Innovative Trial Designs for Improving TB Drug Development.
Innovative trial designs for improving TB drug development.
Filed under: Drug and Alcohol Rehabilitation
J Infect Dis. 2012 Nov 21;
Dodd LE, Proschan MA
MPs are to investigate need for drug companies to share clinical trial data.
Filed under: Drug and Alcohol Rehabilitation
BMJ. 2012; 345: e7980
Iacobucci G
Modulation of Vigilance in the Primary Hypersomnias by Endogenous Enhancement of GABAA Receptors.
Filed under: Drug and Alcohol Rehabilitation
Sci Transl Med. 2012 Nov 21; 4(161): 161ra151
Rye DB, Bliwise DL, Parker K, Trotti LM, Saini P, Fairley J, Freeman A, Garcia PS, Owens MJ, Ritchie JC, Jenkins A
The biology underlying excessive daytime sleepiness (hypersomnolence) is incompletely understood. After excluding known causes of sleepiness in 32 hypersomnolent patients, we showed that, in the presence of 10 ?M ?-aminobutyric acid (GABA), cerebrospinal fluid (CSF) from these subjects stimulated GABA(A) receptor function in vitro by 84.0 ± 40.7% (SD) relative to the 35.8 ± 7.5% (SD) stimulation obtained with CSF from control subjects (Student’s t test, t = 6.47, P < 0.0001); CSF alone had no effect on GABA(A) signaling. The bioactive CSF component had a mass of 500 to 3000 daltons and was neutralized by trypsin. Enhancement was greater for ?2 subunit- versus ?1 subunit-containing GABA(A) receptors and negligible for ?4 subunit-containing ones. CSF samples from hypersomnolent patients also modestly enhanced benzodiazepine (BZD)-insensitive GABA(A) receptors and did not competitively displace BZDs from human brain tissue. Flumazenil-a drug that is generally believed to antagonize the sedative-hypnotic actions of BZDs only at the classical BZD-binding domain in GABA(A) receptors and to lack intrinsic activity-nevertheless reversed enhancement of GABA(A) signaling by hypersomnolent CSF in vitro. Furthermore, flumazenil normalized vigilance in seven hypersomnolent patients. We conclude that a naturally occurring substance in CSF augments inhibitory GABA signaling, thus revealing a new pathophysiology associated with excessive daytime sleepiness. HubMed – drug
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