Migraine and Headache

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Migraine and Headache

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1. Migraine and Headache GJ Gibson 2002/03

5. At least 10 percent of patients have weekly attacks, 20 percent have attacks lasting two to three days. Thus, 5 percent of the general population have at least 18 days of migraine per year, and at least 1 percent have at least 1 day of migraine per week.

7. A recent survey by the WHO rates severe migraine, along with quadriplegia, psychosis, and dementia, as one of the most disabling chronic disorders. This ranking suggests that in the judgement of the WHO, a day with severe migraine is as disabling as a day with quadriplegia.

10. Migraine attacks Frequency: median: 1.5 per month 10%: > 1 per week Duration: median: 1 day 25%: 2 - 3 days

11. Migraine without aura “common migraine” Attacks: 4 - 72 hours Headache > 2 characteristics: unilateral – severe throbbing – increase with activity Associated symptoms > 1: nausea / vomiting photo / phonophobia

12. Menstrual migraine Migraine during menstrual period Menstruation is only a trigger Also other attacks Same as “normal” migraine attack Attacks are only longer Same treatment, but repeated dosing

13. No abnormalities in-between attacks Unpredictability of attacks Myths and misconceptions stress, hysteria, diet, neck, (no) treatment Migraine - problems for patient & physician -

14. Cluster headache - “Horton’s neuralgia” - Intense unilateral (peri)orbital pain Ipsilateral autonomic symptoms (> 1) red eye lacrimation ptosis / miosis eyelid edema nasal congestion / rhinorrhea forehead / facial sweating

15. Cluster headache - “Horton’s neuralgia” - Intense unilateral (peri)orbital pain Ipsilateral autonomic symptoms Urge to move Attack duration = 15 min - 3 hours Frequency up to 8 / day Usually in cluster periods (months) Also in women (often atypical) !

17. Headache > 2 characteristics: bilateral not throbbing not severe no increase with activity No (severe): nausea / vomiting photo / phonophobia “Tension-type headache”

18. Unfortunate, stigmatising term Several headache types ?! Pathophysiology is unknown Stress and tension only secondary role ! “Tension-type headache”

23. “Overuse” Headache Initially infrequent headaches Overuse of acute headache drugs and / or caffeine Chronification up to (nearly) daily headaches

24. “Overuse” headache Headache > 1 day per week History of increase of: days with headache days with acute headache drugs units caffeine per day Headache becomes non-specific and difficult to treat Malaise and cognitive dysfunction

25. “Overuse headache” - withdrawal - Stop all headache drugs and caffeine At least three months ! Withdrawal symptoms (2 weeks) Improvement cognitive function Headache diminishes dramatically Diagnostic characteristics return

26. NB Headache Severe headache in a previously well patient Headaches that disturb sleep, exertional headaches, and late-onset paroxysmal headaches are also more suggestive of an underlying structural lesion, as are headaches accompanied by neurologic symptoms

27. Migraine Classic migrainous headache is a lateralized throbbing headache that occurs episodically following its onset in adolescence or early adult life Migrainous headaches may be lateralized or generalized, may be dull or throbbing, and are sometimes associated with anorexia, nausea, vomiting, photophobia, phonophobia, and blurring of vision They usually build up gradually and may last for several hours or longer

28. Migraine (cont) Focal disturbances of neurologic function may precede or accompany the headaches and have been attributed to constriction of branches of the internal carotid artery Visual disturbances occur quite commonly and may consist of field defects Luminous visual hallucinations

29. Migraine (cont) Patients often give a family history of migraine Attacks may be triggered by: emotional or physical stress lack or excess of sleep missed meals specific foods (e.g.. chocolate) alcoholic beverages menstruation use of oral contraceptives

30. Basilar Artery Migraine Blindness or visual disturbances throughout both visual fields are initially accompanied or followed by dysarthria, disequilibrium, tinnitus, and perioral and distal paresthesias and are sometimes followed by transient loss or impairment of consciousness or by a confusional state This is followed by a throbbing (usually occipital) headache, often with nausea and vomiting

