Migraine is a primary headache disorder ... REPORTS... Migraine: Diagnosis, Management, and New Treatment Options

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1 ... REPORTS... Migraine: Diagnosis, Management, and New Treatment Options R. Michael Gallagher, DO; and F. Michael Cutrer, MD Abstract Objective: The safety and tolerability of medications used to treat acute migraine attacks are summarized, the classification of headaches and the causes of and diagnostic criteria for migraine are reviewed, and the clinical tolerability profiles and therapeutic benefits of second-generation triptans are presented. Background: Migraine is a paroxysmal disorder characterized by attacks of headache, nausea, vomiting, photophobia, and phonophobia. Drugs used to prevent migraine and those that effectively treat acute migraine attacks are readily available. Methods: Mild or moderate migraines are often treated with aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, antiemetic drugs, or isometheptene. Triptans (5-HT 1 receptor agonists) are used to treat moderate or severe migraine and when nonspecific medications have been ineffective. Because sumatriptan, the first triptan used, is effective but can induce adverse events, second-generation triptans (zolmitriptan, naratriptan, rizatriptan, and almotriptan) were developed to increase the benefit-to-risk ratio in migraine management. Results: Important pharmacologic, pharmacokinetic, and clinical differences exist among those drugs, but the tolerability profile of the newer triptans is very good, and they provide rapid relief from headache and sustained duration of effect. Conclusion: Primary care physicians must manage migraine patients with treatments that demonstrate a balance between efficacy and tolerability. (Am J Manag Care 2002;8:S58 S73) Migraine is a primary headache disorder characterized by recurring attacks of throbbing (often unilateral) headache, photophobia, phonophobia, nausea, and other symptoms. The headache may be preceded by transient focal neurologic symptoms known as aura. Migraine is the most common primary headache disorder for which patients present to primary care physicians, yet it remains underdiagnosed and undertreated. 1,2 Migraine sufferers are often the most dissatisfied patients; less than 30% of sufferers report that they are very satisfied with their usual migraine treatment. 3,4 Almost two thirds of migraine sufferers experience unwanted side effects from antimigraine treatment. Those patients often delay taking medication, which results in prolonged pain and disability. 5 The prevalence of a family history of migraine suggests that the disorder may have a genetic component. 6 An estimated 6% of men and 15% to 17% of women in the United States experience migraine, but only 3% to 5% of that population receive preventive therapy. 7 The prevalence of migraine increased 60% (from 25.8 to 41 per 1000 population) from 1981 to In addition, 2 studies conducted many years apart indicated that the incidence of migraine in school children has increased. 9 Those data suggest that the prevalence of migraine is increasing with time; however, this increase could be the result of increased awareness of the disorder among physicians and patients. Pathophysiology of Migraine The characteristics of migraine vary in frequency, duration, and the extent of disability produced among sufferers and between attacks. Some migraine patients experience fewer than 1 attack per month, and others suffer from 1 or more attacks S58 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

2 Migraine: Diagnosis, Management, and New Treatment Options per week. 10 Some migraine patients are disabled by their headaches; others are not. Therefore, the care provided to those who suffer from migraine must be stratified by the frequency and severity of the headache and by the resultant level of disability. 11 Abnormalities in blood vessels may be important in the pathogenesis of migraine and the excessive muscle contraction of tension-type headaches, but current research suggests that headaches are produced by abnormalities in the central nervous system (CNS) regulation of blood vessels within pain-producing intracranial meningeal structures. 12,13 Evidence has shown that changes in the level of serotonin precede the changes in blood vessels and muscle tone that occur during chronic headaches. 12 The influence of serotonin on headache may also explain the effectiveness of medications used to treat migraine. The nature of the CNS dysfunction produced in migraine patients is still unclear and may involve spreading depression-like phenomena and the activation of brain stem monoaminergic nuclei that are part of the central autonomic, vascular, and pain-control centers. A proposed mechanism for the generation of migraine is that of local vasodilation of intracranial and extracerebral blood vessels and a consequent stimulation of surrounding trigeminal sensory nervous pain pathways. 13 This activation of the trigeminovascular system is thought to cause the release of vasoactive sensory neuropeptides (substance P, calcitonin gene-related peptide, neurokinin A, and others) that increase the pain response. 13 The activated trigeminal nerves convey nociceptive information to central neurons in the brain stem trigeminal sensory nuclei, which in turn relay the pain signals to higher centers that may become sensitized as a migraine attack progresses. 13 Diagnosis of Migraine International Headache Society Classification. The International Headache Society (IHS) has developed the first classification system for migraine and other types of headaches (Tables 1 and 2). 14,15 Table 1. The International Headache Society Classification of Migraine Migraine without aura Migraine with aura Migraine with typical aura Migraine with prolonged aura Familial hemiplegic migraine Basilar migraine Migraine aura without headache Migraine with acute onset aura Ophthalmoplegic migraine Retinal migraine Childhood periodic syndromes that may be precursors to or associated with migraine Benign paroxysmal vertigo of childhood Alternating hemiplegia of childhood Complications of migraine Status migrainous Migrainous infarction Migrainous disorder not fulfilling above criteria Source: Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988;8 (suppl 7):1-96. Adapted with permission. The IHS user-friendly classification consists of 2 major categories: primary and secondary headaches. Primary headaches (headache disorders in which an identifiable pathologic factor is not present) consist of migraine (with or without aura), tension-type headaches (episodic or chronic), cluster headaches, posttraumatic headaches, and rebound headaches caused by drug use or withdrawal. Secondary headaches are symptoms of organic diseases such as meningitis or cerebral tumors. The IHS classification system provides valuable information about the diagnosis and treatment of headaches, but primary care physicians and neurologists are ultimately responsible for accurate diagnosis and effective treatment. Migraine prodrome (phase 1 or preheadache period), which may occur hours to days before the onset of headache, consists of nonfocal constitutional symptoms and can vary widely among patients. Some feel euphoric, and others may experience irritability or extraordinary fatigue. Migraine post- VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S59

