Adverse outcomes of antiinflammatory therapy among patients with polymyalgia rheumatica.
OBJECTIVE
To evaluate the incidence and risks of adverse events associated with therapy (both corticosteroids [CS] and nonsteroidal antiinflammatory drugs [NSAIDs]) among a previously identified, population-based cohort of patients first diagnosed with polymyalgia rheumatica (PMR) between 1970 and 1991 who were followed up over the long term.


METHODS
Information on demographics, PMR diagnosis, disease course, and drug therapy, in addition to data on adverse events commonly associated with CS and NSAID treatment, was obtained from the Rochester Epidemiology Project database. Cox proportional hazards and regression analysis models were used to evaluate the relationship between the occurrence of these events and therapy.


RESULTS
Of the 232 patients (69 male, 163 female) included in the study, the mean age at PMR diagnosis was 72.9 years, the average followup was 8.0 years, and 30 patients were also diagnosed with giant cell (temporal) arteritis. Among the 175 patients (49 male, 126 female) treated with CS, the mean duration of CS therapy was 2.4 years, the average daily dose was 9.6 mg, and the mean cumulative dose was 8.4 gm. In total, 65% of the 124 patients treated with CS alone experienced at least 1 adverse event, compared with 67% of the 57 patients treated with NSAIDs alone and 80% of the 51 patients treated with CS and NSAIDs. The average time from initiation of therapy to the first adverse event was 1.6 years (n = 160). Proportional hazards modeling identified 3 variables that independently increased the risk of adverse events: age at PMR diagnosis, a cumulative dose of prednisone > or = 1,800 mg, and female sex. Person-year analysis revealed that the risks of diabetes mellitus, vertebral fractures, femoral neck fractures, and hip fractures were 2-5 times greater among PMR patients compared with age- and sex-matched individuals from the same population. Medical care or consultation by a rheumatologist was a highly significant predictor of a lower initial CS dose.


CONCLUSIONS
The use of CS and NSAIDs in the treatment of PMR is associated with important long-term morbidity.
Gabriel
S E
SE
Mayo Clinic, Rochester, Minnesota 55905, USA.
Sunku
J
J
Salvarani
C
C
O'Fallon
W M
WM
Hunder
G G
GG
D000305:Adrenal Cortex Hormones / Q000009:adverse effects* / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D011111:Polymyalgia Rheumatica / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012727:Sex Characteristics; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D011241:Prednisone