Meta-analysis of two double-blind comparative studies with the sustained-release form of etodolac in rheumatoid arthritis

1993 ◽  
Vol 13 (S2) ◽  
pp. S25-S30 ◽  
Author(s):  
F. Porzio
1973 ◽  
Vol 123 (572) ◽  
pp. 69-71 ◽  
Author(s):  
G. Sedman

The advantages of a new sustained release form of amitriptyline (Lentizol) which can be given in a single dose for the treatment of depressive illness have recently been described by Sims (1972) and Haider (1972). This paper reports a similar double blind cross-over trial in the treatment of depressive illness (ICD 296) of the same substance compared against conventional amitriptyline at an overall higher dosage level.


1980 ◽  
Vol 8 (4) ◽  
pp. 286-292 ◽  
Author(s):  
T Dorman

A double-blind between-group trial was undertaken in fifty depressed patients to compare the efficacy of a sustained release form of amitriptyline (Lentizol®) with dothiepin (Prothiaden®) over a 5-week period. Patients fulfilling defined admission criteria were randomly allocated to treatment with evening dosage of either 50 mg of the sustained release preparation or 75 mg of dothiepin for the first week of the trial. Subject to review as necessary, these dosages were doubled at the end of the first week. Both drugs effected significant and appreciable improvement over the 5-week period, with the mean responses at the end of the trial retaining the same relative positions as at the beginning.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1005.1-1005
Author(s):  
Y. H. Lee ◽  
G. G. Song

Background:Methotrexate (MTX), an effective disease-modifying antirheumatic drug (DMARD) [2], is the most widely used DMARD for the treatment of rheumatoid arthritis (RA). However, not all patients are responsive to the drug; 30% of the patients discontinue therapy within 1 year of commencing the treatment, usually because of the lack of efficacy or undesirable adverse effects Small-molecule Janus kinase inhibitors are clinically developed for the treatment of RA.Objectives:The aim of this study is to investigate the relative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in comparison with adalimumab in patients with active RA and having inadequate responses to MTX.Methods:We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib, and adalimumab in RA patients having inadequate responses to MTX.Results:Four RCTs, comprising 5,451 patients, met the inclusion criteria. The baricitinib 4mg+MTX and upadacitinib 15mg+MTX group showed a significantly higher American College of Rheumatology 20% (ACR20) response rate than the adalimumab 40mg+MTX group. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that baricitinib 4mg+MTX had the highest probability of being the best treatment for achieving the ACR20 response rate, followed by upadacitinib 15mg+MTX, tofacitinib 5mg+MTX, filgotinib 200mg+MTX, filgotinib 100mg+MTX, adalimumab 40mg+MTX, and placebo+MTX. The upadacitinib 15mg+MTX and baricitinib 4mg+MTX groups showed significantly higher ACR50 and ACR70 response rates than adalimumab 40mg+MTX. In terms of Herpes zoster infection, the ranking probability based on the SUCRA indicated that placebo+MTX were likely to be the safest treatments, followed by filgotinib 200mg+MTX, filgotinib 100mg+MTX, adalimumab 40mg+MTX, tofacitinib 5mg+MTX, upadacitinib 15mg+MTX, and baricitinib 4mg+MTX. Regarding safety analysis, no statistically significant differences were found between the respective intervention groups.Conclusion:In RA patients with an inadequate response to MTX, baricitinib 4mg+MTX and upadacitinib 15mg+MTX showed the highest ACR response rates, suggesting a difference in efficacy among the different JAK inhibitors.References:[1]Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya LJTL (2017) Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. 390:457-468[2]Taylor PC, Keystone EC, van der Heijde D et al (2017) Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med 376:652-662[3]Fleischmann R, Pangan AL, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Zhou Y, Othman AA (2018) A phase 3, randomized, double-blind study comparing upadacitinib to placebo and to adalimumab, in patients with active rheumatoid arthritis with inadequate response to methotrexate. ARTHRITIS & RHEUMATOLOGY. WILEY 111 RIVER ST, HOBOKEN 07030-5774, NJ USA, pp[4]Combe B, Kivitz A, Tanaka Y, van der Heijde D, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy J (2019) LB0001 EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS WITH INADEQUATE RESPONSE TO METHOTREXATE: FINCH1 PRIMARY OUTCOME RESULTS. BMJ Publishing Group Ltd, ppDisclosure of Interests:None declared


PEDIATRICS ◽  
1989 ◽  
Vol 84 (4) ◽  
pp. A108-A108
Author(s):  
Student

Choice of dose [in 196 double-blind trials of treatments for rheumatoid arthritis], multiple comparisons, wrong calculation, sub-group and within-group analyses, wrong sampling units. . . , change in measurement scales before analyses, baseline difference, and selecting reporting of significant results were some of the verified or possible causes for the large proportion of results that favored the [newly proposed] drug. Doubtful or invalid statements were found in 76% of the conclusions or abstracts. Bias consistently favored the new drug in 81 trials, and the control in only one trial. It is not obvious how a reliable meta-analysis could be done [reliably] in these trials.


1961 ◽  
Vol 9 (3) ◽  
pp. 324-330 ◽  
Author(s):  
SAMUEL M. GREENBERG ◽  
JOHN F. HERNDON ◽  
DONALD R. MACDONNELL ◽  
THOMAS L. FLANAGAN ◽  
AMADEO BONDI

2012 ◽  
Vol 69 (2) ◽  
pp. 201-204 ◽  
Author(s):  
Aneta Lakic

Introduction. Hyperkinetic disorder or attention-deficit hyperactivity disorder (ADHD) is a clinical entity consisting of a cluster of symptoms including hyperactivity, attention disorder and impulse control disorder group. In the context of ADHD etiology we may say that genetic, clinical and imaging studies point out a disruption of the brain dopamine system, which is corroborated by the clinical effectiveness of stimulant drugs, which increase extracellular dopamine in the brain. Basically, it is a biological and not psychological disorder, which is important both for the comprehension and therapeutical approach to this problem. Today, the best recommended approach regarding children with ADHD is a combination of two therapeutic modalities: pharmacotherapy and behavioral treatment. The first-choice drugs for this disorder belong to the group of sympathomimetics - psychostimulants and atomoxetine (more recently). As the firstchoice therapy, methylphenydate in sustained release form has numerous advantages. Like all drugs, methylphenidate has its unwanted side effects. Most common are: loss of appetite, weight loss, sleeping disorders, irritability, headache. These side effects are well-known and documented in the literature. By analysing the available literature we have found cases of psychiatric side effects such as: psychosis, mania, visual hallucinations, agitation, suicidal ideas. We have not found examples of ADHD in children who use increased dosage of sustained release of methylphenidate leading to depressive symptomatology. On the other side, methylphenidate may be prescribed for off-label use in treatmentresistant cases of depression. Case report. The case of a 7- year-old boy diagnosed with ADHD was on a minimal dose of sustained release form of methylphenidate. After initial titration of the drug, i.e. after raising the dose to the next level the boy developed clinical signs of depression. The treatment was ceased and depressive symptoms were withdrawed. Conclusion. Manifestation of depressive symptomatology after dose increasement of sustained release form of methylphenidate in a 7-year-old boy with ADHD represents an uncommon side effect. Precise drug activity mechanisms responsible for the appearance of these symptoms remains to be explained.


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