The period following heart failure hospitalization (HFH) is a vulnerable time with high rates of death or recurrent HFH.OBJECTIVE To evaluate clinical characteristics, outcomes, and treatment response to vericiguat according to prespecified index event subgroups and time from index HFH in the Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial. DESIGN, SETTING, AND PARTICIPANTSAnalysis of an international, randomized, placebo-controlled trial. All VICTORIA patients had recent (<6 months) worsening HF (ejection fraction <45%). Index event subgroups were less than 3 months after HFH (n = 3378), 3 to 6 months after HFH (n = 871), and those requiring outpatient intravenous diuretic therapy only for worsening HF (without HFH) in the previous 3 months (n = 801). Data were analyzed between May 2, 2020, and May 9, 2020.INTERVENTION Vericiguat titrated to 10 mg daily vs placebo. MAIN OUTCOMES AND MEASURESThe primary outcome was time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH. RESULTS Among 5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black. Baseline characteristics were balanced between treatment arms within each subgroup. Over a median follow-up of 10.8 months, the primary event rates were 40.9, 29.6, and 23.4 events per 100 patient-years in the HFH at less than 3 months, HFH 3 to 6 months, and outpatient worsening subgroups, respectively. Compared with the outpatient worsening subgroup, the multivariable-adjusted relative risk of the primary outcome was higher in HFH less than 3 months (adjusted hazard ratio, 1.48; 95% CI, 1.27-1.73), with a time-dependent gradient of risk demonstrating that patients closest to their index HFH had the highest risk. Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity. Similar results were evident for all-cause death and HFH. Addtionally, a continuous association between time from HFH and vericiguat treatment showed a trend toward greater benefit with longer duration since HFH. Safety events (symptomatic hypotension and syncope) were infrequent in all subgroups, with no difference between treatment arms.CONCLUSIONS AND RELEVANCE Among patients with worsening chronic HF, those in closest proximity to their index HFH had the highest risk of cardiovascular death or HFH, irrespective of age or clinical risk factors. The benefit of vericiguat did not differ significantly across the spectrum of risk in worsening HF.
Background: Biqi capsule is a traditional Chinese medicine widely used as a complementary and alternative treatment for rheumatoid arthritis (RA). The objective is to understand the efficacy, safety and mechanism of Biqi combined with methotrexate (MTX) in RA. Methods: We present a randomized, controlled pilot trial on Biqi combined with MTX against patients with active RA. Seventy patients were randomized 1:1 to receive Biqi + MTX or Leflunomide (LEF) + MTX for 24 weeks, and were assessed at baseline, 4, 12 and 24 weeks. Serum and urine samples were collected for metabolomics. Results: Overall, 81.2% patients in Biqi group achieved ACR20 at 24 weeks. No statistically significant differences were observed in primary or secondary outcomes between the two groups. A better safety profile was observed for Biqi with significantly fewer adverse effects reported (11.4%) compared to LEF group (40%, P < 0.05). Comparison between treatment responders and non-responders indicated a unique urine metabolic profile of enriched fatty acids and decreased acylcarnitines associated with Biqi responders, indicating a restored energy homeostasis in response to Biqi. The gene targets of these metabolites were significantly enriched in interleukin-4 and interleukin-13 pathways, implying that Biqi could ameliorate Th2-derived inflammatory response. Multivariate network analysis indicated that patient morning stiffness and SJC were key factors associated with metabolomics in Biqi-treated patients, whereas CRP was the main factor in LEF group. Therefore, Biqi and LEF likely work by influencing different patient clinical parameters. Conclusions: Our study suggests that Biqi capsule can be a promising alternative option in combination with MTX for RA treatment, and demonstrates the capability of using metabolomics to interrogate mechanism of action for traditional Chinese medicine. Trial registration This trial is registered with ChiCTR, No. ChiCTR-IPR-16009029. Registered August 15, 2016. http://www. chict r.org.cn/showp rojen .aspx?proj=15034