3 REPORTS Table 2. Diagnostic Criteria for Migraine Without Aura A. At least 5 attacks fulfilling the criteria of B to D below B. Headache attacks lasting 4 to 72 hours (untreated or unsuccessfully treated) C. Headache with at least 2 of the following characteristics: 1. Unilateral location 2. Pulsating quality 3. Moderate or severe intensity (inhibits or prohibits daily activities). 4. Intensified when patient walks up or down stairs or performs a similar activity D. During headache, at least 1 of the following must occur: 1. Nausea and/or vomiting 2. Photophobia or phonophobia E. At least 1 of the following must apply: 1. History, physical, and neurologic examinations do not suggest another disorder* 2. History and/or physical and/or neurologic examinations do suggest such a disorder, but it is ruled out by appropriate investigations 3. Such a disorder is present, but migraine attacks do not occur for the first time in close temporal relation to the disorder *Other disorders that may cause headache include head trauma; vascular and neurovascular disorders; substance use or withdrawal; noncephalic infection; metabolic disorder; and disorders of the cranium, neck, eyes, ears, nose, sinuses, teeth, mouth, or other facial or cranial structures. Source: Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988;8(suppl 7):1-96. Adapted with permission. drome appears as the pain wanes, after which the patient feels tired and listless. The clinical diagnosis of migraine without aura requires that the patient experience at least 5 headaches with a duration of 4 to 72 hours. During migraine without aura, unilateral pain of moderate-to-severe intensity seems to pulsate, and patients must experience at least 1 of the following symptoms: nausea, vomiting, photophobia, or phonophobia. 14 Such headaches are often exacerbated by routine physical activity. However, during a migraine, approximately 30% of migraine patients experience an aura (usually visual) that precedes the headache by 5 to 30 minutes, may reflect a wide range of neural deficits, and fades within 30 minutes. It may first be noticed near the visual center as a small spot surrounded by bright, jagged lines. An aura that persists for more than 1 hour may signal an ischemic attack and should be evaluated. 14 Medical History. Obtaining an accurate medical history is the first step in an evaluation for migraine. Information obtained should include the patient s age at first migraine; the site or sites of pain; the frequency, intensity, and duration of pain; the presence of any associated symptom (eg, aura, dizziness); aggravating, precipitating, or ameliorating factors; prior medication use; caffeine intake; prior head trauma; results of neuroimaging studies; and family history. 16 The physician should encourage the patient to keep a headache diary in which the characteristics of each headache and the response to treatment are recorded. That type of diary is also valuable in helping the patient and physician identify factors such as lifestyle, diet, menstrual cycle, and the overuse of medication or caffeine, all of which may precipitate migraine. 16 Physical Examination. After the patient s medical history has been obtained, a physical examination should be performed to evaluate (at the very least) blood pressure, heart rate, extracranial structures (eg, sinuses, scalp arteries, temporomandibular joints), and the range of motion and presence of pain in the cervical spine. 17 Additional laboratory tests and neuroimaging studies should not be necessary unless the physician observes the following danger signals: the sudden onset of a new type of severe headache; headache onset during exertion; first headache in a middle-aged patient; headache accompanied by loss of consciousness or systemic illness (fever, stiff neck, rash); headache associated with meningeal signs; an accelerating pattern of headache; new onset of headache in immunocompromised patients or those with cancer; headache accompanied by signs of disease or focal neurologic symptoms atypical for aura; and papilledema (swelling of the optic disk). 16 In those cases, referral for diagnostic imaging or neurologic testing is appropriate to rule out concomitant illness that may cause headache. Treatment Two types of treatment are available for headaches: abortive (treatment of the S60 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

4 Migraine: Diagnosis, Management, and New Treatment Options acute attack) and prophylactic (prevention of headache by using medication and/or nonpharmacologic measures to lessen precipitating factors, such as stress or lifestyle). Nonpharmacologic Measures of Preventing Migraine. The suggestions below are recommended by a primary care physician for the nonpharmacologic management of migraine. 18 Maintain regular sleeping, eating, and exercise habits. Avoid excessive stress-producing activities. Practice relaxation techniques. Avoid potential triggers such as trauma, caffeine, and certain foods (eg, chocolate, aged cheeses, red wine, foods containing sodium nitrate). Address possible underlying depression or anxiety. Pharmacologic Treatment. Early intervention with appropriate medication can completely abort a migraine so that the patient can function normally and a recurrence is prevented. 19 Simple analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) may be used to treat mild-to-moderate headache or migraine that does not increase in intensity. Triptans (5-HT 1 receptor agonists) are the preferred therapy for moderate-to-severe headaches. In Table 3, therapies recommended by primary care physicians for patients with specific headache patterns are presented. 20,21 During prodrome, many interventions can be effective. Over-the-counter (OTC) or nonprescription products such as NSAIDs, serotonin receptor agonists, aspirin, acetaminophen, or a combination of aspirin and acetaminophen may prevent the headache. 