DOCSLIB.ORG

Pharmacologic Treatment for Episodic Migraine Prevention in Adults

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmacologic Treatment for Episodic Migraine Prevention in Adults SPECIAL ARTICLE Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society S.D. Silberstein, MD, ABSTRACT FACP Objective: To provide updated evidence-based recommendations for the preventive treatment of S. Holland, PhD migraine headache. The clinical question addressed was: What pharmacologic therapies are F. Freitag, DO proven effective for migraine prevention? D.W. Dodick, MD Methods: The authors analyzed published studies from June 1999 to May 2009 using a struc- C. Argoff, MD tured review process to classify the evidence relative to the efficacy of various medications avail- E. Ashman, MD able in the United States for migraine prevention. Results and Recommendations: The author panel reviewed 284 abstracts, which ultimately Correspondence & reprint yielded 29 Class I or Class II articles that are reviewed herein. Divalproex sodium, sodium val- requests to American Academy of proate, topiramate, metoprolol, propranolol, and timolol are effective for migraine prevention and Neurology: [email protected] should be offered to patients with migraine to reduce migraine attack frequency and severity (Level A). Frovatriptan is effective for prevention of menstrual migraine (Level A). Lamotrigine is ineffective for migraine prevention (Level A). Neurology® 2012;78:1337–1345 GLOSSARY AAN ϭ American Academy of Neurology; AE ϭ adverse event; CI ϭ confidence interval; ER ϭ extended-release; MAM ϭ menstrually associated migraine; PMP ϭ perimenstrual period; RCT ϭ randomized controlled trial. Epidemiologic studies suggest approximately 38% ineffective for treatment of episodic migraine. A new of migraineurs need preventive therapy, but only guideline is in development. An updated guideline 3%–13% currently use it.1 In 2000, the American on nonsteroidal anti-inflammatory drugs5 and com- Academy of Neurology (AAN) published guide- plementary alternative treatments has been approved lines for migraine prevention.2,3 Since then, new for publication as a companion to this guideline.5 clinical studies have been published on the efficacy and safety of migraine preventive therapies. This DESCRIPTION OF THE ANALYTIC PROCESS See page 1346 guideline seeks to assess this new evidence to an- The AAN and the American Headache Society partic- swer the following clinical question: For patients ipated in the development process. An author panel of headache and methodologic experts was assembled to Supplemental data at with migraine, which pharmacologic therapies are www.neurology.org proven effective for prevention, as measured by review the evidence. Computerized searches of the reduced migraine attack frequency, reduced num- MEDLINE, PsycINFO, and CINAHL databases iden- Supplemental Data ber of migraine days, or reduced attack severity? tified new studies (published in English). The search This article addresses the safety and efficacy of strategy used the MeSH term “headache” (exploded) pharmacologic therapies for migraine prevention. and a published search strategy for identifying ran- Separate guidelines are available for botulinum domized controlled trials (RCTs) published between toxin.4 The 2008 guideline included a Level B re- June 1999 and May 2007. Additional MEDLINE Podcast commendation that botulinum toxin was probably searches revealed studies published through May From Thomas Jefferson University (S.D.S.), Jefferson Headache Center, Philadelphia, PA; the Armstrong Atlantic State University (S.H.), Savannah, GA; Comprehensive Headache Center (F.F.), Baylor University Headache Medicine Center, Dallas, TX; Mayo Clinic (D.D.), Scottsdale, AZ; New York University School of Medicine (C.A.), Albany; and Elmendorf Air Force Base (E.A.), AK. CME Appendices e-1–e-5, reference e1, and tables e-1 and e-2 are available on the Neurology௡ Web site at www.neurology.org. Approved by the Quality Standards Subcommittee on February 19, 2011; by the Practice Committee on June 19, 2011; by the AHS Board of Directors on March 29, 2012; and by the AAN Board of Directors on January 27, 2012. Study funding: This guideline was developed with financial support from the American Academy of Neurology and the American Headache Society. None of the authors received reimbursement, honoraria, or stipends for their participation in development of this guideline. Go to Neurology.org for full disclosures. Disclosures