Most Read Articles
Pearl Toh, 18 Feb 2016
Treatment with eluxadoline, a new oral medication, relieved two major symptoms of irritable bowel syndrome with diarrhoea (IBS-D) — abdominal pain and diarrhoea, according to a study based on two phase III randomized controlled trials. [N Engl J Med 2016;374:242-253]
01 Apr 2016
Amiodarone is safe and effective for early junctional ectopic tachycardia prophylaxis in paediatric patients following open heart surgery, based on a study.
Tristan Manalac, 6 days ago
Taking oral antibiotics appears to increase the risk of nephrolithiasis, according to a recent study. Moreover, the risk seems to be compounded for individuals with recent antibiotic exposure and those who were exposed at a younger age.
Roshini Claire Anthony, 20 Mar 2018

Individuals with type 2 diabetes (T2D) who initiate therapy with sodium glucose cotransporter-2 (SGLT-2) inhibitors have lower risks of all-cause death and cardiovascular (CV) outcomes, specifically myocardial infarction (MI) and stroke, compared with those who initiate other glucose-lowering therapies, according to results from the CVD-REAL* 2 study.

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, 18 Feb 2016
Treatment with eluxadoline, a new oral medication, relieved two major symptoms of irritable bowel syndrome with diarrhoea (IBS-D) — abdominal pain and diarrhoea, according to a study based on two phase III randomized controlled trials. [N Engl J Med 2016;374:242-253]
01 Apr 2016
Amiodarone is safe and effective for early junctional ectopic tachycardia prophylaxis in paediatric patients following open heart surgery, based on a study.
Tristan Manalac, 6 days ago
Taking oral antibiotics appears to increase the risk of nephrolithiasis, according to a recent study. Moreover, the risk seems to be compounded for individuals with recent antibiotic exposure and those who were exposed at a younger age.
Roshini Claire Anthony, 20 Mar 2018

Individuals with type 2 diabetes (T2D) who initiate therapy with sodium glucose cotransporter-2 (SGLT-2) inhibitors have lower risks of all-cause death and cardiovascular (CV) outcomes, specifically myocardial infarction (MI) and stroke, compared with those who initiate other glucose-lowering therapies, according to results from the CVD-REAL* 2 study.