The safety of veralipride.
The perimenopausal period, from 1 to 4 years, is characterised by vasomotor symptoms, or hot flushes, and other effects due a deficit of estrogens. Approximately 85% of women have hot flushes for 1 year and 25 - 50% continue for up to 5 years. The cause of hot flushes has been linked to dysfunction of the thermoregulatory centre caused by estrogen withdrawal. One proposal for the aetiology of hot flushes is that the thermoregulatory zone is shifted downward in patients who experience hot flushes. Estrogen withdrawal creates a change of the central opioid system and a thermoregulatory instability. Estrogen and/or progestin replacement is the treatment of choice for this distressing symptom. However, steroid replacement may be associated with risks and complications, and is limited in some subjects by well-known contraindications. Veralipride, a synthetic benzamide derivative with antidopaminergic action, is effective in reducing the frequency and severity of hot flushes associated with menopausal hypoestrogenism, gaining interest as a non-hormonal treatment for climacteric flushing. In recent years, extrapyramidal disorders associated with veralipride therapy have been reported and are often due to drug misuse. Adverse effects include acute dyskinesia or Parkinsonism, which may occur after many months of treatment. An association between adverse effects and mistake of administration has been described. This article discusses available data on the benefits and risks of veralipride therapy for menopausal symptoms.
De Leo
Vincenzo
V
Institute of Obstetrics and Gynecology, Obstetrics and Reproductive Medicine, University of Siena, Policlinico Le ScotteViale, Bracci, 53100 Siena, Italy. deleo@unisi.it
Morgante
Giuseppe
G
Musacchio
Maria C
MC
Faldini
Elisa
E
Delia
Ada
A
Petraglia
Felice
F
D000328:Adult; D000368:Aged; D001480:Basal Ganglia Diseases / Q000139:chemically induced*; D065127:Dopamine D2 Receptor Antagonists; D004967:Estrogens / Q000172:deficiency*; D005260:Female; D006207:Half-Life; D019584:Hot Flashes / Q000188:drug therapy / Q000378:metabolism; D006801:Humans; D008875:Middle Aged; D020734:Parkinsonian Disorders / Q000139:chemically induced*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012449:Safety; D013469:Sulpiride / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use
D065127:Dopamine D2 Receptor Antagonists; D004967:Estrogens; D013469:Sulpiride; C027429:veralipride