19 If prodromal warning signs do not occur or intervention fails to abort the migraine in its early stage, migraine-specific medications such as triptans are indicated. Headache characterized by photophobia, phonophobia, and/or nausea and vomiting suggests that the neurovascular inflammatory process has begun, and triptan drugs are highly effective when administered early in this phase of migraine. When migraine evolves into an advanced stage (late headache) and first- and secondline treatments have failed, rescue therapy must be considered. Intravenously administered phenothiazines are often effective and can be combined with dihydroergotamine (DHE) or other serotonin agonists. Opioid analgesics are also used to treat late headache. Selecting Pharmacologic Agents Simple Analgesics and NSAIDs. Simple analgesics, which may be used to treat mild-to-moderate acute migraine, are most effective as first-line treatments when used before the pain becomes severe. 22 Aspirin, which is both an analgesic and an NSAID, inhibits prostaglandin and leukotriene synthesis. 23 Acetaminophen can also be used to treat mild-to-moderate acute migraine. 24 Ibuprofen and OTC combination products containing aspirin, acetaminophen, and caffeine have been approved by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate migraine. Patients should be cautioned that the overuse of all treatments for migraine, including triptans and OTC analgesics (especially combination products containing caffeine) may cause rebound headache. 22 Prescription-strength NSAIDs such as ibuprofen, naproxen sodium, and ketoro- Table 3. Medications Prescribed for Headaches by Primary Care Physicians Headache Pattern Mild-to-moderate migraine Moderate or severe migraine; or poor response to NSAIDs and combination medications Migraine associated with severe nausea or vomiting Severe migraine that fails to respond to other treatments NSAIDs = nonsteroidal anti-inflammatory drugs. Source: Reference 27. Suggested Therapy Nonspecific agents (eg, NSAIDs, combination medications) Migraine-specific agents (eg, triptans, dihydroergotamine) Nonoral route of administration Self-administered rescue medication VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S61

5 REPORTS lac are also effective treatments for mildto-moderate migraine. 25 Diclofenac, a prescription-strength NSAID, reduced the intensity of migraine pain and ameliorated associated symptoms such as photophobia and phonophobia in a placebo-controlled, double-blind, randomized clinical trial. 26 If a moderate dose of an NSAID administered at the onset of migraine is not completely effective within 1 hour, a triptan should be given. 21 Cyclo-oxygenase-2 inhibitors may be useful adjuncts for the treatment of migraine. 27 Opioids. Opioids such as intramuscularly or intravenously administered meperidine or orally administered codeine are used because of their analgesic potential but may exacerbate nausea and vomiting and increase the risk of drug addiction. 25 A clinical trial involving patients treated in an emergency department for acute migraine indicated that a combination of meperidine and hydroxyzine reduced headache pain by approximately 55%, ameliorated nausea, and was not statistically significantly different in effect (P <.05) from treatment with a combination of DHE and hydroxyzine. 28 Antiemetics. Antiemetic drugs may be used to treat acute migraine. Orally or intravenously administered metoclopramide, a dopamine antagonist that affects the 5-HT 3 receptor, may provide relief from pain and nausea or vomiting. 29 Patients should be advised that antiemetics often cause adverse events such as diarrhea, drowsiness, or restlessness. Ergot Compounds. Ergot compounds such as ergotamine (ET) or DHE were the first drugs used to treat migraine. 25 Ergot compounds are pharmacologically nonselective but have been used successfully in patients with moderate-to-severe migraine since the turn of the century. Their clinical efficacy is at least equal to that of NSAIDs. 30 They have agonist affinity for several different 5-HT receptors (5-HT 1 A, B, D; 5-HT 2 A, B, C), dopamine receptors (DA 2 ), and alpha-adrenergic receptors. 31 The great number of DHE-binding sites in the dorsal raphe nuclei may precipitate migraine. 32 Suppression of the firing rate of those serotonergic neurons and the subsequent stabilization of serotonergic neurotransmission is thought to be one of the modes of action of ET compounds. 32 ET was first introduced for the treatment of migraine in the 1920s. However, its bioavailability is poor and unpredictable after oral administration. 25 The potent vasoconstrictor effect of ET, which can last for up to 3 days, is undesirable. When compared with ET, DHE is a more potent α-adrenergic antagonist and is therefore a potent vasoconstrictor. DHE is a more potent antiemetic than ET, has less effect on the uterus, and is not associated with rebound headache. 25 Caffeine in combination with analgesics or ET improves the absorption of the medication and also potentiates pain relief, possibly as a result of its vasoconstrictor effect. 25 The combination of ET and caffeine, although effective in only 50% of patients, is a treatment option for acute migraine. 25 The efficacy of ET is enhanced by the addition of pentobarbital and the levorotatory alkaloids of belladonna. Although complete evidence regarding the efficacy of DHE is unavailable, intravenous administration can abort approximately 90% of attacks. 33 In one study, DHE nasal spray significantly reduced the severity of headache. 34 In another double-blind, placebo-controlled study of migraine patients, those who used an intranasal formulation of DHE as opposed to placebo experienced statistically significant migraine resolution (ie, mild or no pain) within 4 hours of taking the drug (70% versus 28%, P <.001). 35 In that study, the most common adverse events associated with intranasal DHE were local, such as rhinitis (21% of patients), nausea (4%), and taste perversion (9%). Patients with ischemic heart disease, a history of myocardial infarction, or clinical signs of coronary artery disease should not take DHE. Ergot compounds should not be prescribed for pregnant patients or those with peripheral vascular disease, hypertension, coronary heart disease, or impaired renal or hepatic function. 25 The adverse events produced by ergots include nausea, acro- S62 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

