A Review of Aceclofenac: Analgesic and Anti-Inflammatory Effects on Musculoskeletal Disorders.

Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic properties. Although there are some differences in the authorized indications between countries, aceclofenac is mainly recommended for the treatment of inflammatory and painful processes, such as low back pain (LBP), scapulohumeral periarthritis, extraarticular rheumatism, odontalgia, and osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS). The analgesic properties and tolerability profile of aceclofenac in musculoskeletal disorders are reviewed, focusing on relevant and recent studies. The efficacy and safety comparison of aceclofenac with other analgesics and anti-inflammatory agents in OA, AS, RA, and LBP is described. Relevant studies were identified following a literature search of PubMed using the terms "aceclofenac" and "clinical trials" published from 1 Jan 1992 to 1 Jan 2020. Aceclofenac is at least as effective as other NSAIDs in reducing pain and/or improving functional capacity in chronic pain conditions (OA, AS, RA, and LBP). It is generally well tolerated and appears to have a more favorable GI profile than other NSAIDs. Thus, current evidence indicates that aceclofenac is a useful option for the management of pain and inflammation across a wide range of painful conditions.

Documento de expertos sobre el uso apropiado de los SYSADOA en situaciones clínicas controvertidas / Experts Document About an Adequate Utilization of SYSADOAs in Controversial Clinical Situations

Antecedentes y objetivo: Los SYSADOA (del inglés, symptomatic slow-acting drugs for osteoarthritis) orales son compuestos naturales que han demostrado ser útiles y seguros en el tratamiento de la artrosis (AO). Sin embargo, su uso en ciertas situaciones clínicas carece aún de evidencia científica y recomendaciones claras. El objetivo de este trabajo fue conocer la opinión de un grupo de expertos sobre el uso de los SYSADOA en el tratamiento de la AO en situaciones clínicas controvertidas. Materiales y métodos: Siguiendo el método del uso apropiado mediante la técnica Delphi, se valoraron 206 consultas concretas, estructuradas en 24 preguntas clínicas. Un panel de expertos, compuesto por un total de 15 especialistas, respondió a las dos rondas de consulta a través de una plataforma online. Los resultados se analizaron y debatieron en una reunión presencial con los coordinadores y el comité científico. Según el porcentaje de panelistas que coincidieron en los mismos, se clasificaron los resultados en términos de unanimidad, consenso, mayoría y discrepancia. Resultados: Se consensuaron los siguientes puntos: (1) el fenotipo del paciente condiciona el uso de los SYSADOA orales; (2) los SYSADOA orales se consideran adecuados en la AO primaria (rodilla, mano y cadera) y en algunos tipos de AO secundaria; no se consideran adecuados en AO erosiva de manos, hombro, columna y tobillo; (3) los SYSADOA orales pueden ser prescritos a pacientes con riesgo o enfermedad cardiovascular, enfermedad digestiva, hipertensión, dislipemia, enfermedad vascular periférica, diabetes tipo 2 y, a excepción de diacereína, en pacientes con reflujo esofágico. No se obtuvo acuerdo en la prescripción de los SYSADOA orales en pacientes con enfermedad hepática y renal.(AU)

Background and objective: SYSADOAs (symptomatic slow-acting drugs for osteoarthritis) are natural compounds that have been shown to be useful and safe in the treatment of osteoarthritis (OA). However, their use in certain clinical situations still lacks scientific evidence and clear recommendations. The objective of this work was to learn the opinion of a group of experts regarding the appropriate use of SYSADOA in the treatment of OA in controversial clinical situations. Materials and methods: Following the Delphi technique, 206 specific consultations, structured in 24 clinical questions, were evaluated. A panel of experts composed of a total of 15 specialists, answered the two rounds of consultation through an online platform. The results were analysed and discussed in a face-to-face meeting with the coordinators and the scientific committee. According to the percentage of panellists who agreed on their findings, the results were classified in terms of unanimity, consensus, majority and discrepancy. Results: The following points were agreed upon: (1) the patient's phenotype determines the use of SYSADOAs; (2) SYSADOAs are considered appropriate in primary OA (knee, hand and hip) and in some types of secondary OA; they are not considered appropriate in OA of the shoulder, spine, ankle and erosive OA of the hands; (3) SYSADOAs may be prescribed for patients at risk of or with cardiovascular disease, digestive disease, hypertension, dyslipaemia, peripheral vascular disease, type 2 diabetes and, excluding diacerein, for patients with oesophageal reflux. No agreement was obtained on the prescription of SYSADOAs for patients with hepatic and renal disease. Conclusions: There is limited literature on the use of SYSADOAs for the treatment of OA in controversial situations. Through this work it has been possible to establish the position of a group of experts regarding clinical situations for which there is no scientific evidence concerning their use.(AU)

