Minocycline added to subcutaneous interferon ß-1a in multiple sclerosis: randomized RECYCLINE study.

BACKGROUND AND PURPOSE: Combining different therapies may improve disease control in patients with relapsing-remitting multiple sclerosis (RRMS). This study assessed the efficacy and safety of minocycline added to subcutaneous (sc) interferon (IFN) ß-1a therapy. METHODS: This was a double-blind, randomized, placebo-controlled multicentre study. Within 3 months (±1 month) of starting sc IFN ß-1a 44 µg three times weekly, patients with RRMS were randomized to minocycline 100 mg twice daily or placebo, added to sc IFN ß-1a, for 96 weeks. The primary efficacy endpoint was the time to first qualifying relapse. Secondary efficacy endpoints were the annualized relapse rate for qualifying relapses, the number of new/enlarging T2-weighted lesions and change in brain volume [magnetic resonance imaging (MRI) was performed only in a few selected centres]. In addition, a number of tertiary efficacy endpoints were assessed. RESULTS: One hundred and forty-nine patients received minocycline and 155 received placebo; MRI data were available for 23 and 27 patients, respectively. The time to first qualifying relapse did not differ significantly for minocycline versus placebo (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 0.48). There were no statistically significant differences between the two groups on other efficacy endpoints, although some numerical trends in favour of minocycline were observed. No unexpected adverse events were reported, but more patients discontinued because of adverse events with minocycline versus placebo. CONCLUSION: Minocycline showed no statistically significant beneficial effect when added to sc IFN ß-1a therapy.

Assessment of acute stroke cerebral CT examinations by anaesthesiologists.

BACKGROUND AND PURPOSE: It is essential to diagnose ischaemic stroke as soon as possible after symptom onset, so that thrombolytic treatment can be initiated as quickly as possible. This might be greatly facilitated if cerebral CT could be carried out in a pre-hospital setting. The aim of this study was to evaluate if anaesthesiologists, who in Norway provide pre-hospital medical care, could be trained to assess cerebral CT scans to exclude radiological contraindications for thrombolytic stroke treatment. METHODS: Thirteen anaesthesiologists attended an 8-h course in acute stroke assessment, including a 2-h introduction to the neuroradiology of acute stroke. Each participant then assessed 12 non-contrast cerebral CT examinations of acute stroke patients with specific regard to radiological contraindications for thrombolytic therapy. Test results were compared with those of three experienced neuroradiologists. Inter-rater agreement between anaesthesiologists and neuroradiologists was calculated using Cohen's Kappa statistics. Robustness of the results was assessed using the non-parametric bootstrap. RESULTS: Among the neuroradiologists, Kappa was 1 for detecting radiological contraindications for thrombolytic therapy. Twelve of the 13 anaesthesiologists showed good or excellent agreement (Kappa > 0.60) with the neuroradiologists. The anaesthesiologists spent a median time of 2 min and 18 s on each CT scan. CONCLUSIONS: This study suggests that anaesthesiologists who are experienced in pre-hospital care may be quickly trained to assess cerebral CT examinations in acute stroke patients with regard to radiological contraindications for thrombolytic therapy.

Patient selection for intra-arterial cerebral revascularization in acute ischemic stroke.

In acute ischemic stroke, rapid revascularization of the cerebral 'penumbra volume' is the key to better patient outcome. The largest and most proximal cerebral thrombotic artery occlusions can in most cases only be opened by intra-arterial intervention. The use of intra-arterial revascularization is rapidly expanding throughout Europe and North America, despite the risk for serious complications and the fact that the benefit of this treatment has not yet been proven in large, randomized clinical trials. Oslo University Hospital has performed approximately 60 intra-arterial procedures annually in acute ischemic stroke during the last few years. In this paper, we discuss important clinical and ethical aspects learned from our own experience. The future of intra-arterial cerebral revascularization will depend on an accurate preintervention patient selection.