Dataset Information

Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

ABSTRACT:

Background

Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few.

Objective

Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR.

Methods

We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12.5 mg, n = 240; 25 mg, n = 241) or placebo (n = 239) were administered daily. We assessed the response rates, time to first post-dose laxation, spontaneous bowel movements (SBMs), OIC symptoms and patient-reported outcomes over 12 weeks.

Results

OIC response rates for the naloxegol 25-mg (p < 0.001) and the 12.5-mg (p = 0.005) LIR dose groups were higher than placebo. Median times to first post-dose SBM were 7.6, 19.2 and 41.1 hours for the naloxegol 25 mg, naloxegol 12.5 mg and placebo groups, respectively. Other SBM measures, daily symptoms of OIC, and both the Patient Assessment of Constipation - Symptoms and Patient Assessment of Constipation-Quality of Life scores improved from baseline with naloxegol treatment. Changes from baseline in opioid dose, pain scores and opioid withdrawal scores were similar among treatment groups.

Conclusions

Naloxegol was efficacious, generally safe and well tolerated in the patients with OIC and LIR, while preserving opioid analgesia. ClinicalTrials.gov identifiers: NCT01309841; NCT01323790.

SUBMITTER: Tack J

PROVIDER: S-EPMC4625753 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

Tack Jan J Lappalainen Jaakko J Diva Ulysses U Tummala Raj R Sostek Mark M

United European gastroenterology journal 20151001 5

<h4>Background</h4>Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few.<h4>Objective</h4>Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR.<h4>Methods</h4>We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12.5 mg, n = 240; 25 mg, n ...[more]

PMID: 26535126

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Project description:IntroductionOpioid-induced constipation (OIC) is the most common side effect of opioid treatment. Treatment for OIC typically involves a laxative. However, some patients have an inadequate response to these (laxative inadequate responders, or LIR). This has led to the development of treatments such as naloxegol. This analysis estimates the impact of naloxegol on the health state utility of LIR patients, examines if this utility impact is driven by the change in OIC status, and estimates the utility impact of relief of OIC.MethodsThe analysis was conducted using data from two 12-week randomized controlled trials, KODIAC 4 (ClinicalTrials.gov identifier, NCT01309841) and KODIAC 5 (ClinicalTrials.gov identifier, NCT01323790), plus KODIAC 7 (ClinicalTrials.gov identifier, NCT01395524), a 12-week extension to KODIAC 4. All were designed to assess the efficacy and safety of oral naloxegol (12.5 and 25 mg) compared to placebo. Health state utility data were collected through the EuroQol-five dimensions questionnaire (EQ-5D-3L). Descriptive analysis was undertaken to estimate how EQ-5D utility scores and EQ-5D domain responses varied with treatment, OIC status, and over time. A repeated measure mixed-effects model was used to predict the change from baseline in health state utility score over time.ResultsCompared with placebo, LIR patients treated with naloxegol 25 mg reported a 0.08 improvement in the EQ-5D overall score after 12 weeks of treatment. The analyses also suggest that change in OIC status is a key driver of the impact of OIC treatment on health state utility. When other factors are controlled, relieving OIC is associated with a 0.05 improvement in health state utility, although treatment with naloxegol is associated with an improvement in health state utility over and above the improvement in OIC status.ConclusionThese analyses suggest that treatment with naloxegol improves patients' health state utility; driven predominantly by the relief of patients' constipation.FundingAstraZeneca.

Dataset Information

Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

Background

Objective

Methods

Results

Conclusions

Publications

Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

Similar Datasets

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