SUBJECTS/METHODS: A cross-sectional survey was conducted among 188 adolescents aged 13-18 yrs living in Kuala Lumpur, Malaysia. Household food insecurity and dietary intake data were collected using the Radimer/Cornell hunger and food insecurity instrument and 2-day 24-h dietary recalls, respectively. Diet quality was determined using the Malaysian Healthy Eating Index (HEI). Weight and height were measured and body mass index-for-age, as well as height-for-age z scores were calculated.
RESULTS: The present study revealed that 47.9% of the adolescents experienced household food insecurity, 24.5% experienced individual food insecurity, 18.6% household food security, and 9.0% child hunger. The mean score of diet quality was 56.83 ± 10.09, with a significantly lower HEI score among food insecure adolescents (household food insecure, individual food insecure, and child hunger) than household food secure adolescents (P = 0.001). The differences between food secure and food insecure households were found to be significant for energy (P = 0.001) and nutrients including proteins (P = 0.006), carbohydrates (P = 0.005), dietary fiber (P = 0.001), folate (P < 0.001), and vitamin C (P = 0.006). The multiple linear regression showed that adolescents who experienced food insecurity (β = -0.328; P = 0.003) were found to be significantly associated with poor diet quality (F = 2.726; P < 0.01), wherein 13.3% of the variation in the diet quality was explained by the food security status.
CONCLUSIONS: Experiencing food insecurity contributed to poor diet quality among urban poor adolescents. Further longitudinal studies are needed to comprehensively understand this association to improve food insecurity and diet quality among urban poor communities.
METHODS: This multicentre, randomised, open-label phase 3 study was done at 26 sites (primarily secondary or tertiary centres) in 12 countries. Men, boys, and young adults aged 12 years or older with severe haemophilia A or haemophilia B with inhibitors previously treated with on-demand bypassing agents were randomly assigned (2:1) to receive once-a-month 80 mg subcutaneous fitusiran prophylaxis (fitusiran prophylaxis group) or to continue with bypassing agents on-demand (bypassing agents on-demand group) for 9 months. The primary endpoint was mean annualised bleeding rate during the efficacy period in the intention-to-treat population estimated by negative binomial model. Safety was assessed as a secondary endpoint in the safety population. This trial is complete and is registered with ClinicalTrials.gov, NCT03417102.
FINDINGS: Between Feb 14, 2018, and June 23, 2021, 85 participants were screened for inclusion, of whom 57 (67%; 57 [100%] men; median age 27·0 years [IQR 19·5-33·5]) were randomly assigned: 19 (33%) participants to the bypassing agent on-demand group and 38 (67%) participants to the fitusiran prophylaxis. Negative binomial model-based mean annualised bleeding rate was significantly lower in the fitusiran prophylaxis group (1·7 [95% CI 1·0-2·7]) than in the bypassing agents on-demand group (18·1 [10·6-30·8]), corresponding to a 90·8% (95% CI 80·8-95·6) reduction in annualised bleeding rate in favour of fitusiran prophylaxis (p<0·0001). 25 (66%) participants had zero treated bleeds in the fitusiran prophylaxis group versus one (5%) in the bypassing agents on-demand group. The most frequent treatment-emergent adverse event in the fitusiran prophylaxis group was increased alanine aminotransferase in 13 (32%) of 41 participants in the safety population; there were no increased alanine aminotransferase treatment-emergent adverse events in the bypassing agents on-demand group. Suspected or confirmed thromboembolic events were reported in two (5%) participants in the fitusiran prophylaxis group. No deaths were reported.
INTERPRETATION: Subcutaneous fitusiran prophylaxis resulted in statistically significant reductions in annualised bleeding rate in participants with haemophilia A or haemophilia B with inhibitors, with two-thirds of participants having zero bleeds. Fitusiran prophylaxis might show haemostatic efficacy in participants with haemophilia A or haemophilia B with inhibitors; therefore, the therapeutic might have the potential to improve the management of people with haemophilia.
FUNDING: Sanofi.
METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.
DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.