Fortschritte der Neurologie-Psychiatrie
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Fortschr Neurol Psychiatr · May 2004
Review[The value of platelet inhibitors in the secondary prophylaxis of stroke -- a review].
The goal of secondary prophylaxis following cerebral ischemia is a long lasting inhibition of thrombogenesis to prevent recurrent stroke or other vascular events. Platelet inhibitors (PI) according to meta-analyses lead to a relative risk reduction (RRR) of 22 % for vascular events after stroke. The aim of this article is a summary and critical review of all relevant studies and meta-analyses for secondary prevention of stroke and to give a differentiated therapeutic recommendation. ⋯ ASA reduces the RR after TIA/stroke by approximately 13 % and has the same efficacy with less side effects in lower dosages (50 - 325 mg/Tag). Ticlopidine is a reserve drug due to its unfavorable side effect profile (neutropenia, TTP). Clopidogrel is better than ASA (RRR 8.7 %) for vascular patients in preventing another vascular event (stroke, MI, vascular death). This effect is pronounced in patients at high risk for atherothrombotic events such as previous MI, cardiac surgery, or diabetes. Dipyridamole+ASA is better than ASA in patients with TIA/stroke (in indirect comparison also than Clopidogrel) for the secondary prevention of recurrent stroke (RRR 23 %), but not for the prevention of other vascular events. Therefore, Clopidogrel should be primarily given to patients with a high vascular risk (one or more cardiovascular risk factors) or to patients with ASA intolerance. Dipyridamole/ASA should be primarily given to TIA/stroke patients with a lower cardiovascular comorbidity. Studies for the combination of Clopidogrel/ASA (MATCH, CHARISMA) and for the comparison of both combinations (PRoFESS) are underway. At present, the combination of clopidogrel and ASA for cerebrovascular prevention should only be given within controlled studies or as an individual treatment with an accordingly acquired informed consent.
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Fortschr Neurol Psychiatr · May 2004
[Legal decisions of german supreme courts about prescription of drugs for not registered indications ("off-label-use")].
In the medical treatment of patients drugs not registered for this specific indication are often prescribed. This so-called "off-label-use" is an increasing point of discussion and in the past years had to be settled in court more than once. The debate covers some questions, i. e. whether the health insurance funds have to pay for the prescribed "off-label-use" drugs, and who is responsible in case of side-effects. ⋯ The decisions show some changes. According to a recent sentence of the German Supreme Court for Social Law an "off-label" medication to be paid by health insurance funds is only allowed under strong conditions: presence of a life-threatening disease or a disease causing a long term severe impairment of the quality of life, no other medication available, and sufficient data from scientific literature supporting an clinical efficacy of the drug. However, in case of an "off-label" medication the physician is fully responsible for all legal consequences.