Naldemedine Treatment of Opioid-Induced Constipation Improves Symptoms, Quality of Life
To evaluate the effects of naldemedine on opioid-induced constipation, data from two 12-week phase 3 trials were evaluated.
|The following article features coverage from PAINWeek 2017 in Las Vegas, Nevada. Click here to read more of Clinical Pain Advisor's conference coverage.|
LAS VEGAS — In patients with opioid-induced constipation, naldemedine was shown to improve patient assessment of symptoms and quality of life, according to research presented at PAINWeek 2017, held September 5-9, in Las Vegas, Nevada.1
To evaluate the effects of naldemedine on opioid-induced constipation, data from two 12-week phase 3 trials (ClinicalTrials.gov identifier: NCT01965158, COMPOSE 1 [n=547]; and COMPOSE 2 [n=1550]) and a 52-week phase 3 trial (COMPOSE 3 [n=1246]) were evaluated. Adult patients (61% women; 79% white across all trials) on a stable opioid regimen with <3 spontaneous bowel movements per week were randomly assigned to receive naldemedine (0.2 mg) or placebo. Stable laxative regimens were allowed in the COMPOSE 3 trial only.1,2
Naldemedine improved Patient Assessment of Constipation Symptoms (PAC-SYM) scores from baseline across all studies (–1.01 at week 2; –1.00 at week 12; P <.001 for both). Compared with placebo, naldemedine significantly improved mean changes in PAC-SYM scores on week 2 (difference between groups –0.32; P <.001) and week 12 (–0.27; P <.001). Naldemedine improved symptoms compared with placebo for each individual PAC-SYM subdomain (abdominal, rectal, and stool symptoms).
Compared with placebo, naldemedine also significantly improved the Patient Assessment of Constipation Quality of Life (PAC-QOL) scores at weeks 2 and 12 (difference between groups, –0.35 and –0.32, respectively; P <.001 for both). When the PAC-QOL subdomains were evaluated individually (physical discomfort, psychosocial discomfort, worries and concerns, and dissatisfaction symptoms), naldemedine performed significantly better than placebo in each subdomain (P <.001 for all).
Patient satisfaction with abdominal and constipation symptoms was also assessed via a 7-grade subject global satisfaction score (SGSS) at the last study visit (–3 [markedly worsened] to +3 [markedly improved], with 0 being unchanged). The SGGS was significantly better in the naldemedine group compared with placebo in all 3 studies, which were independently evaluated (P <.001 for all). When the results of the 12-week studies were pooled, the mean SGSS were 1.5 compared with 0.9 for naldemedine and placebo, respectively. In the 52-week study, the SGSS was 1.7 for naldemedine compared with 1.0 for placebo.2
The incidence of adverse events was similar for naldemedine and placebo (47.1% vs 45.6%).1
According to the study authors, "Treatment with naldemedine 0.2 mg once daily for up to 12 weeks was associated with significant improvements in constipation symptoms and quality of life compared with placebo."1 They added that "SGSS appears to be a simple way to assess the impact on quality of life of [opioid-induced constipation] treatment."2
Read more of Clinical Pain Advisor's coverage of PAINWeek 2017 by visiting the conference page.
- Camilleri M, Tack J, Yamada T, Cai B, Ferreira JCA. Effect of treatment with naldemedine on the patient assessment of constipation symptoms and the patient assessment of constipation quality of life questionnaires in patients with chronic non-cancer pain and opioid-induced constipation. Presented at: PAINWeek 2017; September 5-9; Las Vegas, Nevada.
- Tack J, Camilleri M, Yamada T, Cai B, Ferreira JCA. Subject global satisfaction score to assess overall effect of naldemedine compared with placebo on constipation and abdominal symptoms in subjects with chronic non-cancer pain and opioid-induced constipation. Presented at: PAINWeek 2017; September 5-9; Las Vegas, Nevada.