Experts document about an adequate utilization of SYSADOAs in controversial clinical situations.

BACKGROUND AND OBJECTIVE: SYSADOAs (Symptomatic Slow-Acting Drugs for Osteoarthritis) are natural compounds that have been shown to be useful and safe in the treatment of osteoarthritis (OA). However, their use in certain clinical situations still lacks scientific evidence and clear recommendations. The objective of this work was to learn the opinion of a group of experts regarding the appropriate use of SYSADOA in the treatment of OA in controversial clinical situations. MATERIALS AND METHODS: Following the Delphi technique, 206 specific consultations, structured in 24 clinical questions, were evaluated. A panel of experts composed of a total of 15 specialists, answered the two rounds of consultation through an online platform. The results were analysed and discussed in a face-to-face meeting with the coordinators and the scientific committee. According to the percentage of panellists who agreed on their findings, the results were classified in terms of unanimity, consensus, majority and discrepancy. RESULTS: The following points were agreed upon: (1) the patient's phenotype determines the use of SYSADOAs; (2) SYSADOAs are considered appropriate in primary OA (knee, hand and hip) and in some types of secondary OA; they are not considered appropriate in OA of the shoulder, spine, ankle and erosive OA of the hands; (3) SYSADOAs may be prescribed for patients at risk of or with cardiovascular disease, digestive disease, hypertension, dyslipaemia, peripheral vascular disease, type 2 diabetes and, excluding Diacerein, for patients with oesophageal reflux. No agreement was obtained on the prescription of SYSADOAs for patients with hepatic and renal disease. CONCLUSIONS: There is limited literature on the use of SYSADOAs for the treatment of OA in controversial situations. Through this work it has been possible to establish the position of a group of experts regarding clinical situations for which there is no scientific evidence concerning their use. This work may contribute towards improving the management protocols of SYSADOAs in the treatment of OA and offer a useful approach in uncertain situations.

Experts Document About an Adequate Utilization of SYSADOAs in Controversial Clinical Situations. / Documento de expertos sobre el uso apropiado de los SYSADOA en situaciones clínicas controvertidas.

BACKGROUND AND OBJECTIVE: SYSADOAs (symptomatic slow-acting drugs for osteoarthritis) are natural compounds that have been shown to be useful and safe in the treatment of osteoarthritis (OA). However, their use in certain clinical situations still lacks scientific evidence and clear recommendations. The objective of this work was to learn the opinion of a group of experts regarding the appropriate use of SYSADOA in the treatment of OA in controversial clinical situations. MATERIALS AND METHODS: Following the Delphi technique, 206 specific consultations, structured in 24 clinical questions, were evaluated. A panel of experts composed of a total of 15 specialists, answered the two rounds of consultation through an online platform. The results were analysed and discussed in a face-to-face meeting with the coordinators and the scientific committee. According to the percentage of panellists who agreed on their findings, the results were classified in terms of unanimity, consensus, majority and discrepancy. RESULTS: The following points were agreed upon: (1) the patient's phenotype determines the use of SYSADOAs; (2) SYSADOAs are considered appropriate in primary OA (knee, hand and hip) and in some types of secondary OA; they are not considered appropriate in OA of the shoulder, spine, ankle and erosive OA of the hands; (3) SYSADOAs may be prescribed for patients at risk of or with cardiovascular disease, digestive disease, hypertension, dyslipaemia, peripheral vascular disease, type 2 diabetes and, excluding diacerein, for patients with oesophageal reflux. No agreement was obtained on the prescription of SYSADOAs for patients with hepatic and renal disease. CONCLUSIONS: There is limited literature on the use of SYSADOAs for the treatment of OA in controversial situations. Through this work it has been possible to establish the position of a group of experts regarding clinical situations for which there is no scientific evidence concerning their use. This work may contribute towards improving the management protocols of SYSADOAs in the treatment of OA and offer a useful approach in uncertain situations.

