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

Santos, Paulo Sergio Faro; Melhado, Eliana Meire; 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-0042-1755320

Brasil

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Brazilian Academy of Neurology • Arq. Neuropsiquiatr. 80 (9) • 2022 • https://doi.org/10.1055/s-0042-1755320 linkcopiar

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

Autoria SCIMAGO INSTITUTIONS RANKINGS

Resumo

Antecedentes Migrânea afeta um bilhão de pessoas em todo o mundo e mais de 30 milhões de brasileiros; além disso, é um distúrbio subdiagnosticado e subtratado.

Objetivo Sabe-se sobre a necessidade de difundir o conhecimento sobre o tratamento profilático da migrânea; por isso, a Sociedade Brasileira de Cefaleias (SBCe) nomeou um comitê de autores com o objetivo de estabelecer um consenso com recomendações sobre o tratamento profilático da migrânea episódica com base em artigos da literatura mundial, assim como da experiência pessoal.

Métodos As reuniões foram realizadas inteiramente online, com a participação de 12 grupos que revisaram e escreveram sobre as categorias farmacológicas dos medicamentos e, ao final, reuniram-se para a leitura e conclusão do documento. As classes de medicamentos estudadas na parte II deste Consenso foram: anti-hipertensivos, inibidores seletivos de recaptação de serotonina, inibidores de recaptação de serotonina e noradrenalina, bloqueadores dos canais de cálcio, outros medicamentos e politerapia racional.

Resultados Desta lista de medicamentos, apenas o candesartan foi estabelecido como eficaz no controle da migrânea episódica. Flunarizina, venlafaxina, duloxetina e pizotifeno foram definidos como provavelmente eficazes, enquanto lisinopril, enalapril, escitalopram, fluvoxamina, quetiapina, atorvastatina, sinvastatina, ciproheptadina e melatonina foram possivelmente eficazes na profilaxia da doença.

Conclusões Apesar do esforço da comunidade científica em encontrarmedicamentos realmente eficazes no tratamento da migrânea, dado o grande número de medicamentos testados para este fim, ainda dispomos de poucas opções terapêuticas.

Palavras-chave: Cefaleia Histamínica; Enxaqueca Sem Aura; Consenso; Medicina Preventiva

