PMID- 23247907
OWN - NLM
STAT- MEDLINE
DCOM- 20130423
LR  - 20131121
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 8
IP  - 5
DP  - 2012 Sep-Oct
TI  - Safety and tolerability of OROS(R) hydromorphone ER in adults with chronic 
      noncancer and cancer pain: pooled analysis of 13 studies.
PG  - 299-314
LID - jom.2012.0130 [pii]
LID - 10.5055/jom.2012.0130 [doi]
AB  - OBJECTIVE: This analysis was designed to assess the pooled safety and 
      tolerability of once-daily hydromorphone extended release (ER) (OROS(R) 
      hydromorphone ER) in opioid-naive and opioid-tolerant patients with chronic 
      cancer or noncancer pain. DESIGN: Safety results were pooled from 13 controlled 
      and uncontrolled clinical studies, with varying approaches to dosing and 
      titration, pain etiology, and duration of exposure. PATIENTS AND INTERVENTIONS: 
      Of the 3,075 patients in the pooled population, 2,335 (76 percent) received at 
      least one dose of OROS hydromorphone ER, with a duration of dosing of up to 1.5 
      years; 420 patients were treated for at least 6 months and 141 for longer than 1 
      year. MAIN OUTCOME MEASURES: The primary outcome measure was the occurrence of 
      adverse events (AEs). Descriptive statistics were used to analyze the incidence 
      of AEs in the overall population as well as according to baseline 
      characteristics. RESULTS: Overall AE incidence with OROS hydromorphone ER 
      treatment was 80.5 percent (1,880/2,335 patients). The most common 
      treatment-related AEs were constipation (28.9 percent, 674 patients) and nausea 
      (22.7 percent, 529 patients), and most cases were mild to moderate in severity. 
      The incidence of overall AEs did not undergo a notable change over time. 
      Opioid-related AEs were higher in patients >/=65 years of age, female patients, and 
      opioid-naive patients. Serious adverse events (SAEs) were reported by 10.2 
      percent (239) of patients. A total of 64 deaths occurred, none of which were 
      considered related to OROS hydromorphone ER treatment. CONCLUSIONS: OROS 
      hydromorphone was generally well tolerated in short- and long-term studies and 
      demonstrated a consistent AE profile over time.
FAU - Hale, Martin E
AU  - Hale ME
AD  - Gold Coast Research, LLC, Weston, FL, USA.
FAU - Wallace, Mark S
AU  - Wallace MS
FAU - Taylor, Donald R
AU  - Taylor DR
FAU - Kutch, Michael
AU  - Kutch M
FAU - Nalamachu, Srinivas
AU  - Nalamachu S
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - Q812464R06 (Hydromorphone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*adverse effects
MH  - Chronic Pain/*drug therapy
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - Hydromorphone/administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
EDAT- 2012/12/19 06:00
MHDA- 2013/04/24 06:00
CRDT- 2012/12/19 06:00
PHST- 2011/06/20 00:00 [received]
PHST- 2011/07/12 00:00 [revised]
PHST- 2012/04/02 00:00 [accepted]
PHST- 2012/12/19 06:00 [entrez]
PHST- 2012/12/19 06:00 [pubmed]
PHST- 2013/04/24 06:00 [medline]
AID - jom.2012.0130 [pii]
AID - 10.5055/jom.2012.0130 [doi]
PST - ppublish
SO  - J Opioid Manag. 2012 Sep-Oct;8(5):299-314. doi: 10.5055/jom.2012.0130.