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Acute
gouty arthritis (AGA), with the global incidence of around 0.03% in women and
0.08% or 0.13% in men, is one of the most common inflammatory joint diseases.
Indomethacin,
etoricoxib and prednisolone were found to be equally effective in the treatment
of gouty arthritis. However, prednisolone showed fewer AEs and was better than
the other two in reducing joint inflammation.
Acute gouty arthritis
(AGA), with the global incidence of around 0.03% in women and 0.08% or 0.13% in
men, is one of the most common inflammatory joint diseases. It is more
prevalent in men above 40 years of age. It occurs due to the deposition of
monosodium urate crystals, linked to purine metabolic disorder. AGA consists of
three stages. It starts with increased uric acid levels (hyperuricemia), but
there are no symptoms. The second stage is when recurrent gout attacks occur
with no symptoms. The third stage of gout is long-term chronic gout with no
symptom-relief. Patients suffering from gout may usually come up with pain as
their primary symptom, but the treatment strategy should consider inflammation
control along with pain. The underlying mechanism resulting in an inflammatory
response is not entirely known. Previous studies have suggested the involvement
of environmental toxin 4-Nonylphenol in promoting inflammatory response in IBD.
However, it is not known if this toxin plays a role in the inflammatory
response of AGA.
NSAIDs are currently the choice of treatment for AGA due to their significant property of relieving pain and inhibiting inflammation. Indomethacin 50 mg three times a day is considered a standard treatment for AGA. However, many studies have indicated that there are many adverse events (AEs) linked to indomethacin use. NSAIDs with less AEs, i.e. selective COX-2 inhibitors, were formulated. These agents work by inhibiting the COX-2 enzyme responsible for catalyzing the prostaglandin synthesis. Unlike other NSAIDs, selective COX-2 inhibitors produce less gastrointestinal AEs but offer similar analgesic and anti-inflammatory properties. Etoricoxib, a selective COX-2 inhibitor, is widely used for treating gout. Research has even suggested corticosteroids to be an effective and safe alternative for treating gout in older adults. A study result indicated that prednisolone 35 mg once a day for five days was safe and offered equivalent efficacy to naproxen 500 mg twice a day for gout management.
Rationale behind research: Many
clinical studies have compared the effectiveness of prednisolone or etoricoxib
with indomethacin. But, there is a lack of studies evaluating the comparative
efficacy and safety of all three drugs i.e. indomethacin, prednisolone and
etoricoxib in the treatment of AGA.
Objective: The
present open-label randomized and active comparator trial was carried out to
evaluate the comparative efficacy (analgesic and anti-inflammatory) and
safety/tolerability of indomethacin 50 mg thrice a day etoricoxib 120 mg once a
day and prednisolone 35 mg once a day for treating AGA
Study Outcomes:
Baseline: Patients’
demographic characteristics and pain intensity were assessed at the baseline.
Primary Outcomes: Reduction
of pain in the index joint as experienced by the patient: assessed using 5-point
Likert scale (0=very good, 1 =good, 2=fair, 3= poor, 4= very poor).
Secondary Outcomes:
Changes of physician’s assessment of following parameters from baseline:
Patients’
global assessment of response to therapy: assessed using 5-point Likert scale
(0=very good, 1 =good, 2=fair, 3= poor, 4= very poor)
AEs: Gastric or abdominal pain, dizziness, edema, fatigue or drowsiness, and dry mouth were recorded
Time Points:
Outcomes:
Primary
and Secondary outcomes: A significant reduction in symptoms
of acute gout attack in time- patients' assessment of pain, physician
assessment of joint swelling, tenderness, erythema and activity were noted with
all the three drugs. The reduction of pain and tenderness was similar with oral
prednisolone, etoricoxib, and indomethacin (Figure 1). Oral prednisolone,
etoricoxib, and indomethacin were similar in the efficacy of reducing
inflammation indicator i.e. erythema (Figure 1). But, indomethacin caused a
more significant reduction in swelling as compared to indomethacin (Figure 1).
The joint activity was equally improved with all the three drugs. (Figure 1) Also, the patients' response to global
therapy was similar for all the three drugs (Figure 2).
AEs: In indomethacin group, the total AEs observed were significantly more frequent as compared to the other two groups.
The current study was
conducted to evaluate the comparative efficacy and safety of indomethacin,
prednisolone and etoricoxib, for the treatment of AGA. The study outcomes
demonstrated similar efficacy of indomethacin, oral prednisolone and etoricoxib
in improving pain, tenderness, and joint activity in patients with AGA after four
days. All three drugs were equally
effective in reducing inflammation. However, the swelling reduction was more
pronounced with prednisolone compared to other drugs. In all the three groups,
the patients' assessment of response was found to be similar.
As per 2012 ACR guidelines, the single use of systemic corticosteroids, oral colchicine and NSAIDs is recommended without prioritizing one over the other. The condition of the patient and the presence of comorbidities should be the criteria to decide the treatment. Colchicine was not used in the study as it quickly results in AEs due to its similar therapeutic and toxic doses. Two NSAIDs, etoricoxib and indomethacin, were used in the study which is recommended as first-line treatment for AGA. Etorixicib showed comparable efficacy to that of indomethacin, suggesting that this selective COX-2 inhibitor is an effective treatment for AGA.
Indomethacin, on the
other side, showed a higher incidence of adverse events which suggest that
etoricoxib could be a better choice over indomethacin for treating AGA.
Prednisolone also showed similar efficacy to indomethacin. However, it was
better than indomethacin in reducing joint swelling. Few studies have suggested
the use of corticosteroids in early stages of disease for quick symptomatic
relief, but its more use can be related to severe adverse effects. The use of
corticosteroids in moderation may lead to fewer AEs. Also, there were fewer
gastrointestinal tract related AEs observed with prednisolone than those with
NSAIDs. Although all the three drugs had comparable efficacy, prednisolone was
better than the other two in reducing joint swelling. It was also associated
with fewer AEs compared to the other two.
The present study could
help clinicians to decide the treatment based on the patient’s condition, and
co-morbidities as all three drugs, indomethacin, oral prednisolone and
etoricoxib exhibited comparable efficacy in the treatment of AGA.
Medical Science Monitor
Comparison of Prednisolone, Etoricoxib, and Indomethacin in Treatment of Acute Gouty Arthritis: An Open-Label, Randomized, Controlled Trial study
Lingling Xu et. al
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