Abstract | BACKGROUND: OBJECTIVE: DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: University-based clinic. PATIENTS: INTERVENTION: MEASUREMENTS: Number of relapses, cumulative dose of corticosteroid, and number of adverse events were assessed on completion of follow-up. RESULTS: Compared with combined prednisone and placebo therapy, treatment with prednisone and methotrexate reduced the proportion of patients who experienced at least one relapse (45% vs. 84.2%; P = 0.02) and the proportion of patients who experienced multiple relapses (P = 0.004). The mean cumulative dose of prednisone was 4187 +/- 1529 mg in the methotrexate group and 5489.5 +/- 1396 mg in the placebo group (mean difference, 1302 mg [95% CI, 350 to 2253 mg]; P = 0.009). Overall, the rate and severity of adverse events were similar between groups. Treatment was discontinued in 3 patients in the methotrexate group who experienced definite drug-related adverse events. In sensitivity analysis that included patients lost to follow-up, differences between groups in number of relapses and cumulative dose of prednisone were significant. CONCLUSIONS:
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Authors | J A Jover, C Hernández-García, I C Morado, E Vargas, A Bañares, B Fernández-Gutiérrez |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 134
Issue 2
Pg. 106-14
(Jan 16 2001)
ISSN: 0003-4819 [Print] United States |
PMID | 11177313
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenal Cortex Hormones
- Immunosuppressive Agents
- Placebos
- Prednisone
- Methotrexate
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Topics |
- Adrenal Cortex Hormones
(adverse effects, therapeutic use)
- Aged
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Giant Cell Arteritis
(drug therapy)
- Humans
- Immunosuppressive Agents
(administration & dosage, adverse effects, therapeutic use)
- Male
- Methotrexate
(administration & dosage, adverse effects, therapeutic use)
- Placebos
- Prednisone
(administration & dosage, adverse effects, therapeutic use)
- Recurrence
- Sensitivity and Specificity
- Statistics, Nonparametric
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