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Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data.
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Sabaté Jean-Marc, Beato-Zambrano Carmen, Cobo Manuel, Lemaire Antoine, Montesarchio Vincenzo, Serna-Montros Judith, Namane Rafik, Martín Baccarelli Santiago, Rico-Villademoros Fernando
Аннотация
OBJECTIVE: The aim of the NALOPOOL project was to assess the efficacy and safety of naloxegol in patients with cancer pain who exhibited opioid-induced constipation (OIC) and were treated under real-world conditions.
METHODS: We pooled individual patient data from three multicenter observational studies conducted with naloxegol in patients with cancer who exhibited OIC and were prescribed naloxegol under real-world conditions. Efficacy outcomes were evaluated after 4 weeks of treatment. All analyses were performed via a visit-wise approach. Heterogeneity was assessed via Cochran's Q-test or Levene's test.
RESULTS: Spontaneous bowel movements (SBM) response (≥3 SBM per week and an increase of ≥1 from baseline; three studies) was reported in 223 of 314 evaluable patients (71%, 95% CI 66-76); clinically relevant improvement in the Patient Assessment of Constipation Quality-of-Life Questionnaire (>0.5 points; three studies) occurred in 179 of 299 evaluable patients (60%, 95% CI 56-74) and in the Patient Assessment of Constipation Symptoms (>0.5 points; two studies) was reported in 131 of 190 evaluable patients (69%, 95% CI 62-76); and clinically relevant improvement in the Bowel Function Index (score ≥ 12 points at the endpoint; two studies;) was reported in 133 of 195 evaluable patients (68%, 95% CI 62-75). No significant heterogeneity was found for any efficacy outcome. The pooled proportion of patients who discontinued the drug owing to adverse reactions was 6.1% (95% CI 3.8% to 8.4%).
CONCLUSIONS: Our results support the use of naloxegol for the management of OIC in patients with cancer pain who do not respond to laxative treatment.
METHODS: We pooled individual patient data from three multicenter observational studies conducted with naloxegol in patients with cancer who exhibited OIC and were prescribed naloxegol under real-world conditions. Efficacy outcomes were evaluated after 4 weeks of treatment. All analyses were performed via a visit-wise approach. Heterogeneity was assessed via Cochran's Q-test or Levene's test.
RESULTS: Spontaneous bowel movements (SBM) response (≥3 SBM per week and an increase of ≥1 from baseline; three studies) was reported in 223 of 314 evaluable patients (71%, 95% CI 66-76); clinically relevant improvement in the Patient Assessment of Constipation Quality-of-Life Questionnaire (>0.5 points; three studies) occurred in 179 of 299 evaluable patients (60%, 95% CI 56-74) and in the Patient Assessment of Constipation Symptoms (>0.5 points; two studies) was reported in 131 of 190 evaluable patients (69%, 95% CI 62-76); and clinically relevant improvement in the Bowel Function Index (score ≥ 12 points at the endpoint; two studies;) was reported in 133 of 195 evaluable patients (68%, 95% CI 62-75). No significant heterogeneity was found for any efficacy outcome. The pooled proportion of patients who discontinued the drug owing to adverse reactions was 6.1% (95% CI 3.8% to 8.4%).
CONCLUSIONS: Our results support the use of naloxegol for the management of OIC in patients with cancer pain who do not respond to laxative treatment.