title: Efficacy of etifoxine compared to lorazepam monotherapy in the treatment of patients with adjustment disorders with anxiety: a double-blind controlled study in general practice.
abstract: Adjustment Disorders With Anxiety (ADWA) account for almost 10% of psychologically motivated consultations in primary care. The aim of this double-blind randomised parallel group study was to compare (non-inferiority test) the efficacies of etifoxine, a non-benzodiazepine anxiolytic drug, and lorazepam, a benzodiazepine, for ADWA outpatients followed by general practitioners. 191 outpatients (mean age: 43, female: 66%) were assigned to receive etifoxine (50 mg tid) or lorazepam (0.5-0.5-1 mg /day) for 28 days. Efficacy was evaluated on days 7 and 28 of the treatment. The main efficacy assessment criterion was the Hamilton Rating Scale for Anxiety score (HAM-A) on Day 28 adjusted to Day 0. The anxiolytic effect of etifoxine was found not inferior to that of lorazepam (HAM-A score decrease: 54.6% vs 52.3%, respectively, p=0.0006). The two drugs were equivalent on Day 28. However, more etifoxine recipients responded to the treatment (HAM-A score decreased by >or=50%, p=0.03). Clinical improvement (based on Clinical Global Impression scale CGI, Social Adjustment Scale Self-Report SAS-SR, and Sheehan scores) was observed in both treatment arms, but more etifoxine patients improved markedly (p=0.03) and had a marked therapeutic effect without side effects as assessed by CGI, p=0.04. Moreover, 1 week after stopping treatment, fewer patients taking etifoxine experienced a rebound of anxiety, compared to lorazepam (1 and 8, respectively, p=0.034).
authors.affiliation: CPCET et Pharmacologie Clinique, Institut des Neurosciences Cognitives de la Méditerranée, Faculté de Médecine, UMR CNRS Université de la Méditerranée, Assistance Publique Hôpitaux de Marseille-Hôpital de la Timone, 13385 Marseille Cedex 5, France.
authors.forename: N
authors.initials: N
authors.lastname: Nguyen
authors.forename: E
authors.initials: E
authors.lastname: Fakra
authors.forename: V
authors.initials: V
authors.lastname: Pradel
authors.forename: E
authors.initials: E
authors.lastname: Jouve
authors.forename: C
authors.initials: C
authors.lastname: Alquier
authors.forename: M-E
authors.initials: ME
authors.lastname: Le Guern
authors.forename: J
authors.initials: J
authors.lastname: Micallef
authors.forename: O
authors.initials: O
authors.lastname: Blin
mesh_terms: D000275:Adjustment Disorders / Q000150:complications / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000150:complications / Q000188:drug therapy*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D005194:Family Practice; D005260:Female; D006801:Humans; D008140:Lorazepam / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000627:therapeutic use*; D011446:Prospective Studies; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D014151:Anti-Anxiety Agents; D010078:Oxazines; D008140:Lorazepam; C002125:etifoxine