In chronic angina patients, ranolazine monotherapy was well tolerated and increased exercise performance throughout its dosing interval at all doses studied without clinically meaningful hemodynamic effects. One-year survival was not lower than expected in this high-risk patient population. This metabolic approach to treating myocardial ischemia may offer a new therapeutic option for chronic angina patients.
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. Results: A total of 405 patients were randomized and received trial medication. Most (82.1%) were taking two to three concomitant AEDs. Median percent reductions in seizure frequency per 28 days from baseline to maintenance (intention-to-treat, ITT) were 37.3% for lacosamide 400 mg/day (p = 0.008) and 37.8% for lacosamide 600 mg/day (p = 0.006) compared to 20.8% for placebo, with responder rates of 38.3% and 41.2%, respectively, compared to placebo (18.3%, p < 0.001; ITT). Patients randomized to lacosamide showed large reductions in secondarily generalized tonic-clonic seizures, with median percent reductions in seizure frequency of 59.4% for lacosamide 400 mg/day and 93.0% for lacosamide 600 mg/day compared to 14.3% for placebo, and responder rates of 56.0% and 70.2% compared to placebo (33.3%). Dose-related adverse events included dizziness, nausea, and vomiting. Discussion: Adjunctive treatment with lacosamide 400 and 600 mg/day reduced seizure frequency for patients with uncontrolled partial-onset seizures. Lacosamide 400 mg/day provided a good balance of efficacy and tolerability; lacosamide 600 mg/day may provide additional benefit for some patients as suggested by secondary efficacy analyses, including response in patients with secondarily generalized tonic-clonic seizures.
Family, peers and other environmental factors are likely to influence children's dietary behavior but few measures of these phenomena exist. Questionnaires to measure family and peer influences on children's fruit, juice and vegetable (FJV) consumption were developed and pilot tested with an ethnically diverse group of Grade 4-6 children. Principal components analyses revealed subscales with acceptable internal consistencies that measured parent and peer FJV modeling, normative beliefs, normative expectations, perceived peer FJV norms, supportive and permissive parenting practices, food rules, permissive eating, and child food preparation. Internal consistencies were adequate to high, but test-re-test correlations often were low. Children also completed questionnaires on FJV availability and accessibility in the home, and food records for 2 days in the classroom. Parental modeling, peer normative beliefs and FV availability were significantly correlated with FJV consumption. Further research with these scales is warranted.
In this post hoc exploratory analysis, adjunctive lacosamide demonstrated significant seizure reduction over placebo regardless of the inclusion of 'traditional' sodium channel blockers in the concomitant AED regimen. Future prospective studies evaluating single AED combinations (e.g. lacosamide plus one other drug) are needed to better evaluate the potential for additive or synergistic effects of lacosamide in combination with AEDs not considered 'traditional' sodium channel blockers.
Objective: To pilot test theory-based questionnaires to measure socioenvironmental in¯uences on children's fruit, juice and vegetable (FJV) consumption as reported by parents. Design: Cross-sectional. Setting: Parents of fourth to sixth grade students completed socioenvironmental questionnaires. The students completed food records (FRs) for 2 days in the classroom. Subjects: Interviews were completed by 109 parents (17% African-American, 32% Hispanic-American and 51 Euro-American). Results: Student mean daily FJV intake was 2.1 servings. Principal components analyses revealed subscales measuring positive and negative parenting practices; selfef®cacy for modelling and planning/encouraging FJV consumption, and making FJV available; encouraging, consequences and discouraging food socialization practices; negative home, cost and canned/frozen food barriers; meal planning; child shopping; mother food preparation; and child lunch and dinner FJV preparation practices. Internal consistencies were adequate to high. Negative parent practices and negative home FJV barriers were signi®cantly negatively correlated with child FJV consumption variables. Planning/encouraging self-ef®cacy was positively associated with fruit consumption, and child dinner FJV preparation was signi®cantly negatively correlated with child juice consumption. Conclusions: These questionnaires may provide important insights about the relationship between parent-reported socioenvironmental in¯uences and children's FJV consumption. Future work should test these questionnaires with larger groups of parents and youths, with more reliable estimates of usual FJV intake, e.g. 7-day food records, to obtain a detailed understanding of how parents in¯uence what children eat. Tests of models of relationships among these variables are warranted, but should control for possible confounding variables, e.g. socioeconomic status, gender of the child, etc.
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