NAUSEA REDUCED IN MIGRAINE PATIENTS FOLLOWING ADMINISTRATION OF DHE-45, STUDY SHOWS
SAN FRANCISCO, June 24 /PRNewswire/ -- In a new study to be presented here this week, nausea and vomiting were significantly reduced in patients with acute migraine following administration of DHE-45(R) (dihydroergotamine mesylate) Injection, USP, manufactured by Sandoz Pharmaceuticals Corp. "In our study, therapy with DHE-45 alone was associated with a significant decrease in nausea and vomiting at 30 and 60 minutes following injection in patients with these complaints," said principal investigator Fred D. Sheftell, M.D., director of the New England Center for Headache in Stamford, Conn. "Our conclusion is that DHE-45 is less associated with nausea than previously thought, and that pre- administering an anti-nauseant is probably unnecessary in most patients." The study is among a wave of new clinical evidence underscoring the significance of the rediscovery of DHE-45 as a serotonin agonist and antagonist, and the data demonstrates that this drug relieves the debilitating symptoms of migraine. The results will be presented here June 25-27 at the 35th Annual Scientific Meeting of the American Association for the Study of Headache.
Nausea and Vomiting Reduced
In the study, 183 patients with acute migraine headache were treated in physician offices with a 1 mg intramuscular injection of DHE-45. No anti-nauseant was used. At the outset, half of the patients had nausea, and vomiting was present in four percent. Within 30 minutes, 64 percent of the patients had no nausea and 99 percent reported no vomiting. Within an hour, nausea was relieved in 75 percent of the patients, and the virtual elimination of vomiting remained the same.
The relief of headache pain was equally dramatic. At the outset of the study, 94 percent of the patients complained of moderate to severe headache pain. Pain disappeared or was reduced to mild pain in nearly half of patients within 30 minutes, and in 78 percent of patients within 60 minutes.
Improved Functional Ability
"We also observed that side effects of fatigue and sedation were more associated with anti-nauseant therapy than with DHE-45 at a ratio of 10 to 1, when compared to a second group of 133 patients who received an anti-nauseant at treatment outset," Dr. Sheftell said. "This is an important observation because fatigue and sedation are the symptoms patients most associate with impaired ability to function." DHE-45 was developed by Sandoz Pharmaceuticals Corp. in the 1940s. The medical community is now rediscovering DHE-45 as a serotonin agonist and antagonist that rapidly eradicates migraine at its source without dependency. DHE-45 was synthesized by Sandoz Pharmaceuticals Corp. to provide an alternative to ergotamine tartrate for patients debilitated by the nausea and vomiting that commonly accompany a migraine attack. DHE-45 differs chemically and functionally from ergotamine tartrate. It provides comparable efficacy, but is easier on the stomach. DHE-45 is currently available as an intravenous and intramuscular injection in the United States. A nasal spray formulation of the drug is now awaiting marketing approval. In Canada, DHE-45 is additionally approved for subcutaneous administration. -0- 6/24/93 /CONTACT: Jill Goodwin of Sandoz Pharmaceuticals Corp., 201-503-5932; Matt Lindley or Maree Gaetani of BBK, 617-734-4400, for Sandoz/
CO: Sandoz Corporation ST: California IN: MTC SU:
DJ -- NE002 -- 5179 06/24/93 09:08 EDT
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|Date:||Jun 24, 1993|
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