Randomized control trial of oral arginine therapy for children with sickle cell anemia hospitalized for pain in Nigeria.

Low arginine bioavailability is associated with vaso-occlusive painful crisis (VOC) severity in sickle cell anemia (SCA) and predicts need for pediatric hospitalization. Intravenous arginine therapy has opioid-sparing effects and was found to significantly decrease pain scores in children hospitalized with SCA-VOC in a phase-two randomized placebo-controlled trial (RCT). Efficacy of oral arginine is unknown. Our objective was to determine the safety and efficacy of oral arginine therapy in Nigerian children with SCA. A double-blind RCT of oral L-arginine-hydrochloride (100 mg/kg TID) was conducted in children with SCA-VOC, aged 5-17 years, hospitalized at two Nigerian sites. The primary outcome measure was analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS). Secondary outcomes included daily pain scores, time-to-crisis-resolution and length-of-hospital-stay. An intention-to-treat analysis was performed. Sixty-eight children (age 5-17 years, mean 10.6 ± 0.4 years; 56% male), were randomized to receive L-arginine (35 patients) or placebo (33 patients). The mean total MQS for the arginine group was 73.4 (95% CI, 62.4-84.3) vs 120.0 (96.7-143.3) for placebo (P < .001). The mean rate of decline in worst pain scores was faster in the arginine arm vs placebo (1.50 [1.23-1.77] vs 1.09 [0.94-1.24] point/d, P = .009). Children receiving arginine had a shorter time-to-crisis-resolution (P = .02), shorter hospital-stay (P = .002) and experienced no serious adverse event. Pain control was more rapid, total analgesic requirement was significantly reduced, and most notably, time-to-crisis-resolution and length-of-hospital-stay were shorter in children with SCA-VOC receiving arginine vs placebo. Given the established safety and low cost, oral arginine is a promising adjuvant therapy for SCA-VOC management.

Effects of arginine-based immunonutrition on inpatient total costs and hospitalization outcomes for patients undergoing colorectal surgery.

OBJECTIVE: The aim of this study was to assess the effects of an arginine-based immunonutrition intervention for patients undergoing elective colorectal surgery on postsurgical utilization and cost outcomes. METHODS: This analysis was based on data from two Washington State databases: Surgical Care and Outcomes Assessment Program (SCOAP) linked to the Comprehensive Hospital Abstract Reporting System (CHARS). The sample (N=722) comprises adult patients who underwent elective colorectal surgery with anastomosis in a Washington State hospital that participated in the Strong for Surgery (S4S) initiative between January 1, 2012, and December 31, 2013. A generalized linear model was used to predict the outcomes, adjusting for demographic characteristics and patient health conditions within a multivariate regression framework. RESULTS: Findings from this study demonstrated significantly fewer readmissions and hospital days for the intervention group during the 180 d after index hospitalization. Clinical benefits included decreased risk for infections and venous thromboembolism. There was a similar pattern toward lower total costs in the immunonutrition patient group; however, these were not statistically different compared with the control group at any time point. Savings in the immunonutrition group were substantial-mean total costs per patient were less by ∼$2500 at index hospitalization, $3500 less through 30 d of follow-up, and $5300 less over 180 d compared with the control group. CONCLUSION: These findings suggest that arginine-based immunonutrition should be thoroughly evaluated for incorporation into clinical practice for patients undergoing elective surgery. Moreover, there is a need to assess the effects of the intervention in other hospitals both within and outside Washington.

Cost-effectiveness of a disease-specific oral nutritional support for pressure ulcer healing.

BACKGROUND & AIMS: The Oligo Element Sore Trial has shown that supplementation with a disease-specific nutritional formula enriched with arginine, zinc, and antioxidants improves pressure ulcer (PU) healing in malnourished patients compared to an isocaloric-isonitrogenous support. However, the use of such a nutritional formula needs to be supported also by a cost-effectiveness evaluation. METHODS: This economic evaluation - from a local healthcare system perspective - was conducted alongside a multicenter, randomized, controlled trial following a piggy-back approach. The primary efficacy endpoint was the percentage of change in PU area at 8 weeks. The cost analysis focused on: the difference in direct medical costs of local PU care between groups and incremental cost-effectiveness ratio (ICER) of nutritional therapy related to significant study endpoints (percentage of change in PU area and ≥40% reduction in PU area at 8 weeks). RESULTS: Although the experimental formula was more expensive (mean difference: 39.4 Euros; P < 0.001), its use resulted in money saving with respect to both non-nutritional PU care activities (difference, -113.7 Euros; P = 0.001) and costs of local PU care (difference, -74.3 Euros; P = 0.013). Therefore, given its efficacy it proved to be a cost-effective intervention. The robustness of these results was confirmed by the sensitivity analyses. CONCLUSION: The use of a disease-specific oral nutritional formula not only results in better healing of PUs, but also reduces the costs of local PU care from a local healthcare system perspective.

Nutritional strategies in cardiovascular disease control: an update on vitamins and conditionally essential nutrients.

Several nutritional interventions for cardiovascular disease (CVD) prevention and therapy have recently appeared in the biomedical literature. These include appropriate use of several vitamins (E, C, B6, folate) and conditionally essential nutrients (CoQ10, L-arginine, propionyl L-carnitine). Possible undesirable consequences of long term nutritional supplementation with vitamin E and of adverse drug-nutrient interactions between the statins and CoQ10 are also considered. Although additional intervention studies are needed, current scientific evidence generally supports nutritional supplementation with these nutrients as an effective adjunctive strategy for CVD control.