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A Single-Dose Comparison of the Acute Effects between the New Somatostatin Analog SOM230 and Octreotide in Acromegalic Patients

Department of Internal Medicine (J.v.d.H., W.W.d.H., R.A.F., A.-J.v.d.L., P.U., L.J.H., S.W.L.), Section of Endocrinology, Erasmus Medical Center, 3015 GD Rotterdam, The Netherlands; and Novartis Pharma A.G. (V.B., C.B., K.W.P., I.L., G.W., T.K.), CH-4002 Basel, Switzerland

Address all correspondence and requests for reprints to: Joost van der Hoek, M.D., Department of Internal Medicine, Section of Endocrinology, Room Bd228, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail: j.vanderhoek{at}erasmusmc.nl.

Treatment with the somatostatin receptor (sst) subtype 2 predominant analogs octreotide and lanreotide induces clinical and biochemical cure in approximately 65% of acromegalic patients. GH-secreting pituitary adenomas, which are not controlled, also express sst₅. We compared the acute effects of octreotide and SOM230, a new somatostatin analog with high affinity for sst_1,2,3,5 on hormone release in acromegalic patients. In a single-dose, proof-of-concept study, 100 µg octreotide and 100 and 250 µg SOM230 were given sc to 12 patients with active acromegaly. Doses of 100 and 250 µg SOM230 dose-dependently suppressed GH levels from 2–8 h after administration (-38 ± 7.7 vs. -61 ± 6.7%, respectively; P < 0.01). A comparable suppression of GH levels by octreotide and 250 µg SOM230 was observed in eight patients (-65 ± 7 vs. -72 ± 7%, respectively). In three patients, the acute GH-lowering effect of 250 µg SOM230 was significantly superior to that of octreotide (-70 ± 2 vs. -17 ± 15%, respectively; P < 0.01). In one patient, the GH-lowering effect of octreotide was better than that of SOM230. Tolerability for SOM230 was good. Glucose levels were initially slightly elevated after octreotide and SOM230, compared with control day, whereas insulin levels were only significantly suppressed by octreotide. We conclude that SOM230 is an effective GH-lowering drug in acromegalic patients with the potential to increase the number of patients controlled during long-term medical treatment.

Abbreviations: CD, Control day; HPRT, hypoxanthine-guanine phosphoribosyl transferase; OCT, octreotide; oGTT, oral glucose tolerance test; PRL, prolactin; SS, somatostatin; sst, SS receptor.

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