专用口服营养补充剂治疗营养不良老年住院成人的再入院和死亡率：随机临床试验

Clin Nutr. 2016 Feb;35(1):18-26.

Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial.

Deutz NE, Matheson EM, Matarese LE, Luo M, Baggs GE, Nelson JL, Hegazi RA, Tappenden KA, Ziegler TR; NOURISH Study Group.

Center for Translational Research in Aging & Longevity, Department of Health & Kinesiology, Texas A&M University, 1700 Research Parkway, College Station, TX 77845, USA.

Department of Family Medicine, Medical University of South Carolina, 5 Charleston Center Dr, Charleston, SC, USA.

Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, USA.

Abbott Nutrition, Research and Development, 3300 Stelzer Rd, Columbus, OH, USA.

Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, 905 S. Goodwin Ave, Urbana, IL, USA.

Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, 1648 Pierce Dr NE, Atlanta, GA, USA.

BACKGROUND: Hospitalized, malnourished older adults have a high risk of readmission and mortality.

OBJECTIVE: Evaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.

DESIGN: Multicenter, randomized, placebo-controlled, double-blind trial.

SETTING: Inpatient and posthospital discharge.

PATIENTS: Older (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.

INTERVENTIONS: Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.

MEASUREMENTS: Primary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).

RESULTS: The primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.

LIMITATIONS: Limited generalizability; patients represent a selected hospitalized population.

CONCLUSIONS: Although no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.

CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.govNCT01626742.

KEYWORDS: High-protein beta-hydroxy-beta-methylbutyrate; Hospitalization; Lean body mass; Malnourished; NOURISH study; Oral nutritional supplement

PMID: 26797412

DOI: 10.1016/j.clnu.2015.12.010