Drug	Frequency of dosage and administration route	Adverse events	Evidence level	Recommendation level	Pregnancy/ breastfeeding
POSITIVE EVIDENCE
Angiotensin-converting enzyme inhibitors
Lisinopril	10–20 mg/day 2x/day; maximum 80 mg orally	Dry cough, fatigue, dizziness, vertigo, lipothymia, hyperkalemia	1 class II study	Level C: possibly efficacious	C-D-D / Use with care Breastfeeding: Low risk
Enalapril	10-20mg/day 1x or 2x/day; maximum 40 mg orally		1 class II study	Level C: possibly efficacious	C-D-D / use with care Breastfeeding: Potential severe adverse events in the baby; stop medication or breastfeeding
Captopril	50 mg/day; up to 450 mg/day 3x/day orally		1 class III study	Level U: conflicting data.	C-D-D / use with care Breastfeeding: Very low risk
Angiotensin receptor blockers
Candesartan	8–16 mg/day; maximum 32 mg 1–2x/day orally	Dizziness, arterial hypotension, fatigue, paresthesia, hyperkalemia	2 class I studies	Level A: Established as efficacious	C-D-D / Contraindicated Breastfeeding: Low risk; moderately safe; monitor use
Calcium channel blockers
Flunarizine	5–10 mg/day 1x at night orally	Somnolence, weight gain, depression, fatigue, vertigo, arterial hypotension, hypokinesis, tremor, rigidity	Class II (> 2 studies)	Level B: Probably efficacious	Category C Breastfeeding: High risk
Nicardipine	60–120 mg/day 3x/day orally	Headache, dizziness, facial redness, dyspnea	1 class II study and 1 class IV study	Level U: conflicting data	Unknown fetal risk due to lack of studies Breastfeeding: avoid it because of lack of information.
Nifedipine	10–60 mg/day -1–3x/day orally	Dizziness, leg edema, facial redness, headache	2 class III studies (1 positive and one negative)	Level U: conflicting data	Category C Breastfeeding: very low risk
Drug	Frequency of dosage and administration route	Adverse events	Evidence level	Recommendation level	Pregnancy/ breastfeeding
Neuroleptics
Quetiapine	25–150 mg/ day 1 or 2x/day Maximum 800 mg orally	Excessive sedation, confusion, weight gain	2 class III studies	Level C: Possibly efficacious	Category C Breastfeeding: Very low risk
Aripiprazole	5–20 mg/day 1x/day Maximum 30 mg orally		1 class III study	Level U: Conflicting data	Category C Breastfeeding: Low risk
Ziprasidone	40–80 mg/day 2x/day orally		1 class IV study	Level U: Conflicting data	Category C Breastfeeding: High risk
Statins
Atorvastatin	10–80 mg/day- average 20 mg 1x/day orally	Headache, dizziness, nausea, abdominal pain, insomnia	1 class II study	Level C: Possibly efficacious	Category X Breastfeeding: High risk
Simvastatin	5–80 mg/day - average 20 mg 1x/day orally	Headache, dizziness, nausea, abdominal pain, insomnia	1 class II study and 1 class III study	Level C: Possibly efficacious	Category X Breastfeeding: High risk
Vitamin K inhibitor
Warfarin	2.5–5 mg/day Maximum 10 mg/day (INR 2–3) 1x/day orally	Digestive, urinary, oral, and nasal bleeding	2 class III studies	Level C: Possibly efficacious	Category X Breastfeeding: Very low risk
Other drugs
Melatonin	3 mg/day 1x at night orally	Fatigue, somnolence, difficulty in concentrating, depressive symptoms, headache, diarrhea, abnormal dreams,	1 class II study	Level C: Possibly efficacious	C/C/C Use with care Breastfeeding: Very low risk
Cyproheptadine	1–6.5 mg/day 1x/day orally	Somnolence, increased appetite, weight gain, dry mouth, blurred vision, glaucoma	> 2 class III studies and 1 class II study	Level C: Possibly efficacious	Category B Breastfeeding: Contraindicated
Pizotifen	1.5–3.0 mg/day 1–3x/day orally	Weight gain	> 2 class II studies	Level B: Probably efficacious	Category B Breastfeeding: Not recommended
Drug	Frequency of dosage and administration route	Adverse events	Evidence level	Recommendation level	Pregnancy/ breastfeeding
NEGATIVE EVIDENCE
Angiotensin receptor blockers
Telmisartan			1 class I study
	40–80 mg/day 1x/day orally	Dizziness, arterial hypotension, fatigue, paresthesia, hyperkalemia		Level B: Probably inefficacious	C-D-D / use with care Breastfeeding: High risk
Selective serotonin reuptake inhibitor
Sertraline	50–100 mg/day 1x/day Maximum 200 mg orally	See escitalopram	1 class II study	Level C: Possibly inefficacious	Category C Breastfeeding: Very low risk
Fluoxetine	20–60 mg/day 1x/day orally		≥ 2 class II studies	Level B: Probably inefficacious	Category C Breastfeeding: Low risk
Citalopram	10–20 mg/day 1x/day orally		2 class II studies	Level B: Probably inefficacious	Category B and C Breastfeeding: Very low risk
Other drugs
Clonidine	25 to 75 Mg/day 2x/day Maximum 900 μg orally	Anxiety, tiredness, dry mouth, dizziness, dyspnea, palpitations, nausea, vomiting, stomachache, abdominal bloating, orthostatic hypotension, fainting, somnolence, rash, headache, irritability, insomnia	≥ 2 class I studies	Level A: Established as not efficacious	Category C Breastfeeding: High risk
Montelukast	5–20 mg/day orally	Not reported	Class I, class II and class III studies	Level B: Probably inefficacious	Category C Breastfeeding: Low risk

