Consensus of the Brazilian Headache Society (SBCe) for the Prophylactic Treatment of Episodic Migraine: part I

Melhado, Eliana Meire; Santos, Paulo Sergio Faro; Kaup, Alexandre Ottoni; Costa, Aline Turbino Neves Martins da; Roesler, Célia Aparecida de Paula; Piovesan, Élcio Juliato; Sarmento, Elder Machado; Theotonio, Giselle Oliveira Martins; Campos, Henrique Carneiro de; Fortini, Ida; Souza, Jano Alves de; Maciel Júnior, Jayme Antunes; Segundo, João Batista Alves; Carvalho, João José Freitas de; Speziali, José Geraldo; Calia, Leandro Cortoni; Barea, Liselotte Menke; Queiroz, Luiz Paulo; Souza, Marcio Nattan Portes; Figueiredo, Marcos Ravi Cerqueira Ferreira; Costa, Maria Eduarda Nobre de Magalhães; Peres, Mário Fernando Prieto; Jurno, Mauro Eduardo; Peixoto, Patrícia Machado; Kowacs, Pedro André; Rocha-Filho, Pedro Augusto Sampaio; Moreira Filho, Pedro Ferreira; Silva-Neto, Raimundo Pereira; Fragoso, Yara Dadalti

doi:10.1055/s-0042-1756441

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Brazilian Academy of Neurology • Arq. Neuro-Psiquiatr. 80 (08) • Aug 2022 • https://doi.org/10.1055/s-0042-1756441 copy

Consensus of the Brazilian Headache Society (SBCe) for the Prophylactic Treatment of Episodic Migraine: part I

Consenso da Sociedadade Brasileira de Cefaleia (SBCe) para o tratamento profilático da migrânea episódica: parte I

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The Brazilian Headache Society (Sociedade Brasileira de Cefaleia, SBCe, in Portuguese) nominated a Committee of Authors with the aim of establishing a consensus with recommendations regarding prophylactic treatment for episodic migraine based on articles published in the worldwide literature, as well as personal experience. Migraine affects 1 billion people around the world and more than 30 million Brazilians. In addition, it is an underdiagnosed and undertreated disorder. It is well known within the medical community of neurologists, and especially among headache specialists, that there is a need to disseminate knowledge about prophylactic treatment for migraine. For this purpose, together with the need for drug updates and to expand knowledge of the disease itself (frequency, intensity, duration, impact and perhaps the progression of migraine), this Consensus was developed, following a full online methodology, by 12 groups who reviewed and wrote about the pharmacological categories of the drugs used and, at the end of the process, met to read and establish conclusions for this document. The drug classes studied were: anticonvulsants, tricyclic antidepressants, monoclonal anti-calcitonin gene-related peptide (anti-CGRP) antibodies, beta-blockers, antihypertensives, calcium channel inhibitors, other antidepressants (selective serotonin reuptake inhibitors, SSRIs, and dual-action antidepressants), other drugs, and polytherapy. Hormonal treatment and anti-inflammatories and triptans in minimum prophylaxis schemes (miniprophylaxis) will be covered in a specific chapter. The drug classes studied for part I of the Consensus were: anticonvulsants, tricyclic antidepressants, monoclonal anti-CGRP antibodies, and beta-blockers.

Keywords
Migraine Disorders; Consensus; Preventive Medicine

Recommendation levels	Requirements	Recommendation
Level A	At least two class-I studies	Established as effective, ineffective or harmful for the given condition in the population specified.
Level B	At least one class-I study or two class-II studies	Probably effective, ineffective or harmful for the given condition in the population specified.
Level C	At least one class-II study or two class-III studies	Possibly effective, ineffective or harmful for the given condition in the population specified.
Level U	Inappropriate or conflicting data	In the light of current knowledge, the treatment is not proven.

