1. In a randomized double-blind placebo-controlled study, naldemedine use was associated with constipation prevention and a significant improvement of constipation-related quality of life (QOL) in cancer patients initiating opioid pain therapy.
Evidence Rating Level: 1 (Excellent)
Along with cancer treatment comes pain which has often been treated with opioids. However, these opioids have some adverse effects such as constipation which can diminish one’s quality of life (QOL). The most commonly seen adverse effect is opioid induced constipation (OIC), sometimes so bad it may limit adherence. Due to this lack of prior research, this study employed a double-blind randomized controlled trial to determine the effects of preventative naldemedine versus placebo for OIC in cancer patients. The main research outcome was the amount of patients with a Bowel Function Index (BFI) of less than 28.8 on day 14 of the trial. Other outcomes of interest included frequency of opioid-induced nausea and vomiting (OINV), the number of patients who had three or more spontaneous bowel moments (SBM) per week and complete SBM (CSBM) per week. To be included in the trial, patients had to be 20 years or older with cancer beginning opioid therapy. The patients that met the criteria were randomly assigned to either receive naldemedine (Symproic 0.2 mg) or placebo in a 1:1 basis. They received their first dose of either placebo or naldemedine at the same time as their first dose of opioids. A total of 99 patients were enrolled, with 49 receiving naldemedine and 50 receiving placebo. On day 14 of the trial, 31 patients (64.6%; 95% CI, 51.1 to 78.1) in the naldemedine group and 8 patients (17.0%; 95% CI, 6.3 to 27.8) in the placebo group had a BFI of <28.8. Thus, the difference seen between the groups was 47.6% (95% CI, 30.3 to 64.8; P<.0001). On day 7, halfway through the trial, there were more patients in the naldemedine group compared to the placebo group that had a BFI of <28.8, had three or more SBM per week and CSBM per day. There was less use of antiemetic drugs in the naldemedine group compared to the placebo group. The patients in the naldemedine reported higher overall QOL at day 7 and 14 compared to patients in the placebo group. The results of this study show that prophylactic naldemedine was an effective way to prevent constipation and improve QOL in cancer patients receiving opioid for pain management.
Click to read the study in JCO
Image: PD
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