Continuous intravenous dosing with ciprostene using a portable pump in ambulatory patients.

Abstract

Parenteral compounds present special drug delivery challenges. This open-label study evaluated a portable infusion pump as a means to deliver intravenous ciprostene, a stable prostacyclin analog. Ten patients with peripheral vascular disease and claudication received ciprostene (titrated to 120 ng/kg/min) infused over 8 hours 1 day per week for 4 consecutive weeks. Patients successfully maintained the pump strapped to the waist. The mean +/- standard deviation delivery error, with volumes of 6 to 10 mL over 8 hours, was -0.895 +/- 3.177%. Accordingly, the pump performed well with a potent drug under these clinical conditions. Headache, flushing, and infusion site irritation during infusion were the most frequent side effects. Blood pressure remained unchanged during infusion; however, heart rate increased significantly (P < .05, maximum increase was 13.9 +/- 2.1 beats per minute [mean +/- standard error of the mean]. Mean (+/- standard error of the mean) relative claudication times on treadmill remained unchanged; however, absolute claudication times increased (P < .05) from 6.6 +/- 1.8 to 10.0 +/- 2.2 minutes. Ciprostene inhibited adenosine diphosphate-induced platelet aggregation by 56.0 +/- 12.7% (mean +/- standard error of the mean). Mean template bleeding times and plasma concentrations of platelet-specific proteins (beta-thromboglobulin, platelet factor 4) did not change.

• Authors: D L Wolf, C M Metzler, M O Froeschke, J R Luderer
• Journal: Journal of clinical pharmacology (J Clin Pharmacol) Vol. 33 Issue 2 Pg. 150-3 (Feb 1993) ISSN: 0091-2700 [Print] England
• PMID: 8440764 (Publication Type: Journal Article)

Chemical References

• Epoprostenol
• ciprostene

Topics

• Adult
• Aged
• Blood Pressure (drug effects)
• Epoprostenol (administration & dosage, analogs & derivatives, therapeutic use)
• Exercise Test
• Female
• Heart Rate (drug effects)
• Humans
• Infusion Pumps
• Infusions, Intravenous
• Intermittent Claudication (drug therapy)
• Male
• Middle Aged
• Outpatients
• Peripheral Vascular Diseases (drug therapy)
• Platelet Aggregation (drug effects)