Abstract
Background: Unstable bladder symptoms are a common problem in general practice. Drug therapy with anticholinergic drugs is frequently used in the management of this condition. However such drugs are associated with a high incidence of anticholinergic adverse effects. Tolterodine is a competitive anticholinergic agent, selective for the bladder as opposed to the salivary glands.
Objective: To monitor the safety of tolterodine as used in general practice patients in England for the treatment of urinary frequency, urgency and incontinence.
Design: Prospective observational cohort study.
Patients and participants: 14 526 patients [mean age 62.7 (SD 16.4) years; 68.6% female].
Methods: Patients prescribed tolterodine in general practice, soon after the release of the drug in the UK, were followed up for a minimum of 6 months using the technique of prescription-event monitoring (PEM).
Results: The most common adverse events reported were dry mouth, headache, malaise, constipation, dyspepsia, nausea and vomiting and pain in abdomen. We identified some uncommon events as possible adverse drug reactions — notably hallucinations, tachycardia and palpitations. The prevalence of these events was compared with that in patient cohorts for other drugs on the PEM database. The age- and sex-adjusted relative risk of hallucinations on tolterodine compared with 10 drugs of other therapeutic classes, and with terodiline, another drug indicated for bladder instability, was 4.85 [95% confidence interval (CI) 2.72 to 8.66] and 1.25 (95% CI 0.62 to 2.53), respectively. There was no significant difference for tachycardia/palpitation in this comparison.
Conclusions: Tolterodine is well tolerated in general practice at the recommended daily dose. Hallucinations, tachycardia and palpitations are infrequently associated with the drug.
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Acknowledgements
We are very grateful to the general practitioners in England who supported this Prescription-Event Monitoring (PEM) study. We thank the Prescription Pricing Authority, the Health Authorities of England, and the Office for National Statistics, for their important participation in this study. And also we thank Dr Nick Dunn for the initial follow-up and assessment of green form reports. The Drug Safety Research Unit is a registered charity; it receives unconditional grants from pharmaceutical companies, which have no operational or editorial control on the PEM studies conducted by the Unit. The Drug Safety Research Unit has received such funds from Pharmacia & Upjohn Ltd, the manufacturers of tolterodine.
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Layton, D., Pearce, G.L. & Shakir, S.A.W. Safety Profile of Tolterodine as Used in General Practice in England. Drug-Safety 24, 703–713 (2001). https://doi.org/10.2165/00002018-200124090-00005
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DOI: https://doi.org/10.2165/00002018-200124090-00005