Actual status of veralipride use

Figures & data

Table 1 Hot flushes decrease with several treatments

	Mechanism	Dose	Hot flushes decrease vs placebo	Secondary effects	Withdrawal (%)
Clonidine	α-2 adrenergic				–
Carranza-Lira^Citation7	agonist	0.1 mg e/12 hr	83% vs 50%	Mouth dryness, depression, nauseas, insomnia, somnolence
Gabapentin	GABA analog				–
Reddy^Citation8		900 mg/day	54%–71% vs 29	Dizziness, headache, disorientation up to 50%
Biglia^Citation9		900 mg/day	Frequency 57.0% Intensity 66.9%		34.8
Venlafaxine	SNRI				–
Evans^Citation10		75 mg/day	61% vs 20%	Anti-cholinergic effects	–
Phillips^Citation11		75–225 mg/day		Hepatitis	–
Ladd^Citation12			60%
Desvenlafaxine	SNRI
Archer^Citation13,Citation14		100–150 mg/day	63% vs 47% 66.6% vs 50.8%		More than placebo
Speroff^Citation15		100 mg/day	64%		–
Paroxetine
Stearns^Citation16	SSRI	25 mg/day	65% vs 38%		–
Fluoxetine	SSRI
Loprinzi^Citation17		20 mg/day	50% vs 36%		–
Oktem^Citation18		20 mg/day	62%		33
Suvanto-Luukonen^Citation19		10–30 mg/day	No better than placebo		34
Citalopram	SSRI
Suvanto-Luukonen^Citation19		10–30 mg/day	No better than placebo		34
Soares^Citation20		20–60 mg/day	86.6% decrease in depression		–
Kalay^Citation21		10–20 mg/day	37% vs 13%		–
Propranolol	β adrenergic
Carranza^Citation7	blocker	20 mg e/12 hr	50% vs 50%		–
Coope^Citation22		40 mg e/8 hr	Similar than placebo		–
Alcoff^Citation23			Favorable vs placebo		–
Vitamin E
Barton^Citation24		800 IU/day	One hot flush less than with placebo	Clinically similar to placebo	–
Biglia^Citation25			Frequency 10.2%
			Intensity 7.28%		34.8
Methyil-dopa	α2 adrenergic
Andersen^Citation26	agonist	375–1125 mg/day	65% vs 38%		–
Nesheim^Citation27		250–500 e/12hr	85%		33
Cimicifuga racemosa
Oktem^Citation18		40 mg/day	85%		33
Jacobson^Citation28		Not indicated	No better than placebo		Risk of hepatotoxycity^Citation30
Borrelli^Citation29		4 mg e/12 hr	Similar to estrogen		–

Abbreviaitons: SSRI, serotonin selective reuptake inhibitors; SNRI, serotonin noradrenalin reuptake inhibitors.

Table 2 Veralipride efficiency with several evaluated schedules

	Schedule	N	Time	Study	Results
David^Citation36	A	47	2 months	Double blind, placebo controlled, crossover	Hot flush reduction 80% Residual effect 3 months after withdrawal
Wesel^Citation39	B	40		Double blind, randomized	Similar decrease in hot flushes between groups
Melis^Citation40	C	40	1 month	Randomized, double blind, placebo controlled	85% reduction
Vercellini^Citation41	D	36	2 months	Randomized, double blind, placebo controlled	Reduction 78% vs placebo 33%
Carranza-Lira^Citation7	E	75	3 months	Comparative, randomized, placebo controlled	80% reduction in frequency, 71% in intensity, 82% duration, sweats 66.6%
Morgante^Citation31	F	29	6 months	Randomized, comparative	Without differences between in number of hot flushes and Kupperman’s index Hot flushes decrease in 63% and 66% at 3rd and 6th month respectively
Boukobza^Citation42	G	166	3 months	Open, multicentric	Hot flush reduction 89.9% In 64.5% residual effect 3 months after withdrawal
Vercellini^Citation43	H	25	28 days	Open, observational trial	92% of patients have decrease in frequency and intensity of hot flushes
Marais^Citation44	I	–	1–14 months	Comparative, placebo controlled	48%–72% decrease

Notes: A, 100 mg/day for 20 days and 10 days drug free; B, 100 mg/day for 20 days and 10 days drug free versus conjugated estrogens 1.25 mg/day; C, 100 mg/day; D, 100 mg/day; E, 100 mg/day from Monday to Friday; F, Raloxifene plus veralipride in alternate days versus raloxifene and veralipride in alternate months; G, 100 mg/day for 20 days and 10 days drug free; H, 100 mg/day 20 days.

Table 3 Secondary effects with veralipride use, according to schedule

	Secondary effect	Schedule	N or %
David^Citation36	Depression+	100 mg/day 20 days and 10 days drug free	19%–47%
Boukozoba^Citation42	Breast tenderness	100 mg/day 20 days and 10 days drug free for 3 months	1.2%
	Insomnia		0.6%
	Mouth dryness		0.6%
	Somnolence		1.2%
	Digestive problems		0.6%
	Dizziness		0.6%
	Weakness		0.6%
Masmoudi^Citation46	Parkinsonism	Several schedules	N
	Acute dyskinesia		15
	Parkinsonism plus other in 8 cases		2
	Tardive dyskinesia		6
	Postural tremor		3
	Myoclonia		1
	Dystonia		1
Montemurro^Citation47	Acute coronary syndrome	100 mg/day	1
Kunhardt^Citation48	Pyrosis	100 mg/day 20 days	1
	Hair fall	and 10 days drug free	1
	Mamary pruritus		1
	Mastodynia		3
	Placebo
	Headache, joint pain, vaginal discharge mastodynia 1/e		1 each
Raja^Citation49	Tardive dyskinesia	Not reported	1
Sining^Citation50	Dystonia (Hypertension under enalapril treatment)	100 mg/day (2 months)	1
Teive^Citation51	Increase in	Not reported	1
	Parkinsonian symptoms

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