Current medical research and opinion · 2016
Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials.
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Setnik Beatrice, Pixton Glenn C, Webster Lynn R
Аннотация
OBJECTIVE: Clinical trial safety data following chronic administration of extended-release opioids within an older population is limited. Embeda * is an extended-release formulation of morphine sulfate surrounding sequestered naltrexone hydrochloride (MSN) and is designed to deter opioid misuse and abuse. The present analysis compared pooled safety outcomes among patients aged ≥65 years and those aged <65 years from three phase 2/3 studies (ranging from 2 weeks to 12 months) in patients treated with MSN.
RESEARCH DESIGN AND METHODS: Subgroup analysis of patients aged ≥65 years and <65 years was performed on pooled data for adverse events (AEs), potentially clinically significant laboratory values (hematology/chemistry), and signs/symptoms of opioid withdrawal using the Clinical Opiate Withdrawal Scale (COWS) (phase 3 trials only) for patients who received at least one dose (short-term studies, maximum dose was 160 mg/d or 320 mg/d depending on study; long-term study, no maximum dose) of study medication during titration and maintenance phases.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT00420992, NCT00415597.
RESULTS: During titration, 173 (17.1%) of 1012 patients treated with MSN were aged ≥65 years, while during maintenance 76/564 (13.5%) patients were aged ≥65 years. Treatment-emergent AEs were similar in frequency and type between the two cohorts, with the most common being constipation, nausea, and somnolence; no consistent patterns relating to age and only one possibly treatment-related serious AE in patients ≥65 years was noted. No clinically significant differences in laboratory values or COWS scores (average maximum score ≤2.5) were observed between age groups.
CONCLUSIONS: Safety outcomes following daily administration of MSN (2 weeks-12 months) were similar between patients aged ≥65 years and <65 years. Key limitations include the variable study designs and length of treatment (2 weeks-12 months), small sample size, and the inclusion of only those patients who were otherwise in relatively good health with restrictions on concomitant medications.
RESEARCH DESIGN AND METHODS: Subgroup analysis of patients aged ≥65 years and <65 years was performed on pooled data for adverse events (AEs), potentially clinically significant laboratory values (hematology/chemistry), and signs/symptoms of opioid withdrawal using the Clinical Opiate Withdrawal Scale (COWS) (phase 3 trials only) for patients who received at least one dose (short-term studies, maximum dose was 160 mg/d or 320 mg/d depending on study; long-term study, no maximum dose) of study medication during titration and maintenance phases.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT00420992, NCT00415597.
RESULTS: During titration, 173 (17.1%) of 1012 patients treated with MSN were aged ≥65 years, while during maintenance 76/564 (13.5%) patients were aged ≥65 years. Treatment-emergent AEs were similar in frequency and type between the two cohorts, with the most common being constipation, nausea, and somnolence; no consistent patterns relating to age and only one possibly treatment-related serious AE in patients ≥65 years was noted. No clinically significant differences in laboratory values or COWS scores (average maximum score ≤2.5) were observed between age groups.
CONCLUSIONS: Safety outcomes following daily administration of MSN (2 weeks-12 months) were similar between patients aged ≥65 years and <65 years. Key limitations include the variable study designs and length of treatment (2 weeks-12 months), small sample size, and the inclusion of only those patients who were otherwise in relatively good health with restrictions on concomitant medications.