PMID- 10565590
OWN - NLM
STAT- MEDLINE
DCOM- 19991126
LR  - 20190813
IS  - 0013-9580 (Print)
IS  - 0013-9580 (Linking)
VI  - 40
IP  - 11
DP  - 1999 Nov
TI  - An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes 
      of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. 
      North American Diastat Group.
PG  - 1610-7
AB  - PURPOSE: To assess safety of diazepam rectal gel (DZPRG) for control of acute 
      seizures in epilepsy patients and to evaluate tolerance with repeated use of 
      DZPRG at intervals of > or =5 days. METHODS: Subjects were persons with epilepsy, 
      age 2 years or older, with seizure clusters or prolonged seizures. Onset of a 
      treatable episode was defined; caregivers were trained to administer DZPRG and to 
      monitor respiration, seizures, and adverse effects (AEs). DZPRG was dispensed in 
      a single-use, prefilled syringe; dosage was determined by age and weight. Maximal 
      use was > or =5-day intervals, < or =5 times/month. After use, caregivers 
      returned data booklets and syringe. Caregivers and physicians completed global 
      ratings yearly. RESULTS: In 149 subjects treated, 77% of 1,578 administrations 
      resulted in seizure freedom for the next 12 h. One hundred twenty-five received 
      two or more treatments (two to 78; median, 8), 0.03-4.3/month (median, 0.4). To 
      evaluate tolerance, subjects with two or more episodes were divided into low (two 
      to seven episodes) and high use (eight to 78 episodes treated). There was no 
      difference in proportion seizure free 12 h after the first administration versus 
      last administration, for either infrequent or frequent administration. Sedation 
      occurred in 17%, attributed to DZPRG in 9%. No respiratory depression was 
      attributable to DZPRG. Three subjects withdrew because of AEs attributable to 
      (agitation) or possibly attributable to DZPRG (chest pain, rash). Five subjects 
      withdrew because of AEs unrelated to DZPRG. Caregiver and physician global 
      ratings were highly positive at both 12 and 24 months. CONCLUSIONS: DZPRG is safe 
      and effective in children and adults with epilepsy with breakthrough seizures. 
      Neither tolerance nor significant medication-related AEs were seen with repeated 
      DZPRG administration at intervals > or =5 days.
FAU - Mitchell, W G
AU  - Mitchell WG
AD  - Children's Hospital Los Angeles and University of Southern California School of 
      Medicine 90027, USA. wmitchell@chla.usc.edu
FAU - Conry, J A
AU  - Conry JA
FAU - Crumrine, P K
AU  - Crumrine PK
FAU - Kriel, R L
AU  - Kriel RL
FAU - Cereghino, J J
AU  - Cereghino JJ
FAU - Groves, L
AU  - Groves L
FAU - Rosenfeld, W E
AU  - Rosenfeld WE
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Gels)
RN  - 0 (Suppositories)
RN  - Q3JTX2Q7TU (Diazepam)
SB  - IM
MH  - Administration, Rectal
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Anticonvulsants/*administration & dosage/adverse effects/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Diazepam/*administration & dosage/adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Epilepsy/*drug therapy
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Suppositories
MH  - Treatment Outcome
EDAT- 1999/11/24 00:00
MHDA- 1999/11/24 00:01
CRDT- 1999/11/24 00:00
PHST- 1999/11/24 00:00 [pubmed]
PHST- 1999/11/24 00:01 [medline]
PHST- 1999/11/24 00:00 [entrez]
AID - 10.1111/j.1528-1157.1999.tb02047.x [doi]
PST - ppublish
SO  - Epilepsia. 1999 Nov;40(11):1610-7. doi: 10.1111/j.1528-1157.1999.tb02047.x.