Terodiline was first marketed in 1965 as an antianginal agent (‘Bicor’) in Scandinavia, a relatively small market.
RE-BIRTH OF TERODILINE
Terodiline
was first marketed in 1965 as an antianginal agent (‘Bicor’) in Scandinavia, a
relatively small market (Wibell, 1968). This period of original market-ing of
terodiline in the 1960s is worthy of note because it antedates (a) any serious
regulatory or clinical inter-est in drug-induced prolongation of the QT
interval and (b) the first description of torsade de pointes as a unique
proarrhythmia associated with prolonged QT interval (Dessertenne, 1966).
Moreover, the re-development of terodiline in the early 1980s coincided with
increasing number of reports of QT interval prolon-gation and torsade de
pointes in association with two other antianginal drugs, prenylamine (Picard,
Auzepy and Chauvin, 1971; Oakley et al.,
1980; Abinader and Shahar, 1983) and lidoflazine (Kaden and Kubler, 1977;
Hanley and Hampton, 1983). These two drugs ceased to be available for clinical
use in the UK – prenylamine in 1988 and lidoflazine in 1989.
Because
of the potent anticholinergic properties of terodiline, urinary retention
proved to be a frequent and troublesome side effect during its use as an
antiang-inal agent. Terodiline was therefore re-developed in the early 1980s
for clinical use in urinary incontinence due to detrusor instability. In
isolated airway prepa-rations from rats, terodiline had also been shown to
block the bronchoconstrictor effect of acetylcholine. The shift in the
acetylcholine dose-response curve induced by terodiline indicated that its
anticholiner-gic property might also explain its observed cilio-stimulatory
effect (Iravani and Melville, 1975). It is therefore not surprising that in the
period inter-vening between these two indications, terodiline was also being
investigated for use in chronic obstruc-tive airways disease (Castenfors,
Hedenstiarna and Glenne, 1975), presumably in an attempt to harness the same,
otherwise unwanted, pharmacological property observed during its use as an
antianginal agent.
Terodiline was first introduced in the United King-dom under
the brand name of ‘Terolin’ (later changed to ‘Micturin’) in July 1986 for use
in urinary frequency, urgency and incontinence in patients with detrusor
instability and neurogenic bladder disorders. In the EU, it was also approved
in Denmark, Ireland, Luxembourg, Belgium, the Netherlands, Spain and West
Germany, but not in France, Greece, Italy or Portugal. Overall, the drug was
approved in 20 coun-tries worldwide and marketed in a number of these, but the
major markets were the UK, Sweden and Japan. The recommended dose in the United
King-dom was 12.5–25 mg twice daily in young adults and otherwise healthy
elderly patients, but 12.5 mg twice daily in frail elderly patients. In
general, the doses used in Sweden were lower than those used in the United
Kingdom, and the dose approved in Japan was half the UK recommended dose.
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