deemed relevant by the authors, if any, are provided at the end of this article. Copyright © 2012 by AAN Enterprises, Inc. 1337 Table 1 Classification of migraine preventive therapies (available in the United States) Level A: Medications Level B: Medications Level C: Medications Level U: Inadequate Other: Medications that with established are probably are possibly or conflicting data are established as efficacy (>2 Class I effective (1 Class I effective (1 Class II to support or refute possibly or probably trials) or 2 Class II studies) study) medication use ineffective Antiepileptic drugs Antidepressants/ ACE inhibitors Carbonic anhydrase Established as not SSRI/SSNRI/TCA Lisinopril inhibitor effective Divalproex sodium Amitriptyline Angiotensin receptor Acetazolamide Antiepileptic drugs blockers Sodium valproate Venlafaxine Candesartan Antithrombotics Lamotrigine Topiramate ␤-Blockers ␣-Agonists Acenocoumarol Probably not effective ␤-Blockers Atenolola Clonidinea Coumadin Clomipraminea Metoprolol Nadolola Guanfacinea Picotamide Possibly not effective Propranolol Triptans (MRMb) Antiepileptic drugs Antidepressants Acebutolola SSRI/SSNRI Timolola Naratriptanb Carbamazepinea Fluvoxaminea Clonazepama Triptans (MRMb) Zolmitriptanb ␤-Blockers Fluoxetine Nabumetonea Frovatriptanb Nebivolol Antiepileptic drugs Oxcarbazepine Pindolola Gabapentin Telmisartan Antihistamines TCAs Cyproheptadine Protriptylinea ␤-Blockers Bisoprolola Caϩϩ blockers Nicardipinea Nifedipinea Nimodipine Verapamil Direct vascular smooth muscle relaxants Cyclandelate Abbreviations: ACE ϭ angiotensin-converting-enzyme; MRM ϭ menstrually related migraine; SSNRI ϭ selective serotonin– norepinephrine reuptake inhibitor; SSRI ϭ selective serotonin reuptake inhibitor; TCA ϭ tricyclic antidepressant. a Classification based on original guideline and new evidence not found for this report. b For short-term prophylaxis of MRM. 2009, which were reviewed and included as supple- • Assessed the efficacy of therapeutic agents for mental articles. headache other than episodic migraine in adults Studies of pharmacologic agents available in the • Assessed acute migraine treatment, migraine United States were included in the analysis if they aura treatment/prevention, or nonpharmaco- randomized adult patients with migraine to the agent logic treatments (e.g., behavioral approaches) under study or a comparator drug (including placebo) • Used quality of life measures, disability assess- and utilized masked outcome assessment. At least 2 ment, or nonstandardized outcomes as primary panelists independently reviewed each study and rated efficacy endpoints it according to the AAN therapeutic classification of ev- • Tested the efficacy of drugs not available in the idence scheme (appendix e-3 on the Neurology® Web United States site at www.neurology.org). Differences in ratings were resolved by author panel discussion. Since the 2000 guideline publication, the AAN revised its evidence classification criteria to in- ANALYSIS OF EVIDENCE The original search clude study completion rates. Studies with com- identified 179 articles. A supplemental search pletion rates below 80% were downgraded; several (2007–2009) yielded 105 additional articles. Of the studies in the original guideline have thus been total 284 articles, 29 were classified as Class I or Class downgraded. II and are reviewed herein. Studies were excluded if We found no new Class I or II studies published they: for acebutolol, atenolol, bisoprolol, carbamazepine, 1338 Neurology 78 April 24, 2012 clonazepam, clonidine, clomipramine, fluvoxamine, 500–1,000 mg/day had a mean reduction in 4-week guanfacine, nabumetone, nadolol, nicardipine, ni- migraine headache rate from 4.4/week (baseline) to fedipine, or protriptyline. Recommendations for 3.2/week (Ϫ1.2 attacks/week) in the ER divalproex so- these agents are based on the evidence reviewed in dium group and from 4.2/week to 3.6/week (Ϫ0.6 the original guideline (see table 1). Currently, no attacks/week) in the placebo group (CI 0.2–1.2; Class I or Class II studies exist for anticoagulants p ϭ 0.006).9 No significant differences were de- (limited Class III and IV studies were identified; ta- tected between groups in the number of ble 1 includes anticoagulants). treatment-emergent AEs. Clinical context. In most headache trials, patients Angiotensin receptor blockers and angiotensin- taking divalproex sodium or sodium valproate re- converting-enzyme inhibitors. In the 2000 guide- line, there were no studies testing the efficacy of ported no more AEs than those on placebo. How- angiotensin receptor blockers or angiotensin- ever, weight gain has been clinically observed with divalproex sodium long-term use.9,10 Treatment with converting-enzyme (ACE) inhibitors for migraine these agents requires careful follow-up and testing prevention. Since that publication, 3 reports have because of pancreatitis, liver failure, and teratogenic- been published. ity risks.11 Candesartan. In a Class II crossover study (12-week Gabapentin. Since the 2000 publication, a Class
