Abstract
Simple SummaryPrescription opioid pain medications help ease pain, but they also cause some unwanted side effects such as constipation. In this study we evaluated the safety and efficacy of naloxegol used to treat constipation that is caused by opioids. We found that naloxegol improved constipation and quality of life in patients with cancer-related pain and opioid-induced constipation.The Naloxegol Cancer Study (NACASY) was a multinational European study aimed to evaluate the 4-week safety and efficacy of naloxegol in a real-world setting in patients with cancer pain diagnosed with opioid-induced constipation. The primary safety endpoint was the incidence of adverse events leading to study discontinuation. We recruited 170 patients who received at least one dose of naloxegol (i.e., safety population). Out of 170 patients, 20 (11.8%, 95%CI 6.9–16.6) discontinued the study due to adverse events, and, of them, 12 (7.1%, 95%CI 3.2–10.9%) were study discontinuations due to naloxegol-related adverse events. From 76 patients subjects who had completed both 4 weeks of treatment and 28 days of the diary, 55 patients (72.4%, 95% CI 62.3–82.4%) were regarded as responders (i.e., showed ≥3 bowel-movements per week and an increase of ≥1 bowel-movement over baseline) to naloxegol treatment. The Patient Assessment of Constipation—Quality of Life Questionnaire total score and all its subscales improved from baseline to 4 weeks of follow up. Our findings support and provide new evidence about the beneficial effect of naloxegol in terms of improvement of constipation and quality-of-life in patients with cancer-related pain and opioid-induced constipation and show a safety profile consistent with previous pivotal and real-world studies.
Highlights
Cancer-related pain is one of the most frequent and bothersome symptoms affecting patients with cancer [1]
This was a four-week, single-arm, open-label, multinational, multicenter, prospective, real-world observational study in adult subjects with opioid-induced constipation (OIC), receiving naloxegol in routine clinical practice, as prescribed by their physicians according to the conditions established in its Summary of Product Characteristics (SmPC) and with the further recommendation to halt all currently used maintenance laxative therapy
Of the 170 patients, 143 patients who had at least one post-baseline efficacy assessment were included in the efficacy analysis; 76 patients were included in Efficacy Population 1 and 98 in Efficacy Population 2 (Figure 1)
Summary
Cancer-related pain is one of the most frequent and bothersome symptoms affecting patients with cancer [1]. The frequency of cancer pain is related to the stage of disease. Pain prevalence increases from 33% in patients after curative treatment up to 64% in patients with metastatic, advanced, or terminal disease [2]. Opioids remain the cornerstone of analgesic treatment for severe cancer pain [3,4]. Opioid-induced constipation (OIC) is the most common and debilitating reported side-effect, with an overall prevalence ranging from 51% to 87% [6]. OIC negatively impacts patients’ health-related quality of life (HRQoL), and impairs patients’ ability to perform daily activities [7]. Many patients decide to discontinue or limit their opioid therapy, resulting in insufficient pain control [8]
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