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In the April 2008 issue of JMCP, D’Souza et al. compared persistence, adherence, and switch rates for immediate-release (IR) and extended-release (ER) formulations of oxybutynin and tolterodine for patients enrolled in a regional managed care health plan. Only 55.5% of patients refilled their first prescription for an overactive bladder (OAB) medication, and 13.2% persisted with the index medication for 1 year. The switch rate was 13.3% for the overall sample and 24.0% of patients with at least 1 refill. Although no difference was observed for persistence rates for any of the 4 OAB drugs, adherence rates were slightly higher for ER versus IR drugs.1 We commend D’Souza and colleagues for their efforts in the development of these findings. However, the results of this analysis are confounded by 2 major factors: (1) several limitations of retrospective data analyses and (2) the challenges associated with the clinical management of OAB. Also, the slight advantage offered by ER drugs raises a potential question regarding the “true” value offered by once-daily dose regimens versus multiple-dose regimens. In the category of difficulty in clinical management, low persistence and adherence rates associated with OAB therapies may be attributable to the undesirable adverse events associated with anti-cholinergic agents, including dry mouth, constipation, tachycardia, and blurred vision.2 Some postulate that the ER drug formulations could minimize the undesirable events and increase patient compliance by maintaining flat plasma drug concentrations.3,4 However, available data suggest that less frequent dosing intervals do not necessarily translate to increased compliance, indicating that side effects and inconvenience alone cannot explain non-adherence. Medication adherence and persistence are also dependent on the perceived benefit of therapy experienced by the patient. Humanistic outcomes, such as quality of life, offer a greater understanding of the potential benefits offered by various drug therapies but are just starting to be included in clinical trials. This lack of quality-of-life data is an important deficit in currently available information that needs to be addressed since the statistically significant effects observed for anti-muscarinic drugs in clinical trials (e.g., urinary frequency, volume voided per micturition) may not always translate to a clinically relevant benefit for patients in the real world.

Overactive Bladder Disease: The Urge for Better Therapies