COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations

Michael A Ueberall, Gerhard H H Mueller-Schwefe
Current Medical Research and Opinion 2015, 31 (7): 1413-29
25942606

BACKGROUND: Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and interferes with analgesic efficacy.

OBJECTIVES: This PROBE trial compares the overall safety and tolerability of oxycodone/naloxone (OXN) with those of traditional opioid therapy with oxycodone (OXY) or morphine (MOR) in the setting of the German healthcare system.

RESEARCH DESIGN AND METHODS: This was a prospective, randomized, open-label, blinded endpoint (PROBE) streamlined study (German pain study registry: 2012-0012-05; EudraCT: 2012-001317-16), carried out in 88 centers in Germany, where a total of 453 patients, requiring WHO step III opioids to treat low back pain, were randomized to OXN, OXY or MOR (1:1:1) for 3 months. The primary outcome was the percentage of patients without adverse event-related study discontinuations who presented with a combination of a ≥50% improvement of pain intensity, disability and quality-of-life and a ≤50% worsening of bowel function at study end.

RESULTS: Significantly more OXN patients met the primary endpoint (22.2%) vs. OXY (9.3%; OR: 2.80; p < 0.001) vs. MOR (6.3%; OR: 4.23; p < 0.001), with insignificant differences between OXY vs. MOR (p = 0.155). A ≥50% improvement of pain intensity, functional disability and quality-of-life has been found for OXN in 75.0/61.1/66.0% of patients and thus for all parameters significantly more than with OXY (58.9/49.0/48.3; p < 0.001 for each) or MOR (52.5/46.2/37.3; p < 0.001 for each). A total of 86.8% of OXN patients kept normal BFI scores during treatment, vs. 63.6% for OXY (p < 0.001) vs. 53.8% for MOR (p < 0.001). Overall 189 TEAEs (OXN: 45, OXY: 69, MOR: 75) in 92 patients (OXN: 21, OXY: 44, MOR: 37) occurred, most gastrointestinal (50.8%). One limitation is the open-label design, which presents the possibility of interpretive bias.

CONCLUSION: Under the conditions of this PROBE design, OXN was associated with a significantly better tolerability, a lower risk of OIC and a significantly better analgesic efficacy than OXY or MOR.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
25942606
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"