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Microsoft powerpoint - crx-139 acr 2007 poster_final km1 [read-only]
A Clinical Study of Very Low Dose Prednisolone and Paroxetine for Active Rheumatoid Arthritis
Edward Keystone1, Jude Rodrigues2, Jiri Vencovsky3, Carter Thorne4, Marco Matucci-Cernic5, Johannes Bijlsma6, Melissa Nichols7, Theresa Podrebarac7, Josef S. Smolen81University of Toronto, Canada; 2Clinical Research and Arthritis Center, Windsor, Canada; 3Institute of Rheumatology, Prague, Czech Republic; 4Arthritis Program Research Group, Newmarket, Canada; 5
University of Florence, Italy; 6University Medical Center Utrecht, The Netherlands; 7Combinatorx, Cambridge, MA; 8University of Vienna, Austria
ACR Responses over time
Rheumatoid arthritis (RA) is the most common adult inflammatory
EULAR Good Response and Remission
arthritis affecting approximately 1% of the worldwide population. Oralglucocorticoids are effective for the control of RA disease activity and
are disease-modifying. However, the use of chronic glucocorticoids is
limited by dose-dependent toxicities. CRx-139 is a novel combination
agent containing a very low dose of prednisolone and paroxetine.
Paroxetine, a selective serotonin reuptake inhibitor (SSRI), is thought to
selectively amplify the immunologic and anti-inflammatory benefits of
glucocorticoids without potentiating their side effects. Previously,
CRx-139 has been shown to reduce TNFα, IL-6 and C-reactive protein
To evaluate the activity of CRx-139 in reducing RA disease activity in
comparison to very low dose prednisolone in patients on DMARD
Days 42 and 70
CRx-139-treated patients achieved ACR20 responses superior to prednisolone given
alone. At Day 42, 55% of CRx-139High-treated versus 36% of prednisolone-treated
EULAR good response and remission in the CRx-139High group suggested a dose
patients achieved an ACR20 response (p=0.026). 32% of CRx-139high-treated patients
A 14-week, randomized, multi-center study was conducted in RA
response. 19% of subjects in the CRx-139High group achieved remission at Day 42
achieved ACR50 response compared to 13% of the prednisolone-treated (p=0.008).
patients (n= 209). Patients with at least 6 tender and 4 swollen joints
and maintained that level of response to Day 70. CRx-139 activity could not be
However, the effect was not maintained to Day 70 which was the primary endpoint.
remained on stable doses of DMARDs and NSAIDs. Oral
glucocorticoids were discontinued at least 1 month prior. All patientsreceived 3 mg prednisolone as a split dose for 2 weeks. Patients were
Median ACR Core Assessments
CRx-139Low: prednisolone 3 mg plus paroxetine 10 mg (n=71)
Baseline D42 D70 Baseline D42 D70
Baseline D42 D70
CRx-139High: prednisolone 3 mg plus paroxetine 20 mg (n=69)
The primary efficacy endpoint in this study was to evaluate the
proportion of ACR 20 responders from Baseline to the end of the
CRx-139 was generally well tolerated. An equal number of serious adverse events
treatment period (Day 70), after 56 days of combination treatment and
occurred with prednisolone alone and CRx-139-treated patients.
14 days of prednisolone treatment using the intent to treat (ITT)
population with a non-responder imputation (NRI) for missing values.
Secondary efficacy endpoints were to evaluate the difference in DAS28
response, CRP levels, and inflammatory cytokine levels between RA
subjects treated with each of two doses of CRx-139 plus DMARD
therapy and subjects treated with steroid plus DMARD therapy after 10
CRx-139High-treatment produced a clinically meaningful decrease in disease
activity as demonstrated by the proportion of patients achieving ACR50, EULAR
weeks of treatment in the ITT population with last observation carried
good response and remission at Day 42. The patients who achieved remission
forward (LOCF) for missing values unless otherwise noted.
CRx-139High-treated patients had an improvement in the median percent reduction
had durability of the response to Day 70. Pain was sensitive to change with CRx-
of pain (-49.38% vs.-23.44%; *p=0.0027) at Day 42 compared to prednisolone.
139 treatment. The activity of low dose glucocorticoid (3 mg/day) may be higher
This effect was not durable to Day 70.
in this study given the split-dosing regimen and lack of a placebo group.
ACR 2007, Boston
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