Study	Drug	Type	n	Doses	I	D	F	AC	AC
Bordini et al.¹⁴⁶	PPN vs FNZ vs PPN + FNZ	Double-blind and parallel randomized clinical trial	15 15 15	PPN 60 mg/day FNZ 10 mg/day	S	NA	S	NA	A
Pascual et al.¹⁴⁷	BB vs VPA vs BB + VPA	Open clinical trial	52	BB 40–160 mg/day VPA 300–1,000 mg/day	NA	NA	↓	NA	A
Rampello et al.¹⁶	AMT vs CTP vs AMT + CTP	Open and parallel randomized clinical trial	44 44 29	AMT 50 mg/day CTP 20 mg/day	NS	S	S	NA	A
Keskinbora et al.¹⁴⁸	TPM vs AMT vs TPM + AMT	Double-blind and parallel randomized clinical trial	5 4 6	TPM 25-200 mg/day AMT 10-150 mg/day	NS	NS	NS	NA	A
Domingues et al.¹⁴⁹	PPN vs NTP vs PPN + NTP	Double-blind and parallel randomized clinical trial	25 24 27	PPN 80 mg/day NTP 40 mg/day	NA	NA	S NS S	NA	A
Krymchantowski et al.¹⁵⁰	TPM vs NTP vs TPM + NTP vs TPM + PCB vs NTP+PCB	Parallel randomized, placebo-controlled trial	80	TPM 100 mg/day NTP 30 mg/day	NA	NA	S	NA	A
Drug	Frequency of dosage and administration route	Adverse events		Evidence level	Recommendation level		Pregnancy/ breastfeeding
Nimodipine	90 mg/day – 3x/day; Maximum 360 mg orally	Vertigo, facial redness, muscle pain, abdominal pain, weight loss, pruritus		1 class I study (negative) 2 class II studies (negative) and 2 class III studies (positive)	Level U: Conflicting data.		Undetermined risk in pregnancy Breastfeeding: Very low risk
Verapamil	120–480 mg/day 3–4x/day or R** 1–2x/day orally	Constipation, skin erythema, headache		2 class IV studies	Level U: Conflicting data		Category C Breastfeeding: Very low risk
Serotonin and noradrenaline reuptake inhibitors
Venlafaxine	37.5–150 mg/day 1x/day orally	Insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation, hyperhidrosis, abnormal dreams, decreased " libido		> 2 class II studies	Level B: Probably efficacious		Category C Breastfeeding: Use with care
Duloxetine	30–120 mg/day 1x/day orally			2 class II studies	Level B: Probably efficacious		Category C Breastfeeding: Use with care
Serotonin reuptake inhibitors
Escitalopram	5–10mg/day 1x/day orally	Insomnia, nausea, headache, asthenia, diarrhea, anorexia, somnolence, anxiety, nervousness, dry mouth, decreased libido, tremor, ejaculatory dysfunction, impotence, abnormal dreams, constipation, vomiting		1 class III study	Level C: Possibly efficacious		Category B Breastfeeding: Very low risk
Paroxetine	20 mg/day 2x/day orally			1 class IV study	Level U: Conflicting data		Category D Breastfeeding: Very low risk
Fluvoxamine	50 mg/day 1x at night orally	Somnolence, constipation, dry mouth, nausea, weakness		1 class II study	Level C: Possibly efficacious		Category C Breastfeeding: Very low risk

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[TFN1] Abbreviations: A, adults; AC, consumption of analgesics; AMT, amitriptyline; BB, beta-blocker; CTP, citalopram; D, duration; ES, age group; F, frequency; FNZ, flunarizine; I, intensity; NA, not assessed; NS, not significant; NTP, nortriptyline; P, pediatrics; PCB, placebo; PPN, propranolol; S, significance with p < 0.05; TPM, topiramate; VPA, valproic acid.

[TFN2] ↓ reduction, but without statistical analysis