Attitudes and Recommendations of Physicians towards Alcohol Consumption and Cardiovascular Health: A Perspective from Argentina.

Despite epidemiological findings of improvements in cardiovascular risk factors with a light-to-moderate intake of alcohol, many misconceptions remain regarding alcohol intake and the risks and benefits of consumption. We sought to examine physician attitudes and recommendations regarding alcohol intake in a cohort of Argentine physicians and to establish their sources of knowledge. An online national survey was distributed through the Argentine Federation of Cardiology (FAC) to cardiologists, internal medicine specialists, general and other subspecialty physicians in Argentina. The survey was completed by 745 physicians, of whom 671 (90%) were cardiologists. In total, 35% of physicians viewed moderate alcohol intake to be beneficial for cardiovascular health, 36% believed only wine offered such benefits, 24% viewed any intake to be harmful, and 5% had other opinions. More than half (57%) self-reported their knowledge came from academic sources. Regarding knowledge of drinking guidelines, only 41% of physicians were aware of the concept of "standard drink". Physicians were generally not comfortable converting standard drinks into other metric units, however men tended to be more comfortable than women (p = 0.052). Physicians were not satisfied with their knowledge of drinking guidelines (3.01 ± 2.73, on a 0⁻10 scale). Physicians were generally comfortable in counselling patients regarding safe limits of consumption (6.22 ± 3.20, on a 0⁻10 scale). Argentine physicians were not satisfied with their knowledge of alcohol consumption guidelines or their understanding of the reported metrics. Only one-third of study participants viewed moderate alcohol intake as beneficial for cardiovascular health. This study shows the necessity to optimize the sources of knowledge.

Recomendaciones para la detección, investigación y derivación del dolor lumbar inflamatorio en Atención Primaria / Reccomendations for the detection, study and referral of inflammatory low-back pain in Primary Care

Objetivo. Diseñar una estrategia de detección y derivación precoz de pacientes con posible espondiloartritis mediante el desarrollo de recomendaciones consensuadas dirigidas a los médicos de Atención Primaria (AP). Métodos. Se utilizó una metodología modificada de RAND/UCLA y revisión sistemática de la literatura. Se seleccionó un grupo de discusión formado por reumatólogos y médicos de AP. Se estudió el mapa del proceso y se propusieron recomendaciones y algoritmos que fueron sometidos a 2 rondas Delphi para evaluar el grado de aceptación y preferencia de criterios en un grupo amplio de reumatólogos y médicos de AP. Del análisis de la segunda ronda Delphi se extrajeron las recomendaciones finales. Resultados. Se presentan recomendaciones, junto con su grado medio de acuerdo, para la derivación rápida de pacientes con sospecha de espondiloartritis. En concreto, se recomienda investigar el dolor lumbar crónico en menores de 45 años en 4 fases: 1) clínica: preguntas clave; 2) clínica: preguntas extra; 3) exploración física, y 4) pruebas complementarias. Se debe derivar a Reumatología si existen: 1) dolor lumbar inflamatorio; 2) signos indicativos de espondiloartritis, o 3) HLA B27 positivo, elevación de proteína C reactiva o signos radiológicos de sacroilitis. Se incluyen recomendaciones sobre el proceso de derivación y otras adicionales. Conclusiones. El grado de acuerdo con estas sencillas recomendaciones es amplio. Es necesario diseñar estrategias de formación y sensibilización desde los servicios de Reumatología para mantener una óptima colaboración de AP en la identificación de los casos y facilitar que los servicios de Reumatología estén preparados para asumir las derivaciones (AU)

