-term administration up to 1 year. Clinical trial outcomes show a favourable balance of efficacy and tolerability with solifenacin; the present report further supports this efficacy and tolerability by providing evidence for both short- and long-term improvements in QoL.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle