PMID- 28967801
OWN - NLM
STAT- MEDLINE
DCOM- 20171127
LR  - 20171128
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 129
IP  - 8
DP  - 2017 Nov
TI  - Dose-response of pregabalin for diabetic peripheral neuropathy, postherpetic 
      neuralgia, and fibromyalgia.
PG  - 921-933
LID - 10.1080/00325481.2017.1384691 [doi]
AB  - OBJECTIVES: The pregabalin dose-response for pain, Patient Global Impression of 
      Change (PGIC), and sleep quality measures in painful diabetic peripheral 
      neuropathy (pDPN), postherpetic neuralgia (PHN), and fibromyalgia (FM) is 
      relevant for physicians treating these patients. This analysis aimed to 
      demonstrate the dose-response of pregabalin for each indication and describe the 
      onset (incidence), onset/continuation (prevalence), and resolution of adverse 
      events (AEs) occurring during treatment. METHODS: Data from 14 
      placebo-controlled, fixed-dose pregabalin trials in pDPN, PHN, and FM were pooled 
      within each indication. Patients had mean baseline pain scores >/=6 on an 11-point 
      numeric rating scale. A hyperbolic E(max) dose-response model examined the 
      dose-response of pregabalin for pain, PGIC, and sleep quality. Safety assessments 
      included onset and prevalence of common AEs each week, and resolution in the 
      first 2 months of treatment. RESULTS: In all indications, the likelihood of 
      patients experiencing pain relief and improvements in PGIC and sleep quality 
      increased in a dose-dependent manner with increasing doses. In all indications, 
      new incidences of dizziness and somnolence were highest after 1 week of 
      treatment, with few subsequent new reports at a given dose. Prevalence rates 
      decreased steadily after 1 week of treatment. In FM, new onset weight gain 
      emerged 6-8 weeks following treatment; prevalence rates generally increased then 
      remained steady over time. With the exception of weight gain, many AEs resolved 
      in month 1. CONCLUSION: The dose-response of pregabalin for pain, PGIC, and sleep 
      quality was demonstrated, highlighting the benefit of achieving the maximum 
      recommended dose of 300 mg/day for pDPN, 300-600 mg/day for PHN, and 
      300-450 mg/day for FM. Common AEs are generally seen within 1 week of starting 
      treatment, with few subsequent new reports at a given dose. New onset weight gain 
      occurs after 6 weeks of treatment, reinforcing the need for regular monitoring of 
      weight.
FAU - Arnold, Lesley M
AU  - Arnold LM
AD  - a Department of Psychiatry and Behavioral Neuroscience, Women's Health Research 
      Program , University of Cincinnati College of Medicine , Cincinnati , OH , USA.
FAU - McCarberg, Bill H
AU  - McCarberg BH
AD  - b Department of Family Medicine , University of California at San Diego School of 
      Medicine , San Diego , CA , USA.
FAU - Clair, Andrew G
AU  - Clair AG
AD  - c US Medical Affairs , Pfizer , New York , NY , USA.
FAU - Whalen, Ed
AU  - Whalen E
AD  - d Statistics , Pfizer , New York , NY , USA.
FAU - Thomas, Neal
AU  - Thomas N
AD  - e Statistics , Pfizer , Groton , CT , USA.
FAU - Jorga, Anamaria
AU  - Jorga A
AD  - c US Medical Affairs , Pfizer , New York , NY , USA.
FAU - Pauer, Lynne
AU  - Pauer L
AD  - f Global Product Development - Clinical Sciences & Operations , Pfizer , Groton , 
      CT , USA.
FAU - Vissing, Richard
AU  - Vissing R
AD  - g Neuroscience and Pain Division , Pfizer Inc , Louisville , KY , USA.
FAU - Park, Peter W
AU  - Park PW
AD  - h North America Medical Affairs , Pfizer Inc , New York , NY , USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20171016
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics/administration & dosage/*therapeutic use
MH  - Diabetic Neuropathies/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Fibromyalgia/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Pregabalin/administration & dosage/adverse effects/*therapeutic use
MH  - Sleep/drug effects
MH  - Young Adult
OTO - NOTNLM
OT  - Pregabalin
OT  - diabetic peripheral neuropathy
OT  - dose-response
OT  - fibromyalgia
OT  - postherpetic neuralgia
EDAT- 2017/10/03 06:00
MHDA- 2017/11/29 06:00
CRDT- 2017/10/03 06:00
PHST- 2017/10/03 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2017/10/03 06:00 [entrez]
AID - 10.1080/00325481.2017.1384691 [doi]
PST - ppublish
SO  - Postgrad Med. 2017 Nov;129(8):921-933. doi: 10.1080/00325481.2017.1384691. Epub 
      2017 Oct 16.