Continuous intravenous dosing with ciprostene using a portable pump in ambulatory patients.
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.
Wolf
D L
DL
Upjohn Research Clinics, Bronson Methodist Hospital, Kalamazoo, Michigan.
Metzler
C M
CM
Froeschke
M O
MO
Luderer
J R
JR
D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D011464:Epoprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005080:Exercise Test; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007260:Infusion Pumps; D007262:Infusions, Intravenous; D007383:Intermittent Claudication / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D016491:Peripheral Vascular Diseases / Q000188:drug therapy; D010974:Platelet Aggregation / Q000187:drug effects
D011464:Epoprostenol; C045329:ciprostene