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Naldemedine a potential treatment for opioid-induced constipation

Roshini Claire Anthony
15 days ago

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
3 years ago

WHO (2012) estimates that around 450 million people suffer from mental illness, with one–in–four families having at least one member with a mental illness at any point in time. According to the Malaysian Mental Health Association, mental illness is often misunderstood. For centuries, it has been seen as either possession by evil spirits, a moral weakness or punishment from a higher being. Those suffering from mental illness are commonly perceived to be restless, violent and unpredictable.

one year ago
Orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, and liraglutide were effective in achieving weight loss among overweight and obese adults at 52 weeks, a recent study found. Phentermine-topiramate and liraglutide were associated with the highest odds of achieving at least 5 percent weight loss.
2 years ago
A study on participants from the Women's Health Initiative showed the dissociation between calcium/vitamin D supplementation and reduction in menopausal symptoms.
Elvira Manzano, one year ago
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