Pancreatic enzyme replacement therapy (PERT) increased body weight of individuals with pancreatic exocrine insufficiency (PEI) following pancreatoduodenectomy as compared with placebo; however, the effect was not significant, according to a study recently published in Clinical Gastroenterology and Hepatology.
PEI after pancreatoduodenectomy can result in nutritional deficits, and a decrease in quality of life. However, there are no evidence-based guidelines for PERT for patients with PEI after pancreatoduodenectomy. This randomized, double-blind trial included 304 individuals undergoing pancreatoduodenectomy in 7 South Korean hospitals, 151 of whom were randomly assigned to PERT (Norzyme [40,000 IU pancreatin] 3 times daily for 3 months) and 153 of whom were randomly assigned to placebo. An inclusion criterion was fecal elastase level ≤200 µg/g before or after surgery, while completion criteria were defined as completing more than two-thirds of the whole dose without taking additional digestive enzymes.
All participants received preoperative and 3-month postoperative physical exams, blood tests, and oral glucose tolerance tests. Change in body weight at 3 months vs baseline for PERT vs placebo comprised the primary end point, while secondary end points included quality of life, nutritional parameters, and bowel habits.
Among the study population, 71 completed the PERT protocol and 93 completed placebo, with 67 participants excluded from the intention-to-treat group. At the 3-month mark, the PERT group gained a mean of 1.09 kg and the placebo group lost a mean of 2.28 kg (mean difference between groups, 3.37 kg; P <.001). However, intention-to-treat analysis did not result in a statistically significant difference in body weight (PERT -0.68 kg; placebo -1.19 kg; P =.302).
Similarly, neither body mass index nor defecation frequency showed significant differences in both per-protocol and intention-to-treat sets. At the 3-month mark, serum prealbumin rose in both groups (PERT 10.9 mg/dL; placebo 7.8 mg/dL; P =.002). The risk for weight loss was significantly associated with poor PERT compliance (hazard ratio 4.018; P <.001). Quality of life did not differ significantly between the groups.
Limitations to this study included a lack of comparison of medication and dosage timing, due to the single-country study population design, and a potential lack of generalizability due to variance in dietary habits in other countries. Additionally, long-term analyses of the effects of PERT were not performed.
In the intent to treat analysis of data from a randomized trial, the researchers found no significant effect of PERT on mean body weights of patients with pancreatic PEI after pancreatoduodenectomy. Yet, with active education and monitoring, PERT may increase body weight and nutritional paramters.
Disclosure: This clinical trial was supported by Korea PharmBio. Please see the original reference for a full list of authors’ disclosures.
Kim H, Yoon YS, Han Y, et al. Effects of pancreatic enzyme replacement therapy on body weight and nutritional assessments after pancreatoduodenectomy in a randomized trial [published online September 11, 2019]. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.08.061