31. Ophthalmoplegic Migraine Lateralized pain - often about the eye - is accompanied by nausea, vomiting, and diplopia due to transient external ophthalmoplegia

32. Rarely... Neurologic or somatic disturbance accompanying typical migrainous headaches becomes the sole manifestation of an attack (“migraine equivalent”) Very rarely, the patient may be left with a permanent neurologic deficit following a migrainous attack

39. Analgesic Drugs Aspirin, acetaminophen, propoxyphene, and codeine are all superior to placebo Effervescent formulations Because gastric stasis often accompanies migraine attacks, metoclopramide enhances the effectiveness of analgesic drugs These drugs occasionally cause tardive dyskinesia which may be irreversible, and patients should be informed of this risk before beginning treatment

40. Analgesic drugs (cont) Two types of combined medications are often used in the treatment of migraine: isometheptene in combination with acetaminophen and dichloralphenazone aspirin in combination with caffeine and butalbital There is no evidence that these preparations are more effective than other analgesics

41. Nonsteroidal Anti-inflammatory Drugs Nonsteroidal anti-inflammatory drugs can be the first choice of treatment for patients with mild-to-moderately-severe migraine attacks Naproxen Aspirin in oral doses of 500 mg Ketorolac

42. Ergot Preparations In controlled trials, ergotamine has proved to be effective in no more than 50 % of patients when given orally, sublingually, rectally, or nasally The addition of caffeine to ergotamine enhances its absorption and possibly its vasoconstrictive activity Ergotamine is best absorbed rectally Metoclopramide may improve the absorption of ergotamine administered orally Contraindicated in patients with coronary artery or peripheral vascular disease

44. Dopamine Antagonists Migraine was relieved in 67 % of patients given a 10 mg intravenous dose of metoclopramide, as compared with 19 % of those given placebo

45. Migraine: Acute Treatment The majority of patients took over-the-counter medications or prescription medications that are not specific for migraine headaches. Only 12,6 % of patients took medications that were specific for migraine; of these, only 4 % took triptans for their headaches

46. Choice of Symptomatic Treatment A simple analgesic or nonsteroidal anti-inflammatory drug is appropriate for mild-to-moderate attacks, and ergotamine or sumatriptan for moderate-to-severe attacks If these treatments fail, metoclopramide, prochlorperazine, or chlorpromazine can be used Acute attacks may by so frequent and the patient’s pain so severe and continuous that hospitalization is required In these cases, dihydroergotamine given intravenously for 3 to 4 days, discontinuation of all other drugs, and amininstration of intravenous fluids may prove effective

47. During acute attacks, many patients find it helpful to rest in a quiet, darkened room until symptoms subside A simple analgesic (e.g.. Aspirin) taken right away often provides relief, but treatment with extracranial vasoconstrictors or other drugs is sometimes necessary

49. triggering factors may include stress, menses, pregnancy and oral contraceptive pills, infection in the head and neck, trauma or surgery, red wine, aged cheeses, vasodilating medications, strong odors, irregular diet or sleep and bright sunlight or flickering lights

