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.

Belgian Schizophrenia Outcome Survey - results of a 2-year naturalistic study in patients stabilised on monotherapy with olanzapine, risperidone or haloperidol.

Objectives: This Schizophrenia Outcome Survey compared medical costs, psychopathology and adverse events in outpatients for 2 years following hospitalisation for an acute schizophrenic episode.

Methods: Adults stabilised with haloperidol, olanzapine or risperidone entered this observational study
Results: Among 323 patients (haloperidol 32, olanzapine 149, risperidone 142), baseline characteristics were similar in the olanzapine and risperidone groups, except for more first episodes in the risperidone group (p=0.

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.

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.

Piracetam and levetiracetam: close structural similarities but different pharmacological and clinical profiles.

Piracetam (PIR) and levetiracetam (LEV), an S-enantiomer, are pyrrolidone derivatives that share similar chemical structures but have distinct pharmacological profiles and consequently different clinical uses. Although the mode of action of neither drug has been fully elucidated, they do not interact with inhibitory or excitatory neurotransmission or alter membrane excitability. A brain-specific stereoselective binding site has been identified for which LEV and other S-enantiomers, but not PIR, have high affinity.

The clinical safety of high-dose piracetam--its use in the treatment of acute stroke.

Recent post-marketing surveillance reports have confirmed the benign safety profile and lack of organ toxicity shown by piracetam during its 25 years of clinical usage. Tolerance has proved equally good with the more recent use of larger doses (up to 24 g/day) for the long-term control of cortical myoclonus and when given intravenously to patients with acute stroke. This paper provides a brief review of these findings and records the safety of piracetam as found in the Piracetam in Acute Stroke Study (PASS), a randomized multicenter placebo-controlled study in 927 patients with acute ischemic stroke.

Piracetam relieves symptoms in progressive myoclonus epilepsy: a multicentre, randomised, double blind, crossover study comparing the efficacy and safety of three dosages of oral piracetam with placebo.

Objective: To compare the efficacy, tolerability, and safety of three daily dosage regimens of oral piracetam in patients with progressive myoclonus epilepsy.

Methods: Twenty patients (12 men, eight women), aged 17-43 years, with classical Unverricht-Lundborg disease were enrolled in a multicentre, randomised, double blind trial of crossover design in which the effects of daily doses of 9.6 g, 16.

Economic evaluation of Nootropil in the treatment of acute stroke in France.

The primary objective of this study was to investigate the economic impact of treatment of acute ischaemic stroke with piracetam vs placebo according to the societal perspective in France. Socio-demographic, clinical and resource utilisation data for piracetam and placebo patients during the acute phase following stroke was obtained from the Piracetam Acute Stroke Study (PASS) clinical trial database. The economic analysis was based on the population defined as being treated within 6 h 59 min following stroke and presenting an initial Orgogozo score of less than 55.

Piracetam as an adjuvant to language therapy for aphasia: a randomized double-blind placebo-controlled pilot study.

Objective: To determine whether piracetam 4.8 g/day together with intensive language therapy improved language function more than language therapy alone.

Design: Double-blind, placebo-controlled parallel group study.

Piracetam in the treatment of myoclonus: an overview.

Myoclonus is a rare, but disabling symptom, occurring in a number of diseases of different origin. Aetiological and neurophysiological classifications, as well as the current treatment in myoclonus are discussed. An overview of the treatment of myoclonus with piracetam in 62 case reports, 3 open trials and 2 doubleblind trials, covering 171 patients is reported.

Cerebral venous thrombosis in paroxysmal nocturnal haemoglobinuria.

Dural sinus thrombosis developed in two young women with paroxysmal nocturnal haemoglobinuria (PNH). The incidence, the clinical presentation, the radiologic findings, the therapy and the pathophysiology of haemolysis and thrombosis are discussed.