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Lanreotide 60 mg, a New Long-Acting Formulation: Effectiveness in the Chronic Treatment of Acromegaly

Endocrinology Unit, Niguarda Hospital (R.A., R.C.), I-20162 Milan, Italy; Endocrinology Chair, Department of Clinical Sciences, University of Rome La Sapienza (R.B., G.T.), 00161 Rome, Italy; Department of Molecular and Clinical Endocrinology and Oncology, University of Naples Federico II (R.P., A.C.), 80131 Naples, Italy; Division of Endocrinology and Metabolism, University of Turin (S.G., V.G.), 10126 Turin, Italy; and DISEM, University of Genoa (L.B., M.G.), 16132 Genoa, Italy

Address all correspondence and requests for reprints to: Dr. R Cozzi, Viale Ezio 5, I-20149 Milan, Italy. E-mail: renatocozzi{at}tiscali.it.

Lanreotide (LAN) 60 mg (LAN60), a new long-acting formulation of LAN alleged to suppress GH/IGF-I hypersecretion for 28 d in acromegalic patients, was administered in a prospective open multicenter study to 92 patients with active acromegaly (61 women and 31 men, aged 20–79 yr). LAN60 was given as adjuvant treatment (AT) in 62 patients; the other 30 patients [primary treatment (PT)] were de novo (n = 20) or previously treated only by pharmacotherapy (n = 10). After wash-out from previous treatments, LAN60 was started im every 28 d for 3 injections; the dose was then individually tailored, aiming at lowering GH to less than 2.5 µg/liter and IGF-I to the normal range. After a median follow-up of 24 months (range, 6–48 months), IGF-I normalized in 65% of patients, decreasing from 199 ± 8% (expressed as a percentage of the upper limit of normal range; mean ± SE) to 87 ± 4% (P < 0.0001). GH fell to less than 2.5 µg/liter in 63% of patients and to less than 1 µg/liter in 25%, decreasing from 20 ± 3 to 3 ± 0.4 µg/liter (P < 0.0001). A progressive increase in the rate of IGF-I normalization was observed (from 49% at 1 yr to 77% at 3 yr). The rate of GH/IGF-I normalization was 72% at 36 months by Kaplan-Meier analysis. No tachyphylaxis was observed throughout the study. Shortening the interval between injections to 21 d improved GH/IGF-I suppression. PT and AT patients achieved similar final GH/IGF-I levels and rates of normalization. Tumor shrank in 39% of assessable patients and in 50% of PT. Plasma glucose levels did not change, and high density lipoprotein cholesterol increased (by 19.3 ± 5.1%; P = 0.0215). Gallstones appeared or worsened in 13% of patients. LAN60 is a new, very effective and long-lasting formulation for the treatment of acromegaly. The persistence of a powerful suppression of GH/IGF-I levels, the progressive increase in the rate of IGF-I normalization, and the similarity in the efficacy achieved in PT and AT patients point to a role for LAN60 in the primary treatment of acromegaly.

Abbreviations: AT, Adjuvant treatment; HDL, high density lipoprotein; LAN, lanreotide; LAN30, lanreotide 30 mg; LAN60, lanreotide 60 mg; NS, neurosurgery; OC, octreotide; OC-LAR, octreotide long-acting repeatable; PT, primary treatment; RT, radiotherapy; SA, somatostatin analogs; ULNR, upper limit of normal range.

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