Let me talk again about modified or delayed release prednisone (Lodotra)
as two studies have been presented at the ACR 2013 Meeting in San Diego.
F. Buttgereit and colleagues
presented this study [Abstract # 2255]: "Threshold Analysis of
Patient Reported Morning Stiffness Where Delayed-Release (DR) Prednisone Was
Compared to, and Replaced, Immediate Release Prednisone in Rheumatoid Arthritis
(RA) Patients Receiving Conventional Disease-Modifying Antirheumatic Drugs
(DMARDs) Over 1 Year." IR-prednisone, taken in
the morning, is compared to DR-prednisone, taken once daily at bedtime (e.g.
10pm). Conclusion: DR prednisone, as compared to IR prednisone, produces
significantly higher MS response rates as defined by 25/50/75% improvement
thresholds. [...]."
The same patients were analysed in
this study, which had been presented by R. Alten and colleagues [Abstract #
2265]: "Switching From Immediate Release (IR) Prednisone To Delayed
Release (DR) Prednisone Improves Patient Reported Outcomes In Rheumatoid
Arthritis (RA) Patients On Conventional Disease-Modifying Antirheumatic Drugs
(DMARDs)." Conclusion: "This analysis
demonstrates that RA patients on stable DMARD therapy, who have not adequately
responded to IR-prednisone with respect to morning stiffness, showed
statistically significant and clinically meaningful improvement in this symptom
when switched to DR prednisone [...]."
Where's the catch? There's more than one. First: would you call a
patient, who suffers two hours of morning stiffness, stable? Second: the
advocates of Lodotra claim chronotherapy for their therapy, but we're already
doing chronotherapy. We give immediate release prednisone in the morning to
optimize (reduce) side effects. Lodotra is given in the evening to be released
during the night to optimize (increase) therapeutic effects. In any study
designed as this study DR prednisone will be better than IR prednisone. This is
due to the time, when the drug is given. So the study shows that prednisone
given at different times has different effects on morning stiffness. If you
really want to test, if the DR mechanism has any advantage over IR prednisone,
you would have to give both at the same time in the evening. My guess is that
significance dwindles to a trend. Unless I see such a designed study, I won't
prescribe DR prednisone.
Links to other blogposts on Lodotra on
this blog:
http://rheumatologe.blogspot.de/2013/06/modified-release-prednisone-at-eular.html
http://rheumatologe.blogspot.de/2013/06/modified-release-prednisone-at-eular.html
http://rheumatologe.blogspot.de/2012/11/lodotra-auf-dem-kongress-der.html (Text in German)
http://rheumatologe.blogspot.de/2012/06/modified-release-prednisone.html
http://rheumatologe.blogspot.de/2010/06/lodotra-my-problems-with-new-miracle.html
http://rheumatologe.blogspot.de/2012/06/modified-release-prednisone.html
http://rheumatologe.blogspot.de/2010/06/lodotra-my-problems-with-new-miracle.html
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