Rosalie Kane: A Career's Worth of "Evergreen" Insights.

The author reminisces about her collegial relationships and friendship with Rosalie Kane over a span of nearly 40 years. She also reflects on the main themes of Rosalie's scholarly work as a social gerontologist, highlighting seminal publications and why Rosalie's insights remain valuable and "evergreen" decades later.

Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Crossover Study Evaluating the Abuse Potential of the Antiepileptic Drug Lacosamide in Healthy Recreational Drug Users.

Purpose: This phase 1, randomized, double-blind, placebo- and active comparator-controlled crossover study assessed the abuse potential of the antiepileptic drug, lacosamide.

Methods: After a qualification phase, 38 healthy, recreational central nervous system-depressant users were randomized to treatment sequences comprising single oral therapeutic (200 mg) and supratherapeutic (800 mg) doses of lacosamide, alprazolam (1.5 and 3 mg), and placebo.

Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes.

To evaluate the safety and effectiveness of lacosamide in a real-life setting with the use of a flexible dose titration schedule and individualised maintenance doses up to the maximum approved dose of 400 mg/day. Adults with a diagnosis of focal seizures, with or without secondary generalization, were enrolled in this open-label Phase IV trial (NCT01235403). Lacosamide was initiated at 100 mg/day (50 mg bid) and uptitrated over a 12-week period to 200, 300 or 400 mg/day, based on safety and seizure control.

Trends in Informal Care for Disabled Older Americans, 1982-2012.

Background And Objectives: We examine trends in informal care from the perspective of both community-dwelling disabled older Americans and their caregivers from 1982 to 2012. We decompose hours of care received from spouses and children according to changes in: (a) the number of potential spousal and child caregivers ("family structure"), (b) the likelihood that existing spouses and children are caregivers ("caregiving propensity"), and (c) the amount of care provided by individual caregivers ("time burden").

Research Design And Methods: We examine two sets of time trends based on distinct samples of community-dwelling disabled older Americans from the 1982-2004 waves of the National Long-Term Care Survey (NLTCS) and the 2000-2012 waves of the Health and Retirement Study (HRS).

The German Long-Term Care Insurance Program: Evolution and Recent Developments.

Background And Objectives: Since 1995, Germany has operated one of the longest-running public programs providing universal support for the cost of long term services and supports (LTSS). Its self-funding, social insurance approach provides basic supports to nearly all Germans. We discuss its design and development, including recent reforms expanding the program and ensuring its ongoing sustainability.

Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension.

Objective: Assess the safety of adjunctive lacosamide for the treatment of uncontrolled primary generalized tonic-clonic seizures in patients (16-65 years) with primary generalized (genetic) epilepsy (PGE).

Methods: An open-label pilot safety study (SP0961; NCT01118949), comprising 12 weeks' historical baseline, 4 weeks' prospective baseline, 3 weeks' titration (target: 400mg/day adjunctive lacosamide) and 6 weeks' maintenance. Patients who continued to the extension study (SP0962; NCT01118962) then received ≤59 weeks of flexible treatment (100-800mg/day lacosamide with flexible dosing of concomitant antiepileptic drugs).

A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures.

This noninterventional, observational, postauthorization safety study (SP0942, NCT00771927) evaluated the incidence of predefined cardiovascular- (CV) and psychiatric-related treatment-emergent adverse events (TEAEs), in patients with epilepsy and uncontrolled partial-onset seizures, when initiating adjunctive therapy with lacosamide or another approved antiepileptic drug (AED) according to standard medical practice. Active recording of predefined TEAEs of interest took place at three-monthly recommended visits for up to 12months. Of 1004 patients who received at least one dose of adjunctive AEDs, 511 initially added lacosamide therapy, 493 added another AED, 69 were ≥65years of age, and 72 took concomitant antiarrhythmic drugs.

Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials.

Objective: The objective of this study was to describe a priori protocol-defined analyses to evaluate the safety and tolerability of adjunctive oral lacosamide (200-600 mg/day) in adults (ages 16-70 years) with partial-onset seizures (POS) using data pooled from three similarly designed randomized, double-blind, placebo-controlled trials (SP667, SP754 [NCT00136019], SP755 [NCT00220415]).

