Growth of children receiving a dehydrated potato-soy protein concentrate or corn-soy blend as part of a food aid program in Northern Senegal

Rations distributed by food aid programs are intended to improve the growth of undernourished children. In practice, food programs target individual children and provide a supplement to the family that is intended to increase the energy and nutrient intake of undernourished children. Multiple food rations are available yet few studies have compared their differential effect on the growth of children. The objective of the study was to compare growth in undernourished Senegalese children who received a newly developed dehydrated potato-soy protein concentrate blend (PSB) to those supplemented with the currently available corn-soy blend (CSB). The first child at each site was randomly assigned to receive PSB or CSB and subsequent children alternately received PSB or CSB. Eligibility for obtaining the food ration was basedon criteria determined by the USAID (P.L. 480) Title II Food Aid Program. Children received iso-caloric amounts of the two supplements each month (23,000kcals). Weight, height and mid-upper arm circumference (MUAC) were taken over a fourmonth period. Z-scores were calculated for weight-for-age (WAZ), weight-for-height (WHZ) and for length/height-for-age measures (HAZ).The study was conducted at 7 clinics which served as food distribution sites in northern Senegal. The study enrolled348 children 18-56 months old with a weight-for-age z-score below the �yellow� zone of the locally available growth chart (equivalent to WAZ < -1.0). WAZ and HAZ significantly increased over time but there was no difference between the two ration groups. In a subset of 280 children (145 PSB, 135 CSB) who attended all four appointments and received the full complement of ration, there was significant and equivalent increase for both groups in WAZ and WHZ. These findings indicate thatchildren participating in the food aid program significantly improved their growth over a four-month period. Using the new PSB as a ration had the same impact on growth as the standard CSB and required less fuel to prepare

Growth Of Children Receiving A Dehydrated Potato-Soy Protein Concentrate Or Corn-Soy Blend As Part Of A Food Aid Program In Northern Senegal

Rations distributed by food aid programs are intended to improve the growth of undernourished children. In practice, food programs target individual children and provide a supplement to the family that is intended to increase the energy and nutrient intake of undernourished children. Multiple food rations are available yet few studies have compared their differential effect on the growth of children. The objective of the study was to compare growth in undernourished Senegalese children who received a newly developed dehydrated potato-soy protein concentrate blend (PSB) to those supplemented with the currently available corn-soy blend (CSB). The first child at each site was randomly assigned to receive PSB or CSB and subsequent children alternately received PSB or CSB. Eligibility for obtaining the food ration was based on criteria determined by the USAID (P.L. 480) Title II Food Aid Program. Children received iso-caloric amounts of the two supplements each month (23,000kcals). Weight, height and mid-upper arm circumference (MUAC) were taken over a four-month period. Z-scores were calculated for weight-for-age (WAZ), weight-for-height (WHZ) and for length/height-for-age measures (HAZ).The study was conducted at 7 clinics which served as food distribution sites in northern Senegal. The study enrolled 348 children 18-56 months old with a weight-for-age z-score below the "yellow" zone of the locally available growth chart (equivalent to WAZ ≤ -1.0). WAZ and HAZ significantly increased over time but there was no difference between the two ration groups. In a subset of 280 children (145 PSB, 135 CSB) who attended all four appointments and received the full complement of ration, there was significant and equivalent increase for both groups in WAZ and WHZ. These findings indicate that children participating in the food aid program significantly improved their growth over a four-month period. Using the new PSB as a ration had the same impact on growth as the standard CSB and required less fuel to prepare

Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials

Background: To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody. Methods: YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593). Findings: 3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference −0·2 ETDRS letters [−2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [−0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [−1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [−1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]). Interpretation: Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema. Funding: F Hoffmann-La Roche.</p

Clinical pharmacology of intravitreal anti-VEGF drugs

Clinical efficacy of intravitreal anti-VEGF drugs has been widely demonstrated in several angiogenesis-driven eye diseases including diabetic macular edema and the neovascular form of age-related macular degeneration. Pegaptanib, ranibizumab, and aflibercept have been approved for use in the eye, whereas bevacizumab is widely used by ophthalmologists to treat patients "off-label". These drugs are active in the nanomolar to picomolar range; however, caution is required when establishing the rank order of affinity and potency due to in vitro inter-experimental variation. Despite the small doses used for eye diseases and the intravitreal route of administration may limit systemic side effects, these drugs can penetrate into blood circulation and alter systemic VEGF with unknown clinical consequences, particularly in vulnerable groups of patients. Clinical pharmacokinetics of ocular anti-VEGF agents should therefore be taken into account when choosing the right drug for the individual patient. The gaps in current understanding that leave open important questions are as follows: (i) uncertainty about which drug should be given first, (ii) how long these drugs can be used safely, and (iii) the choice of the best pharmacological strategy after first-line treatment failure. The current review article, based on the information published in peer-reviewed published papers relevant to anti-VEGF treatments and available on the PubMed database, describes in detail the clinical pharmacology of this class of drugs to provide a sound pharmacological basis for their proper use in ophthalmology clinical practice