Objective. To design a strategy for the early detection and referral of patients with possible spondyloarthritis based on recommendations developed, agreed upon, and directed to primary care physicians. Methods. We used a modified RAND/UCLA methodology plus a systematic literature review. The information was presented to a discussion group formed by rheumatologists and primary care physicians. The group studied the process map and proposed recommendations and algorithms that were subsequently submitted in two Delphi rounds to a larger group of rheumatologists and primary care physicians. The final set of recommendations was derived from the analysis of the second Delphi round. Results. We present the recommendations, along with their mean level of agreement, on the early referral of patients with possible spondyloarthritis. The panel recommends that the study of chronic low back pain in patients under 45 years be performed in four phases 1) clinical: key questions, 2) clinical: extra questions, 3) physical examination, and 4) additional tests. Conclusions. The level of agreement with these simple recommendations is high. It is necessary to design strategies for the education and sensitization from rheumatology services to maintain an optimal collaboration with primary care and to facilitate referral to rheumatology departments (AU)

Improved prediction of knee osteoarthritis progression by genetic polymorphisms: the Arthrotest Study.

OBJECTIVE: The aim of this study was to develop a genetic prognostic tool to predict radiographic progression towards severe disease in primary knee OA (KOA) patients. METHODS: This investigation was a cross-sectional, retrospective, multicentric association study in 595 Spanish KOA patients. Caucasian patients aged ≥40 years at the time of diagnosis of primary KOA of Kellgren-Lawrence grade 2 or 3 were included. Patients who progressed to Kellgren-Lawrence score 4 or who were referred for total knee replacement within 8 years after diagnosis were classified as progressors to severe disease. Clinical variables of the initial stages of the disease (gender, BMI, age at diagnosis, OA in the contralateral knee, and OA in other joints) were registered as potential predictors. Single nucleotide polymorphisms and clinical variables with an association of P < 0.05 were included in the multivariate analysis using forward logistic regression. RESULTS: A total of 23 single nucleotide polymorphisms and the time of primary KOA diagnosis were significantly associated with KOA severe progression in the exploratory cohort (n = 220; P < 0.05). The predictive accuracy of the clinical variables was limited: area under the curve (AUC) = 0.66. When genetic variables were added to the clinical model (full model), the prediction of KOA progression was significantly improved (AUC = 0.82). Combining only genetic variables (rs2073508, rs10845493, rs2206593, rs10519263, rs874692, rs7342880, rs780094 and rs12009), a predictive model with good accuracy was also obtained (AUC = 0.78). The predictive ability for KOA progression of the full model was confirmed on the replication cohort (two-sample Z-test; n = 62; P = 0.190). CONCLUSION: An accurate prognostic tool to predict primary KOA progression has been developed based on genetic and clinical information from OA patients.

Reccomendations for the detection, study and referral of inflammatory low-back pain in primary care.

OBJECTIVE: To design a strategy for the early detection and referral of patients with possible spondyloarthritis based on recommendations developed, agreed upon, and directed to primary care physicians. METHODS: We used a modified RAND/UCLA methodology plus a systematic literature review. The information was presented to a discussion group formed by rheumatologists and primary care physicians. The group studied the process map and proposed recommendations and algorithms that were subsequently submitted in two Delphi rounds to a larger group of rheumatologists and primary care physicians. The final set of recommendations was derived from the analysis of the second Delphi round. RESULTS: We present the recommendations, along with their mean level of agreement, on the early referral of patients with possible spondyloarthritis. The panel recommends that the study of chronic low back pain in patients under 45 years be performed in four phases 1) clinical: key questions, 2) clinical: extra questions, 3) physical examination, and 4) additional tests. CONCLUSIONS: The level of agreement with these simple recommendations is high. It is necessary to design strategies for the education and sensitization from rheumatology services to maintain an optimal collaboration with primary care and to facilitate referral to rheumatology departments.