Methods: Patients with POS (≥2 years' duration, ≥2 previous antiepileptic drugs [AEDs]) uncontrolled by a stable dosing regimen of 1-3 concomitant AEDs were randomized to treatment with lacosamide at doses of 200 mg/day, 400 mg/day, or 600 mg/day, or placebo. Studies comprised a 4- to 6-week titration phase to target dose followed by a 12-week maintenance phase.

Long-term adjunctive lacosamide treatment in patients with partial-onset seizures.

Objective: To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619).

Long-term care financing: lessons from France.

Unlabelled: POLICY POINTS: France's model of third-party coverage for long-term services and supports (LTSS) combines a steeply income-adjusted universal public program for people 60 or older with voluntary supplemental private insurance. French and US policies differ: the former pay cash; premiums are lower; and take-up rates are higher, in part because employer sponsorship, with and without subsidization, is more common-but also because coverage targets higher levels of need and pays a smaller proportion of costs. Such inexpensive, bare-bones private coverage, especially if marketed as a supplement to a limited public benefit, would be more affordable to those Americans currently most at risk of "spending down" to Medicaid.

Lacosamide cardiac safety: clinical trials in patients with partial-onset seizures.

Objective: To evaluate the cardiac safety of adjunctive lacosamide in a large pool of adults with partial-onset seizures (POS).

Methods: Post-randomization changes from baseline for electrocardiographic (ECG) measurements, diagnostic findings, and relevant adverse events (AEs) were compared for pooled data from three randomized, placebo-controlled trials of adjunctive lacosamide for the treatment of POS.

Results: Lacosamide did not prolong the QTc interval or affect heart rate as determined by an analysis of data from patients randomized to lacosamide 200, 400, or 600 mg/day (n = 944) compared with placebo (n = 364).

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years.

Long-term (up to 8 years of exposure) safety and efficacy of the antiepileptic drug lacosamide was evaluated in this open-label extension trial (SP615 [ClinicalTrials.gov identifier: NCT00552305]). Patients were enrolled following participation in a double-blind trial or one of two open-label trials of adjunctive lacosamide for partial-onset seizures.

Efficacy of lacosamide by focal seizure subtype.

The purpose of this post hoc exploratory analysis was to determine the effects of the antiepileptic drug, lacosamide, on focal (partial-onset) seizure subtypes. Patient data from the three lacosamide pivotal trials were grouped and pooled by focal seizure subtype at Baseline: simple partial seizures (SPS), complex partial seizures (CPS), and secondarily generalized partial seizures (SGPS). Both efficacy outcomes (median percent change from Baseline to Maintenance Phase in seizure frequency per 28 days and the proportion of patients experiencing at least a 50% reduction in seizures) were evaluated by lacosamide dose (200, 400, or 600 mg/day) compared to placebo for each seizure subtype.

Development of lacosamide for the treatment of partial-onset seizures.

Lacosamide is an antiepileptic drug (AED) available in multiple formulations that was first approved in 2008 as adjunctive therapy for partial-onset seizures (POS) in adults. Unlike traditional sodium channel blockers affecting fast inactivation, lacosamide selectively enhances sodium channel slow inactivation. This mechanism of action results in stabilization of hyperexcitable neuronal membranes, inhibition of neuronal firing, and reduction in long-term channel availability without affecting physiological function.

Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures.

Purpose: To examine the safety and tolerability of rapidly initiating adjunctive lacosamide via a single intravenous loading dose followed by twice-daily oral lacosamide in lacosamide-naive adults with partial-onset seizures.

Methods: This open-label, multicenter trial, enrolled patients with epilepsy who were taking 1-2 antiepileptic drugs (AEDs) in one of four sequential cohorts containing 25 subjects each. An intravenous lacosamide loading dose (200, 300, or 400 mg) was administered over 15 min followed 12 h later by initiation of oral dosing consisting of one-half of the loading dose administered twice daily for 6.

Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial.

Purpose: To evaluate the long-term (up to 5 years exposure) safety and efficacy of lacosamide as adjunctive therapy in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs) in open-label extension trial SP756 (NCT00522275).

Methods: Patients who completed the double-blind trial SP754 (NCT00136019) were eligible to participate in this open-label extension trial (SP756). At the conclusion of trial SP754, patients had transitioned to lacosamide 200 mg/day.

European long-term care programs: lessons for community living assistance services and supports?

