title: Long-term efficacy and safety of oxycodone-naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study.
abstract: BACKGROUND
  Two-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years.
  
  
  METHODS
  In this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52).
  
  
  RESULTS
  Fifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0-10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated.
  
  
  CONCLUSIONS
  This study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs.
authors.affiliation: Department of Internal Medicine and Medical Therapy, Section of Geriatrics, University of Pavia, Milan, Italy; Department of Geriatrics, Agency for Elderly People of Pavia, Santa Margherita Institute, Pavia, Milan, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Guerriero
authors.affiliation: Department of Oncology, Pain and Palliative Care Research Unit, IRCCS-Mario Negri Institute for Pharmacological Research, Milan, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Roberto
authors.affiliation: Unit of Medical Statistics, Biometry and Epidemiology GA Maccacaro, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Greco
authors.affiliation: Department of Internal Medicine and Medical Therapy, Section of Geriatrics, University of Pavia, Milan, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Sgarlata
authors.affiliation: Department of Geriatrics, Agency for Elderly People of Pavia, Santa Margherita Institute, Pavia, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Rollone
authors.affiliation: Department of Oncology, Pain and Palliative Care Research Unit, IRCCS-Mario Negri Institute for Pharmacological Research, Milan, Italy.
authors.forename: Oscar
authors.initials: O
authors.lastname: Corli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012449:Safety; D013997:Time Factors
chemical_list: D000700:Analgesics; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009270:Naloxone; D010098:Oxycodone
keywords: chronic noncancer pain; constipation; geriatric; oxycodone/naloxone