Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.

BACKGROUND

More than 50 years after the introduction of corticosteroids, few studies have focused on corticosteroid-induced adverse events after long-term systemic therapy.

OBJECTIVES

To assess the frequency, risk factors and patient's opinion regarding clinical adverse events occurring early during prednisone therapy.

PATIENTS AND 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.