Tolerability of solifenacin and oxybutynin immediate release in older (>65 years) and younger (≤65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study

Abstract

Objective:

Overactive bladder (OAB) is a common condition whose prevalence increases with age. Antimuscarinic agents are the pharmacologic treatment of choice, but adverse events such as dry mouth may lead to early discontinuation. The purpose of this analysis was to compare the incidence and severity of dry mouth and other adverse events with solifenacin 5 mg/day and oxybutynin immediate release (IR) 15 mg/day in patients ≤65 years and >65 years in the Canadian VECTOR study (VEsicare in Comparison To Oxybutynin for oveRactive bladder patients).

Research design and methods:

VECTOR was a randomized, multicentre, prospective, double-blind, double-dummy study in 132 subjects with ≥1 urgency episode per 24 h, with or without urgency incontinence, and ≥8 micturitions per 24 h for ≥3 months. After a 2-week washout, patients received solifenacin 5 mg once daily or oxybutynin IR 5 mg tid for 8 weeks. For the current post-hoc analysis, adverse events were evaluated in subgroups of patients ≤65 years and >65 years, using a full logistic regression model, multinomial logit regression model and reduced model.

Clinical trial registration:

NCT00431041.

Results:

The incidence and severity of dry mouth and other adverse events with solifenacin were similar between younger and older patients. In both age subgroups, solifenacin 5 mg/day was associated with fewer episodes and lower severity of dry mouth, and a lower discontinuation rate, compared with oxybutynin IR 15 mg/day.

Conclusions:

Solifenacin 5 mg/day was better tolerated than oxybutynin IR 15 mg/day in younger (≤65 years) and older (>65 years) subgroups. Solifenacin was equally well tolerated in both age subgroups. Limitations of the analysis were that the study was not preplanned to perform post-hoc subgroup analysis, patients knew that dry mouth was a primary outcome, and the study used fixed doses of each drug.

Key words::

• Elderly
• Overactive bladder
• Oxybutynin
• Solifenacin

Transparency

Declaration of funding

The study was undertaken with a research grant from Astellas Pharma Canada, Inc. All authors had full access to the data cited and were involved in the review and editing of the manuscript throughout. The primary author (S.H.) had final responsibility for the decision to submit this manuscript for publication.

Declaration of financial/other relationships

The authors declare the following for relevant research, consultancy and/or advisory work. S.H.: Allergan, American Medical Systems, Astellas, Coloplast, Johnson & Johnson, Pfizer. P.P.: Aeterna Zentaris, American Medical Systems, Amgen, Astellas, Astra Zeneca, Dendreon, GSK, Lilly, Pfizer, Protox (with stock ownership or options), Spectrum, Uromedica. L.S.: Astellas. B.E.: Aeterna Zentaris, Allergan, Amgen, Astellas, Astra Zeneca, Bayer Healthcare, Ferring, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, Protox, Spectrum. J.G.: Allergan, Astellas, Johnson & Johnson, Medtronic, Pfizer, Sanofi-Aventis. K.C.: American Medical Systems, Astellas, GSK, Pfizer. S.R.: Astellas, Bayer, Lilly, Pfizer. H.D.: Astellas. J.S.: Allergan, Astellas, Gynecare, Pfizer, Triton. J.B.: Abbott Pharma, Astellas, Astra Zeneca, Ferring, Palladin, Pfizer, Triton. E.H.: American Medical Systems, Astellas, Bayer, GSK, Pfizer. J.C.: Astellas, Ortho-McNeil, Oryx, Pfizer, Triton.

Acknowledgements

Statistical analysis was provided by St. Clare Chung, Ann Leung, and Joon Foo from SciAn Services Inc., funded by Astellas. Medical writing and editorial assistance were provided by Steven Sharpe PhD of SharpeCom Ltd, funded by Astellas.

Some of the results of this study were presented as an abstract and poster at the 34th Annual meeting of the International Urogynaecological Association (IUGA), Como, Italy, June 16–20, 2009 (poster 129).