scholarly journals AB0876 THE BENEFIT AND SAFETY OF DIACEREIN IN AGED AND OBESE PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS: DATA FROM THE DISSCO CLINICAL STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1744.1-1744
Author(s):  
J. P. Pelletier ◽  
J. P. Raynauld ◽  
M. Dorais ◽  
P. Paiement ◽  
J. Martel-Pelletier

Background:The DISSCO trial (6-month international, multicentre, double-blind, randomised study on the effect of diacerein vs celecoxib in symptomatic knee osteoarthritis [OA] patients) showed that diacerein had comparable efficacy to celecoxib at reducing the level of pain (WOMAC pain).Objectives:To assess the effect of age, body mass index (BMI), and gender on the efficacy/safety profile of diacerein following 6 months of treatment.Methods:Of the patients (n=380) that were randomised, 186 received treatment with 50 mg diacerein once daily for the first month and twice daily thereafter. This study was done on the intent-to-treat population (n=183). Efficacy outcome assessments which included absolute change in WOMAC pain (score 0-50) and function (score 0-170), and VAS (score 0-10) were analysed following stratification based on age (< 65 vs ≥ 65 years old) and BMI (< 30 vs ≥ 30 kg/m2) at time of randomisation. Treatment effects on continuous efficacy outcomes were performed using covariance analysis (ANCOVA). For gastrointestinal (GI) safety outcomes, the adverse events (AEs), including diarrhoea, soft faeces, abdominal pain and dyspepsia, and the time-to-onset from baseline were stratified according to age of patients at randomisation. Treatment-related GI AEs were also assessed according to the gender. The independent variables were treatment, stratification variable, interaction between both, and the outcome measure at baseline. Comparisons between groups were carried out using Chi-square.Results:No significant differences were found between the two age groups (<65 years old [n=105], ≥65 years old [n=78]) in the level of reduction in WOMAC pain (-10.3 ± 1.1, -8.6 ± 1.3, respectively; p=0.30), VAS (-2.3 ± 0.2, -2.2 ± 0.3, p=0.73) or improved physical function (-29.7 ± 3.7, -22.1 ± 4.2, p=0.18). The reported incidences of treatment-related GI AEs were also similar between the two age groups; more specifically for diarrhoea, incidence for patients <65 years old [n=12] 11.3% and for those ≥65 years old [n=7] 8.8% (p=0.63) with a mean time-to-onset (day 43 ± 49, 61 ±51, respectively; p=0.11). Moreover, gender had no influence on treatment-related GI AEs (p=0.42).In regard to treatment response of obese (n=101) vs. non-obese (n=82) patients in terms of pain reduction (WOMAC: -10.1 ± 1.2, -9.1 ± 1.1, respectively; p=0.58; VAS: -2.6 ± 0.3, -2.0 ± 0.3; p=0.15), or improved WOMAC physical function (-29.8 ± 4.2, -23.5 ± 3.8; p=0.26), there were also no significant differences.Conclusion:In symptomatic knee OA patients, the level of effectiveness and safety profile of treatment with diacerein were found not to be influenced by age, BMI or gender.Disclosure of Interests:Jean-Pierre Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica, Speakers bureau: TRB Chemedica and Mylan, Jean-Pierre Raynauld Consultant of: ArthroLab Inc., Marc Dorais Consultant of: ArthroLab Inc., Patrice Paiement Employee of: ArthroLab Inc., Johanne Martel-Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica

2020 ◽  
Author(s):  
Shuang Zheng ◽  
Liudan Tu ◽  
Flavia Cicuttini ◽  
Zhaohua Zhu ◽  
Weiyu Han ◽  
...  

Abstract Background:To describe demographic and clinical factors associated with the prevalence and incidence of depression and explore the temporal relationship between depression and joint symptoms in patients with symptomatic knee osteoarthritis (OA). Methods:413 participants were selected from a randomized controlled trial in people with symptomatic knee OA and vitamin D deficiency (age 63.2 ± 7.0 year, 50.4% female). Depression severity and knee joint symptoms were assessed using the patient health questionnaire (PHQ-9) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively, at baseline and 24 months. Results: The prevalence and incidence of depression was 25.4% and 11.2%, respectively. At baseline, having younger age, a higher body mass index (BMI), greater scores of WOMAC pain (PR: 1.05, 95%CI:1.03, 1.07), dysfunction (PR: 1.02, 95%CI:1.01, 1.02) and stiffness (PR: 1.05, 95%CI: 1.02, 1.09), lower education level, having more than one comorbidity and having two or more painful body sites were significantly associated with a higher prevalence of depression. Over 24 months, being female, having a higher WOMAC pain (RR: 1.05, 95%CI: 1.02, 1.09) and dysfunction score (RR: 1.02, 95%CI: 1.01, 1.03) at baseline and having two or more painful sites were significantly associated with a higher incidence of depression. In contrast, baseline depression was not associated with changes in knee joint symptoms over 24 months. Conclusion: Knee OA risk factors and joint symptoms, along with co-existing multi-site pain are associated with the prevalence and development of depression. This suggests that managing common OA risk factors and joint symptoms may be important for prevention and treatment depression in patients with knee OA.Trial registration: ClinicalTrials.gov identifier: NCT01176344Anzctr.org.au identifier: ACTRN12610000495022


