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Do you ever have one of those days?. The Ultimate Migraine. A rhetorical look at treatments, research trials, and why having one is such a headache. Overview. Migraines – What are they? What are the symptoms? What causes them? Is there a cure?
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The Ultimate Migraine A rhetorical look at treatments, research trials, and why having one is such a headache
Overview • Migraines – What are they? What are the symptoms? What causes them? Is there a cure? • Treatments – Do they work? Are there side effects? How effective are they? • Clinical Research Trials – Purpose(s); How do they work? Are they a treatment alternative? • Non-Prescription Meds – Are they a valid treatment option? Plus, one company’s success at snowing the public for a bigger piece of the Kopfschmerzen pie.
What is a Migraine? • Recurring headache, mild to severe • Often one-sided, but not always • Characterized by throbbing, pulsating sensations • Usually last from four to 72 hours, though may last a number of days or weeks
Causes • Blood vessels in the head constrict, then dilate • Low neurotransmitter levels may be a factor • Heredity • Age
Types of Migraines • Classic • Common • Hemiplegic • Abdominal • Transformed • Chronic • Probable
Symptoms • Sensitivity to light • Sensitivity to sound • Nausea, with or w/o vomiting • Scotomata (blind spots) • Teichopsia (bright shimmering or wavy lines) • Fortification spectra (zigzag pattern) • Photopsia (flashing lights) • Paresthesias • Visual and/or auditory hallucination
Common Triggers • Certain foods, including cheese, chocolate and processed meats • Smoking and nicotine • Caffeine • Monosodium glutamate • Aspartame • Weather • Allergies • Bright lights incl. Sunlight • Loud noises • High altitudes
Other Headache Types • Tension • Sinus • Acute • Medication Overuse • Hormone • Cluster
Evolution of Medication 1899 Aspirin 1928 Ergots 1974 Antiemetics 1979 NSAIDs 1990s Triptans
Abortive Therapy Treatments • Aspirin – painkiller • Ergot(amine) – suppository • Antiemetic – anti-nausea therapy • NSAID – anti-inflammatory • Triptan – serotonin receptor antagonist
Triptans • Imitrex (sumatriptan succinate) • Amerge (naratriptan hydrochloride) • Zomig (zolmotriptan) • Axert (almotriptan malate) • Relpax (eletriptan hydrobromide) • Maxalt (rizatriptan) • Frova (frovatriptan)
Imitrex • First introduced in 1991 • Revolutionized migraine treatments • Available three ways injection tablets nasal
Imitrex Tablets • 25mg, 50mg, 100mg • Mild, short-lived side effects • No more than 200mg in 24 hrs.
Imitrex Nasal Spray • 20mg • Bad taste common • No more than 40mg in 24 hrs.
Imitrex Injection • 6mg. • Injection site irritation common • Mild side effects • No more than two in 24 hrs.
Preventative Meds • Calcium Channel Blockers • Beta Blockers • Vitamin B2 (riboflavin) • Antidepressants • Anticonvulsants ‘Dopamax’
Rescue Meds/Other • Celebrex (celecoxib capsules) • Vioxx • Midrin (isometheptene mucatate, dichloralphenazone, acetaminophen) • Stadol (butorphanol tartrate)
Clinical Research Trials • Test new drugs and treatments • Provide alternatives to standard treatments • Ensured safety is sought by strict protocol • Risks, therapeutic benefits involved • Informed consent • Phase I, II, III (IV) • Patient progress carefully monitored
Clinical Research Trials, cont. • Placebo • Blind/masked trials, randomization • Rescue Medication • Costs • Criteria, medical or otherwise • Trial results
Non-Prescription Meds • May provide temporary relief • Shorter effects; more pills may be needed • Some doctors this is an unsafe practice. • Overmedication and rebound headaches may result.
Excedrin Migraine • Active ingredients: Aspirin, acetaminophen, caffeine • First non-prescription medication for migraines approved by the FDA • Designed to treat ALL symptoms • One of the least expensive meds • Contains “same enhancing ingredient” as some prescription drugs
More on Excedrin Migraine • Three studies conducted • 1,250 evaluated • After two hours, 59% reported pain diminished or gone. • After six, 79% reported pain as mild or gone. • Placebo patients: 33% saw pain diminish after two hours; 52% reported mild or no pain after six hours
The Problem? Bristol-Meyers Squibb already had an identical product on the market, one that already carried the Excedrin moniker and contained the same active ingredients.
Extra-Strength Excedrin • Active ingredients: aspirin, acetaminophen, caffeine • Same ingredients and amounts as Excedrin Migraine • Indicated for temporary pain relief
Comparison? Is it really that difficult to figure out? (Well, maybe if you’re the FDA!) Vs.
Rhetoric • Television • Magazines • Web • Medical pamphlets
Summation • No two migraines are the same • Symptoms and triggers vary • Variety of treatments available • Non-prescriptions may worsen headaches • Most marketing leans toward women