The Phase 2 and 3 clinical trial program for DETROL LA Capsules included 1073 patients
who were treated with DETROL LA (n=537) or placebo (n=536). The patients were treated
with 2, 4, 6, or 8 mg/day for up to 15 months. Because clinical trials are conducted
under widely varying conditions, adverse reaction rates observed in the clinical
trials of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice. The adverse reaction
information from clinical trials does, however, provide a basis for identifying
the adverse events that appear to be related to drug use and for approximating rates.
The data described below reflect exposure to DETROL LA 4 mg once daily every morning
in 505 patients and to placebo in 507 patients exposed for 12 weeks in the Phase
3, controlled clinical study.
Adverse events were reported in 52% (n=263) of patients receiving DETROL LA and
in 49% (n=247) of patients receiving placebo. The most common adverse events reported
by patients receiving DETROL LA were dry mouth, headache, constipation, and abdominal
pain. Dry mouth was the most frequently reported adverse event for patients treated
with DETROL LA occurring in 23.4% of patients treated with DETROL LA and 7.7% of
placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation
abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic
agents. A serious adverse event was reported by 1.4% (n=7) of patients receiving
DETROL LA and by 3.6% (n=18) of patients receiving placebo.
The frequency of discontinuation due to adverse events was highest during the first
4 weeks of treatment. Similar percentages of patients treated with DETROL LA or
placebo discontinued treatment due to adverse events. Treatment was discontinued
due to adverse events and dry mouth was reported as an adverse event in 2.4% (n=12)
of patients treated with DETROL LA and in 1.2% (n=6) of patients treated with placebo.
Table 4 lists the adverse events reported in 1% or more of patients treated with
DETROL LA 4 mg once daily in the 12-week study. The adverse events were reported
regardless of causality.
Table 4. Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in
≥1% of Patients Treated with DETROL LA (4 mg daily) in a 12-week, Phase 3 Clinical
Trial
Post-marketing Surveillance
The following events have been reported in association with tolterodine use in worldwide
post-marketing experience: General: anaphylactoid reactions, including
angioedema; Cardiovascular : tachycardia, palpitations, peripheral
edema; Gastrointestinal: diarrhea; Central/Peripheral Nervous:
confusion, disorientation, memory impairment, hallucinations.
Reports of aggravation of symptoms of dementia (e.g. confusion, disorientation,
delusion) have been reported after tolterodine therapy was initiated in patients
taking cholinesterase inhibitors for the treatment of dementia.
Because these spontaneously reported events are from the worldwide post-marketing
experience, the frequency of events and the role of tolterodine in their causation
cannot be reliably determined.