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shuang Zheng ◽  
Liudan Tu ◽  
Flavia Cicuttini ◽  
Zhaohua Zhu ◽  
Weiyu Han ◽  
...  

Abstract Background To describe demographic and clinical factors associated with the presence and incidence of depression and explore the temporal relationship between depression and joint symptoms in patients with symptomatic knee osteoarthritis (OA). Methods Three hundred ninety-seven participants were selected from a randomized controlled trial in people with symptomatic knee OA and vitamin D deficiency (age 63.3 ± 7.1 year, 48.6% female). Depression severity and knee joint symptoms were assessed using the patient health questionnaire (PHQ-9) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively, at baseline and 24 months. Results The presence and incidence of depression was 25.4 and 11.2%, respectively. At baseline, having younger age, a higher body mass index (BMI), greater scores of WOMAC pain (PR: 1.05, 95%CI:1.03, 1.07), dysfunction (PR: 1.02, 95%CI:1.01, 1.02) and stiffness (PR: 1.05, 95%CI: 1.02, 1.09), lower education level, having more than one comorbidity and having two or more painful body sites were significantly associated with a higher presence of depression. Over 24 months, being female, having a higher WOMAC pain (RR: 1.05, 95%CI: 1.02, 1.09) and dysfunction score (RR: 1.02, 95%CI: 1.01, 1.03) at baseline and having two or more painful sites were significantly associated with a higher incidence of depression. In contrast, baseline depression was not associated with changes in knee joint symptoms over 24 months. Conclusion Knee OA risk factors and joint symptoms, along with co-existing multi-site pain are associated with the presence and development of depression. This suggests that managing common OA risk factors and joint symptoms may be important for prevention and treatment depression in patients with knee OA. Trial registration ClinicalTrials.gov identifier: NCT01176344. Anzctr.org.au identifier: ACTRN12610000495022.


Cartilage ◽  
2020 ◽  
pp. 194760352095450
Author(s):  
Evarice Tiendrebeogo ◽  
Magda Choueiri ◽  
Xavier Chevalier ◽  
Thierry Conrozier ◽  
Florent Eymard

Objectives Up to 50% of patients with symptomatic knee osteoarthritis (OA) present with neuropathic pain (NP) features. We assessed the impact of NP according to DN4 (Douleurs Neuropathiques 4 questions) score on the response to intra-articular (IA) hyaluronic acid (HA) injections and the effects of HA injections on NP. Materials and Methods We conducted a post hoc analysis from a multicenter, randomized, double-blind, noninferiority trial comparing the efficacy of 2 HA in symptomatic knee OA at 24 weeks. At baseline, demographic, anthropometric, radiologic data, and symptoms were recorded. The symptomatic effect of HA was assessed by VAS pain, patient global assessment (PGA), WOMAC, DN4, and OMERACT-OARSI response. Results A total of 187 patients were included. NP according to DN4 score was present in 20 patients (10.7%) at baseline. Most common positive DN4 items were tingling (36.9%) and burning (36.4%). NP was associated with WOMAC pain score ( P = 0.02). The presence of NP at baseline did not affect the symptomatic improvement after HA injections according to the VAS pain ( P = 0.71), PGA ( P = 050), WOMAC pain ( P = 0.89), WOMAC function ( P = 0.52), and rate of OMERACT-OARSI responders ( P = 0.21). The prevalence of patients with NP decreased by 50% ( n = 10) at 24 weeks after HA injections. Most improved DN4 items were itching (90%), hypoesthesia to pinprick (88%), and burning (50%). Conclusion In our study, NP was associated with pain severity, but did not influence the response to IA HA. On the other hand, HA injections reduced some NP features, especially itching, sting hypoesthesia, and burning.


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