PMID- 24944376
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140619
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 64
IP  - 5
DP  - 2003 May
TI  - Efficacy and tolerability of conventional nimesulide versus Beta-cyclodextrin 
      nimesulide in patients with pain after surgical dental extraction: a multicenter, 
      prospective, randomized, double-blind, double-dummy study.
PG  - 279-89
LID - 10.1016/S0011-393X(03)00087-0 [doi]
AB  - BACKGROUND: Pain following extraction of an impacted third molar is widely used 
      to assess analgesic efficacy, especially that of a single dose of a drug. The 
      analgesic activity of conventional nimesulide (CN) has been documented in a 
      variety of types of acute and chronic pain. Beta-cyclodextrin nimesulide (BN) is 
      a new formulation in which nimesulide is included in a cyclodextrin molecule, 
      which increases its solubility in water and its dilution rate, allowing extended, 
      rapid absorption of the drug. OBJECTIVE: The aim of this study was to assess the 
      efficacy and tolerability of a single dose of BN compared with CN in patients 
      with pain following extraction of an impacted third molar. METHODS: This was a 
      prospective, randomized, double-blind, double-dummy study conducted at 3 
      dentistry centers in Venezuela. The patients were randomized to 1 of 2 groups. 
      One group received a single dose of BN (400-mg tablet, equivalent to 100 mg of 
      nimesulide); the other group received a single dose of CN (100-mg tablet). Both 
      groups also received a placebo. The efficacy variables were (1) pain intensity 
      (PI), assessed on a visual analog scale (VAS) at the following times: 0, 5, 10, 
      15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, and 12 hours after drug 
      administration; (2) time to first measurable difference in PI from baseline (PID) 
      (PID >/=1 cm on the VAS; ie, the beginning of analgesic action); (3) maximum PID 
      (max PID); (4) sum of PIDs in the 12-hour observation period; (5) pain relief 
      (PR), as rated on a 5-point scale; (6) maximum PR; and (7) sum of the PR scores 
      in the 12-hour observation period (ie, total PR). For the tolerability analysis, 
      all adverse events (AEs) were to be recorded, and the investigators were to 
      assess whether each AE was drug related. RESULTS: Seventy-two patients were 
      enrolled in the study. Of these, 62 patients (40 women, 22 men; mean [SD] age, 
      20.1 [5.9] years) were assessed; 35 were treated with BN and 27 with CN. PI 
      reduction was more rapid and greater in the BN group. The first measurable change 
      in PI (PID >/=1 on the VAS) was reached within 5 minutes by 39% and 15% of the 
      patients in the BN and CN groups, respectively, and within 10 minutes by 52% and 
      30% of the patients in the BN and CN groups, respectively. The max PID was 
      reached <1 hour in 32% and 15% of patients in the BN and CN groups, respectively. 
      No AEs were reported. CONCLUSIONS: In this study population, both BN and CN were 
      similarly effective in relieving pain after extraction of an impacted third 
      molar, and both drugs were well tolerated. PI changes were statistically 
      significantly more rapid and greater with BN than CN.
FAU - Bocanegra, Mildred
AU  - Bocanegra M
AD  - Natera Guarapo Dental Group, Caracas, Venezuela.
FAU - Seijas, Alberto
AU  - Seijas A
AD  - Policlinical Institute, Caracas, Venezuela, and.
FAU - Yibirin, Maria Gonzalez
AU  - Yibirin MG
AD  - Leti Laboratories S.A.V., Guarenas, Venezuela.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC4053005
OTO - NOTNLM
OT  - beta-cyclodextrin nimesulide
OT  - dental pain
EDAT- 2003/05/01 00:00
MHDA- 2003/05/01 00:01
PMCR- 2003/05/01
CRDT- 2014/06/20 06:00
PHST- 2003/03/25 00:00 [accepted]
PHST- 2014/06/20 06:00 [entrez]
PHST- 2003/05/01 00:00 [pubmed]
PHST- 2003/05/01 00:01 [medline]
PHST- 2003/05/01 00:00 [pmc-release]
AID - S0011-393X(03)00087-0 [pii]
AID - 10.1016/S0011-393X(03)00087-0 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2003 May;64(5):279-89. doi: 
      10.1016/S0011-393X(03)00087-0.