72. Triptan Meta-Analysis: background Objective To evaluate the available clinical trial evidence base for oral triptan (5HT1B/1D agonist) drugs and provide a foundation for their use in managing acute migraine. Background Given that seven different triptans are clinically available, physicians need evidence-based guidelines to select the triptans with the highest likelihood of success. Methods Clinical trial databases for randomized and active-controlled studies provided by manufacturers of rizatriptan (Maxalt®), sumatriptan, zolmitriptan, eletriptan, almotriptan, and naratriptan. This independent analysis includes 53 trials with a total of 24,089 patients and is published in the Lancet. Slide 3 Seven different triptans are available to treat acute migraine. Evidence-based guidelines are thus needed to facilitate a clinical decision on which triptan is most appropriate for a particular patient. The similarity of triptan trials renders them amenable to meta-analysis, which provides a foundation for triptans in clinical practice. All manufacturers were asked to provide clinical trial data from their databases pertaining to the relevant triptan that they developed. All companies participated, with the exception of Vernalis (frovatriptan), which declined to do so. Inclusion criteria were randomized, double-blind, placebo-controlled studies. Studies without a control group, or using non-recommended doses, or in selected populations (e.g., adolescents), were excluded from the meta-analysis. Study design: This was a meta-analysis of 53 clinical trials, involving 24,089 patients. The triptans studied included rizatriptan (Maxalt®) (Maxalt®), sumatriptan, naratriptan, zolmitriptan and eletriptan. The primary endpoint in most studies was the proportion of patients who became pain free at 2 hours postdose. Studies had to meet the following inclusion criteria: randomized, double-blind, controlled (placebo or active) clinical trial; treatment of moderate or severe migraine attacks within 8 hours of onset in migraine patients (18-65 years of age) defined according to the International Headache Society criteria; treatment with an oral triptan at a recommended clinical dose; and measurement of the headache on the 4-point pain scale. 76 clinical trials were assessed. 53 met the eligibility criteria and 23 studies were excluded. (Ferrari MD et al. Lancet 2000;358:1668-1675.) Slide 3 Seven different triptans are available to treat acute migraine. Evidence-based guidelines are thus needed to facilitate a clinical decision on which triptan is most appropriate for a particular patient. The similarity of triptan trials renders them amenable to meta-analysis, which provides a foundation for triptans in clinical practice. All manufacturers were asked to provide clinical trial data from their databases pertaining to the relevant triptan that they developed. All companies participated, with the exception of Vernalis (frovatriptan), which declined to do so. Inclusion criteria were randomized, double-blind, placebo-controlled studies. Studies without a control group, or using non-recommended doses, or in selected populations (e.g., adolescents), were excluded from the meta-analysis. Study design: This was a meta-analysis of 53 clinical trials, involving 24,089 patients. The triptans studied included rizatriptan (Maxalt®) (Maxalt®), sumatriptan, naratriptan, zolmitriptan and eletriptan. The primary endpoint in most studies was the proportion of patients who became pain free at 2 hours postdose. Studies had to meet the following inclusion criteria: randomized, double-blind, controlled (placebo or active) clinical trial; treatment of moderate or severe migraine attacks within 8 hours of onset in migraine patients (18-65 years of age) defined according to the International Headache Society criteria; treatment with an oral triptan at a recommended clinical dose; and measurement of the headache on the 4-point pain scale. 76 clinical trials were assessed. 53 met the eligibility criteria and 23 studies were excluded. (Ferrari MD et al. Lancet 2000;358:1668-1675.)

73. Relief of Migraine Pain Slide 4 rizatriptan (Maxalt®) (Maxalt®) 10 mg relieved migraine pain in 69% of patients within 2 hours. This slide shows headache relief for 2 hours for the triptans considered. The recommended initial doses as described in European prescribing information, as well as the standard comparator in the meta-analysis (sumatriptan 100 mg), are compared on slides. All bars shown (95% CI) are calculated or adapted from figures in the published article. Headache relief = improvement to mild or no pain two hours postdose.Slide 4 rizatriptan (Maxalt®) (Maxalt®) 10 mg relieved migraine pain in 69% of patients within 2 hours. This slide shows headache relief for 2 hours for the triptans considered. The recommended initial doses as described in European prescribing information, as well as the standard comparator in the meta-analysis (sumatriptan 100 mg), are compared on slides. All bars shown (95% CI) are calculated or adapted from figures in the published article. Headache relief = improvement to mild or no pain two hours postdose.

74. Freedom from Migraine Pain Slide 5 rizatriptan (Maxalt®) (Maxalt®) 10 mg eliminated migraine pain in 40% of patients within 2 hours. According to the authors, freedom from pain at two hours “has become the preferred and clinically most relevant primary endpoint.” It is also easily definable and highly clinically relevant to the patient. Pain free = improvement to no pain two hours postdose.Slide 5 rizatriptan (Maxalt®) (Maxalt®) 10 mg eliminated migraine pain in 40% of patients within 2 hours. According to the authors, freedom from pain at two hours “has become the preferred and clinically most relevant primary endpoint.” It is also easily definable and highly clinically relevant to the patient. Pain free = improvement to no pain two hours postdose.

