Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial.

OBJECTIVES: To assess efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia. METHODS: An enriched enrollment, randomized withdrawal trial, with 6-week single-blind pregabalin treatment phase and 13-week double-blind phase, where patients with ≥50% decrease in mean pain score at single-blind end point from baseline were randomized (1:1) to pregabalin CR (82.5 to 660 mg/d) or placebo. Primary efficacy outcome was time to loss of therapeutic response (LTR) (<30% decrease in weekly mean pain score from single-blind baseline or discontinuation due to adverse event or lack of efficacy). Secondary efficacy outcomes included change in weekly mean pain score (1-wk recall period) at double-blind end point. RESULTS: In total, 801 patients were randomized and treated in the single-blind phase, and 413 in the double-blind phase (208, pregabalin CR; 205, placebo). Pregabalin CR significantly increased time to LTR versus placebo (Kaplan-Meier analysis) with significantly fewer LTR events with pregabalin CR than with placebo (29 [13.9%] vs. 63 [30.7%]; P<0.0001). Median time to LTR was not estimable. Pregabalin CR significantly improved weekly mean pain score versus placebo: LS mean difference (95% CI) of -1.11 (-1.47, -0.75) and -1.00 (-1.34, -0.65) (P<0.0001) from single-blind baseline and double-blind baseline, respectively. Most commonly reported adverse events in the single-blind phase were dizziness, somnolence, and peripheral edema. Pregabalin CR was well tolerated. DISCUSSION: Time to LTR was significantly longer with pregabalin CR than with placebo. Safety profile of pregabalin CR was comparable to that reported for the immediate-release formulation in patients with postherpetic neuralgia.

Introducing the Axon Registry: An opportunity to improve quality of neurologic care.

Clinical quality data registries are increasingly popular tools used by providers to improve the quality of clinical care and satisfy growing numbers of regulatory and reporting requirements. Specialty societies use registries to provide value to their members and guide improvements in care at the population level. In this article, we outline the rationale, structure, function, and challenges related to the American Academy of Neurology's development of its own clinical quality data registry: the Axon Registry.

The breadth and burden of data collection in clinical practice.

The clinical practice of neurology generates an enormous amount of data. Current data entry tools and reporting requirements are inefficient and frustrating. This comprehensive review of data collection in multiple domains of clinical practice includes billing and payment requirements, electronic health record documentation requirements, quality measurements, public reporting, and the evolution of clinical decision support. Quality measurements are increasingly affecting patient care and physician reimbursement. By understanding current data collection and by using appropriate tools, neurologists can begin to reduce the burden of data collection and ensure maximum reimbursement. The American Academy of Neurology's Axon registry is the next step in the evolution of clinical data collection and will begin to empower every neurologist to succeed in the shifting landscape of health care and physician payment reform.