Therapeutic efficiency of NSAID is handicapped by ongoing discussion of cardiovascular (CV) safety. Areas covered: We update meta-analyses on NSAIDs in patients with and without cardiovascular (CV) diseases and analyse the association between NSAIDs and cardiovascular events in patients with inflammation. We demonstrate the substantial influence of an indication bias and confounding, which falsely increase the CV risk. We demonstrate protective cardiovascular effects of NSAIDs due to their anti-inflammatory activity, in particular in patients with rheumatoid arthritis, osteoarthritis or inflammatory pain. Expert commentary: t-NSAIDs and Coxibes drugs resemble in their observed CV risk which, in contrast, reflects the intrinsic risk of patients with pain and inflammation. The anti-inflammatory NSAIDs reduce the risk of first myocardial infarction in patients with inflammation and elevated CRP. The extended use of NSAIDs is not associated with an increased CV risk in patients with pain and inflammation but with reduction in all-cause mortality.

Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany. Methods Using the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed. Results This prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of − 17.3% (p < 0.0001) and − 14.4% (p < 0.0001), respectively. Results persisted over 24 months (mean change TWPI score: − 24.5%, mean change activity impairment score: − 30.0%). Disease- and health-related QoL also improved significantly under golimumab treatment as indicated by increased IBDQ [mean change: 28.0 (SD: ± 36.1, month 3), 42.1 (SD: ± 39.5, month 24)] and SF-12 scores [PCS-12: 45.9 (SD: ± 8.5), MCS-12: 4.9 (SD: ± 10.6, month 3), PCS-12: 5.9 (SD: ± 9.0), MCS-12: 6.4 (SD: ± 11.1, month 24)]. Disease-related hospitalization rate decreased from 16.0% (BL) to 4.3% at month 24 and the mean number of missed working days due to UC decreased from 8.2 (SD: 17.6, BL) to 0.7 (SD: 2.1) after golimumab induction. Conclusions Golimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC. Trial registration: PEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 (https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html)

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