[Clinical tolerance of a new antidepressant -- milnacipran]

Encephale. 1999 May-Jun;25(3):252-8.
[Article in French]

Abstract

Milnacipran is a new antidepressant which has been developed for its selective inhibition of both serotonin and noradrenaline reuptake with a good safety and tolerability profile. The efficacy and tolerance profile of this antidepressant have been compared with those of tricyclic and selective serotonin reuptake inhibitor antidepressants (SSRIs) in open-label and placebo-controlled trials. But no data in clinical practice are available. The authors studied the tolerability of milnacipran (100 to 200 mg/d) in 28 depressed inpatients receiving usual comedications during a mean period of 33 days (3 to 107 days). The incidence of adverse events was determined with the help of the Pharmacovigilance Center of the Centre Hospitalo-Universitaire (Besançon, France). Among the 28 patients, milnacipran was well tolerated by 18 of them. Side-effects were noted in 10 patients, but they led to withdrawal of the antidepressant in only 2 cases, where dyspnea, palpitations, pollakiuria in a case and headache, nausea, dysuria in the other case occurred. The most frequent adverse event observed was hypotension (n = 6), but in each case it occurred just after the addition of sedative phenothiazines (n = 5) or of a comedication with phenothiazines and valpromide (n = 1). So this side-effect could not be attributed to milnacipran alone. Treatments with heptaminol or theodrenaline and cafedrine were useful. An increase of the cardiac frequency seemed to occur with milnacipran (p < 0.06). It was observed in the 5 inpatients for whom this cardiovascular parameter was recorded before and during the milnacipran treatment. In 5 other patients, the cardiac frequency seemed to decrease when milnacipran was stopped for lack of good efficacy or adverse events. Gastrointestinal disturbances were scarce isolated (nausea n = 1), but necessitated a treatment with metopimazine. The milnacipran prescription (100 mg/d) after an other antidepressant treatment had been done without a withdrawal period and without problem, even when the previous antidepressant was a SSRIs with a long half-life and CYP450 inhibitory properties. The authors concluded to the good tolerability of milnacipran in usual clinical practice.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Cardiovascular Diseases / chemically induced
  • Cardiovascular Diseases / prevention & control
  • Cyclopropanes / adverse effects*
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / rehabilitation
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Heptaminol / therapeutic use
  • Hospitalization
  • Humans
  • Hypotension / chemically induced
  • Male
  • Middle Aged
  • Milnacipran
  • Phenylpropanolamine / analogs & derivatives
  • Phenylpropanolamine / therapeutic use
  • Selective Serotonin Reuptake Inhibitors / adverse effects*
  • Theophylline / analogs & derivatives
  • Theophylline / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Vasodilator Agents / therapeutic use

Substances

  • Cyclopropanes
  • Serotonin Uptake Inhibitors
  • Vasodilator Agents
  • cafedrine
  • Phenylpropanolamine
  • Heptaminol
  • Theophylline
  • Milnacipran