Tolterodine Fumarate

The first class of oral pharmacologic treatments for overactive bladder (OAB) are antimuscarinics that are associated with poor persistence, anticholinergic adverse events, and increased anticholinergic burden (ACB) with risk of cognitive impairment. Mirabegron, a β3-adrenoceptor agonist, is an oral treatment that does not contribute to ACB and has early evidence of improved persistence. The objective of the analysis was to assess the cost-effectiveness of mirabegron for OAB vs six antimuscarinics in the US.

A Markov state-transition model assessed US commercial health-plan and Medicare Advantage perspectives over a 3-year time horizon in an OAB patient population. Transition probabilities between five micturition and five incontinence severity states were derived from a network meta-analysis of 44 trials of oral OAB treatments. Therapy beginning with an oral OAB agent could discontinue or switch to another oral agent and could be followed by tibial nerve stimulation, sacral neuromodulation, or onabotulinumtoxinA. The primary outcome was cost per quality-adjusted life year (QALY). Utilities were mapped from incontinence and micturition frequencies as well as demographics. Based on analysis of data from a large healthcare system, elevated ACB was associated with increased healthcare utilization and probability of cognitive impairment.

From both commercial and Medicare Advantage perspectives, mirabegron was the most clinically effective treatment, while oxybutynin was the least expensive. Tolterodine immediate release (IR) was also on the cost-effectiveness frontier. The analysis estimated costs per QALY of $59,690 and $66,347 for mirabegron from commercial health plan and Medicare Advantage perspectives, respectively, compared to tolterodine IR. Other antimuscarinics were dominated.

This analysis estimated that mirabegron is a cost-effective treatment for OAB from US commercial health plan and Medicare Advantage perspectives, due to fewer projected adverse events and comorbidities, and data suggesting better persistence.

Storage lower urinary tract symptoms (LUTS) in men are usually chronic, with a high prevalence and a substantial impact on quality of life; therefore, adequate therapies are desirable and crucial for these men. First line treatment for all patients with storage LUTS should always be behavioral. The gold standard for pharmacological treatment of overactive bladder/storage symptoms is a muscarinic receptor antagonist such as tolterodine. First-marketed antimuscarinics were limited by several adverse events such as dry mouth, constipation, tachycardia, accommodation disorder, and cognitive dysfunction, resulting in poor compliance and early treatment discontinuation in a large number of patients. In order to improve compliance with oral drug treatment, tolterodine was developed, providing a better efficacy/adverse event profile. Tolterodine is available in the following two formulations: the intermediate release (IR) and extended release form (ER). Tolterodine ER 4 mg administered once daily is pharmacokinetically equivalent to tolterodine IR 2 mg twice daily but has a lower incidence of adverse events and increased efficacy. Combination therapy of tolterodine and an alpha-blocker is significantly more efficacious than either monotherapy. Even when compared and added to tamsulosin, tolterodine shows a good safety profile. The incidence of acute urinary retention requiring catheterization and treatment withdrawals due to adverse events are low in all the studies included in the present review.