PMID- 23658495
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130510
LR  - 20211021
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 6
DP  - 2013
TI  - Effectiveness and gastrointestinal tolerability during conversion and titration 
      with once-daily OROS(R) hydromorphone extended release in opioid-tolerant patients 
      with chronic low back pain.
PG  - 319-29
LID - 10.2147/JPR.S39980 [doi]
AB  - PURPOSE: To describe the efficacy and safety of hydromorphone extended-release 
      tablets (OROS hydromorphone ER) during dose conversion and titration. PATIENTS 
      AND METHODS: A total of 459 opioid-tolerant adults with chronic moderate to 
      severe low back pain participated in an open-label, 2- to 4-week 
      conversion/titration phase of a double-blind, placebo-controlled, randomized 
      withdrawal trial, conducted at 70 centers in the United States. Patients were 
      converted to once-daily OROS hydromorphone ER at 75% of the equianalgesic dose of 
      their prior total daily opioid dose (5:1 conversion ratio), and titrated as 
      frequently as every 3 days to a maximum dose of 64 mg/day. The primary outcome 
      measure was change in pain intensity numeric rating scale; additional assessments 
      included the Patient Global Assessment and the Roland-Morris Disability 
      Questionnaire scores. Safety assessments were performed at each visit and 
      consisted of recording and monitoring all adverse events (AEs) and serious AEs. 
      RESULTS: Mean (standard deviation) final daily dose of OROS hydromorphone ER was 
      37.5 (17.8) mg. Mean (standard error of the mean [SEM]) numeric rating scale 
      scores decreased from 6.6 (0.1) at screening to 4.3 (0.1) at the final titration 
      visit (mean [SEM] change, -2.3 [0.1], representing a 34.8% reduction). Mean (SEM) 
      change in Patient Global Assessment was -0.6 (0.1), and mean change (SEM) in the 
      Roland-Morris Disability Questionnaire was -2.8 (0.3). Patients achieving a 
      stable dose showed greater improvement than patients who discontinued during 
      titration for each of these measures (P < 0.001). Almost 80% of patients 
      achieving a stable dose (213/268) had a >/=30% reduction in pain. Commonly reported 
      AEs were constipation (15.4%), nausea (11.9%), somnolence (8.7%), headache 
      (7.8%), and vomiting (6.5%); 13.0% discontinued from the study due to AEs. 
      CONCLUSION: The majority of opioid-tolerant patients with chronic low back pain 
      were successfully converted to effective doses of OROS hydromorphone ER within 2 
      to 4 weeks.
FAU - Hale, Martin E
AU  - Hale ME
AD  - Gold Coast Research, LLC, Weston, FL, USA.
FAU - Nalamachu, Srinivas R
AU  - Nalamachu SR
FAU - Khan, Arif
AU  - Khan A
FAU - Kutch, Michael
AU  - Kutch M
LA  - eng
PT  - Journal Article
DEP - 20130501
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC3645948
OTO - NOTNLM
OT  - OROS hydromorphone ER
OT  - chronic low back pain
OT  - conversion and titration
OT  - extended-release opioids
OT  - noncancer pain
OT  - opioid rotation
EDAT- 2013/05/10 06:00
MHDA- 2013/05/10 06:01
PMCR- 2013/05/01
CRDT- 2013/05/10 06:00
PHST- 2013/05/10 06:00 [entrez]
PHST- 2013/05/10 06:00 [pubmed]
PHST- 2013/05/10 06:01 [medline]
PHST- 2013/05/01 00:00 [pmc-release]
AID - jpr-6-319 [pii]
AID - 10.2147/JPR.S39980 [doi]
PST - epublish
SO  - J Pain Res. 2013 May 1;6:319-29. doi: 10.2147/JPR.S39980. Print 2013.