There has been one study
on Modified-Release Prednisone at the ACR 2015 Annual Meeting in San Francisco.
I have voiced my concerns about Modified-Release Prednisone before and this
study makes me even more confident in my views.
Maurizio Cutolo and
colleagues presented: “Efficacy and Safety of Modified-Release Prednisone in
Patients with Polymyalgia Rheumatica: Results of a Multicenter, Randomized,
Active-Controlled Phase 3 Study”. Methods: “Patients meeting the 2012 EULAR/ACR
classification criteria for PMR (excluding US) were randomized to double-blind
MR prednisone or IR prednisone 15 mg/day for 4 weeks. MR prednisone/placebo was
taken at approx. 10pm and IR prednisone/placebo was taken between 5am and 9am.
[…]” The duration of the study is too short to say anything about adverse
events in long term therapy using glucocorticoids. Comparing “ approx. 10pm”
with “between 5am and 9am” looks suspicious as one compares an optimized time
slot with one that wasn’t optimized. Why compare approx. 10pm and approx. 5am? Results:
“The study randomized 62 patients; 66% female, mean age 69 years. […].” I’d say
the study is very low powered. Conclusion: “Although the primary analysis of
non-inferiority was not met, the consistently positive and clinically
meaningful results for MR prednisone compared with IR prednisone observed in
this study provide an indication of a beneficial clinical effect of MR over IR
prednisone in patients with PMR, with improvements observed as early as Week 1.”
My own conclusion is different:
“Although Modified-Release Prednisone has been given an advantage, the primary
analysis of non-inferiority was not met.” Especially morning stiffness, global
pain, and CRP didn’t show significant differences (please look at the chart in
the abstract). If you really want to test, if the modified-release mechanism
has any advantage over prednisone, you would have to give both at the same time
in the evening.
References:
Cutolo M, Hopp M, Liebscher S, Dasgupta B, Buttgereit F. Efficacy and
Safety of Modified-Release Prednisone in Patients with Polymyalgia Rheumatica:
Results of a Multicenter, Randomized, Active-Controlled Phase 3 Study
[abstract]. Arthritis Rheumatol. 2015;
67 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-modified-release-prednisone-in-patients-with-polymyalgia-rheumatica-results-of-a-multicenter-randomized-active-controlled-phase-3-study/.
Accessed December 3, 2015.
Modified Release
Prednisone at the EULAR 2013 http://rheumatologe.blogspot.de/2013/06/modified-release-prednisone-at-eular.html
Lodotra (modified or
delayed release prednisone) at the ACR 2013 Meeting in San Diego http://rheumatologe.blogspot.de/2013/11/lodotra-modified-or-delayed-release.html
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