OCTREOTIDE - EFFECTIVE TREATMENT FOR HYPERPARATHYROIDISM - A PROSPECTIVE, RANDOMIZED, CONTROLLED CLINICAL-TRIAL

Background. Recent studies suggest a role for somatostatin in the medi cal treatment of hyperparathyroidism. In a prospective, randomized, co ntrolled, triple blinded clinical trial in patients with primary or se condary hyperparathyroidism, we evaluated the response of biochemical parameters relevant in hyperparathyroidism to the somatostatin analog octreotide. Methods. Forty patients each with primary or secondary hyp erparathyroidism were studied. Among other parameters, serum calcium a nd serum phosphate, parathyroid hormone, calcitonin, osteocalcin, and octreotide were assessed before and repeatedly for 4 hours after a sin gle intravenous application of 200 mu g octreotide or placebo. Subsequ ent to operation, which was performed on all patients, somatostatin-re ceptor autoradiography of parathyroid tissue was performed. Results. A fter administration of octreotide, which resulted in an increase of pl asma levels to pharmacologic levels, no significant changes in any of the biochemical parameters investigated for were observed. Multivariat e analysis did not identify patient subpopulations that responded to e ither drug or placebo (p > 0.05). Forty-five percent of patients recei ving octreotide reported side effects. Parathyroid tissue samples of p atients with primary or secondary hyperparathyroidism were negative fo r somatostatin-receptor expression. Conclusions, Octreotide has no dis cernible effect on biochemical parameters of patients with primary or secondary hyperparathyroidism. Absence of somatostatin receptors, toge ther with lack of octreotide effects, suggests that somatostatin is no t effective in the medical therapy of hyperparathyroidism.