Preliminary results with Sandostatin nasal powder in acromegalic patients.
This report details the first half of a double-blind, crossover sequence (Latin square) study of local and hormonal effects of nasally insufflated Sandostatin compared with those of subcutaneously injected Sandostatin. Nine of the planned 16 patients have been studied. They received a single application of 0.5, 1.0, and 2.0 mg Sandostatin as nasal powder and 0.1 mg by subcutaneous (SC) injection. The results indicate that absorption from the nasal epithelium occurs after approximately 10 minutes and comprises approximately 20% of the dose administered. This indicates that peak serum Sandostatin values occur very rapidly, ie, 10 minutes after application. After approximately 2 hours, the serum disappearance rates are similar to those obtained after SC injection. The suppressive effect on serum growth hormone (GH) levels is equal with the two forms of application and suggests that future clinical treatment with an intranasal application of 0.5 mg thrice daily is feasible. No side effects were noted apart from an immediate swelling of nasal mucosa, which receded gradually over the following 2 hours. This was either unnoticed or considered insignificant by the patients and will probably be deemed harmless by the rhinologist in eventual long-term clinical trials.
Harris
A G
AG
Division of Clinical Pharmacology, Cedars-Sinai Medical Center/University of California Los Angeles School of Medicine 90048.
Weeke
J
J
Christensen
S E
SE
Kaal
A
A
Illum
P
P
Orskov
H
H
D000042:Absorption; D000172:Acromegaly / Q000188:drug therapy*; D000281:Administration, Intranasal; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D013006:Growth Hormone / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D009297:Nasal Mucosa / Q000187:drug effects; D015282:Octreotide / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D011208:Powders; D011863:Radioimmunoassay
D011208:Powders; D013006:Growth Hormone; D015282:Octreotide