Load more

Recommended publications
  • What Are the Acute Treatments for Migraine and How Are They Used?
    2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”.
    [Show full text]
  • Pharmacokinetics, Pharmacodynamics and Drug
    pharmaceutics Review Pharmacokinetics, Pharmacodynamics and Drug–Drug Interactions of New Anti-Migraine Drugs—Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies Danuta Szkutnik-Fiedler Department of Clinical Pharmacy and Biopharmacy, Pozna´nUniversity of Medical Sciences, Sw.´ Marii Magdaleny 14 St., 61-861 Pozna´n,Poland; [email protected] Received: 28 October 2020; Accepted: 30 November 2020; Published: 3 December 2020 Abstract: In the last few years, there have been significant advances in migraine management and prevention. Lasmiditan, ubrogepant, rimegepant and monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) are new drugs that were launched on the US pharmaceutical market; some of them also in Europe. This publication reviews the available worldwide references on the safety of these anti-migraine drugs with a focus on the possible drug–drug (DDI) or drug–food interactions. As is known, bioavailability of a drug and, hence, its pharmacological efficacy depend on its pharmacokinetics and pharmacodynamics, which may be altered by drug interactions. This paper discusses the interactions of gepants and lasmiditan with, i.a., serotonergic drugs, CYP3A4 inhibitors, and inducers or breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) inhibitors. In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR). Keywords: migraine; lasmiditan; gepants; monoclonal antibodies; drug–drug interactions 1. Introduction Migraine is a chronic neurological disorder characterized by a repetitive, usually unilateral, pulsating headache with attacks typically lasting from 4 to 72 h.
    [Show full text]
  • Current and Prospective Pharmacological Targets in Relation to Antimigraine Action
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Erasmus University Digital Repository Naunyn-Schmiedeberg’s Arch Pharmacol (2008) 378:371–394 DOI 10.1007/s00210-008-0322-7 REVIEW Current and prospective pharmacological targets in relation to antimigraine action Suneet Mehrotra & Saurabh Gupta & Kayi Y. Chan & Carlos M. Villalón & David Centurión & Pramod R. Saxena & Antoinette MaassenVanDenBrink Received: 8 January 2008 /Accepted: 6 June 2008 /Published online: 15 July 2008 # The Author(s) 2008 Abstract Migraine is a recurrent incapacitating neuro- (CGRP1 and CGRP2), adenosine (A1,A2,andA3), glutamate vascular disorder characterized by unilateral and throbbing (NMDA, AMPA, kainate, and metabotropic), dopamine, headaches associated with photophobia, phonophobia, endothelin, and female hormone (estrogen and progesterone) nausea, and vomiting. Current specific drugs used in the receptors. In addition, we have considered some other acute treatment of migraine interact with vascular receptors, targets, including gamma-aminobutyric acid, angiotensin, a fact that has raised concerns about their cardiovascular bradykinin, histamine, and ionotropic receptors, in relation to safety. In the past, α-adrenoceptor agonists (ergotamine, antimigraine therapy. Finally, the cardiovascular safety of dihydroergotamine, isometheptene) were used. The last two current and prospective antimigraine therapies is touched decades have witnessed the advent of 5-HT1B/1D receptor upon. agonists (sumatriptan and second-generation triptans), which have a well-established efficacy in the acute Keywords 5-HT. Antimigraine drugs . CGRP. treatment of migraine. Moreover, current prophylactic Noradrenaline . Migraine . Receptors treatments of migraine include 5-HT2 receptor antagonists, Ca2+ channel blockers, and β-adrenoceptor antagonists. Despite the progress in migraine research and in view of its Introduction complex etiology, this disease still remains underdiagnosed, and available therapies are underused.
