Innovation in cardiovascular disease in Europe with focus on arrhythmias: current status, opportunities, roadblocks, and the role of multiple stakeholders.

The European Heart Rhythm Association (EHRA) held an Innovation Forum in February 2016, to consider issues around innovation. The objective of the forum was to extend the innovation debate outside of the narrow world of arrhythmia specialists and cardiology in general, and seek input from all stakeholders including regulators, strategists, technologists, industry, academia, health providers, medical societies, payers, and patients. Innovation is indispensable for a continuing improvement in health care, preferably at higher efficacy and lower costs. It requires people who have been trained in a good scientific environment, high-quality research for achieving ground breaking inventions and the certainty of return on innovation investments. In the context of cardiovascular disease, innovation can imply better risk assessment and stratification, device technology, drug development, and process design. Several areas of promising developments were identified as well as several roadblocks to innovation. To drive innovation forward all stakeholders need to play a significant role. In a globalized and extremely competitive world, the leading role of Europe in medical innovation can only be achieved through a combined and well-coordinated effort from all involved parties.

Analysis of resolution criteria in patients with schizophrenia treated with olanzapine for an acute psychotic episode.

Resolution was defined as achieving the severity component of the remission criteria (simultaneous ratings of mild or less on 8 of the PANSS items evaluating the core symptoms of schizophrenia). Analysis of a 6-week open label study with olanzapine 5-20 mg in 306 patients with acute exacerbation, shows resolution to be a clinically meaningful measure and an achievable outcome for treatment of acute psychosis.

Open study evaluating the onset of antipsychotic action of olanzapine in the treatment of patients with schizophrenia, schizophreniform or schizo-affective disorder.

OBJECTIVE This 6-week, open-label study with olanzapine was designed to determine the onset of antipsychotic action of a 10-mg/day starting dose of olanzapine, continued as a fixed dose for at least 4 weeks. METHODS A total of 306 patients experiencing an acute exacerbation of schizophrenia were prospectively followed-up. Response was defined as a 20% improvement on the Positive And Negative Syndrome Scale (PANSS) positive score, sustained until week 6. Onset of action was defined as the time point at which a 20% improvement in positive symptoms occurred and was maintained to week 6. RESULTS Significant improvements from baseline were observed throughout the study with respect to PANSS positive and PANSS total score (P<0.001). Within the first week of treatment, 20.6% of patients showed a 20% decrease in PANSS positive score, which was maintained until week 6. By weeks 2, 3 and 4 the percentage of responders had risen to 38.2, 49.7 and 52.3%, respectively. Olanzapine 10 mg/day was well tolerated, with the frequency of extrapyramidal symptoms and sexual dysfunction markedly lower following treatment than at baseline. CONCLUSION In this clinical open study, about half of the patients showed a response within 3 weeks, which is at least maintained until week 6.

Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy.

PURPOSE: To evaluate the long-term clinical usefulness of levetiracetam (LEV, Keppra((R))(1)) as add-on therapy in patients with refractory epilepsy. METHODS: Data for all 1422 patients with refractory epilepsy treated with LEV during the development program were analyzed for changes in seizure frequency per week, seizure freedom, and adverse events. RESULTS: Median percent reduction from baseline in seizure frequency per week over the whole treatment period was 39.6%, and no decrease over time was observed within each cohort exposed to LEV for durations ranging from 6 to 54 months. The median treatment period was 399 days (range 1-8 years). The proportion of responders during the first 3 months of LEV treatment was 39.2%. This proportion remained stable at 6 months (36.1%). Overall, 38.6 and 20.1% of patients had reductions in seizure frequency of at least 50 and 75%. Sixty-five (4.6%) patients were seizure-free over their entire treatment period, compared with 167 (11.7%) and 126 (8.9%) during their last 6 and 12 months of follow-up. Ninety-seven (19.8%) of 491 patients who received only one other antiepileptic drug (AED) in addition to LEV were seizure-free during their last 6 months. The proportion of patients who reduced their number of concomitant AEDs was 14.4% (205 patients), while 5.5% (79 patients) were treated with LEV only at the end of follow-up. Accidental injury (28.0%), infection (26.6%), headache (25.8%), somnolence (23%), asthenia (22.6%), and dizziness (18.9%) were among the most common adverse events. CONCLUSION: LEV offers sustained efficacy in patients with refractory partial seizures, and its long-term tolerability is similar to that seen in the short-term placebo-controlled trials.