This double-blind, placebo-controlled, multicenter, parallel-group study assessed whether subcutaneous sumatriptan administered during the migraine aura would prolong or modify the aura and prevent or delay development of the headache. One hundred seventy-one patients (88 receiving 6 mg sumatriptan, 83 receiving placebo) treated a single attack of migraine with typical aura at home, by self-injection. The median duration of aura following the first injection was 25 minutes for the sumatriptan group and 30 minutes for the placebo group (NS). The aura symptom profile was similar for the two treatment groups. The proportion of patients who developed a moderate or severe headache within 6 hours after dose administration was similar in the two groups--68% among those receiving sumatriptan and 75% among those receiving placebo (NS). Sumatriptan given during the aura did not prolong or alter the nature of the migraine aura and did not prevent or significantly delay headache development.
Two double-blind, randomized, placebo-controlled multicentre studies were carried out to assess the efficacy and tolerability of subcutaneous (s.c.) injections of 1-3 mg and 1-8 mg sumatriptan, respectively, in the acute treatment of migraine. Data are presented from a total of 519 patients. In both studies, the primary endpoint of efficacy was a reduction in headache severity from severe or moderate to mild or no headache. All doses of sumatriptan were significantly more effective than placebo in relieving symptoms, and the response appeared to be dose-related; an effective response to treatment was achieved within 30 min in 73% of patients treated with 6 mg sumatriptan and 80% of patients treated with 8 mg sumatriptan s.c., compared with 22% for placebo. Sumatriptan was well tolerated and the majority of adverse events were mild and transient. The most frequent complaint was irritation and pain at the site of injection. No changes in laboratory values were noted and ECG readings were unaltered by treatment. On the basis of these results, the 6 mg subcutaneous dose has been selected for further evaluation in large-scale studies.
Within this limitation the paediatric measurement option seems to introduce a valuable method for clinical application in paediatric intensive care medicine.
These results verify an insufficient structural quality in palliative care in Lower-Saxony. In the authors' opinion effective improvements can only be achieved by implementing a parallel strategy:improvement of basic knowledge in pain management with sufficient transfer of this knowledge into practice as well as raising the rate of availability of opioid-prescription-forms,and, on the other hand, establishing local palliative-care-teams with nursing and medical expertise with 24/7 on-demand availability to optimize palliative care.
When sufficiently supported at home by palliative experts the number of patients dying at home is reasonably higher than the rate observed under regular conditions. This would also comply with the wishes of most patients who prefer to die in the privacy of their own home. The project data suggest that the concept of SUPPORT should be capable to improve the current state of palliative medicine in other areas of Germany as well.
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