The British Journal of Rheumatology, Vol 37, 189-195, Copyright © 1998 by British Society for Rheumatology
B Dasgupta, AL Dolan, GS Panayi and L Fernandes
The objective was to compare the efficacy and safety of intramuscular
methylprednisolone acetate (i.m. MP) with oral prednisolone (OP) in the
treatment of polymyalgia rheumatica (PMR), a common steroid-treated illness
where prolonged therapy can lead to steroid side-effects. The cumulative
dose with i.m. MP injections given every 3-4 weeks is considerably smaller
than that with conventional OP, and may therefore be associated with fewer
long-term side-effects. A hybrid design was used with an initial 12 week
double-blind placebo-controlled phase followed by an open phase on active
treatment up to 96 weeks. The study was multicentre hospital out-patient
based and included 60 patients with untreated PMR. In the double-blind
phase, either 120 mg 3-weekly i.m. MP or gradually tapering daily OP
(initial dose 15 mg) were administered. In the open phase, subjects
continued their active treatment with gradual tapering of the steroid
dosage. The remission rate at 12, 48 and 96 weeks, and other measures of
disease activity, i.e. sedimentation rate, pain and morning stiffness, and
percentage of adverse reactions and serious complications such as
fractures, were the main outcome measures. Sixty patients entered (30 OP:30
i.m. MP) and 49 (25 OP:24 i.m. MP) completed the study. There were similar
remission rates after the double-blind phase (60.6% OP and 66.6% i.m. MP,
respectively) and similar disease control in the succeeding open phase.
With steroid tapering, the mean erythrocyte sedimentation rate for the
entire cohort registered a significant increase in the absence of an
increase in symptoms. At 96 weeks, the cumulative mean steroid dose in
subjects treated with i.m. MP was equivalent to 56% that of subjects
treated with OP. There were eight fractures with OP compared to one on i.m.
MP. Mean weight gain was significantly greater with OP than i.m. MP (3.42
vs 0.82 kg, P < 0.005). Minor adverse reactions were similar in both
groups apart from slightly increased bruising with i.m. MP. Only patients
on OP reported moon face, hypertension, cataracts, back pain and
depression, but the numbers were small. It is possible to achieve
equivalent long-term disease control in PMR with i.m. MP compared to OP.
I.m. MP was associated with far fewer fractures and lesser weight gain,
presumably related to lower cumulative dose. These findings may have
implications in the steroid treatment of PMR, and other rheumatic and
non-rheumatic diseases.
ORIGINAL PAPERS
An initially double-blind controlled 96 week trial of depot methylprednisolone against oral prednisolone in the treatment of polymyalgia rheumatica
Department of Rheumatology, Southend Health Care Trust, Westcliff-on- Sea, Essex.
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