The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty. This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8). Overall, 641 patients, mean age 62 (range 29-80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4-73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5-76). The single components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups. The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy. EudraCT 2012-004548-31 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004548-31);ClinicalTrials.gov NCT01902134 (https://www.clinicaltrials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1).

Chronic chikungunya disease is associated with a poor quality of life and a variety of symptoms, not restricted to the musculoskeletal system. Patients with chronic chikungunya disease in Guadeloupe were evaluated in order to identify the main factors determining the quality of life. Patients were followed up at a mean of 36 months after chikungunya infection, undergoing detailed clinical examination for musculoskeletal involvement, with assessment of subjective symptoms and the impact on mood, physical activity, and quality of life (SF12). Patients had extensive musculoskeletal involvement shown by tenderness in 9 ± 4 joints and stiffness in 5 ± 4 joints. SF12 physical and mental component scores showed a poor health-related quality of life. Measures of joint pain, stiffness, and inflammation contributed to impaired quality of life scores. In addition, fatigue and interrupted sleep appeared to be important predictors for physical aspects of quality of life. The emergence of anxiodepressive syndromes post-chikungunya infection was associated with both physical and mental component scores of SF12. These data confirm that musculoskeletal symptoms are not the only determinants of quality of life in chronic chikungunya disease. Follow-up of patients should include assessment and management of fatigue, poor sleep quality, and anxiodepressive syndromes.