title: Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
abstract: BACKGROUND
  More than 50 years after the introduction of corticosteroids, few studies have focused on corticosteroid-induced adverse events after long-term systemic therapy.
  
  
  OBJECTIVE
  To assess the frequency, risk factors and patient's opinion regarding clinical adverse events occurring early during prednisone therapy.
  
  
  METHODS
  We conducted a cohort study in two French centres. All consecutive patients starting long-term (> oir = 3 months), high dosage (> or = 20 mg day(-1)) prednisone therapy were enrolled. The main clinical adverse events attributable to corticosteroids were assessed after 3 months of therapy, by comparison with baseline status. The patient's opinion regarding the disability induced by these adverse events was recorded. Risk factors of frequently observed adverse effects were identified by using logistic regression.
  
  
  RESULTS
  Eighty-eight patients were enrolled and 80 were monitored for at least 3 months (women 76%; mean age 59.1 +/- 18.7 years; giant cell arteritis 39%; mean baseline prednisone dosage 54 +/- 17 mg day(-1)). Lipodystrophy was the most frequent adverse event [63.0% (51.0-73.1)], was considered the most distressing by the patients and was most frequent in women and young patients. Neuropsychiatric disorders occurred in 42 patients [52.5% (41.0-63.8)], necessitating hospitalization in five cases. Skin disorders were noted by 37 patients [46.2% (35.0-57.7)] and were more frequent in women. Muscle cramp and proximal muscle weakness were reported by 32.5% (22.5-43.9) and 15% (8.0-24.7) of patients, respectively. Newly developed hypertension occurred in 8.7% (2.9-20.3) of patients. Lastly, 39% (19.7-61.4) of the premenopausal women reported menstrual disorders.
  
  
  CONCLUSIONS
  Lipodystrophy and neuropsychiatric disorders are common adverse events of long-term prednisone therapy and are particularly distressing for the patients concerned. The impact of these adverse events on adherence to corticosteroid therapy is not known.
authors.affiliation: Department of Internal Medicine, Hôpital Saint-Antoine, 184 rue du Faubourg Saint-Antoine, 75571 Paris Cedex 12, France. laurence.fardet@sat.aphp.fr
authors.forename: L
authors.initials: L
authors.lastname: Fardet
authors.forename: A
authors.initials: A
authors.lastname: Flahault
authors.forename: A
authors.initials: A
authors.lastname: Kettaneh
authors.forename: K P
authors.initials: KP
authors.lastname: Tiev
authors.forename: T
authors.initials: T
authors.lastname: Généreau
authors.forename: C
authors.initials: C
authors.lastname: Tolédano
authors.forename: C
authors.initials: C
authors.lastname: Lebbé
authors.forename: J
authors.initials: J
authors.lastname: Cabane
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001294:Attitude to Health; D015331:Cohort Studies; D005260:Female; D013700:Giant Cell Arteritis / Q000139:chemically induced; D006801:Humans; D008060:Lipodystrophy / Q000139:chemically induced* / Q000503:physiopathology / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects*; D012307:Risk Factors
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D011241:Prednisone