    [Show full text]
  • Headache: Clinical Syndromes, Pathophysiology and Management
    HEADACHE: CLINICAL SYNDROMES, PATHOPHYSIOLOGY AND MANAGEMENT Joanna G Katzman, M.D., MSPH Assistant Professor UNM Pain Center and ECHO Pain University of New Mexico Health Sciences Center 11/14/13 After this session, participants will be able to identify and treat various non-migraine headache syndromes, including: Medication Overuse Cluster Tension Ominous (PTC, Meningitis. SAH) CLINICAL HEADACHE SYNDROMES 1. Migraine Headache 2. Cluster Headache 3. Tension-type Headache 4. Benign Intracranial Hypertension 5. Trigeminal Neuralgia 6. Cranial Arteritis 7. Subarachnoid Hemorrhage MIGRAINE PATHOPHYSIOLOGY Migraine Aura Spreading depression in the cortex Release of Potassium Release of glutamate The Trigeminovascular Theory Adapted from Lancet 1998;351:1045 MIGRAINE PATHOPHYSIOLOGY Pain Syndrome Trigeminal nucleus activated Calcitonin gene – related peptide (CGRP) released by trigeminal nerve CGRP release causes vasodilation Plasma protein extravasation causes sterile inflammation in the dura matter MIGRAINE HEADACHE COMMON 1. No aura 2. With nausea, vomiting, photophobia 3. Sleep alleviates symptoms 4. Familial history likely 5. Unilateral, throbbing quality of pain MIGRAINE HEADACHE CLASSICAL 1. With visual aura, such as scintillating scotoma or fortification spectra – thought to represent neuronal spreading depression within the occipital lobe 2. The remainder of clinical presentation is the same as with common migraine MIGRAINE HEADACHE COMPLICATED 1. Involves significant neurological deficits 2. Recovery may take hours to
    [Show full text]
  • Antiepileptic Drugs in Migraine Prophylaxis
    P1: KWW/KKL P2: KWW/HCN QC: KWW/FLX T1: KWW GRBT050-57 Olesen- 2057G GRBT050-Olesen-v6.cls July 25, 2005 16:28 ••Chapter 57 ◗ Antiepileptic Drugs in Migraine Prophylaxis Stephen D. Silberstein and Peer Tfelt-Hansen Migraine and epilepsy are both chronic, believed to result Therapeutic Use from brain hyperexcitability, and the therapeutic agents Carbamazepine (Tegretol), 600 to 1200 mg a day effective for each disorder overlap (1). These disorders are (beginning at 100 mg twice a day), is occasionally used, linked by their symptom profiles, comorbidity, and treat- particularly for patients who have coexisting mania or hy- ment (1,34,41). Each disorder provides a rationale for us- pomania, especially if there is rapid cycling. Monitor car- ing drugs that suppress neuronal excitability in migraine bamazepine plasma levels and white blood counts. prevention. Antiepileptic medication is recommended for migraine prevention because placebo-controlled, double-blind trials Clonazepam prove them effective (22,25,37,46,58). Despite the earlier Clonazepam was studied in one placebo-controlled belief that they are more effective in children who have crossover trial (58) of 34 patients. Those completing paroxysmal electroencephalograms (44), they are effective 4 weeks’ treatment (1 mg daily) had their mean headache regardless of the electroencephalogram (43). With the ex- days per month reduced by 50% compared with an 8% re- ception of valproic acid and topiramate, many anticon- duction for patients receiving placebo (p <0.05). The effect vulsants interfere with the efficacy of oral contraceptives was less at 2 mg daily. Drowsiness was a problem. (7,19). Gabapentin ANTIEPILEPTIC DRUGS Gabapentin’s mode of action in migraine is unclear (66).