6 Migraine: Diagnosis, Management, and New Treatment Options paresthesia, ischemia, habituation, and ergot-dependent headache. According to some research, reports of serious adverse events that occurred after recommended doses of DHE were much fewer than those associated with ET, and physical dependence did not occur. 36 The most frequently noted adverse events with the intravenous administration of DHE are nausea, vomiting, and leg cramps. However, after intramuscular or intranasal administration, the incidence of nausea and vomiting is low and concomitant administration of an antiemetic is not warranted. Newer Antimigraine Drugs A new era in antimigraine drugs began in 1973 with efforts to synthesize a more selective 5-HT 1 agonist. Prior research had indicated that serotonin 5-HT (a potent vasoconstrictor and a pain modulator) was a factor in the generation of migraine. 37 Triptan antimigraine agents are serotonergic agonists that act selectively. They cause vasoconstriction by affecting serotonin (5- HT 1B ) receptors in human intracranial arteries and inhibit nociceptive transmission by their effect on 5-HT 1D receptors on peripheral trigeminal sensory nerve terminals in the meninges and central terminal in brain stem sensory nuclei. Those complementary sites of action are the basis of the clinical effectiveness of those 2 types of agonists in treating migraine pain and its associated symptoms. 13 Sumatriptan. In 1991, sumatriptan, a first-generation triptan, was introduced. Sumatriptan produces agonist effects at 3 5-HT receptors (5-HT 1B, 5-HT 1D, and 5- HT 1F ) and weaker effects at other 5-HT 1 receptors. 38 It is about 5-fold more potent at 5-HT 1D receptors than at 5-HT 1A receptors when compared with DHE, which is about 10-fold more potent at 5-HT 1A than at 5-HT 1D receptors. 38 Sumatriptan relieves migraine pain and associated symptoms of nausea, vomiting, photophobia, and phonophobia Second-Generation Triptans. Naratriptan, zolmitriptan, and rizatriptan entered the US market in late 1997 and Almotriptan became available in the United States in 2001, frovatriptan has been approved by the FDA, and FDA approval of eletriptan is pending. It was hoped that those second-generation triptans would be superior in effect to sumatriptan by providing a shorter onset of action after oral administration, a longer half-life, greater oral bioavailability, and improved tolerability. 42 However, current clinical trial data pertaining to 2-hour pain relief and pain-free endpoints suggest that the differences among triptans are subtle rather than dramatic. Some patients found sumatriptan ineffective or difficult to tolerate, especially when administered subcutaneously. Many of those patients benefit from treatment with a newer triptan or with the oral form of sumatriptan. The overall efficacy rates for all orally administered triptans is approximately 65%. 42 However, patients may prefer one treatment as opposed to another. Adverse events associated with triptans include nausea, paresthesia, fatigue, somnolence, dizziness, pain, heaviness or tightness in the chest or throat, warm or cold sensations, and dry mouth. Triptans, like ergot-containing drugs, are contraindicated or prescribed with caution for those with uncontrolled blood pressure, coronary artery disease, or peripheral vascular disease. 39 Naratriptan. Naratriptan is a secondgeneration drug approved for marketing as an oral formulation to abort migraine. The pharmacologic profile of naratriptan is superior to that of sumatriptan; its bioavailability is about 60%, which reduces the effective dose to 2.5 mg. 42 The half-life of naratriptan is about 6 hours (2 to 3 times longer than that of sumatriptan), which seems to slightly lower the percentage of patients who experience recurrent migraine. 43 However, clinical trials indicate that 2.5 mg of naratriptan is less effective than 100 mg of sumatriptan but also produces fewer adverse events. According to 1 study, adverse events produced by naratriptan included vomiting (7% of patients), nausea (7%), and tingling (3%). 41 Adverse VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S63

7 REPORTS events reported in other clinical trials included dizziness, drowsiness, and malaise or fatigue (4% to 7%); paresthesia (2% to 4%); and pain and pressure sensation (2% to 4%). The side effect of chest tightness is not mentioned on the product label, which indicates that a low incidence of chest pain or pressure and throat or neck symptoms are associated with naratriptan. It is important to note that the decreased frequency of chest symptoms associated with that drug does not diminish the importance of alerting patients with active or potential coronary artery disease or cardiac ischemia to their potential occurrence. Zolmitriptan. Zolmitriptan, the next second-generation triptan to enter the market, has an oral bioavailability of approximately 50%, which exceeds that of sumatriptan (14%). 42 In addition, the halflife of zolmitriptan (3 hours) provided a more prolonged therapeutic plasma concentration than did sumatriptan. In a recent study, zolmitriptan was effective in relieving acute migraine 2 hours after administration at an oral dose of 2.5 mg (in 67% of the patients) or 5 mg (in 65%). 44 Patients using zolmitriptan 2.5 mg or 5 mg had a statistically significant 2-hour response rate compared with that of patients using sumatriptan 25 mg (P <.001). When compared with sumatriptan 50 mg, zolmitriptan 2.5 mg also produced a statistically significant 2-hour response (P =.017). The rate of headache recurrence consistently associated with zolmitriptan is about 30%. 45 Adverse events of zolmitriptan, including those affecting the CNS, are similar to those of oral sumatriptan, although zolmitriptan can cross the blood-brain barrier. 42 The most common adverse events caused by zolmitriptan 2.5 mg were nausea (in 8% to 11% of the patients), dizziness (8% to 9%), paresthesia (6%), somnolence (5% to 7%), chest tightness (5%), and vomiting (2%). 46,47 In clinical practice, zolmitriptan 2.5 mg is equivalent to sumatriptan 50 mg. Rizatriptan. Rizatriptan, another second-generation triptan, has an improved pharmacologic profile and an oral bioavailability of about 40%. 40 Its half-life (2.5 to 3 hours) is only slightly longer than that of sumatriptan. Rizatriptan has a more rapid onset (t max < 1 hour) than other triptans currently on the market. 40 In clinical trials, rizatriptan produced pain relief 2 hours after administration at doses ranging from 2.5 to 40 mg; a dose of 10 mg produced the most benefit (52% of patients experienced relief from headache and few adverse events). 