Clinical effects of intravenous cetiedil, a candidate anti-sickling agent.
As part of a Phase I clinical trial, the clinical effects resulting from both single and multiple dose infusions of cetiedil, a candidate anti-sickling agent, were evaluated. Multiple doses of up to 0.45 mg/kg every six hours for four days were safe and well-tolerated in adult male volunteers. Most adverse reactions to cetiedil are related to its anticholinergic properties (dryness of mouth, blurred vision, spacy feelings, disorientation) or vasodilatory effects (light-headedness, vertigo, cold extremities); these side-effects were dose-related with regard to incidence, severity and duration. Moderate to slight reductions in systolic and diastolic blood pressure and pulse rate were statistically significant but no dose-related. There were no significant changes in respiratory rate, ECG, biochemical or haematological parameters. Adverse reactions were transient and required neither medical intervention nor discontinuance of infusions.
D000328:Adult; D000986:Antisickling Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001381:Azepines / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004341:Drug Evaluation; D006801:Humans; D008297:Male; D011674:Pulse / Q000187:drug effects; D011897:Random Allocation; D012119:Respiration / Q000187:drug effects
D000986:Antisickling Agents; D001381:Azepines; C006955:cetiedil