Content
Volume 11, 2008
Identification of differential genetic profiles in severe forms of fi bromyalgia
and chronic fatigue syndrome/myalgic encephalomyelitis: a population-based genetic
association study
FJ Garcia-Fructuoso, JI Lao-Villadoniga, C Santos, V Poca-Dias, J Fernandez-Sola
Pages 1-24 ¦ Abstract
Evaluation of the analgesic efficacy of two lumiracoxib regimens in the treatment
of post-operative dental pain: single-centre, double-blind, randomised, placebo-controlled,
parallel-group study
G Krammer, K Stricker, S Jayawardene, R Rosemary
Pages 25-39 ¦ Abstract
Analgesic efficacy of a single dose of lumiracoxib, rofecoxib and placebo in
the treatment of postoperative dental pain and evaluation of the pharmacokinetics
of lumiracoxib
G Krammer, K Stricker, N Patel, L Choi, H Thurston
Pages 41-58 ¦ Abstract
Garcia-Fructuoso FJ, Lao-Villadoniga JI, Santos C, Poca-Dias V, Fernandez-Sola
J
Identification of differential genetic profiles in severe forms of fi bromyalgia
and chronic fatigue syndrome/myalgic encephalomyelitis: a population-based genetic
association study
J Clin Res 2008; 11: 1-24
Background: Fibromyalgia (FM) and chronic fatigue syndrome or myalgic encephalomyelitis
(CFS/ME) are believed to be two separate illnesses that are diagnosed using separate
but overlapping clinical criteria; to date there are no biological markers for
either condition. The symptoms of both disorders can differ markedly in presentation,
frequency and intensity and therefore it is necessary to distinguish between the
subtypes. Since recent studies have begun to determine the genetic background
of these diseases, the authors suggest the use of single nucleotide polymorphism
(SNP) analysis to investigate their different genetic profiles.
Methods: A group of 403 women (186 FM and 217 CFS/ME) were recruited for the study using
the American College of Rheumatology 1990 and the US Centers for Disease Control
and Prevention (CDC) research definition for FM and CFS diagnosis criteria, respectively.
The Fibromyalgia Impact Questionnaire and the CDC Symptom Inventory questionnaires
were used to define severity subgroups. For each sample, 107 SNPs were genotyped
by SNPlex ™ . An independent secondassociation study with 282 women (126 FM and
156 CFS/ME) was used to validate the results.
Results: Fifteen SNPs were identified that were able to discriminate between FM and CFS
patients with a likelihood ratio (LR+) of 11.5 (95% specifi city). Analysis of
further SNPs allowed differential genetic profiling between the most aggressive
FM phenotype and the mild forms (LR+ 12.4) and between a severe CFS/ME phenotype
and a milder one (LR+ 12.4).
Conclusions: In this study, the authors claim that FM and CFS/ME are, at least in a subgroup
of patients, two separate diseases with an important genetic component and suggest
that CFS/ME diagnosis should be an exclusion criterion for FM diagnosis. In addition,
severe cases might be different disease subtypes with distinctive genetic profiles.
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Krammer G, Stricker K, Jayawardene S, Rosemary R
Evaluation of the analgesic efficacy of two lumiracoxib regimens in the treatment
of post-operative dental pain: single-centre, double-blind, randomised, placebo-controlled,
parallel-group study
J Clin Res 2008; 11: 25-39
This single-centre, double-blind, randomised, placebo-controlled, parallel-group
study compared the efficacy and safety of two dosing regimens of lumiracoxib (200
mg single dose and 200 mg with an optional 200 mg re-dose) and placebo in patients
with moderate-to-severe post-operative dental pain. Patients were randomised (1:1:1)
to receive lumiracoxib 200 mg ( n =70), lumiracoxib 200 mg with an optional 200-mg
re-dose (n =70), or placebo ( n =70) after third-molar extraction. Both lumiracoxib
regimens were statistically superior to placebo for the primary efficacy variable,
which was the summed (time-weighted) pain intensity difference (categorical scale),
calculated over a 0–8-hour post-dose time-period ( p <0.001). Both regimens
of lumiracoxib were also superior to placebo for all secondary variables measured.
Lumiracoxib was well tolerated and provided effective pain relief superior to
placebo in patients with moderate-to-severe pain following dental surgery.
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Krammer G, Stricker K, Patel N, Choi L, Thurston H
Analgesic efficacy of a single dose of lumiracoxib, rofecoxib and placebo in
the treatment of postoperative dental pain and evaluation of the pharmacokinetics
of lumiracoxib
J Clin Res 2008; 11: 41-58
This study compared the efficacy of lumiracoxib with rofecoxib and placebo in
patients with postoperative dental pain. A total of 689 patients were randomised
to receive a single dose of lumiracoxib 400 mg ( n =318), rofecoxib 50 mg ( n
=318) or placebo ( n =53). For the primary efficacy variable (summed [time-weighted]
pain intensity difference [categorical] calculated over the fi rst 8 hours post-dose
[SPID-8]), lumiracoxib (least squares mean [LSM] 8.69) was statistically significantly
more effective compared with placebo (LSM –2.00; p <0.001) in reducing the
pain intensity. In comparison with rofecoxib, lumiracoxib was also statistically
significantly more effective for SPID-8 (LSM 7.14; p =0.003). Both lumiracoxib
and rofecoxib were superior to placebo for all the secondary variables assessed.
The pharmacokinetic assessments showed an anticlockwise hysteresis in the effect
versus concentration profile. Lumiracoxib 400 mg was effective in the treatment
of postoperative dental pain.
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