40 Common adverse events included dizziness (in 4% of the patients), nausea (3%), somnolence (3%), chest symptoms (2%), and fatigue (1%). As with other triptans, the number of adverse events caused by rizatriptan was dose dependent. Newer Triptans. Eletriptan has an oral bioavailability of almost 50%; it is rapidly absorbed (t max < 1 hour) but has a half-life of 5 hours. 42 In 2 recent multicenter studies, the efficacy and tolerability of eletriptan in acute migraine were examined. In the first study, doses of oral eletriptan 5, 20, or 30 mg were studied in the treatment of acute migraine in 365 patients. 48 Two hours after administration of the drug, relief from headache was reported by 41%, 47%, and 49% of patients who had received eletriptan 5, 20, or 30 mg, respectively. Thirty-five percent of the patients had received placebo. In the second trial, the effect of oral eletriptan 20, 40, or 80 mg was compared with that of sumatriptan 100 mg or placebo in 270 patients. 48 Relief from headache 2 hours after drug administration was reported by 44%, 67%, 80%, and 57% of the patients who had received eletriptan 20, 40, or 80 mg or sumatriptan 100 mg, respectively. In that study, 25% of the patients had received placebo. The adverse events produced by eletriptan were similar to those of sumatriptan. In another study, adverse events from doses of eletriptan 20 or 40 mg were less than those produced by sumatriptan 100 mg. 49 Frovatriptan, another second-generation triptan, has a higher affinity for 5- HT 1B/1D receptors than does sumatriptan. In higher doses, frovatriptan is an agonist S64 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

8 Migraine: Diagnosis, Management, and New Treatment Options of the 5-HT receptors that might cause vasodilation on, for example, coronary vessels. 42 It is absorbed relatively slowly and reaches its t max 2 hours after administration; its pharmacokinetic properties are similar to those of naratriptan. Thus, 2 hours after receiving frovatriptan 2.5 or 5 mg, 38% and 37% of the patients, respectively, reported headache relief. Four hours after they received the drug, 68% and 67% of patients, respectively, reported headache relief. 50 Frovatriptan has a long half-life (> 10 hours); this may result in a lower incidence of headache recurrence, which was reported by 7% to 25% of patients. 51 Prophylaxis Against Migraine The objective of prophylactic treatment of migraine is to reduce the frequency, severity, and/or duration of attacks while keeping adverse events to a minimum. No single prophylactic drug is superior when potential adverse events are also considered. 25 Prophylactic therapy is indicated when patients report that their acute migraines are not adequately controlled or that they often use medication to treat an acute attack (Table 3). Prophylaxis should be considered when nonpharmacologic attempts have failed. 25 Low doses of prophylactic medication should be used at first and slowly titrated upward. 25 Treatment can be administered for 3 months, reassessed before being continued for an additional 6 months or more, and then gradually withdrawn after the frequency of migraine attacks has been decreased. Prophylaxis is also indicated after the diagnosis of comorbid conditions (such as depression) that can be treated with medications effective in the treatment of migraine. 52 Patients with sleep disturbances or depression may benefit most from treatment with a tricyclic antidepressant (eg, amitriptyline, doxepin, nortriptyline, imipramine, protriptyline, desipramine). Those with agitation or bipolar disorder or patients who have terminated their drug therapy may benefit from divalproate sodium. A beta-blocker such as atenolol, nadolol, metoprolol, propranolol, or timolol may be the most effective initial therapy in patients who experience situational anxiety or letdown migraine or in those with hypertension. A calcium channel blocker may be appropriate for patients with peripheral vascular disease or hypertension. Doses of those medications to prevent migraine often are much lower than those used to treat a comorbid disorder. The amine ergot alkaloid methysergide is an effective prophylactic agent in migraine therapy. 53 Although the drug is devoid of α-adrenergic activity, long-term use may result in pleural, pericardial, or retroperitoneal fibrosis. However, those problems can usually be avoided by close medical monitoring and by advising the patient to take a 1-month drug holiday every 6 months. Beta-blocking adrenergic drugs without intrinsic sympathomimetic activity are the only class of beta-blockers effective for the prophylaxis of migraine. 25 Their effect is observed within 4 weeks and seems to increase with time. That group of drugs is particularly useful for treating patients whose attacks are triggered by stress. Propranolol and timolol have been studied in numerous clinical trials and have also been found to be effective. 54 However, the adverse events caused by beta-blocking drugs must be considered before they are prescribed. Propranolol is likely to produce adverse events on the CNS, which may cause physicians to avoid prescribing it. Metoprolol, which has been shown to decrease the number of migraine attacks by 22% to 49%, is a useful alternative to propranolol. A lack of adequate, controlled clinical trials prevents conclusions with respect to the use of atenolol or nadolol as alternatives to propranolol. 25 Valproate, a gamma-aminobutyric acid transaminase inhibitor and activator of glutamic acid decarboxylase, was found to be effective in double-blind, placebo-controlled trials in reducing migraine frequency in at least 48% to 65% of patients; the placebo-treated patients experienced a reduction of 14% to 18%. Unlike other prophylactic agents, valproate reduced the severity and duration of migraine VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S65

