PMID- 26695349 OWN - NLM STAT- MEDLINE DCOM- 20160929 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 32 IP - 3 DP - 2016 TI - Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. PG - 563-72 LID - 10.1185/03007995.2015.1131153 [doi] AB - 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 /=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. FAU - Setnik, Beatrice AU - Setnik B AD - a Pfizer Inc , Durham , NC , USA ; FAU - Pixton, Glenn C AU - Pixton GC AD - a Pfizer Inc , Durham , NC , USA ; FAU - Webster, Lynn R AU - Webster LR AD - b PRA Health Sciences , Salt Lake City , UT , USA. LA - eng SI - ClinicalTrials.gov/NCT00415597 SI - ClinicalTrials.gov/NCT00420992 PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20160126 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Analgesics, Opioid) RN - 0 (Delayed-Action Preparations) RN - 0 (Drug Combinations) RN - 0 (Narcotic Antagonists) RN - 0 (morphine, naltrexone combination) RN - 5S6W795CQM (Naltrexone) RN - 76I7G6D29C (Morphine) SB - IM MH - Aged MH - Analgesics, Opioid/*administration & dosage/adverse effects MH - Chemistry, Pharmaceutical MH - Delayed-Action Preparations MH - Drug Combinations MH - Female MH - Humans MH - Male MH - Middle Aged MH - Morphine/*administration & dosage/adverse effects MH - Naltrexone/*administration & dosage/adverse effects MH - Narcotic Antagonists/*administration & dosage/adverse effects MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Abuse deterrent OT - age OT - chronic pain OT - extended-release OT - opioids EDAT- 2015/12/24 06:00 MHDA- 2016/09/30 06:00 CRDT- 2015/12/24 06:00 PHST- 2015/12/24 06:00 [entrez] PHST- 2015/12/24 06:00 [pubmed] PHST- 2016/09/30 06:00 [medline] AID - 10.1185/03007995.2015.1131153 [doi] PST - ppublish SO - Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.