    [Show full text]
  • Migraine Headache Prophylaxis Hien Ha, Pharmd, and Annika Gonzalez, MD, Christus Santa Rosa Family Medicine Residency Program, San Antonio, Texas
    Migraine Headache Prophylaxis Hien Ha, PharmD, and Annika Gonzalez, MD, Christus Santa Rosa Family Medicine Residency Program, San Antonio, Texas Migraines impose significant health and financial burdens. Approximately 38% of patients with episodic migraines would benefit from preventive therapy, but less than 13% take prophylactic medications. Preventive medication therapy reduces migraine frequency, severity, and headache-related distress. Preventive therapy may also improve quality of life and prevent the progression to chronic migraines. Some indications for preventive therapy include four or more headaches a month, eight or more headache days a month, debilitating headaches, and medication- overuse headaches. Identifying and managing environmental, dietary, and behavioral triggers are useful strategies for preventing migraines. First-line med- ications established as effective based on clinical evidence include divalproex, topiramate, metoprolol, propranolol, and timolol. Medications such as ami- triptyline, venlafaxine, atenolol, and nadolol are probably effective but should be second-line therapy. There is limited evidence for nebivolol, bisoprolol, pindolol, carbamazepine, gabapentin, fluoxetine, nicardipine, verapamil, nimodipine, nifedipine, lisinopril, and candesartan. Acebutolol, oxcarbazepine, lamotrigine, and telmisartan are ineffective. Newer agents target calcitonin gene-related peptide pain transmission in the migraine pain pathway and have recently received approval from the U.S. Food and Drug Administration; ​​​how- ever, more studies of long-term effectiveness and adverse effects are needed. The complementary treatments petasites, feverfew, magnesium, and riboflavin are probably effective. Nonpharmacologic therapies such as relaxation training, thermal biofeedback combined with relaxation training, electromyographic feedback, and cognitive behavior therapy also have good evidence to support their use in migraine prevention. (Am Fam Physician. 2019; 99(1):17-24.
    [Show full text]
  • Management of Migraines
    Management of Migraines Authors: Matt Brown, Pharm.D., 2014, Harrison School of Pharmacy, Auburn University; Katie Warren, Pharm.D., 2014, Harrison School of Pharmacy, Auburn University; Lydia Thornhill, Pharm.D., 2014, Harrison School of Pharmacy, Auburn University; Wesley T. Lindsey, Pharm.D., Clinical Associate Professor in Drug Information, Drug Information and Learning Resource Center, Harrison School of Pharmacy, Auburn University Universal Activity #: 0178-0000-14-104-H01-P | 1.25 contact hours (.125 CEUs) Initial Release Date: November 25, 2014 | Expires May. 1, 2016 Alabama Pharmacy Association | 334.271.4222 | www.aparx.org | [email protected] WINTER 2014: CONTINUING EDUCATION | WWW.APARX.ORG 1 EducatiONAL OBJECTIVES After the completion of this activity pharmacists will be able to: • Describe the clinical presentation of migraine headaches. • Discuss medications used in acute migraine treatment. • Discuss common medications for migraine prevention. INTRODUCTION a band around the largest part of the head. These headaches usually Migraine is one of the most common reasons adults in the occur around a time of stress and may persist for months. These United States present to the emergency department (ED).1 It types of headaches differ from migraines in that they lack aura; accounts for almost 3% of ED visits and annually costs anywhere they are also more prominent in men, whereas migraines are more between $1 to $17 billion. Migraines are known to affect common in women. approximately 23 million people in the U.S. alone. Those affected A migraine attack can be divided into several phases that include are most likely to be between the ages of 20 to 55, but migraines are the premonitory phase, migraine aura (if present), the migraine also seen in children as young as five as well as in the elderly.