9 REPORTS attacks. 55,56 Adverse events of valproate include nausea, tremor, transient hair loss, increase in appetite, and weight gain. Hepatotoxicity was observed in patients treated with valproate who were younger than 2 years of age. Women of childbearing age who consider treatment with valproate must be cautioned about the potential increased risk of spina bifida in the newborn. The tricyclic antidepressant amitriptyline may be effective because of its 5-HT 2 - receptor-blocking and/or calcium-channelblocking effect on cerebral blood vessels and its inhibitory effect on the dorsal raphe nuclei. 57 Amitriptyline, which reduces the frequency and duration of migraine attacks, is superior to placebo and more effective than propranolol in decreasing the severity of migraine attacks. 58,59 However, amitriptyline produces anticholinergic adverse events and causes increased appetite and weight gain. Other tricyclic antidepressants with varying adverse-event profiles can also be tried. The use of calcium antagonists in migraine prophylaxis has been disappointing. 60 The dihydropyridine derivatives nifedipine and nimodipine can actually cause headache. Either verapamil or diltiazem is usually used to prevent migraine only after trials of the more effective betablockers or amitriptyline have failed. According to 1 review, verapamil was 19% to 49% more effective than placebo in decreasing the frequency of migraine attacks. 61 The most common adverse events produced by verapamil are hypertension and constipation. Despite widespread use for treatment of migraine, the results of clinical studies of diltiazem are underwhelming. Tolerability and Safety of Migraine Treatment Some adverse events (particularly nausea) of drugs used to treat migraine can mimic the signs or symptoms of the disorder. It is therefore critical to distinguish drug-induced symptoms from those caused by headache. Nausea, a common symptom of migraine, occurs in 78% of migraine sufferers. Because it is often moderate to severe, nausea contributes to the disability of the patient. 62 It can also interfere with the administration of oral medication. Exacerbation of nausea after the administration of oral medication can indicate either the development of new nausea or a disease-related worsening of nausea, and alternative medications for the treatment of migraine should be explored. Clinical Safety of Dihydroergotamine and Ergotamine. The clinical safety experience with DHE is based on 21 clinical studies; unfortunately, few of those studies had clinical controls, many were open label and unblinded, and most did not compare DHE with placebo. 63 Adverse events were often not documented systematically because the focus of the studies was the efficacy of the medication. No clinical studies evaluated the effects or efficacy of long-term intramuscular administration of DHE, and only a few evaluated the results of repetitive intravenous administration in hospital patients. Although nausea was reported in a number of trials after treatment of migraine with DHE, critical quantitative observations demonstrated that the drug-induced symptom was difficult to differentiate from nausea caused by migraine. Open trials reported few adverse events of DHE. In summary, closed clinical trials and open-label studies suggested that serious adverse events occur very rarely after a recommended dose of DHE has been taken, regardless of the route of administration. 64 The clinical safety experience with ET indicates that it is much more likely than DHE to produce nausea and vomiting, uterine effects, and rebound headache. 63 Most of the adverse events produced by ET were associated with excessive dosage and/or long-term administration. The peripheral vasoconstrictor effect of ET is considerably stronger than that of DHE. When primary care physicians prescribe either DHE or ET, they must be aware that both are safe in the treatment of migraine with or without aura when used in recommended doses and frequencies in adults who have no contraindications to the S66 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

10 Migraine: Diagnosis, Management, and New Treatment Options medications. When compared with ET, DHE causes less arterial constriction and (according to indirect comparisons) less frequent nausea and vomiting. 63 The Quality Standards Subcommittee of the American Academy of Neurology appointed an advisory committee from experts in its headache and facial pain section to review the clinical literature on the appropriate use of DHE and ET in the treatment of migraine. 65 On the basis of that thorough literature review, practice guidelines were formulated to define the limits of ergot use. ET and DHE were found to be safe and effective for the treatment of migraine as long as recommended dosages were not exceeded and high-risk patients (those with uncontrolled hypertension, coronary or peripheral artery disease, thyrotoxicosis, or sepsis) did not receive those drugs. The committee also recommended restricting the use of ET in some instances, because its overuse has been associated with physical and psychological dependence. Drug-dependent patients often experience predictable recurrent and/or rebound headaches, and subsequent medications are required to alleviate the symptoms of withdrawal, such as nausea. None of those symptoms has been associated with DHE. Clinical Safety of Triptans. First- and second-generation triptans represent a breakthrough treatment for patients with acute migraine. However, those drugs cause some degree of coronary vasoconstriction in susceptible patients. 66,67 At therapeutic doses, triptans are unlikely to cause myocardial ischemia in individuals with normal coronary circulation. 66 Although that effect is not clinically significant for patients who do not have coronary artery disease, triptans are contraindicated in those who have or are at risk for that disorder. 66 Adverse-event databases compiled for the triptans show that the risk of lifethreatening cardiovascular events produced by those medications is probably less than 1 in 1 million. 67 The level of risk associated with triptans is actually similar to (or perhaps even better than) that of prescription NSAIDs. 67 The patient s level of risk (rather than the number of risk factors) is the most important factor. 67 Therapeutic gain refers to the proportion of patients who respond to treatment with a drug tested minus the proportion of patients who respond to placebo. A review of 30 clinical trials demonstrated that, 1 hour after administration, subcutaneous sumatriptan 6 mg administered for the acute treatment of migraine resulted in a greater therapeutic gain than did 100 mg of orally administered sumatriptan or 20 mg of intranasal sumatriptan 2 hours after administration. 68 Although 6 mg of subcutaneous sumatriptan is more effective than the other doses and dosage forms mentioned above, it causes more adverse events than does 100 mg of oral sumatriptan, which appears to have the better benefit-to-risk ratio. However, most adverse events produced by the subcutaneous form of the drug were mild and short-lasting, and patients may find that the greater efficacy and quicker onset of action of subcutaneous sumatriptan outweigh the higher incidence of adverse events. 69 Placebo-controlled studies have reported an incidence of chest-related adverse events in up to 4% of patients treated with second-generation triptans, compared with an incidence ranging from less than 1% to 3% in placebo-treated patients. 20 An analysis of safety data indicates that migraine patients seem to have a higher level of risk for cardiovascular events than does the general population; this implies that such events may be associated with the underlying condition rather than the treatment. 70,71 However, those agents should be used with caution in any patient with vascular risk factors. Clinical judgment is key when the decision to use triptans is made. If a patient has ischemic heart disease and uncontrolled high blood pressure, the primary care physician or specialist should not prescribe a triptan. 70 A patient with a family history of heart disease and a high cholesterol level should first receive other medications for migraine treatment before treatment with a triptan is initiated. Safety is indeed a viable concern in the selection of appropriate migraine treat- VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S67

