Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder.
The incidence, severity and tolerability of dry mouth was compared in 790 women with overactive bladder who were treated with extended-release oxybutynin chloride 10 mg/day or extended-release tolterodine tartrate 4 mg/day for 12 weeks in a multicenter, double-blind, parallel-group study. Dry mouth was the most common adverse event associated with treatment, with an incidence rate of 28.1% in the oxybutynin group and 21.6% in the tolterodine group (P = 0.039). The majority of dry mouth events were mild in both treatment groups. Severe dry mouth occurred in 1.5% and 0.5% of patients in the oxybutynin and tolterodine groups, respectively (P = 0.173). Seven patients on extended-release oxybutynin and 4 patients on extended-release tolterodine discontinued treatment due to dry mouth (P = 0.380). The results of this analysis showed that dry mouth was common with both treatments, but most events were mild; there was no difference in the rate of severe dry mouth or in the rate of withdrawal due to dry mouth.
Armstrong
Robert B
RB
Clinical Affairs, Ortho-McNeil Pharma ceutical, Inc., Raritan, NJ 08869, USA. rarmstro@ompus.jnj.com
Luber
Karl M
KM
Peters
Kenneth M
KM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D003408:Cresols / Q000009:adverse effects* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D006801:Humans; D008333:Mandelic Acids / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D010665:Phenylpropanolamine / Q000009:adverse effects* / Q000627:therapeutic use; D012720:Severity of Illness Index; D000068737:Tolterodine Tartrate; D014549:Urinary Incontinence / Q000188:drug therapy*; D014987:Xerostomia / Q000139:chemically induced*
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C005419:oxybutynin