Clinical management of patients with hip and knee osteoarthritis: patient satisfaction with treatment switch.

Hip and knee osteoarthritis (OA) is a common cause of disability, with great quality of life and economic impact, hence the need for effective treatment. Patient satisfaction with treatment is a measure of therapeutic effectiveness and may be used to assess treatment switch in OA patients. A 3-month multicenter, prospective, epidemiologic, non-interventional study was conducted in patients with hip and/or knee OA to assess therapeutic efficacy in patients requiring treatment switch due to lack of effectiveness and/or tolerability in primary care settings. Therapeutic effectiveness was assessed by patient satisfaction using the osteoARthritis Treatment Satisfaction (ARTS) scale. The 3-month disease change [by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a pain visual analog scale (VAS)] and its correlation with treatment satisfaction were also assessed, as well as patient gastrointestinal (GI) and cardiovascular (CV) profiles. 5,976 patients were analyzed (mean age 68.8 years, 65.1 % female). 67 and 61.8 % showed high GI and CV risk, respectively. The proportion of patients on acetaminophen treatment during the study decreased from 74.8 % at baseline to 23.9 %, while the proportion on non-steroidal anti-inflammatory drugs (NSAIDs) increased from 59.8 to 85.8 %. At 3 months, the standardized (0-100) overall ARTS score increased from 57.7 to 71.6 (p < 0.0001), while disease severity decreased. There was a significant (p < 0.0001) negative association between the ARTS, and the WOMAC and VAS scores. Treatment switching from acetaminophen to NSAIDs as a consequence of poor effectiveness and/or tolerability resulted in increased patient satisfaction with treatment and lower OA severity.

Psychometric characteristics of the Spanish version of instruments to measure neck pain disability.

BACKGROUND: The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ). METHODS: Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed. RESULTS: Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. VALIDITY: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15. CONCLUSION: Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance. TRIAL REGISTRATION: Clinical Trials Register NCT00349544.

Polymorphism of the FABP2 gene: a population frequency analysis and an association study with cardiovascular risk markers in Argentina.

BACKGROUND: The FABP2 gene encodes for the intestinal FABP (IFABP) protein, which is expressed only in intestinal enterocytes. A polymorphism at codon 54 in exon 2 of the FABP2 gene exchanges an Alanine (Ala), in the small helical region of the protein, for Threonine (Thr). Given the potential physiological role of the Ala54Thr FABP2 polymorphism, we assess in this study the local population frequency and analyze possible associations with five selected markers, i.e. glycemia, total cholesterol, body mass index (BMI), hypertension, and high Cardiovascular Risk Index (CVR index). METHODS: We studied 86 men and 116 women. DNA was extracted from a blood drop for genotype analysis. Allele frequencies were calculated by direct counting. Hardy Weinberg Equilibrium was evaluated using a Chi-square goodness of fit test. For the polymorphism association analysis, five markers were selected, i.e. blood pressure, Framingham Risk Index, total cholesterol, BMI, and glycemia. For each marker, the Odds Ratio (OR) was calculated by an online statistic tool. RESULTS: Our results reveal a similar population polymorphism frequency as in previous European studies, with q = 0.277 (95% confidence limits 0.234-0.323). No significant association was found with any of the tested markers in the context of our Argentine nutritional and cultural habits. We did, however, observe a tendency for increased Cholesterol and high BMI in Thr54 carriers. CONCLUSION: This is the first study to look at the population frequency of the Thr54 allele in Argentina. The obtained result does not differ from previously reported frequencies in European populations. Moreover, we found no association between the Thr54 allele and any of the five selected markers. The observed tendency to increased total cholesterol and elevated BMI in Thr54 carriers, even though not significant for p < 0.1 could be worth of further investigation to establish whether the Thr54 variant should be taken into consideration in cardiovascular prevention strategies.