Safety of veralipride for the treatment of vasomotor symptoms of menopause.
OBJECTIVE
Veralipride is a nonhormonal option for the treatment of vasomotor symptoms of menopause. Incidence of adverse events in a Mexican population and drug compliance according to correct use were evaluated.


METHODS
We carried out a longitudinal, prospective, and analytical study in Mexican women who received veralipride to treat symptoms of menopause from 2011 to 2012. There were 386 treatment cycles; 272 were assigned to dosing schedule 1, which included 20 days of treatment with 10 days of suspension, and 114 were assigned to dosing schedule 2, which included 5 days of treatment and 2 days of suspension.


RESULTS
A total of 57 adverse events were registered during the 386-month treatment. For the 20 × 10 dosing schedule, the highest incidence was observed for anxiety (2.2%), drowsiness, and weakness (1.5%); for the 5 × 2 dosing schedule, the highest incidence was observed for drowsiness (5.3%) and headache (2.6%). The Hamilton Depression Rating Scale was used to assess the presence and severity of depression; improvement was noted. The Unified Parkinson's Disease Rating Scale was used to assess neurological movement disorders; no adverse neurological events were detected. Based on the assessments of both women and physicians, the highest frequency was observed for "very satisfied" (45.5% and 52.3%, respectively), followed by "satisfied" (23.9% and 27.3%, respectively).


CONCLUSIONS
Both dosing schedules show acceptable safety profiles for up to 6 months of use when used according to the contraindications in the current prescribing information for standard use (2012) and recent medical literature.
From the Unit of Endocrine, Diabetes, and Metabolism Research, Specialties Hospital, National Medical Center, Instituto Mexicano del Seguro Social, México City, México.
Marcelino Hernández
MH
Valencia
María de Jesús Vega
Mde J
Arias
Cuauhtémoc Celis
CC
González
Imelda Hernández
IH
Marín
Juan Humberto Martín
JH
González
Enrique Rafael Morcate
ER
Campos
María Antonia Basavilvazo
MA
Rodríguez
Ignacio Morales
IM
Álvarez
María Antonia Valdés
MA
Vargas
José Braulio Everardo Otero
JB
Flores
Samuel Santoyo
SS
Haro
Manuel Cortes
MC
Bonilla
Roberto Bernardo
RB
Escudero
Rosalba Alonso
RA
Campero
D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects* / Q000502:physiology; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D013469:Sulpiride / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014666:Vasomotor System / Q000187:drug effects*
D013469:Sulpiride; C027429:veralipride