PMID- 30214820
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 2055-0294 (Print)
IS  - 2055-0294 (Electronic)
IS  - 2055-0294 (Linking)
VI  - 4
DP  - 2018
TI  - Safety profile of prophylactic rescue dosing of immediate-release oral opioids in 
      cancer patients.
PG  - 25
LID - 10.1186/s40780-018-0121-3 [doi]
LID - 25
AB  - BACKGROUND: Appropriate prophylactic rescue dosing of opioids is considered 
      effective for cancer pain relief, but no study has reported the safety of such 
      prophylactic rescue. We compared the safety of prophylactic rescue dosing of 
      immediate-release oral opioids with that of regular rescue dosing. METHODS: The 
      study included 103 cancer patients who used either immediate-release morphine 
      syrup or immediate-release oxycodone powder at Shizuoka Cancer Center between 
      January and December 2016. Patients were divided into those who mostly used 
      (prophylactic group) and those who never used (regular group) prophylactic rescue 
      doses of opioids and compared the incidence of adverse events (AEs). We also 
      investigated whether the prophylactic rescue dose negatively interfered with its 
      objective activity, such as meals. RESULTS: Incidence of each AE in the 
      prophylactic versus regular groups was as follows: somnolence, 20.6% versus 
      14.3%; nausea, 22.1% versus 17.1%; constipation, 19.1% versus 20.0%; urinary 
      retention, 1.5% versus 2.9%; delirium, 4.4% versus 8.6%; and pruritus, 0% versus 
      2.9%. No serious AE associated with prophylactic rescue dosing was observed. No 
      significant difference was observed in the incidence of any AE between the two 
      groups (p > 0.05, Fisher's exact test). No AE interfered with the objective 
      activity of the prophylactic rescue dose. CONCLUSION: Incidence of AEs associated 
      with prophylactic rescue dosing is not different from that associated with 
      regular rescue dosing. In addition, the prophylactic rescue dose did not 
      adversely affect its objective activity, suggesting the safety of appropriate 
      prophylactic rescue dosing was similar to that of regular rescue dosing. TRIAL 
      REGISTRATION: The study approval number in the institution; H29-J30-29-1-3. 
      Registered June 5, 2017.
FAU - Tanaka, Rei
AU  - Tanaka R
AUID- ORCID: 0000-0001-7309-7374
AD  - 1Department of Pharmacy, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
FAU - Ishikawa, Hiroshi
AU  - Ishikawa H
AD  - 1Department of Pharmacy, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
FAU - Sato, Tetsu
AU  - Sato T
AD  - 1Department of Pharmacy, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
FAU - Shino, Michihiro
AU  - Shino M
AD  - 1Department of Pharmacy, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
FAU - Omae, Katsuhiro
AU  - Omae K
AD  - 2Clinical Research Promotion Unit of Clinical Research Center, Shizuoka Cancer 
      Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 
      Japan. ISNI: 0000 0004 1774 9501. GRID: grid.415797.9
FAU - Sato, Tetsumi
AU  - Sato T
AD  - 3Department of Palliative Medicine, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
FAU - Osaka, Iwao
AU  - Osaka I
AD  - 3Department of Palliative Medicine, Shizuoka Cancer Center, 1007 Shimonagakubo, 
      Nagaizumi-cho, Sunto-gun, Shizuoka-ken, 411-8777 Japan. ISNI: 0000 0004 1774 
      9501. GRID: grid.415797.9
LA  - eng
PT  - Journal Article
DEP - 20180910
PL  - England
TA  - J Pharm Health Care Sci
JT  - Journal of pharmaceutical health care and sciences
JID - 101672177
PMC - PMC6130058
OTO - NOTNLM
OT  - Immediate-release opioid
OT  - Morphine
OT  - Opioid
OT  - Oxycodone
OT  - Prophylactic rescue
OT  - Rescue dose
COIS- RT, RPh. Ph.D.: Pharmacist at Shizuoka Cancer Center; HI, RPh.: Pharmacist at 
      Shizuoka Cancer Center; TS, RPh.: Pharmacist at Shizuoka Cancer Center; MS, RPh.: 
      Pharmacist at Shizuoka Cancer Center; KO.: Statistician at Shizuoka Cancer 
      Center; TS, M.D. Ph.D.: Doctor at Shizuoka Cancer Center; IO, M.D.: Doctor at 
      Shizuoka Cancer Center.This study was conducted with the approval of Shizuoka 
      Cancer Center Ethical Review Board (approval number: H29-J30-29-1-3). 
      https://www.scchr.jp/clinicaltrial/wp-content/uploads/sites/13/2016/11/keizi29-6-13.pdfNot 
      applicable.All of authors declare that they have no competing interests.Springer 
      Nature remains neutral with regard to jurisdictional claims in published maps and 
      institutional affiliations.
EDAT- 2018/09/15 06:00
MHDA- 2018/09/15 06:01
PMCR- 2018/09/10
CRDT- 2018/09/15 06:00
PHST- 2018/01/30 00:00 [received]
PHST- 2018/07/26 00:00 [accepted]
PHST- 2018/09/15 06:00 [entrez]
PHST- 2018/09/15 06:00 [pubmed]
PHST- 2018/09/15 06:01 [medline]
PHST- 2018/09/10 00:00 [pmc-release]
AID - 121 [pii]
AID - 10.1186/s40780-018-0121-3 [doi]
PST - epublish
SO  - J Pharm Health Care Sci. 2018 Sep 10;4:25. doi: 10.1186/s40780-018-0121-3. 
      eCollection 2018.