11 REPORTS ment for a patient; however, it is important to recognize that whether the patient can tolerate the drug is also an important (yet separate) issue. It is crucial to approach those 2 distinct characteristics as separate factors in treatment choice. The safety of a drug is of primary importance to ensure that a patient is least likely to experience any serious life-threatening outcomes from treatment. After the safety of treatment has been established, the tolerability of the treatment (ie, the point at which adverse events are sufficiently reduced so that a patient is most likely to continue treatment) becomes an added consideration. Almotriptan Pharmacology, Efficacy, and Tolerability Almotriptan, the most recent 5-HT 1B/1D agonist agent, demonstrates selective and equipotent nanomolar affinity for 5-HT 1B and 5-HT 1D receptors; this mechanism of action is similar to that of sumatriptan. 72 Functional affinity assays indicate that almotriptan has a lower potency than does sumatriptan at the 5-HT 1D receptor and that its potency at the 5-HT 1B receptor is similar to that of rizatriptan and sumatriptan. 72 Almotriptan exhibits 25 times the vasoconstrictor activity of sumatriptan in the human meningeal artery. 72 The oral formulation of almotriptan has the highest bioavailability (70%) among the second-generation triptans; its half-life, however, is 3.0 to 3.7 hours. Almotriptan is rapidly absorbed after an oral dose and reaches a peak plasma concentration of 66.2 ng/ml at 1.38 hours after administration. 73 The plasma elimination half-life of almotriptan is 3.9 hours in healthy volunteers. This may have clinical relevance, especially when compared with sumatriptan s half-life of about 2 hours (regardless of the route of administration). 71 Sumatriptan s shorter half-life may explain its association with recurring headache, which has affected 21% to 57% of patients in trials of both oral and subcutaneous formulations of the drug. 71 Oral almotriptan has a bioavailability of 70%. In contrast, zolmitriptan has an absolute bioavailability of 49%, and sumatriptan has an absolute bioavailability of only 14% Of the approximately 45% of almotriptan that is metabolized, about 27% is metabolized by monoamine oxidase A and 12% by the cytochrome P-450 isozymes CYP 3A4 and 2D6. As a result, almotriptan has no substantial effect on the pharmacokinetics of fluoxetine, which is metabolized by CYP 2D6, or other commonly used drugs such as verapamil or propranolol Moclobemide, a reversible monoamine oxidase-a (MAO-A) inhibitor, modestly decreased the clearance of almotriptan. Thus the lowest available dose of almotriptan should be used in patients treated with MAO-A inhibitors. 79 MAO-A inhibitors dramatically reduce the metabolism of sumatriptan and zolmitriptan; thus concurrent administration of MAO-A inhibitors or the use of sumatriptan or zolmitriptan within 2 weeks of the discontinuation of MAO-A inhibitor therapy is contraindicated. The efficacy of almotriptan was established in 3 multicenter, randomized, double-blind, placebo-controlled trials In those studies, a significantly higher percentage of patients who received either almotriptan 6.25 or 12.5 mg as opposed to placebo experienced pain relief (mild or no pain) 2 hours after treatment. A higher percentage of patients in all 3 studies reported pain relief after treatment with the 12.5-mg dose as opposed to the mg dose. In 2 of those studies, oral almotriptan (as opposed to placebo) produced statistically significant 2-hour pain relief rates (59% versus 34% and 65% versus 33%, respectively), and 1 hour after administration, significant pain relief was also experienced by patients given oral almotriptan as opposed to placebo (36% versus 19%, P =.007; and 34% versus 21%, P =.001). 80,81 In Table 4, the 2-hour painrelief rates after oral almotriptan administration during an initial migraine are summarized. When compared with the results of placebo, oral almotriptan 12.5 mg provided consistent pain relief over the course of 3 consecutive migraine attacks in another double-blind, placebo-controlled study. 82 Although oral almotriptan 12.5 mg also S68 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

12 Migraine: Diagnosis, Management, and New Treatment Options produced pain relief rates similar to those of oral sumatriptan 100 mg in a randomized, double-blind, placebo-controlled clinical study, almotriptan 12.5 mg was associated with a significantly lower incidence of treatment-related adverse events (P <.05). 81 In addition, almotriptan 12.5 mg and sumatriptan 50 mg were compared in a randomized, double-blind trial. 83 Pain relief occurred 2 hours after administration in 58% of patients treated with almotriptan and in 57% of those treated with sumatriptan. However, significantly fewer patients in the almotriptan group (P <.05) experienced treatmentrelated adverse events (9.1% versus 15.5%) and chest symptoms in particular (0.3% versus 2.2%). The tolerability of almotriptan was in most instances similar to that of placebo. In controlled clinical trials, nausea in 2% of the patients was the only adverse event recorded in 2% or more of those treated with almotriptan. 84 Headache was frequently noted when oral almotriptan 6.25 to 25 mg was administered. Infrequent adverse events, all of which were mild and transient in nature, included abdominal cramps, vasodilation, palpitations, tachycardia, dry mouth, diarrhea, vomiting, and dyspepsia. In those trials, the adverse events were similar to those attributed to placebo. 