Objective: To uncover lessons from abroad for Community Living Assistance Services and Supports (CLASS), a federally run voluntary public long-term care (LTC) insurance program created under the Accountable Care Act of 2010.

Data Sources: Program administrators and policy researchers from Austria, England, France, Germany, and the Netherlands.

Study Design: Qualitative methods focused on key parameters of cash for care: how programs set benefit levels; project expenditures; control administrative costs; regulate the use of benefits; and protect workers.

Allowing spouses to be paid personal care providers: spouse availability and effects on Medicaid-funded service use and expenditures.

Purpose Of The Study:  Medicaid service use and expenditure and quality of care outcomes in California's personal care program known as In-Home Supportive Service (IHSS) are described. Analyses investigated Medicaid expenditures, hospital use, and nursing home stays, comparing recipients who have paid spouse caregivers with those having other relatives or unrelated individuals as their caregivers. 

Design And Methods:  Medicaid claims and IHSS assessment data for calendar year 2005 were linked for IHSS recipients aged 18 years or older (n = 386,447) 

Results:  The rates of ambulatory care-sensitive hospital admissions and Medicaid-covered nursing home placements were at least comparable among IHSS recipients' with spouse, parent, other relative, or nonrelative caregivers.

A pooled analysis of lacosamide clinical trial data grouped by mechanism of action of concomitant antiepileptic drugs.

Background: Lacosamide, a new antiepileptic drug (AED) with a different pharmacological action that enhances sodium channel slow inactivation, is approved for the adjunctive treatment of partial-onset seizures in adults. Previous analyses of pooled phase II/III trials have demonstrated that lacosamide provides additional efficacy when added to a broad range of AEDs.

Objective: To further evaluate the efficacy and safety of lacosamide by grouping patients based upon the sodium channel-blocking properties of their concomitant AEDs.

Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials.

Background: Lacosamide is an antiepileptic drug (AED) approved for the adjunctive treatment of partial-onset seizures in adults. Completed phase II/III clinical trials of lacosamide provide a valuable opportunity to evaluate clinically relevant aspects of the resulting large patient pool.

Objective: To provide insight into the clinical utility of lacosamide by performing a priori-defined and post hoc analyses on a large, pooled patient population.

Private long-term care insurance: value to claimants and implications for long-term care financing.

Purpose: The purpose of this study was to obtain a profile of individuals with private long-term care (LTC) insurance as they begin using paid LTC services and track their patterns of service use, satisfaction with services and insurance, claims denial rates, and transitions over a 28-month period.

Design And Methods: Ten LTC insurance companies contributed a random sample of 1,474 qualified individuals who were interviewed in-person by a trained nurse and then interviewed telephonically every 4 month for a 28-month period. Used in the analysis were descriptive statistics and techniques for analyzing longitudinal panel data.

Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial.

Purpose: To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs).

Methods: This multicenter, double-blind, placebo-controlled trial randomized patients 1:2:1 to placebo, lacosamide 400 mg, or lacosamide 600 mg/day. After an 8-week baseline period, patients began treatment with placebo or lacosamide 100 mg/day, were force-titrated weekly (100 mg/day increments) to the target dose, and entered a 12-week maintenance period.

New state strategies to meet long-term care needs.

Consumer-directed long-term care service programs give participants the flexibility they want, while reducing unmet need for home and community-based services and supports. States' efforts to expand such programs under Medicaid, including those supported by federal Cash and Counseling demonstration and evaluation grants, are often hindered by challenges related to costs, staffing and organizational issues, new infrastructure requirements, and resistance from stakeholders. Yet states have developed a number of successful strategies for overcoming these challenges, even in financially trying times.

Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial.

Purpose: To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) when added to one to three concomitant antiepileptic drugs (AEDs) in patients with uncontrolled partial-onset seizures.

Methods: This multicenter, double-blind, placebo-controlled trial randomized patients (age 16-70 years) with partial-onset seizures with or without secondary generalization to placebo, lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week baseline, a 4-week titration, and a 12-week maintenance period.

Lacosamide: pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures.

Lacosamide is an antiepileptic drug approved in the USA and Europe as adjunctive therapy for partial-onset seizures. Studies suggest that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels and possibly interacts with collapsin response mediator protein-2. The efficacy of lacosamide has been shown in animal models of epilepsy and Phase II/III clinical trials.