75. Slide 6 With one dose of rizatriptan (Maxalt®) (Maxalt®) 10 mg, 25% of patients maintained freedom from migraine pain over 24 hours. This composite measurement required patients to take only one dose of their triptan to achieve freedom from pain at 2 hours after treating an acute attack, not to suffer headache recurrence through 24 hours, and to use no additional medication during this same period postattack. The authors recommend this endpoint (sustained freedom from pain), and not recurrence, as the more reliable measurement of sustained efficacy. In fact, recurrence may be an unreliable endpoint, as it does not account for differences in initial headache relief rates and use of rescue medication. Slide 6 With one dose of rizatriptan (Maxalt®) (Maxalt®) 10 mg, 25% of patients maintained freedom from migraine pain over 24 hours. This composite measurement required patients to take only one dose of their triptan to achieve freedom from pain at 2 hours after treating an acute attack, not to suffer headache recurrence through 24 hours, and to use no additional medication during this same period postattack. The authors recommend this endpoint (sustained freedom from pain), and not recurrence, as the more reliable measurement of sustained efficacy. In fact, recurrence may be an unreliable endpoint, as it does not account for differences in initial headache relief rates and use of rescue medication.

76. Consistency of Migraine Treatment Slide 7 rizatriptan (Maxalt®) (Maxalt®) 10 mg provided superior consistency compared to all other triptans, with 86% of patients experiencing headache relief within 2 hours in at least 2 out of 3 migraine attacks. These trends remain consistent when you look at meta-analysis data for 3 out of 3 attacks, where 60% of patients taking rizatriptan (Maxalt®) (Maxalt®) 10 mg achieve headache relief across all 3 attacks. While it is desirable that a treatment should work well on a single attack, what is more important in clinical practice is that medicines should perform reliably, attack after attack after attack. Intra-patient consistency is one method of assessing the likelihood of whether the medicine is going to perform well in a reliable fashion. These studies are not comparative. The study designs varied slightly from one study to another; however, the authors did not consider these slight differences in design to be clinically important. No intra-patient consistency data were available for zolmitriptan in the meta-analysis publication.Slide 7 rizatriptan (Maxalt®) (Maxalt®) 10 mg provided superior consistency compared to all other triptans, with 86% of patients experiencing headache relief within 2 hours in at least 2 out of 3 migraine attacks. These trends remain consistent when you look at meta-analysis data for 3 out of 3 attacks, where 60% of patients taking rizatriptan (Maxalt®) (Maxalt®) 10 mg achieve headache relief across all 3 attacks. While it is desirable that a treatment should work well on a single attack, what is more important in clinical practice is that medicines should perform reliably, attack after attack after attack. Intra-patient consistency is one method of assessing the likelihood of whether the medicine is going to perform well in a reliable fashion. These studies are not comparative. The study designs varied slightly from one study to another; however, the authors did not consider these slight differences in design to be clinically important. No intra-patient consistency data were available for zolmitriptan in the meta-analysis publication.

77. Consistency of Migraine Treatment Slide 8 Again, rizatriptan (Maxalt®) (Maxalt®) 10 mg provided excellent consistency, with 48% of patients eliminating pain within 2 hours in at least 2 out of 3 migraine attacks. Remember that the authors cite pain free at two hours as “preferred and clinically most relevant.” Slide 8 Again, rizatriptan (Maxalt®) (Maxalt®) 10 mg provided excellent consistency, with 48% of patients eliminating pain within 2 hours in at least 2 out of 3 migraine attacks. Remember that the authors cite pain free at two hours as “preferred and clinically most relevant.”

