Naldemedine(纳地美定)的不良反应有哪些？

What kind of medicine is Naldemedine?

Naldemedine, a dual δ-opioid receptor and μ-opioid receptor antagonist developed by Japan's Shionogi Pharmaceutical Co., Ltd., has been approved for marketing in the United States. It is mainly used to treat constipation caused by the use of opioid analgesics in patients with non-cancer pain. It can bind to Mu opioid receptors, Delta opioid receptors, and Kappa opioid receptors, and plays an antagonistic role in the gastrointestinal tract.

Naldemedine is a once-daily oral, peripherally acting opioid receptor antagonist (PAMORA), based on results from the COMPOSE-1 and COMPOSE-2 trials, which each included 12 weeks of treatment with placebo or Naldemedine, taken orally once daily.

The proportion of patients who responded during treatment was significantly higher in the treatment group than in the placebo group: COMPOSE-1 (47.6% vs. 34.6%), COMPOSE-2 (52.5% vs. 33.6%).

The mean weekly SBM frequency was higher in the Naldemedine group (COMPOSE-1, 3.42; COMPOSE-2, 3.56) than in the placebo group (COMPOSE-1, 2.12; COMPOSE-2, 2.16). It can be seen that Naldemedine can effectively treat constipation caused by opioid use in patients with chronic pain.

Adverse reactions of Naldemedine

These include sweating, chills, tearing, fever, cold sensation, facial warmth or hot sensation (flushing), sneezing, abdominal pain, diarrhea, nausea, vomiting, stomach or intestinal wall tear (perforation), etc. Pay attention to your body's reaction during medication. If you are intolerant, contact your doctor in time for symptomatic treatment.

In the COMPOSE-1 and COMPOSE-2 trials, the incidence of treatment-related adverse events in the Naldemedine group (COMPOSE-1, 49%; COMPOSE-2, 50%) was similar to that in the placebo group (45% and 48%, respectively). Treatment-related events were more common in the naldemedine group than in the placebo group, primarily due to higher rates of diarrhea and abdominal pain in the naldemedine group.

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