Lodotra (Modified Release Pred.) | Arthritis Information

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< id=Uid = value=18207016 name=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus.uid sid="1">1: Lancet. 2008 Jan 19;371(9608):205-14. < =1.2> Links
Comment in:
Lancet. 2008 Jan 19;371(9608):183-4.

Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial.

Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, Jeka S, Krueger K, Szechinski J, Alten R.

Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany. frank.buttgereit@charite.de

BACKGROUND: Circadian rhythms are changed in patients with rheumatoid arthritis. A new modified-release delivery system has been developed which adapts the release of the administered glucocorticoid to the circadian rhythms of endogenous cortisol and disease symptoms to improve the benefit-risk ratio of glucocorticoid therapy in rheumatoid arthritis. We aimed to assess the efficacy and safety of a new modified-release prednisone tablet compared with immediate-release prednisone in patients with this disease. METHODS: In a 12-week, multicentre, randomised, double-blind trial, 288 patients with active rheumatoid arthritis were randomly assigned to either a modified-release prednisone tablet (n=144) or to an immediate-release prednisone tablet (n=144). The modified-release tablet was taken at bedtime and prednisone was released with a delay of 4 h after ingestion. This treatment was compared with morning administration of immediate-release prednisone as an active comparator. The primary outcome measure was duration of morning stiffness of the joints. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00146640. FINDINGS: The mean relative change in duration of morning stiffness of the joints from baseline to end of treatment was significantly higher with modified-release prednisone than with immediate-release prednisone (-22.7%vs -0.4%; difference=22.4% [95% CI 0.49-44.30]; p=0.045). Patients in the prednisone modified-release group achieved a mean reduction of 44.0 (SD 136.6) min compared with baseline. The absolute difference between the treatment groups was 29.2 min (95% CI -2.59 to 61.9) in favour of modified-release prednisone (p=0.072). The safety profile did not differ between treatments. INTERPRETATION: Modified-release prednisone is well tolerated, convenient to administer, and produces a clinically relevant reduction of morning stiffness of the joints in addition to all known therapeutic effects of immediate-release prednisone.

I'm interested in this and am wondering if anyone else taking pred has any further info or comment on this new med.

K.
hi katalina i have been on pred 13yrs  at present it is my only med..
not really sure what to make of that.. maye due to being 12.20am..
will have to reread. just wanted to say. i  have  read they are working on
making a drug that has prednisones make up ie highly anti inflamitory.
but whithout the side effects. i think that is one to watch for..
Boney
Hi Katalina, thanks for the interesting post, and Stephen I shall be looking out for that new pred style drug also after nearly 8 years on pred with as many side effects I can think of!!!!!  Cheers Janie. hi katalina i had to look up what the circadium rythem ..is..
it would be interetng to see how efficient the modified pred is over
the whole 24hr period rather than morning stiffness.. when ra is on a roll
morning stiffness becomes all day stiffness.. and for some of us we are relying
on pred 24-7....
i copied some info on circadium rythem
Boney
great deal of research on biological clocks was done in the last half of the 20th century. It is now known that the molecular circadian clock can function within a single cell; i.e., it is cell-autonomous.[4] At the same time, different cells may communicate with each other resulting in a synchronized output of electrical signaling. These may interface with endocrine glands of the brain to result in periodic release of hormones. The receptors for these hormones may be located far across the body and sychronize the peripheral clocks of various organs. Thus, the information of the time of the day as relayed by the eyes travels to the clock in the brain, and, through that, clocks in the rest of the body may be synchronized. This is how the timing of, for example, sleep/wake, body temperature, thirst, and appetite are coordinately controlled by the biological clock.

[edit] Importance in animals

Circadian rhythms are important in determining the sleeping and feeding patterns of all animals, including human beings. There are clear patterns of core body temperature, brain wave activity, hormone production, cell regeneration and other biological activities linked to this daily cycle. In addition, photoperiodism, the physiological reaction of organisms to the length of day or night, is vital to both plants and animals, and the circadian system plays a role in the measurement and interpretation of daylength.


Boney,

I'm totally with ya on the 24/7 pred reliance.  Like you, this is the only Rx drug that I take for my inflammatory RA.  I take the pred in the morning, around 5-6AM, with my other, non-RA related meds.  I have insomnia, so the idea of taking the pred at 2AM instead isn't a big issue for me, in terms of having to wake up to take it, so I took the pred at 2AM today.  When I awakened, I didn't feel quite as stiff as I normally do.  I'm going to continue to take the pred at 2AM for a couple weeks and see if it makes a difference in duration of morning stiffness for me.  However, by mid-day, just about every flippin' joint, and  connective tissue in my body is stiff and aching like hell again anyway.  Our weather here has been cold, wet and nasty the last few days and my RA seems to flare more when the barometric pressure fluctuates.

K.

I hate pred. *shudder* I can't take it, but I know a lot of our members depend on it for much needed relief. I have to wonder though - I know Pred makes people eat more often, would time-released Pred result in 24/7 munchies or would it just level off at some point? Would you get used to the feeling and start to eat normally again? Stupid questions probably. I just wonder.

hi katalina you are a early riser ..i  do the same as you and take all my meds in
the morning.. but not so Early.. hi mrs A ..24/7 Munchies.. i have very little weight gain while on pred.
i did put weight on while on mtx i was eating lots due to the siky feeling.. I just have a question for all of you on pred. Have you ever considered going off this killer drug and only using it as a last resort? It may help your swelling and pain, but the damage it does to your bone and endocrine system is 10 fold in comparison. I just don't get the rationale. hi lorster. what you consider a killer drug has been a life saver for many..
for some of us not taking pred is not a option.. my life would be pretty bad
whith out it.. at present i have used all the old dmrds some twice.. bad reactions
to most at some stage or other..others stopped working. i am not able to get the
biologics .. i have had reaction to medrol injects..
so here i am..  any surgestions most welcome..
Boney
I tried methotrexate and it swelled my body, including my lungs and i couldn't breathe.  I tried Plaq and it did the same thing and i was almost in the ER at this time.
 
I take prednisone and only have munchies on high doses, no weight gain from it, no sickness or side effects.   I would take this drug over any others anyday.  Any bone damage can be repaired and i am already overweight so not worried about looking good.
 
Pred is my life saver.
hi bubba im sure you look great   
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