PMID- 24944400
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140619
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 64
IP  - 8
DP  - 2003 Sep
TI  - Intravenous lysine clonixinate for the acute treatment of severe migraine 
      attacks: a double-blind, randomized, placebo-controlled study.
PG  - 505-13
LID - 10.1016/j.curtheres.2003.08.008 [doi]
AB  - BACKGROUND: Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown 
      to be effective in the treatment of migraine. However, few commercially available 
      NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from 
      nicotinic acid, has been proved effective in various algesic syndromes (eg, renal 
      colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC 
      has been shown to be effective in the treatment of migraine of moderate severity. 
      OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of 
      the IV formulation of LC in the treatment of severe migraine. METHODS: This 
      double-blind, randomized, placebo-controlled, prospective study enrolled patients 
      with severe migraine (without aura) as defined by the criteria of the 
      International Headache Society. When patients presented to a neurology hospital 
      with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de 
      Janeiro, Brazil) with a severe migraine attack that had lasted <4 hours, they 
      were randomized to 1 of 2 groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 
      mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse 
      effects (AEs) were assessed before (0 minute) and 30, 60, and 90 minutes after 
      study drug administration. Rescue medication was available 2 hours after study 
      drug administration, and its use was compared between groups. RESULTS: Thirty-two 
      patients (23 women, 9 men; mean [SD] age, 32 [2] years; range, 18-58 years) 
      entered the study. Twenty-nine patients (21 women, 8 men; mean [SD] age, 32 [2] 
      years; range, 18-56 years) completed the study. Three patients (all in the 
      placebo group) did not complete the study (1 patient was unable to rate the pain 
      severity after drug administration and 2 patients refused IV drug 
      administration). Among study completers, 17 patients received LC and 12 placebo. 
      At 30 minutes, 1 patient (8.3%) in the placebo group and 5 patients (29.4%) in 
      the LC group were pain free; the between-group difference was not statistically 
      significant. At 60 and 90 minutes, respectively, 3 (25.0%) and 5 (41.7%) patients 
      in the placebo group and 12 (70.6%) and 14 (82.4%) patients in the LC group were 
      pain free (P = 0.021 and P = 0.028 between groups at 60 and 90 minutes, 
      respectively). Six patients (50.0%) in the placebo group and 1 patient (5.9%) in 
      the LC group required rescue medication at 2 hours (P = 0.010 between groups). 
      Three patients (25.0%) in the placebo group experienced AEs, including vomiting, 
      dizziness, and malaise (1 patient [8.3%] each); 11 patients (64.7%) in the LC 
      group experienced 1 AE, including burning pain at the injection site (5 patients 
      [29.4%]), heartburn (4 patients [23.5%]), and dizziness and malaise (1 patient 
      [5.9%] each) (P = 0.025). CONCLUSIONS: NSAIDs administered by the IV route cannot 
      be used routinely in an outpatient environment, although an attempt to improve 
      drugs in this class is clearly justified. This study demonstrated that IV LC was 
      effective and well tolerated in the treatment of severe migraine attacks. This 
      finding differs from results with the oral formulation, which is effective only 
      in migraine of moderate severity.
FAU - Krymchantowski, Abouch Valenty
AU  - Krymchantowski AV
AD  - Department of Neurology, Universidade Federal Fluminense, Instituto de Neurologia 
      Deolindo Couto, Headache Center of Rio de Janeiro, Rio de Janeiro, Brazil.
FAU - Silva, Marcus Tulius T
AU  - Silva MT
AD  - Department of Neurology, Universidade Federal Fluminense, Instituto de Neurologia 
      Deolindo Couto, Headache Center of Rio de Janeiro, Rio de Janeiro, Brazil.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC4053037
OTO - NOTNLM
OT  - acute treatment
OT  - lysine clonixinate
OT  - migraine
OT  - severe attacks
EDAT- 2003/09/01 00:00
MHDA- 2003/09/01 00:01
PMCR- 2003/09/01
CRDT- 2014/06/20 06:00
PHST- 2003/07/01 00:00 [accepted]
PHST- 2014/06/20 06:00 [entrez]
PHST- 2003/09/01 00:00 [pubmed]
PHST- 2003/09/01 00:01 [medline]
PHST- 2003/09/01 00:00 [pmc-release]
AID - S0011-393X(03)00154-1 [pii]
AID - 10.1016/j.curtheres.2003.08.008 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2003 Sep;64(8):505-13. doi: 
      10.1016/j.curtheres.2003.08.008.