Background Gout patients are more clinically complex than 20 years ago due to advanced age, comorbidities and polypragmasia. A lot of patients have contraindications or refractoriness to anti-inflammatory drugs. Using short term intravenous systemic corticosteroids seems to be safe and convenient for these patients, especially in case of polypragmasia.
Objectives To assess the clinical efficacy of Dexamethasone (D.) i.v. in gouty arthritis refractory to NSAIDs and to compare it with Prednisolone (P.) i.v. in equivalent doses.
Methods We performed a randomized single-center clinical trial. 64 patients were enrolled during 2009-2011. All patients had gouty arthritis and met ACR 1977 criteria for acute gout. 50 (78,1%) patients were males. The initial treatment was a NSAID at an adequate dose taken for at least 14 days. We randomized patients in 2 groups: group 1 (n=36) received D. 0,15 mg/kg i.v.; group 2 (n=28) received P. 1 mg/kg i.v., both drugs in 100 ml 0,9% solution of NaCl during 5 consecutive days. Groups were comparable in sex, age, duration of disease and duration of last attack. 26 (40,6%) patients had polyarthritis. The majority of patients had cardiovascular diseases: hypertension - 54 (84,4%), ischemic disease - 7 (10,9%), chronic heart failure – 4 (6,3%). Other comorbidities included diabetes – 13 (20,3%), and renal impairment – 39 (60,9%). The number of affected and swollen joints, pain in mm on visual analogue scale (VAS) during rest and activity were assessed the day before and the day after treatment. We also estimated the changes of inflammatory parameters (hs-C-reactive protein, ESR), and cardiovascular adverse events.
Results After 5 days of treatment, the number of affected and swollen joints significantly decreased in D. and P. groups (p<0,05). The differences were not important for affected (5,7 vs 5,9) and swollen joints (3,7 vs 4,0) suggesting equivalence. VAS during rest and activity also showed a statistically significant pain reduction in both groups (p<0,001). Reduction in the pain score during rest was 47,1 mm for D. group and 44,6 mm for P. group, respectively, and during activity 59,3 mm for D. group and 54,8 mm for P. group, respectively, but these changes did not differ between the groups (p>0,05). In 6 (16,7%) patients in D. group and 1 (3,6%) patient in P. group, we observed a complete resolution of symptoms (p=0,125). The disappearance of arthritis with minimal residual pain during activity was noted in 16 (44,4%) patients from D. group and in 12 (42,9%) patients from P. group. The aim of treatment was achieved in 22 (61,1%) patients treated with D. compared with 13 (46,4%) patients treated with P. The reduction of ESR level was similar in groups (16 mm vs 15 mm), whereas changes in hsC- reactive protein levels were higher with D. treatment (7,1 mg/l vs 2,8 mg/l; p<0,05). The most common adverse effect was hypertension at the first day of treatment in 14 (38,9%) patients treated with D. and in 9 (32%) patients treated with P., which needed an adjustment of anti-hypertensive medication. Hypertension was mild and asymptomatic in 20 (87%) patients. In 3 patients, we noted headache and palpitation.
Conclusions In gouty arthritis refractory to NSAIDs, Dexamethasone i.v. achieved clinical efficacy in 61,1% of patients compared with 46,4% treated with Prednisolone i.v. Despite a lot of comorbidities especially cardiovascular in our patients, Dexamethasone has proved to be relatively safe.
Disclosure of Interest None Declared