    [Show full text]
  • Prophylactic Treatment of Migraine
    J Headache Pain (2001) 2:147–161 © Springer-Verlag 2001 Prophylactic treatment of migraine Medline, but also the result of the critical evaluation by a Introduction group of experts who discuss the results available in the lit- erature, taking into account their own experiences. In fact, The opportunity to choose a specific prophylactic therapy clinical reports may not be sufficient for giving a step for a patient depends upon the severity of the attacks and approach to treatment choice, particularly for drugs not yet how these headaches alter the quality of life. Prophylactic adequately evaluated, even if they are used by patients or treatment is usually recommended in the case of 3 or more prescribed by physicians [2–4]. severe attacks per month incompletely responding to symp- tomatic treatment and in the case of more than 4 days with headache per month. The main goals for preventive agents in migraine Management of pharmacological treatment treatment are to reduce the frequency and severity of migraine attacks and improve the quality of life. It is gen- To minimize the risk and improve the patient’s compli- erally accepted that a good response to prophylactic treat- ance, prophylactic treatment should be started at low ment is at least a 50% reduction in the frequency or doses, possibly as a monotherapy. Doses can be slowly severity of migraine attacks. Others goals are to expand increased until therapeutic goals are achieved in the the knowledge of preventive treatments, to promote stud- absence of side effects. The treatment should be main- ies in this field, and to avoid the development of a chron- tained for at least 3 months before stopping it.
    [Show full text]
  • Migraine Treatment
    Drug and Biologic Coverage Policy Effective Date .......................................... 10/1/2020 Next Review Date… ................................... 10/1/2021 Coverage Policy Number ............................... IP0029 Migraine Treatment Table of Contents Related Coverage Resources Overview ...................................................................1 Calcitonin Gene-Related Peptide (CGRP) Inhibitors Coverage Policy Statement ......................................2 Multi-Source Brand Name Drugs FDA Indication Criteria ..............................................2 Quantity Limitations Other Uses with Supportive Evidence Criteria .........2 Step Therapy – Legacy Prescription Drug Lists Specific Additional Criteria ........................................2 (Employer Group Plans) Preferred Product Requirement Criteria ...................2 Conditions Not Covered............................................5 Background ...............................................................5 References ...............................................................6 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by
    [Show full text]
  • Migraine Prevention Medication
    How to Choose a Preventive Medication for Migraine Alan M. Rapoport, M.D. The David Geffen School of Medicine at UCLA, Los Angeles, CA Principles of Preventive Treatment Daily preventive migraine therapy is indicated for patients with frequent migraine attacks (1-2 per week or more), significant disability associated with individual attacks, poor reponse to acute care medications, contraindications to triptans and other vasoactive medications, significant triptan side effects, or use of symptomatic treatment more than 3 days per week. Preventive medications should be chosen based on co-existing medical conditions, as the optimal medication may improve both the migraine and the medical condition. For example, consider a beta blocker or calcium channel antagonist for a migraine patient with hypertension; a tricyclic antidepressant taken at bedtime may benefit a migraine patient who is depressed or having difficulty sleeping. Other considerations include desirable and undesirable effects/side effects, as well as potential drug interactions with existing medications. General principles of management : • Establish a therapeutic partnership with the patient • Always start treating with preventive medications at a low dose and gradually increase over an extended period of time, in order to minimize adverse events • Continue well-tolerated medications for at least 2-3 months at a therapeutic level before deciding on effectiveness • Communicate clear expectations to the patient regarding the timing and magnitude of expected clinical benefit • Warn patients of the most frequent adverse events and explain when and how to contact you • Establish a comprehensive migraine management plan that includes long-term goals, tips on when the medication needs to be changed, a regular office visit schedule, and guidelines for contacting the office There are only five FDA-approved medications for migraine prevention and one of them, methysergide, is no longer available in the U.S.
