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Menopause:
doi: 10.1097/GME.0b013e3182a46dcb
Original Articles

Safety of veralipride for the treatment of vasomotor symptoms of menopause

Hernández Valencia, Marcelino MD, PhD; Vega Arias, María de Jesús MD; Celis González, Cuauhtémoc MD; Hernández Marín, Imelda MD; Martín González, Juan Humberto MD; Morcate Campos, Enrique Rafael MD; Basavilvazo Rodríguez, María Antonia MD; Morales Álvarez, Ignacio MD; Valdés Vargas, María Antonia MD; Otero Flores, José Braulio Everardo MD; Santoyo Haro, Samuel MD; Cortes Bonilla, Manuel MD; Bernardo Escudero, Roberto MD; Alonso Campero, Rosalba MD

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Abstract

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.

© 2013 by The North American Menopause Society

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