PMID- 27929709
OWN - NLM
STAT- MEDLINE
DCOM- 20170206
LR  - 20220321
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 129
IP  - 1
DP  - 2017 Jan
TI  - Safety of buprenorphine transdermal system in the management of pain in older 
      adults.
PG  - 92-101
LID - 10.1080/00325481.2017.1270699 [doi]
AB  - OBJECTIVES: To evaluate whether buprenorphine transdermal system (BTDS; Butrans(R)) 
      is an option for the treatment of chronic pain in older adults. METHODS: This 
      retrospective analysis of 16 placebo- and active-controlled and uncontrolled 
      studies (N = 6566) evaluated the safety and tolerability profile in patients 
      exposed to BTDS and compared the safety profiles associated with BTDS treatment 
      in older patients >/= 65 years of age (65 to 98 years) and younger patients < 
      65 years of age (18 to 64 years). Safety analyses included adverse events (AEs), 
      laboratory values, and electrocardiograms. RESULTS: Overall, the incidence of AEs 
      was similar in the >/= 65 year patient cohort (N = 1715) and the < 65 year patient 
      cohort (N = 4843) (63.8% and 61.0%, respectively). The older patient cohort 
      experienced more constipation, peripheral edema, and urinary tract infection, but 
      fewer application-site AEs (eg, erythema, irritation, pruritus, rash) and 
      headaches. A statistically significant treatment-by-age interaction was observed 
      for fall, arthralgia, and localized and non-application site-related rash, 
      suggesting a differential increase in the risk of these events among older 
      patients treated with BTDS that cannot be explained by age or treatment alone. A 
      similar trend was observed for accidents and injuries, and for falls, in patients 
      treated with both BTDS and active controls (oxycodone/acetaminophen [OXY/APAP] 
      and hydrocodone/acetaminophen [HCD/APAP]), suggesting an opioid class effect. 
      However, due to small sample sizes of the active control groups, a statistical 
      test of treatment-by-age interaction could not be conducted for the active 
      controls. The incidences of serious AEs and of clinically significant increases 
      in liver enzymes, such as AST, ALT and bilirubin were small, regardless of age. 
      CONCLUSION: BTDS appears to be a viable option for the management of pain in 
      older adults, but the benefits need to be tempered by potential risks among older 
      adults.
FAU - Pergolizzi, Joseph V
AU  - Pergolizzi JV
AD  - a Naples Anesthesia and Pain Associates , Naples , FL , USA.
AD  - b NEMA Research Inc ., Naples , FL , USA.
FAU - Raffa, Robert B
AU  - Raffa RB
AD  - c Department of Pharmaceutical Sciences , Temple University School of Pharmacy , 
      Philadelphia , PA , USA.
AD  - d Department of Pharmacology and Toxicology , University of Arizona College of 
      Pharmacy , Tucson , AZ , USA.
FAU - Marcum, Zachary
AU  - Marcum Z
AD  - e School of Pharmacy , University of Washington , Seattle , WA , USA.
FAU - Colucci, Salvatore
AU  - Colucci S
AD  - f Purdue Pharma L.P. , One Stamford Forum , Stamford , CT , USA.
FAU - Ripa, Steven R
AU  - Ripa SR
AD  - f Purdue Pharma L.P. , One Stamford Forum , Stamford , CT , USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20161226
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Analgesics, Opioid)
RN  - 40D3SCR4GZ (Buprenorphine)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*therapeutic use
MH  - Buprenorphine/*adverse effects/*therapeutic use
MH  - Chronic Pain/*drug therapy
MH  - Cohort Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Young Adult
OTO - NOTNLM
OT  - 7-day transdermal formulation
OT  - BTDS
OT  - Buprenorphine
OT  - controlled and uncontrolled trials
OT  - elderly
OT  - geriatric pain medicine
OT  - opioid
OT  - pain management in older adults
EDAT- 2016/12/09 06:00
MHDA- 2017/02/07 06:00
CRDT- 2016/12/09 06:00
PHST- 2016/12/09 06:00 [pubmed]
PHST- 2017/02/07 06:00 [medline]
PHST- 2016/12/09 06:00 [entrez]
AID - 10.1080/00325481.2017.1270699 [doi]
PST - ppublish
SO  - Postgrad Med. 2017 Jan;129(1):92-101. doi: 10.1080/00325481.2017.1270699. Epub 
      2016 Dec 26.