Drug Evaluation

Publication Title: 
Investigational New Drugs

In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients.

Daugherty, C. K.
Publication Title: 
Journal of the American Geriatrics Society

We examined the proxy decision-making and informed consent processes for clinical research involving 49 patient-subjects with dementia in an outpatient setting by performing serial in-depth, structured, open-ended telephone interviews. Interviews were tape recorded and transcribed. Transcripts were then coded and analyzed.

Sugarman, J.
Cain, C.
Wallace, R.
Welsh-Bohmer, K. A.
Publication Title: 
Anaesthesia, Resuscitation, and Intensive Therapy

Flunitrazepam, a derivative of benzodiazepine was used for induction and maintenance of anaesthesia in 933 patients. The induction dose was from 1,786 to 2,053 mg. The total dose of 2-2.66 mg was sufficient for maintenance of hypnosis for about 2 hours. The undesirable side effects were very rare. The average time of hypnosis after a single dose of flunitrazepam was 50.1 sec. The sedative action of the drug lasted for some time after regaining of consciousness. In most patients there was no need for administration of analgetics during first 24 hours after the operation.

Rizzi, R.
Butera, G.
Lion, P.
Pesarin, F.
Publication Title: 
South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde

Etomidate (Hypnomidate; Janssen) 1,25% in sterile water was given rectally on 100 occasions to 50 male Long-Evans rats in doses ranging from 4 mg/kg to 12 mg/kg. The onset and duration of ataxia and hypnosis (i.e. loss of righting ability) were recorded. Ataxia was observed in all rats, even at the lowest dose levels. The lowest hypnotic dose was 6 mg/kg, when 2 out of 5 rats lost their righting ability. In all 50 rats given 8 mg/kg or more hypnosis occurred within 4 minutes (range 2-4 minutes, average 3,3 minutes), from which they recovered within an average of 10,4 minutes.

Linton, D. M.
Price, S. K.
Publication Title: 
South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde

Following the preliminary study in rats, etomidate (Hypnomidate; Janssen) 1,25% in sterile water (pH 3,5) was administered rectally to 40 children aged between 6 months and 5 years to induce general anaesthesia for scheduled minor surgical procedures. The doses given ranged from 3,0 mg/kg to 6,5 mg/kg. The time taken for hypnosis to occur and the incidence of muscle movements were recorded. Cardiovascular and respiratory parameters were monitored. Anaesthesia was maintained with nitrous oxide/oxygen and halothane as needed.

Linton, D. M.
Thornington, R. E.
Publication Title: 
Revista Española De Anestesiología Y Reanimación

In this prospective study, 20 patients undergoing mean duration (2-3 h) neurosurgical operations on fossa cranii posterior, and cervical and dorsolumbar rachis, were induced with 0.3 mg/kg etomidate bolus dose. To maintain anesthesia, etomidate perfusions at 10 micrograms/kg/min (group I) and 20 microg/kg/min (group II) were administered. Fentanyl at fractionated doses was used as analgesic without association to nitrous oxide and relaxation was achieved with pancuronium bromide.

Fernández Galinski, S.
Barrera, E.
de Córdoba, J. L.
Covas, M. I.
Esquerdá, A.
Espinosa, W.
Publication Title: 
Bulletin of the World Health Organization

Despite the urgent need of a new antimalarial drugs, particularly those against multiresistant falciparum malaria, only a limited number of drugs are now at an advanced stage of preclinical or clinical development. They include artemisinin derivatives, pyronaridine and benflumetol (all originally developed in China), as well as new antifolate combinations, the hydroxynaphoquinone atovaquone which has a novel mode of action, and a new 8-aminoquinoline which appears more active and less toxic than primaquine. Some of these drugs may become available in the next few years.

Olliaro, P. L.
Trigg, P. I.
Publication Title: 
Tropical medicine & international health: TM & IH

Intramuscular artemether given for five days was evaluated prospectively in 32 patients with acute recrudescent Plasmodium falciparum malaria. All patients had experienced one or more treatment failures with one or more courses of the following drugs: chloroquine, amodiaquine, sulphadoxine-pyrimethamine and erythromycin given alone or in combination. There was a prompt response to treatment with fever and parasite clearance times of 10.7 (3.6) h (range 6-24) and 32.3 (8.3) h (range 24-48) respectively. Parasite reduction at 24 h was 93.2 (7.8)% (range 75-100).

Sowunmi, A.
Odulola, A. M.
Publication Title: 
British Journal of Clinical Pharmacology

AIMS: To assess the haemodynamic, electrocardiographic and glycaemic effects of piperaquine-dihydroartemisinin (Artekin) fixed combination therapy in uncomplicated malaria. METHODS: Sixty-two Cambodians (32 children and 30 adults) with falciparum or vivax malaria were given Artekin given as four age-based oral doses over 32 h. Supine and erect blood pressure, the electrocardiographic QT interval and plasma glucose were measured before treatment and then at regular intervals during a 4-day admission period as part of efficacy and safety monitoring.

Karunajeewa, Harin
Lim, Chiv
Hung, Te-Yu
Ilett, Kenneth F.
Denis, Mey Bouth
Socheat, Doung
Davis, Timothy M. E.
Publication Title: 
Antimicrobial Agents and Chemotherapy

Azithromycin when used in combination with faster-acting antimalarials has proven efficacious in treating Plasmodium falciparum malaria in phase 2 clinical trials. The aim of this study was to establish optimal combination ratios for azithromycin in combination with either dihydroartemisinin or quinine, to determine the clinical correlates of in vitro drug sensitivity for these compounds, and to assess the cross-sensitivity patterns. Seventy-three fresh P.

Noedl, Harald
Krudsood, Srivicha
Leowattana, Wattana
Tangpukdee, Noppadon
Thanachartwet, Wipa
Looareesuwan, Sornchai
Miller, Robert Scott
Fukuda, Mark
Jongsakul, Krisada
Yingyuen, Kritsanai
Sriwichai, Sabaithip
Ohrt, Colin
Knirsch, Charles


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