Effectiveness of the tenoxicam in patients with ankylosing spondylitis

Gaydukova, I.; Апаркина, А. В.; Khondkaryan, E V; Ребров, А. П.

doi:10.17116/jnevro20181182135-39

Cited by 3 publications

(3 citation statements)

References 14 publications

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“…We assume that in some cases, the clinical studies were so-called ‘marketing trials’ [ 34 , 35 , 37 ], i.e. they were conducted not to answer a scientific question but to boost sales by publishing articles in professional journals.…”

Section: Discussionmentioning

confidence: 99%

“…We sequentially reviewed each publication until 20 articles that met our inclusion criteria were accrued [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29]. When we replicated the search a few months later, the results in eLIBRARY were different, in that six additional articles that met the inclusion criteria were found; these were also added to our analysis [30][31][32][33][34][35]. Having consulted the eLIBRARY staff, we could not reliably determine the cause of discrepancy in the search results at different times.…”

Section: Methodsmentioning

confidence: 99%

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Unapproved clinical trials in Russia: exception or norm?

Talantov

Niyazov²,

Viryasova

et al. 2021

BMC Med Ethics

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Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common practice. Methods We searched the Russian language database eLIBRARY for the phrase ‘results of a randomised trial’. We selected publications reporting clinical trials and conducted in Russia. For each of the selected studies, we searched the state register of the approved clinical trials. We assessed whether (1) the investigational medicinal product was approved for marketing in Russia; (2) the therapeutic indications, posology, and administration method in the clinical trial were consistent with the approved labelling; (3) the issue of the journal included an advertisement of the medicinal product in question; and (4) the full description of the methodology corroborated that the clinical trial was randomised, as was stated in the title or abstract. Results Of the 26 selected articles, 22 reported the results of unauthorised clinical trials. Three of those trials were conducted in children. Twenty-one studies reported on data from unauthorised trials for investigational products approved for marketing in Russia. However, in nine cases, the therapeutic indications, posology, or administration method did not match the conditions indicated in the labelling. Moreover, in one case, the unauthorised trial included a drug therapy intervention where the active substance was not approved for use in any medicinal product marketed in Russia. In 14 of the 26 articles, the issue of the journal or the article itself contained an advertisement for the same medicinal product or, in one case, its manufacturer. All publications accompanied by advertisements claimed that the medicinal product in question was efficacious. Conclusions A substantial fraction of the clinical trials initiated by domestic sponsors and reported in Russian medical journals failed to obtain the mandatory prior evaluation and approval from the regulator. This can affect the rights and well-being of the study participants and the scientific validity of the studies.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Unapproved clinical trials in Russia: exception or norm?

Talantov

Niyazov²,

Viryasova

et al. 2021

BMC Med Ethics

View full text Add to dashboard Cite

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“…81 Eight studies on NSAIDs were included, of which two non-inferiority RCTs in r-axSpA, one at low and one at unclear RoB (Table 2). [82][83][84][85][86][87][88][89] The first study demonstrated non-inferiority of two doses of etoricoxib (60 and 90 mg daily) versus naproxen 1000 mg daily on VAS spinal pain (SMD between etoricoxib 60 mg and 90 mg with naproxen: 0.07 (−0.24, 0.10) and 0.03 (−0.19, 0.26). 82 The second RCT demonstrated the non-inferiority of two doses of celecoxib (400 mg and 200 mg) versus diclofenac 150 mg daily in VAS global pain (SMD not possible to calculate).…”

Section: Efficacy Of Pharmacological Interventions: Non Tsdmardsmentioning

confidence: 99%

Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

et al. 2022

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ObjectiveTo update the evidence of non-biological treatments for axial spondyloarthritis (axSpA), as a basis for the 2022 Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA.MethodsA systematic literature review (2016–2021) on efficacy and safety of non-pharmacological and non-biological pharmacological treatments was performed, up to 1 January 2022. The research question was formulated according to the PICO format: Population: adult patients with r-axSpA and nr-axSpA; Intervention: non-pharmacological and non-biological pharmacological treatments; Comparator: active comparator or placebo; Outcomes: all relevant efficacy and safety outcomes. Type of studies included were: randomised controlled trials (RCTs), observational studies (for efficacy of non-pharmacological treatments, and safety), qualitative studies. Cohen’s effect size (ES) was calculated for non-pharmacological and risk ratio (RR) for pharmacological treatments.ResultsOf 107 publications included, 63 addressed non-pharmacological interventions, including education (n=8) and exercise (n=20). The ES for education on disease activity, function, mobility was small to moderate (eg. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ES: 0.06–0.59). Exercise had moderate to high ES on these outcomes (eg. BASDAI, ES: 0.14–1.43). Six RCTs on targeted synthetic disease-modifying antirheumatic drugs (DMARDs) showed efficacy of tofacitinib, upadacitinib and filgotinib (phase 2 only) in r-axSpA (range RR vs placebo for ASAS20: 1.91–3.10), while apremilast and nilotinib were not efficacious. Studies on conventional synthetic DMARDs (n=3), non-steroidal anti-inflammatory drugs (NSAIDs, n=8) and other drugs (n=12) did not provide new evidence on efficacy/safety (efficacy of NSAIDs confirmed; limited efficacy of short-term glucocorticoids in one RCT).ConclusionsEducation, exercise and NSAIDs confirmed to be efficacious in axSpA. JAKi were proved efficacious in r-axSpA.

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Insight into the Formation of Cocrystal and Salt of Tenoxicam from the Isomer and Conformation

et al. 2022

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Tenoxicam (TNX) is a new non-steroidal anti-inflammatory drug that shows a superior anti-inflammatory effect and has the advantages of a long half-life period, a fast onset of action, a small dose, complete metabolism, and good tolerance. Some compounds often have tautomerism, and different tautomers exist in different crystalline forms. TNX is such a compound and has three tautomers. TNX always exists as the zwitterionic form in cocrystals. When the salt is formed, TNX exists in the enol form, which exhibits two conformations depending on whether a proton is gained or lost. Currently, the crystal structure of the keto form is not in the Cambridge Structural Database (CSD). Based on the analysis of existing crystal structures, we derived a simple rule for what form of TNX exists according to the pKa value of the cocrystal coformer (CCF) and carried out validation tests using three CCFs with different pKa values, including p-aminosalicylic acid (PAS), 3,5-dinitrobenzoic acid (DNB), and 2,6-dihydroxybenzoic acid (DHB). The molecular surface electrostatic potential (MEPS) was combined with the pKa rule to predict the interaction sites. Finally, two new cocrystals (TNX-PAS and TNX-DNB) and one salt (TNX-DHB) of TNX were obtained as expected. The differences between the cocrystals and salt were distinguished by X-ray diffraction, vibration spectra, thermal analysis, and dissolution measurements. To further understand the intermolecular interactions in these cocrystals and salt, the lattice energy and energy decomposition analysis (EDA) were used to explain them from the perspective of energy. The results suggest that the melting point of the CCF determines that of the cocrystal or salt, the solubility of the CCF itself plays an important role, and the improvement of the solubility after salt formation is not necessarily better than that of API or its cocrystals.

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Effectiveness of the tenoxicam in patients with ankylosing spondylitis

Cited by 3 publications

References 14 publications

Unapproved clinical trials in Russia: exception or norm?

Unapproved clinical trials in Russia: exception or norm?

Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

Insight into the Formation of Cocrystal and Salt of Tenoxicam from the Isomer and Conformation

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