PMID- 21054853
OWN - NLM
STAT- MEDLINE
DCOM- 20120221
LR  - 20220409
IS  - 1471-2296 (Electronic)
IS  - 1471-2296 (Linking)
VI  - 11
DP  - 2010 Nov 5
TI  - Evaluation of the safety and efficacy of pregabalin in older patients with 
      neuropathic pain: results from a pooled analysis of 11 clinical studies.
PG  - 85
LID - 10.1186/1471-2296-11-85 [doi]
AB  - BACKGROUND: Older patients are typically underrepresented in clinical trials of 
      medications for chronic pain. A post hoc analysis of multiple clinical studies of 
      pregabalin in patients with painful diabetic peripheral neuropathy (DPN) or 
      postherpetic neuralgia (PHN) was conducted to evaluate the efficacy and safety of 
      pregabalin in older patients. METHODS: Data from 11 double-blind, randomized, 
      placebo-controlled clinical studies of pregabalin in patients with DPN or PHN 
      were pooled. Efficacy outcomes included change in Daily Pain Rating Scale score, 
      >/=30% and >/=50% responders, and endpoint pain score </=3. Safety was based on adverse 
      events (AEs). Primary efficacy was analyzed by analysis of covariance with terms 
      for treatment, age category, protocol, baseline pain, and treatment-by-age 
      category interaction. RESULTS: 2516 patients (white, n = 2344 [93.2%]; men, n = 
      1347 [53.5%]; PHN, n = 1003 [39.9%]; pregabalin, n = 1595) were included in the 
      analysis. Patients were grouped by age: 18 to 64 years (n = 1236), 65 to 74 years 
      (n = 766), and >/=75 years (n = 514). Baseline mean pain and sleep interference 
      scores were comparable across treatment and age groups. Significant improvements 
      in endpoint mean pain were observed for all pregabalin dosages versus placebo in 
      all age groups (p </= 0.0009), except for the lowest dosage (150 mg/day) in the 
      youngest age group. Clinically meaningful pain relief, defined as >/=30% and >/=50% 
      pain response, was observed in all age groups. The most common AEs were 
      dizziness, somnolence, peripheral edema, asthenia, dry mouth, weight gain, and 
      infections. The relative risks for these AEs increased with pregabalin dose, but 
      did not appear related to older age or type of neuropathic pain. CONCLUSIONS: 
      Pregabalin (150-600 mg/day) significantly reduced pain in older patients (age >/=65 
      years) with neuropathic pain and improvements in pain were comparable to those 
      observed in younger patients. Titration of pregabalin to the lowest effective 
      dose should allow for effective pain relief while minimizing AEs in older 
      patients with neuropathic pain. Given the common use of polypharmacy in older 
      patients, the absence of known drug-drug interactions makes pregabalin an 
      important treatment option for older patients with pain of neuropathic origin.
FAU - Semel, David
AU  - Semel D
AD  - Pfizer Global Pharmaceuticals, New York, NY, USA. david.semel@pfizer.com
FAU - Murphy, T Kevin
AU  - Murphy TK
FAU - Zlateva, Gergana
AU  - Zlateva G
FAU - Cheung, Raymond
AU  - Cheung R
FAU - Emir, Birol
AU  - Emir B
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20101105
PL  - England
TA  - BMC Fam Pract
JT  - BMC family practice
JID - 100967792
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Analgesics/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia/*drug therapy
MH  - Pregabalin
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
PMC - PMC2988717
EDAT- 2010/11/09 06:00
MHDA- 2012/02/22 06:00
PMCR- 2010/11/05
CRDT- 2010/11/09 06:00
PHST- 2010/04/01 00:00 [received]
PHST- 2010/11/05 00:00 [accepted]
PHST- 2010/11/09 06:00 [entrez]
PHST- 2010/11/09 06:00 [pubmed]
PHST- 2012/02/22 06:00 [medline]
PHST- 2010/11/05 00:00 [pmc-release]
AID - 1471-2296-11-85 [pii]
AID - 10.1186/1471-2296-11-85 [doi]
PST - epublish
SO  - BMC Fam Pract. 2010 Nov 5;11:85. doi: 10.1186/1471-2296-11-85.