Drugs	Target dose and maximum daily dose	Dosage frequency and administration route	Adverse events	Evidence level	Recommendation level	Pregnancy
POSITIVE EVIDENCE
Anticonvulsants
Topiramate	50–200 mg*/day	2x/day orally	Paresthesia, fatigue, nausea, weight loss, difficulty concentrating, memory loss, drowsiness, ataxia, kidney stones	Class I (≥ 2 studies)	Level A: established as efficacious	Category D breastfeeding: very low risk–can be used while breastfeeding
Valproic acid	250–1,000 mg/day	2–3x/day orally	Nausea and/or vomiting, tremors, weight gain, asthenia, and alopecia	Class I (> 2 studies)	Level A: established as efficacious	Category X breastfeeding: very low risk–can be used while breastfeeding
Sodium divalproate	250–1,000 mg/day 1x/day–sustained release, or 125 -500 mg 2x/day orally	Orally		Class I (> 2 studies)	Level A: established as efficacious	Category D breastfeeding: very low risk–can be used while breastfeeding
Levetiracetam	250–1,500 mg	2x/day orally	Drowsiness, fatigue, mood swings, agitation, irritability, aggression, depression, memory loss, confusion, paresthesia, cognitive decline, and increased risk of suicide	2 class-II studies and 3 class-III studies	Level B: possibly efficacious	Category C breastfeeding–not recommended
Gabapentin	900–3,600 mg/day	3x/day Orally	Dizziness, fatigue, nausea, and drowsiness	2 class-II studies (1 effective and 1 not), 2 class-III studies, and 1 class-IV study	C Level: possibly efficacious	Category C breastfeeding: very low risk–can be used while breastfeeding
POSITIVE EVIDENCE
Anticonvulsants
Pregabalin	75–600 mg/day	2x/day orally	–	1 class-II study and 1 class-IV study	Level C: possibly efficacious	Category C breastfeeding: low risk–moderately safe for use; monitor treatment
Zonisamide	100–400 mg/day	1x/day; not available in Brazil	Weight loss, mood disorders, paresthesia, and difficulty concentrating	2 class-II studies	Level B: probably efficacious	Category C breastfeeding: unsafe for use
Carbamazepine	200–2,000 mg/day ÷ in 3 intakes and sustained release: 2 intakes orally	–	Vertigo, headache, ataxia, drowsiness, fatigue, diplopia, nausea, vomiting, and allergic skin reactions	1 class-III study	Level U: conflicting data.	Category D breastfeeding: very low risk–can be used while breastfeeding
Vigabatrin	1–3 g/day ÷ in 1–2x/day; increase 500 mg/ week orally		Sedation, drowsiness, fatigue, difficulty concentrating, and visual field change	1 class-III study	Level U: conflicting data.	Category C breastfeeding: very low risk–can be used while breastfeeding
Clonazepam	0.25–4 mg/day ÷ in 1–3x/day orally		Drowsiness, dizziness, irritability, and chemical dependence	1 class-III study and 1 class-IV study	Level U: conflicting data	Category C breastfeeding: low risk–moderately safe for use; monitor treatment
Beta-blockers
Propranolol	40–240 mg/day 2–3x/day orally	–	Bradycardia, hypotension, lethargy, nightmares, mental confusion, depression, gastrointestinal disorders, paresthesia, and weight gain	Class I (> 2 studies)	Level A: established as efficacious	Category C breastfeeding: very low risk–can be used while breastfeeding
Metoprolol (succinate and tartrate)	50–200 mg/day 1–2x/day orally	–		Class I (> 2 studies)	Level A: established as efficacious	Category C breastfeeding: very low risk–can be used while breastfeeding
Beta-blockers
Timolol	20–60 mg/day 2x/day	Oral	–	Class I (> 2 studies)	Level A: established as efficacious	Category C breastfeeding: unsafe for use–potential adverse reactions
Atenolol	50–100 mg/day 1–2x/day; maximum of 200 mg orally	–	Bradycardia, hypotension, lethargy, nightmares, mental confusion, depression, gastrointestinal disorders, paresthesia, and weight gain	Class III (3 studies)	Level C: possibly efficacious	Category D breastfeeding: high risk–unsafe for use
Nadolol	40–80 mg/day and up to 160 mg/day; 1x/day orally	Not available in Brazil	–	Class II (1 study)	Level C: possibly efficacious	Avoid it: newborn may present bradycardia, hypoglycemia, and associated symptoms; breastfeeding: potential risk of causing adverse effects in infants
Nebivolol	5 mg/day 1x/day orally			Class III (1 study) or Class II	Level C: possibly efficacious	Category C breastfeeding: low risk–moderately safe for use; monitor treatment
Tricyclic Antidepressants (TADs)
Amitriptyline	10–150 mg/day 1x/day orally	–	Dry mouth, drowsiness, fatigue, weight gain, constipation, and dizziness	Many class-I and-II studies	Level A: established as efficacious	C - C - C / dreastfeeding: high risk–contraindicated
Clomipramine	25–75 mg/day 1–3x/day orally	–		2 class-II studies	Level B: probably efficacious	C - C - C / breastfeeding: contraindicated
Nortriptyline	10–50 mg/day 1–3x/day orally	–		1 class-II study	Level C: possibly efficacious	C - C - C /breastfeeding: very low risk
POSITIVE EVIDENCE
Anti-calcitonin gene-related (anti-CGRP) monoclonal antibodies or anti-CGRP receptor
Erenumab	70–140 mg/month 1x/month subcutaneously		Pain in the injection site, upper respiratory tract infection, nasopharyngitis, nausea, and abdominal discomfort	3 class-I studies	Level A: established as efficacious	Category B: breastfeeding: moderately safe for use–monitor treatment
Galcanezumab	240 mg in the 1^st month and 120 mg/month in the subsequent months subcutaneously	–		4 class-I studies	Level A: established as efficacious	Category B breastfeeding: moderately safe for use–monitor treatment
Fremanezumab	225 mg/month 1x/month or 675 mg/month every 12 weeks subcutaneously	–		2 class-I studies	Level A: established as efficacious	There are no data on the presence of fremanezumab in breast milk
Eptinezumab	100 mg/month	every 12 weeks intravenously		1 class-I study	Level B: probably efficacious	There are no controlled data on human pregnancy. There are no data on the effects of this drug on infants or its effects on milk production.
NEGATIVE EVIDENCE
Betab-lockers
Pindolol	7.5–15 mg /day orally	–	Similar to other beta-blockers	2 class-II studies	Level B: probably inefficacious	Category B breastfeeding: unlikely to affect the child when therapeutic doses are used.
Anticonvulsants
Lamotrigine^#	100–200 mg/day 2x/day orally	–	As in “Anticonvulsants”	2 class-II studies	Level B: probably inefficacious	Category C breastfeeding: low risk; moderately safe for use–monitor treatment
Oxcarbazepine	600–1,500 mg/day 2x/day orally	–	Fatigue, dizziness, and nausea	1 class-II study	Level C: possibly inefficacious	Category C breastfeeding: high risk–unsafe for use.

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[1] Address for correspondence Eliana Meire Melhado (e-mail: elianamelhado@gmail.com).