PMID- 23351618
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130412
LR  - 20220409
IS  - 1742-6405 (Print)
IS  - 1742-6405 (Electronic)
IS  - 1742-6405 (Linking)
VI  - 10
IP  - 1
DP  - 2013 Jan 28
TI  - NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated 
      distal sensory polyneuropathy: integrated analysis of two phase III, randomized, 
      controlled trials.
PG  - 5
LID - 10.1186/1742-6405-10-5 [doi]
AB  - BACKGROUND: HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most 
      frequently reported neurologic complication associated with HIV infection. 
      NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the 
      treatment of HIV-DSP. Data from two phase III, double-blind studies were 
      integrated to further analyze the efficacy and safety of NGX-4010 and explore the 
      effect of demographic and baseline factors on NGX-4010 treatment in HIV-DSP. 
      METHODS: Data from two similarly designed studies in which patients with HIV-DSP 
      received NGX-4010 or a low-concentration control patch (capsaicin 0.04% w/w) for 
      30 or 60 minutes were integrated. Efficacy assessments included the mean percent 
      change from baseline in Numeric Pain Rating Scale (NPRS) scores to Weeks 2-12. 
      Safety and tolerability assessments included adverse events (AEs) and pain during 
      and after treatment. RESULTS: Patients (n = 239) treated with NGX-4010 for 30 
      minutes demonstrated significantly (p = 0.0026) greater pain relief compared with 
      controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 
      2-12 was -27.0% versus -15.7%, respectively. Patients who received a 60-minute 
      application of NGX-4010 (n = 243) showed comparable pain reductions (-27.5%) to 
      patients treated for 30 minutes, but this was not statistically superior to 
      controls (n = 115). NGX-4010 was effective regardless of gender, baseline pain 
      score, duration of HIV-DSP, or use of concomitant neuropathic pain medication, 
      although NGX-4010 efficacy was greater in patients not receiving concomitant 
      neuropathic pain medications. NGX-4010 was well tolerated; the most common AEs 
      were application-site pain and erythema, and most AEs were mild to moderate. The 
      transient increase in pain associated with NGX-4010 treatment decreased the day 
      after treatment and returned to baseline by Day 2. CONCLUSIONS: A single 
      30-minute application of NGX-4010 provides significant pain relief for at least 
      12 weeks in patients with HIV-DSP and is well tolerated. TRIAL REGISTRATION: C107 
      = NCT00064623; C119 = NCT00321672.
FAU - Brown, Stephen
AU  - Brown S
AD  - AIDS Research Alliance, Los Angeles, CA, USA. s.brown@aidsresearch.org.
FAU - Simpson, David M
AU  - Simpson DM
FAU - Moyle, Graeme
AU  - Moyle G
FAU - Brew, Bruce J
AU  - Brew BJ
FAU - Schifitto, Giovanni
AU  - Schifitto G
FAU - Larbalestier, Nicholas
AU  - Larbalestier N
FAU - Orkin, Chloe
AU  - Orkin C
FAU - Fisher, Martin
AU  - Fisher M
FAU - Vanhove, Geertrui F
AU  - Vanhove GF
FAU - Tobias, Jeffrey K
AU  - Tobias JK
LA  - eng
SI  - ClinicalTrials.gov/NCT00064623
SI  - ClinicalTrials.gov/NCT00321672
GR  - UL1 RR024160/RR/NCRR NIH HHS/United States
PT  - Journal Article
DEP - 20130128
PL  - England
TA  - AIDS Res Ther
JT  - AIDS research and therapy
JID - 101237921
PMC - PMC3610248
EDAT- 2013/01/29 06:00
MHDA- 2013/01/29 06:01
PMCR- 2013/01/28
CRDT- 2013/01/29 06:00
PHST- 2012/10/31 00:00 [received]
PHST- 2013/01/17 00:00 [accepted]
PHST- 2013/01/29 06:00 [entrez]
PHST- 2013/01/29 06:00 [pubmed]
PHST- 2013/01/29 06:01 [medline]
PHST- 2013/01/28 00:00 [pmc-release]
AID - 1742-6405-10-5 [pii]
AID - 10.1186/1742-6405-10-5 [doi]
PST - epublish
SO  - AIDS Res Ther. 2013 Jan 28;10(1):5. doi: 10.1186/1742-6405-10-5.