Objective: In the SENSCIS trial, participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD) were randomized to receive nintedanib or placebo until the last participant reached week 52 but for 100 weeks or less. Nintedanib reduced the rate of decline in forced vital capacity (FVC) (ml/year) over 52 weeks by 44% (41 ml [95% confidence interval (95% CI): 2.9-79.0]) versus placebo. We investigated the effect of nintedanib over the whole SENSCIS trial.
Methods: The annual rate of decline in FVC (ml/year) over the whole trial was assessed descriptively using 1) on-treatment data plus off-treatment data from participants who prematurely discontinued treatment (intent-to-treat analysis) and 2) only on-treatment data to assess the effect of nintedanib in participants who remained on treatment.
Results: In the intent-to-treat analysis, the adjusted mean (SE) annual rate of decline in FVC over 100 weeks was -54.9 (11.1) and -88.8 (10.9) ml/year in the nintedanib (n = 287) and placebo (n = 288) groups, respectively (difference 34.0 ml/year [95% CI: 3.4-64.5]). In the on-treatment analysis, the adjusted mean (SE) annual rate of decline in FVC over 100 weeks was -55.1 (12.3) and -94.0 (11.7) ml/year in the nintedanib (n = 286) and placebo (n = 288) groups, respectively (difference 38.9 ml/year [95% CI: 5.6-72.1]). The adverse event profile of nintedanib over 100 weeks was consistent with that observed over 52 weeks.
Conclusion: Nintedanib provides a sustained benefit on slowing the progression of SSc-ILD over 100 weeks, with adverse events that are manageable for most patients.
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http://dx.doi.org/10.1002/acr2.11483 | DOI Listing |
Mol Nutr Food Res
January 2025
Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou, 510515, China.
Scope: The relationship of dietary copper intake with new-onset chronic kidney disease (CKD) remained unclear. We aimed to examine the association of dietary copper intake with new-onset CKD in a 30-year follow-up study from young adulthood to midlife.
Methods And Results: A total of 4038 U.
Int J Geriatr Psychiatry
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Department of Neurology, Tianjin Huanhu Hospital, Tianjin, China.
Background: Apolipoprotein E (ApoE) ε4 genotype is a well-known risk factor for Alzheimer's disease (AD). However, its effect on predicting cognitive decline in individuals without dementia and its association with age are unclear.
Objective: To investigate the relationship between ApoE polymorphism and risk of cognitive decline and dementia incidence in the elderly without dementia.
J Am Coll Cardiol
January 2025
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address:
Background: An initial decline in estimated glomerular filtration rate (eGFR) often leads to reluctance to continue life-saving therapies in patients with heart failure (HF).
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Methods: In this prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure), we examined the association between initial decline in eGFR (≥15%) from randomization to 1 month and subsequent outcomes in patients assigned to finerenone or placebo.
PLoS One
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Department of Clinical Physiology, Karolinska University Hospital, Stockholm, Sweden.
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