    [Show full text]
  • Dihydroergotamine Mesylate Injection (DHE 45®)
    Place of Service Dihydroergotamine mesylate injection Office Administration (D.H.E. 45®) Home Infusion Administration Outpatient Facility Administration Infusion Center Administration Self-Administration– May be covered under the pharmacy benefit HCPCS: J1110 per 1 mg Conditions listed in policy (see criteria for details) • Cluster headaches • Migraine headaches AHFS therapeutic class: Antimigraine agent; Ergot Derivative Mechanism of action: Dihydroergotamine is a semisynthetic ergot alkaloid that is structurally and pharmacologically related to ergotamine. (1) Special Instructions and Pertinent Information If member has a Prescription Benefit, please refer cases to Pharmacy Services for prior authorization. If covered under the Medical Benefit, please submit clinical information for prior authorization review via fax. Please include medical rationale why medication cannot be home self- administered. (2) Prior Authorization/Medical Review is required for the following condition(s) All requests for D.H.E. 45® (dihydroergotamine mesylate injection) must be sent for clinical review and receive authorization prior to drug administration or claim payment. Cluster headaches 1. Recommended by a neurologist or a headache specialist, AND 2. Patient is currently on a prophylactic medication from the following list: prednisone, dexamethasone, verapamil, lithium or topiramate, OR contraindication to all agents above recognized as being efficacious for cluster headache prophylaxis, AND 3. Inadequate response, intolerable side effect, or contraindication to sumatriptan and zolmitriptan, AND 4. Number of injections requested per month does not exceed the amount needed to treat the number of headache days experienced per month, AND 5. Not taking D.H.E injection along with any triptan, or an ergot-type drug Covered Doses Up to 3 mg per 24 hours, and up to 6 mg/week, given IM or SQ Coverage Period Cover for 3 months ICD-10: G44.001, G44.009 Dihydroergotamine mesylate injection (D.H.E.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2009/0176792 A1 Gant Et Al
    US 20090176792A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0176792 A1 Gant et al. (43) Pub. Date: Jul. 9, 2009 (54) SUBSTITUTED Publication Classification DBENZHYDRYLPPERAZINES (51) Int. Cl. A63/4985 (2006.01) (75) Inventors: Thomas G. Gant, Carlsbad, CA C07D 24I/04 (2006.01) (US); Sepehr Sarshar, Cardiff by A63/495 (2006.01) the Sea, CA (US) (52) U.S. Cl. ..................... 514/251544/396; 514/255.04 (57) ABSTRACT Correspondence Address: The present invention relates to new dibenzhydrylpiperazine GLOBAL PATENT GROUP - APX modulators of histamine receptors, pharmaceutical composi Ms. LaVern Hall tions thereof, and methods of use thereof. 10411 Clayton Road, Suite 304 ST. LOUIS, MO 63131 (US) Formula I (73) Assignee: AUSPEX PHARMACEUTICALS, INC., Vista, CA (US) (21) Appl. No.: 12/350,032 (22) Filed: Jan. 7, 2009 Related U.S. Application Data (60) Provisional application No. 61/019.520, filed on Jan. 7, 2008. US 2009/0176792 A1 Jul. 9, 2009 SUBSTITUTED 0005 Disclosed herein is a compound having structural DBENZHYDRYLPPERAZINES Formula I: (I) 0001. This application claims the benefit of priority of U.S. provisional application No. 61/019,520, filed Jan. 7, 2008, the disclosure of which is hereby incorporated by ref erence as if written herein in its entirety. 0002 The present invention is directed to dibenzhy drylpiperazine-based histamine receptor modulators and pharmaceutically acceptable salts and prodrugs thereof, the chemical synthesis thereof, and medical use of Such com pounds for the treatment and/or management of nausea, kine tosis, emesis, Vertigo, dermatitis, migraines, labyrinthitis, Méniere's disease and/or any disorder ameliorated by modu lation of histamine receptors.
    [Show full text]