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Naldemedine a potential treatment for opioid-induced constipation

Roshini Claire Anthony
11 Jul 2017

A once-daily dose of naldemedine improved opioid-induced constipation in adults with chronic noncancer pain, according to results from the phase III COMPOSE-1 and COMPOSE-2* trials.

Patients (mean age 53 and 54 years in the COMPOSE-1 and COMPOSE-2 trials, respectively) on a stable opioid regimen for chronic noncancer pain (≥30 mg equivalent of oral morphine daily for ≥1 month prior to screening) and not using laxatives were randomized to receive oral naldemedine (0.2 mg, n=274 [COMPOSE-1] and n=277 [COMPOSE-2]) or placebo (n=273 [COMPOSE-1] and n=276 [COMPOSE-2]) once a day for 12 weeks.

The primary endpoint was the proportion of patients having ≥3 spontaneous bowel movements (SBMs) per week, with an increase of ≥1 SBM per week from baseline for ≥9 weeks and ≥3 of the last 4 weeks of the treatment period.

Compared with placebo, more patients on naldemedine met the primary endpoint in both the COMPOSE-1 (47.6 percent vs 34.6 percent, difference 13 percent, 95 percent confidence interval [CI], 4.8–21.3 percent; p=0.002) and COMPOSE-2 trials (52.5 percent vs 33.6 percent, difference 18.9 percent, 95 percent CI, 10.8–27.0 percent; p<0.0001). [Lancet Gastroenterol Hepatol 2017;doi:10.1016/S2468-1253(17)30105-X]

There was a greater increase in mean SBM frequency per week between baseline and the last 2 weeks of treatment in the naldemedine vs placebo groups in both trials (3.42 vs 2.12 in COMPOSE-1 and 3.56 vs 2.16 in COMPOSE-2; p<0.0001 for both trials).

Adverse event (AE) incidence was comparable between naldemedine and placebo in both COMPOSE-1 (49 percent vs 45 percent) and COMPOSE-2 (50 percent vs 48 percent).

Incidence of treatment-related AEs was higher among patients on naldemedine compared with placebo (22 percent vs 17 percent [COMPOSE-1] and 20 percent vs 11 percent [COMPOSE-2]), driven primarily by the higher incidence of gastrointestinal disorders in individuals on naldemedine compared with placebo (15 percent vs 7 percent [COMPOSE-1] and 16 percent vs 7 percent [COMPOSE-2]).

The most frequent AE among patients on naldemedine compared with placebo were diarrhoea (7 percent vs 3 percent [COMPOSE-1] and 9 percent vs 2 percent [COMPOSE-2]) and abdominal pain (6 percent vs 2 percent [COMPOSE-1] and 5 percent vs 1 percent [COMPOSE-2]). One patient on naldemedine in COMPOSE-1 and one patient on placebo in COMPOSE-2 had a major adverse cardiovascular event.

Study design prevented the researchers from determining if naldemedine was effective in treating both opioid-induced and opioid-exacerbated constipation, as well as whether naldemedine was superior to laxatives.

“Unlike many other opioid-related adverse effects, opioid-induced constipation does not subside over time,” said the researchers.

“Our data ... provide evidence that the use of a [peripherally acting µ-opioid receptor antagonist] for the treatment of opioid-induced constipation is a safe and effective therapeutic approach to reverse the most common and bothersome side effect of opioid use for patients with chronic noncancer pain,” they said.

 

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Most Read Articles
Pearl Toh, 11 Oct 2017
Clinical practice is an art guided by good science, and clinical practice guideline (CPG) is meant to guide in integrating the art and science of clinical practice for the long-term benefits of patients, said Dr Abdul Rashid Abdul Rahman, a consultant cardiovascular physician at An-Nur Specialist Hospital in Bangi, Malaysia, during the 13th Asian-Pacific Congress of Hypertension (APCH) held in Singapore.
08 Oct 2017
Treatment with vismodegib does not appear to increase the risk of subsequent squamous cell carcinoma (SCC) in comparison with standard surgical treatment of basal cell carcinoma (BCC), a recent study suggests.
01 Sep 2017
Complementary medicines can play an important part in maintaining wellness, preventing deficiencies and optimizing health outcomes, says Dr Lesley Braun PhD, Director of the Blackmores Institute. 
Pearl Toh, 06 Oct 2017
Bacillus Calmette-Guérin (BCG) vaccination is not associated with any changes in the risk of developing childhood asthma, suggesting that any associations previously reported may be attributed to confounding factors, according to the QBCIH* study.