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E-Double
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Zomig NS study.......
« on: Sep 20th, 2005, 7:00am » |
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Quote:'Zomig' Nasal Spray Proves Effective in Acute Treatment of Cluster Headache
19.09.2005 09:37:00
ATHENS, Greece, September 19 /PRNewswire/ --
- New Data Support Use of 'Zomig' Nasal Spray as Fast-Acting Treatment to Relieve 'Worst Pain Known to Mankind'
Zolmitriptan ('Zomig') nasal spray is highly effective and well tolerated in the acute treatment of cluster headache,(1) an extremely severe form of headache pain also known as 'suicide headache' due to the excruciating pain it causes. This was the conclusion of data presented for the first time today at the European Federation of Neurological Societies (EFNS) annual congress.(1)
A new clinical study shows that zolmitriptan nasal spray (ZNS) achieved the primary endpoint of headache relief at 30 minutes with significantly higher response compared to placebo (60% ZNS 10mg, 38% ZNS 5mg vs. 21% placebo; p<0.001),(1) demonstrating a reduction from moderate, severe or very severe headache pain to mild or no pain at all.
Conducted at five sites in Germany, Italy and the UK, the study enrolled ninety-two patients, 80 males and 12 females, with a mean age of 42 (ranging from 24 to 61), who suffered from either episodic cluster headache (ECH) or chronic cluster headache (CCH). Patients were randomised into a placebo-controlled, double-blind study protocol. Three attacks were treated with placebo, zolmitriptan 5mg (ZNS5) or zolmitriptan 10mg (ZNS10).
Headache relief at 30 minutes was significantly higher for ZNS10 and ZNS5 in ECH compared to placebo: 80% and 47% vs. 24% (p<0.001), as well as in CCH compared to placebo: 38% and 27% vs. 17% (p<0.001). Headache relief was superior with ZNS10 and ZNS5 compared to placebo from as early as 5 minutes and at every five minute interval up to 30 minutes.
Dr Peter Goadsby, Institute of Neurology, Queen Square, London, the lead investigator of the study, commented, "These results are highly significant when facing the dilemma of how to treat this debilitating type of primary headache disorder. Cluster headache attacks are rapid in onset and patients suffer excruciating pain. Current effective treatments include injection of sumatriptan or inhalation of oxygen, but the fact that zolmitriptan nasal spray has proved effective and well tolerated in cluster headache offers physicians and patients an extremely acceptable alternative for fast-acting reliable relief."
Secondary endpoints of the study included pain-free rate and associated symptom relief (nasal congestion, facial sweating, restlessness and agitation), as well as tolerability compared to placebo. No serious adverse events were reported in either the placebo or zolmitriptan treated groups.
One solution for many headache problems
Other data presented at the EFNS showed that zolmitriptan nasal spray 5mg is effective and well tolerated in adolescents with migraine, with a fast onset of action.(2) Adolescents are a vulnerable patient group with a high unmet need in the availability of acute treatments. This is due to the high placebo response rates in clinical studies involving adolescents, which have made it difficult to demonstrate the efficacy of acute therapies against placebo.
The 1-hour headache response rate in this group of adolescents was 58.1% with zolmitriptan nasal spray compared to 43.3% with placebo (p<0.02); the 2-hour sustained headache response rate was 51.4% with zolmitriptan nasal spray compared to 33.1% with placebo (p<0.01); the 1-hour pain-free rate was 27.7% with zolmitriptan nasal spray compared to 10.2% with placebo (p<0.001).
The common symptoms of migraine: headache pain; nausea; vomiting; sensitivity to light and sound, can result in adolescents' day-to-day lives being dramatically affected. In the case of severe migraine, adolescents can frequently be absent from school, which can have a negative impact on their education.(3)
Patients prefer 'Zomig'
Recent patient preference studies show that in a 'real life' setting, patients who try zolmitriptan nasal spray like it and want to continue using it due to its speed, efficacy and tolerability.(4,5)
The studies show that 60-70% of migraine patients who tried zolmitriptan nasal spray preferred it to their current therapy (often a triptan) due to speed of onset, the need for only one dose per attack and fewer adverse events.(5) As patient preference and treatment satisfaction are vital in influencing patient compliance and treatment outcomes,(6) this data has proven that zolmitriptan nasal spray offers migraine sufferers what they want from their acute treatment.
For more information on cluster headache and migraine please visit the AstraZeneca press office website: www.astrazenecapressoffice.com |
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I can't believe that I have to bang my
Head against this wall again
But the blows they have just a little more
Space in-between them
Gonna take a breath and try again.
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BikerBob
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Re: Zomig NS study.......
« Reply #1 on: Sep 20th, 2005, 7:13pm » |
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I'm surprised that the 1-hour headache response rate was only 58.1% with zolmitriptan nasal spray and that the 1-hour pain-free rate was only 27.7% with zolmitriptan nasal spray.
BB
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Jonny
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Re: Zomig NS study.......
« Reply #2 on: Sep 20th, 2005, 7:17pm » |
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Zomig NS works just as fast as a Trex shot for me.
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It is up to YOU to educate yourself and then help your doctor plan your treatment. If you just sit down in front of your doctor and say "make me better" you are setting yourself up for a great deal of pain.
- Guiseppi
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