84 Patients who experienced migraineassociated photophobia, phonophobia, nausea, or vomiting at baseline had a decreased incidence of those symptoms after the administration of almotriptan as opposed to placebo. In controlled clinical studies, a total of 2809 patients were treated with almotriptan (527 with 6.25 mg, 1313 with 12.5 mg, and 387 with 25 mg) or sumatriptan (582 with 50 mg). 84 The overall adverse event rates in those studies were 12.4% (those who received placebo), 14% (almotriptan 6.25 mg), 15.4% (almotriptan 12.5 mg), 20.4% (almotriptan 25 mg), and 19.4% (sumatriptan 50 mg). The most common adverse events associated with almotriptan use (at a rate of at least 1% a rate greater than that of placebo) in the controlled studies at the recommended doses of 6.25 or 12.5 mg were headache, dry mouth, nausea, paresthesia, and somnolence. No adverse events in the groups who received the 6.25 or 12.5-mg dose occurred at a rate of 1 or more percentage points higher than that of the placebo group. Dry mouth, paresthesia, and somnolence are adverse events produced by triptans, and nausea and headache are often observed in migraine patients. Other adverse events associated with triptan use, such as asthenia, chest pain, localized pain, palpitation, vasodilation, and dizziness, were not associated with almotriptan administered at recommended doses. For both doses, the only adverse event that occurred in 2% or more of the patients was nausea (2% in those who received almotriptan 12.5 mg). The adverse-event profile for sumatriptan in the studies cited above is consistent with data from other studies of that drug. 85,86 Although the types of adverse events in the almotriptan-treated groups were similar to those observed in the groups treated with sumatriptan, almotriptan 6.25 and 12.5 mg produced lower rates of chest pain and nausea than did sumatriptan 50 mg. Vomiting occurred at a higher rate in the placebo-treated group (1.6%) than in any of the other main treatment groups (all > 1%). Adverse-event rates (particularly for chest pain, nausea, Table 4. Clinical Studies of Oral Almotriptan Demonstrating Pain Relief* in the Treatment of Acute Migraine Placebo Almotriptan Almotriptan Study Author(s) (%) 6.25 mg (%) 12.5 mg (%) Dahlöf et al (n = 80) (n = 166) (n = 164) Dowson (n = 99) (n = 183) Pascual et al (n =176) (n = 374) (n = 370) *Pain relief was noted at 2 hours after administration of the drug for initial headache. P =.002 in comparison with placebo. P.001 in comparison with placebo. P =.025 in comparison with placebo. VOL. 8, NO. 3, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S69

13 REPORTS dizziness, or somnolence) in the groups treated with higher doses of almotriptan (25, 100, or 150 mg) were usually higher than those in the patients who received lower doses of the drug. Conclusions Migraine is an underdiagnosed and undertreated disorder that is experienced most often during peak productive years (25 to 55 years of age). The recently developed IHS criteria for headache classification have provided a uniform case definition that has facilitated epidemiologic research on headaches. The disability caused by headaches has a great effect on individuals and on society, and health interventions are critical to the management of those disorders. Physicians must be aware of the diagnostic criteria for headaches and must be able to prescribe effective therapy in accordance with the patient s possible intolerance of various medications. Primary care physicians are concerned with 2 critical aspects in treating migraine patients. The first is the efficacy of an agent in rapidly relieving headache and preventing recurrence. The second is the knowledge that the agent does not produce harmful adverse events. Therefore, at this stage in the development of triptans used to treat acute migraine, the tolerability and safety of the drug are very important considerations, especially when several agents are now available to relieve headache. In most patients, triptans alleviate migraine pain in 2 hours, regardless of the time of onset. However, the adverse events produced by triptans must be considered by the primary care physician before he or she prescribes a particular drug. Although similar adverse events are produced by triptans as a class, a benefitto-risk ratio must always be considered for each drug in that class. This implies that a particular oral dose of a triptan can produce an excellent therapeutic effect as well as minimal adverse events. As newer, more effective oral triptans are developed, it is hoped that an improved benefit-torisk ratio will also be achieved. Naratriptan appears to produce fewer adverse events than do the other marketed triptans. However, when compared with other triptans, its delayed onset of action is a disadvantage. Almotriptan is characterized by a rapid onset of action, effectiveness over 24 hours with a low recurrence rate of migraine, and few adverse events. It is not contraindicated in patients with severe renal or hepatic impairment. However, because of the potential of 5-HT 1B/1D receptor agonists to cause coronary vasospasm, almotriptan should not be given to patients with documented ischemic or vasospastic coronary artery disease, ischemic heart disease, or uncontrolled hypertension. Low tolerability is not synonymous with improved safety. Almotriptan is well tolerated. Controlled clinical trials of that drug indicate that at therapeutic doses, it causes a lower incidence of chest pain than does sumatriptan, that it produces no dose-related clinically relevant effects on electrocardiographic results, and that (when compared with placebo) it produces a low incidence of somnolence and other CNS effects and has a similar tolerability profile. In clinical trials in which 20,000 migraine attacks occurred in nearly 4000 patients, the dropout rate of almotriptan-treated individuals was very low, and those patients experienced no unanticipated adverse events. Almotriptan should expand the armamentarium of antimigraine drugs available to physicians and patients.... REFERENCES Bartelson JD. Treatment of migraine headaches. Mayo Clin Proc 1999;74: Lipton RB, Stewart WF, von Korff M. Migraine impact and functional disability. Cephalalgia 1995;15(suppl 15): Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: Disability and economic costs. Arch Intern Med 1999;159: Lipton RB, Stewart WF, Simon D. Medical consultation for migraine: Results from the American Migraine Study. Headache 1998;38: Gallagher RM, Kunkel R. Migraine patient concerns affecting compliance: Results from the NHF survey. Headache In press. 6. Goadsby PJ. Current concepts of the pathophysiology of migraine. Neurol Clin 1997;15: S70 THE AMERICAN JOURNAL OF MANAGED CARE FEBRUARY 2002

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