title: Adverse events during longterm low-dose glucocorticoid treatment of polymyalgia rheumatica: a retrospective study.
abstract: OBJECTIVE
  To assess the occurrence of adverse events in a cohort of patients with polymyalgia rheumatica (PMR), treated with low-dose glucocorticoids (GC).
  
  
  METHODS
  This was a retrospective study by review of medical records.
  
  
  RESULTS
  We identified 222 patients who had a mean duration of followup of 60 ± 22 months and a mean duration of GC therapy of 46 ± 22 months. We found that 95 patients (43%) had at least 1 adverse event after a mean duration of GC therapy of 31 ± 22 months and a mean cumulative dose of 3.4 ± 2.4 g. In particular, 55 developed osteoporosis, 31 had fragility fractures; 27 developed arterial hypertension; 11 diabetes mellitus; 9 acute myocardial infarction; 3 stroke; and 2 peripheral arterial disease. Univariate analysis showed that the duration of GC treatment was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), arterial hypertension (p < 0.005), and acute myocardial infarction (p < 0.05). Cumulative GC dose was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), and arterial hypertension (p < 0.01). The adverse events occurred more frequently after 2 years of treatment. Multivariate analysis showed that GC duration was significantly associated with osteoporosis (adjusted OR 1.02, 95% CI 1.02-1.05) and arterial hypertension (adjusted OR 1.03, 95% CI 1.01-1.06); GC cumulative dose was significantly associated with fragility fractures (adjusted OR 1.4, 95% CI 1.03-1.8).
  
  
  CONCLUSIONS
  Longterm, low-dose GC treatment of PMR is associated with serious adverse events such as osteoporosis, fractures, and arterial hypertension; these adverse events occur mostly after 2 years of treatment.
authors.affiliation: Rheumatology Unit, Department of Internal Medicine, University of Pisa, Pisa, Italy. mmazzant@int.med.unipi.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Mazzantini
authors.forename: Claudia
authors.initials: C
authors.lastname: Torre
authors.forename: Mario
authors.initials: M
authors.lastname: Miccoli
authors.forename: Angelo
authors.initials: A
authors.lastname: Baggiani
authors.forename: Rosaria
authors.initials: R
authors.lastname: Talarico
authors.forename: Stefano
authors.initials: S
authors.lastname: Bombardieri
authors.forename: Ombretta
authors.initials: O
authors.lastname: Di Munno
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D003920:Diabetes Mellitus / Q000139:chemically induced / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D005260:Female; D050723:Fractures, Bone / Q000139:chemically induced* / Q000453:epidemiology; D005938:Glucocorticoids / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000139:chemically induced / Q000453:epidemiology; D010024:Osteoporosis / Q000139:chemically induced* / Q000453:epidemiology; D011111:Polymyalgia Rheumatica / Q000188:drug therapy*; D012189:Retrospective Studies; D020521:Stroke / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors
chemical_list: D005938:Glucocorticoids