Rheumatoid arthritis (RA) pathogenesis has been associated with dysregulation of long noncoding RNA (lncRNA) and microRNA (miRNA) expression in serum and in lesioned tissue. In this study, a microarray assay was performed to study the profile of lncRNAs in the serum of RA patients and healthy donors, and a set of novel lncRNAs associated with RA was identified. For the remainder of the study, focus is on the top hit, lncRNA uc.477. The upregulation of lncRNA uc.477 and downregulation of miR-19b were validated in the serum of RA patients compared to that of healthy donors, and similar results were further confirmed by quantitative real-time PCR analysis of a cell line: RAderived human fibroblast-like synoviocytes (HFLS-RA). LncRNA uc.477 could interfere with the processing of pri-miR-19b to produce its mature form and thereby played a pro-inflammatory role. In addition, Huayu Qiangshen Tongbi formula (HQT), a traditional Chinese medicine (TCM), has been shown to exert a promising therapeutic effect on RA and to exhibit long-term safety in our previous clinical retrospective study. Importantly, HQT treatment normalized the levels of lncRNA uc.477 and miR-19b in HFLS-RA in vitro and in mouse models of collagen-induced arthritis. HQT treatment, knockdown of lncRNA uc.477, and overexpression of miR-19b resulted in a comparable inhibition of pro-inflammatory cytokine gene expression in HFLS-RA cells. Together, these data suggest that the therapeutic effects of HQT on RA are closely related to its modulation of lncRNA uc.477 and miR-19b.
Thirst is distressing but overlooked by healthcare professionals. Patients experience thirst due to comorbidities, physical or cognitive limitations, and iatrogenesis. Nasogastric tube (NGT) use and nil-by-mouth(NBM) orders are common practices that can lead to thirst. However, thirst in these populations has never been formally studied. We aim to examine prevalence of recognition and treatment of thirst among NGT + NBM and NBM patients. Our descriptive study was conducted intermittently over 25 weeks, across 1.5 years, in 12 adult general medicine wards of a tertiary hospital. Cognitively intact NGT + NBM or NBM inpatients, defined as Abbreviated Mental Test score ≥ 8, were studied. One-time questionnaire was administered. Variables included: demography, co-morbidities, clinical condition, feeding route, thirst defined by thirst distress and/or intensity ≥ 3, pain, hunger and volume status. 88 NGT + NBM and NBM patients were studied. 69.3% suffered from thirst. Thirsty patients experienced significant thirst-related distress (mean score ± SD: 5.7 ± 2.5). Subjects with previous stroke and who were euvolemic tended towards thirst. 13.6% were asked about thirst by doctors or nurses. Thirst was a major source of patient distress in our study. We suggest that thirst needs to be actively identified and targeted to achieve person-centred care.
Objectives: To evaluate the current evidence whether Chinese medicine compound (CMC) can reduce the serum levels of rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP).Methods: We comprehensively searched PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure (CNKI), the Database for Chinese Technical Periodicals (VIP), and Wanfang data. We then performed a systematic review and meta-analysis of all randomized controlled trials (RCTs) assessing the CMC therapy methods. This study is registered with PROSPERO, number CRD42020216284.Results: In total, 65 studies were eligible for inclusion, including 6099 patients. The result of the meta-analysis showed that compared with common Western medicine therapy, CMC monotherapy or combined with Western medicine was able to reduce serum RF (SMD= −0.85, 95%CI −1.04 to −0.67) and anti-CCP (SMD= −0.56, 95%CI −0.79 to −0.32) levels to some extent. In the efficacy meta-analysis, a greater number of CMC-treated patients achieved the efficacy criteria after a period of treatment, where the relative risk (RR) was 1.20 [1.08, 1.33] for achieving ACR20, 1.57 [1.38, 1.78] for ACR50, and 2.21 [1.72, 2.84] for ACR70. At the same time, there was a statistically significant difference in the effective rate of the patient's TCM symptoms (RR = 1.22, 95%CI 1.19–1.26).Conclusions: Through this meta-analysis and systematic review, we found that CMC for the treatment of RA is effective in reducing RF and anti-CCP levels and might have better clinical efficacy than Western medicine monotherapy. Some active components are responsible for this efficacy and worth further exploring.
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