78. Tolerability and Safety Profile All oral triptans in the meta-analysis were well tolerated. “No triptan was demonstrably safer than the others.” Safety can only be reliably assessed after large-scale and long-term clinical exposure. Slide 9 It is important to first note that this class of drugs is generally well tolerated. Also, some reported AEs in clinical trials are related to migraine symptoms (e.g., headache, nausea, and vomiting, which are migraine symptoms, may be reported as AEs in studies). With regard to safety, the primary concern with all triptans has historically been related to their potential for coronary vasoconstriction. However, the meta-analysis authors cite that the usual mechanism is not myocardial ischemia and, when patients are warned about such symptoms, they rarely cause problems. It is also important to consider, as the authors cite, that no triptan should be used in patients with cardiovascular disease or major risk factors. Finally, the meta-analysis authors cite that “no triptan was demonstrably safer than the others.” Hence, no triptan can make a claim regarding being “safer” than any other triptan. For full information on any product, please consult the local product circular.Slide 9 It is important to first note that this class of drugs is generally well tolerated. Also, some reported AEs in clinical trials are related to migraine symptoms (e.g., headache, nausea, and vomiting, which are migraine symptoms, may be reported as AEs in studies). With regard to safety, the primary concern with all triptans has historically been related to their potential for coronary vasoconstriction. However, the meta-analysis authors cite that the usual mechanism is not myocardial ischemia and, when patients are warned about such symptoms, they rarely cause problems. It is also important to consider, as the authors cite, that no triptan should be used in patients with cardiovascular disease or major risk factors. Finally, the meta-analysis authors cite that “no triptan was demonstrably safer than the others.” Hence, no triptan can make a claim regarding being “safer” than any other triptan. For full information on any product, please consult the local product circular.

79. Slide 10 rizatriptan (Maxalt®) (Maxalt®) 10 mg shows a consistently high level of efficacy across all endpoints shown here. And, if we go back to Lipton et al. in Headache, efficacy is clearly the highest priority for a patient. Patients experiencing a migraine attack want to be pain free, they want to remain pain free, and they want it fast.Slide 10 rizatriptan (Maxalt®) (Maxalt®) 10 mg shows a consistently high level of efficacy across all endpoints shown here. And, if we go back to Lipton et al. in Headache, efficacy is clearly the highest priority for a patient. Patients experiencing a migraine attack want to be pain free, they want to remain pain free, and they want it fast.

85. Distinguishing between migraine without aura and episodic tension headache is difficult, and it is uncertain whether migraine with aura and migraine without aura are the same disorder as far as treatment is concerned

86. Preventive Migraine Therapy in addition to Acute Treatment? The consensus at this time is when the disability is sufficient to disrupt normal function Two severe disabling headaches per month not relieved with acute abortive treatment are sufficient to warrant preventive medication 8 mild to moderate headaches per month that are easily relieved by distraction, mild medication that does not create rebound headaches, or change of lifestyle would not necessarily warrant preventive medications

87. Prevention of Migraine Preventive treatment should be considered only when: attacks of migraine occur more than 2/3 times a month attacks are severe and limit normal activity the patient is unable to cope with the attacks symptomatic therapies have failed or had serious side effects attempts at nonpharmacologic prevention have failed

88. Prevention of migraine (cont) Each medication should be given for an adequate time to judge its effectiveness For patients with frequent migraine, this period is usually 2 to 3 months Preventive medication is usually continued for 6 months or longer and gradually withdrawn after the frequency of headaches diminishes 5-HT-influencing drugs: methysergide and amitriptyline

92. Beta-Adrenergic Antogonists Numerous clinical trials have shown that beta-adrenergic-antagonist drugs are effective in preventing migraine They should be considered the treatment of choice for patients whose attacks of migraine are related to stress Are effective in no more than 65 % of patients

93. Hormonal Therapy Menstrual migraine, defined as an attack occurring in association with menses, is frequently refractory to treatment May benefit from preventive treatment - for example, propranolol or amitriptyline - limited to the time of their menses Percutaneous estradiol gel, applied just before and throughout menses, has reduced the frequency of headaches

94. Hormonal therapy (cont) For woman already taking estrogen who have frequent migraine attacks, it may be beneficial either to stop or to increase the hormones Treatment strategies are aimed at preventing either a decrease or a substantial fluctuation in serum estrogen levels

95. New strategy? complete prophylaxis for an average of 4.1 months duration after the injection of botulinum toxin type A (Botox®) into the facial and scalp musculature (additional 38 % obtained a partial response)

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