Consensus of the Brazilian Headache Society (SBCe) for prophylactic treatment of episodic migraine: part 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

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

Consensus of the Brazilian Headache Society (SBCe) for prophylactic treatment of episodic migraine: part II

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Background

Migraine affects 1 billion people worldwide and > 30 million Brazilians; besides, it is an underdiagnosed and undertreated disorder.

Objective

The need to disseminate knowledge about the prophylactic treatment of migraine is known, so the Brazilian Headache Society (SBCe, in the Portuguese acronym) appointed a committee of authors with the objective of establishing a consensus with recommendations on the prophylactic treatment of episodic migraine based on articles from the world literature as well as from personal experience.

Methods

Meetings were held entirely online, with the participation of 12 groups that reviewed and wrote about the pharmacological categories of drugs and, at the end, met to read and finish the document. The drug classes studied in part II of this Consensus were: antihypertensives, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, calcium channel blockers, other drugs, and rational polytherapy.

Results

From this list of drugs, only candesartan has been established as effective in controlling episodic migraine. Flunarizine, venlafaxine, duloxetine, and pizotifen were defined as likely to be effective, while lisinopril, enalapril, escitalopram, fluvoxamine, quetiapine, atorvastatin, simvastatin, cyproheptadine, and melatonin were possibly effective in prophylaxis of the disease.

Conclusions

Despite an effort by the scientific community to find really effective drugs in the treatment of migraine, given the large number of drugs tested for this purpose, we still have few therapeutic options.

Keywords:
Cluster Headache; Migraine Without Aura; Consensus; Preventive Medicine

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.¹⁴⁶146 Bordini CA, Arruda MA, Ciciarelli MC, Speciali JG. Propranolol vs flunarizine vs flunarizine plus propranolol in migraine without aura prophylaxis. A double-blind trial. Arq Neuropsiquiatr 1997; 55(3B):536–541	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.¹⁴⁷147 Pascual J, Leira R, Láinez JM. Combined therapy for migraine prevention? Clinical experience with a beta-blocker plus sodium valproate in 52 resistant migraine patients. Cephalalgia 2003;23(10):961–962	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.¹⁶16 Rampello L, Alvano A, Chiechio S, et al. Evaluation of the prophylactic efficacy of amitriptyline and citalopram, alone or in combination, in patients with comorbidity of depression, migraine, and tension-type headache. Neuropsychobiology 2004;50(04):322–328	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.¹⁴⁸148 Keskinbora K, Aydinli I. A double-blind randomized controlled trial of topiramate and amitriptyline either alone or in combination for the prevention of migraine. Clin Neurol Neurosurg 2008;110(10):979–984	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.¹⁴⁹149 Domingues RB, Silva AL, Domingues SA, Aquino CC, Kuster GW. A double-blind randomized controlled trial of low doses of propranolol, nortriptyline, and the combination of propranolol and nortriptyline for the preventive treatment of migraine. Arq Neuropsiquiatr 2009;67(04):973–977	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.¹⁵⁰150 Krymchantowski AV, da Cunha Jevoux C, Bigal ME. Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders. J Headache Pain 2012;13 (01):53–59. Doi: 10.1007/s10194-011-0395-4 https://doi.org/10.1007/s10194-011-0395-...	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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[1] Address for correspondence Eliana Meire Melhado (e-mail: elianamelhado@gmail.com).