Clinical results of long‐term slow‐release lanreotide treatment of acromegaly

Abstract

Medical therapy is frequently needed to normalize growth hormone/insulin-like growth factor I secretion in acromegaly. The aim of this study was to determine the long-term effects of the slow-release (SR) somatostatin analogue lanreotide in 57 acromegalic patients. SR lanreotide (30 mg) was given every 14 days for 12 months. In 33% of patients, the drug dosage was raised to 60 mg and/or the time interval was shortened to 10 days. Two months of clinical evaluation followed drug discontinuation in 47 out of 48 (84%) patients who completed the 12-month period. A drug-related decrease in GH/IGF-I levels was observed. Basal GH/IGF-I levels were significantly (P < 0.001) reduced at 12 months, IGF-I was normalized in 35% of patients and GH levels were < 5 micrograms L-1 in 54%. There was a clinical improvement in patients complaining of joint pain, rachialgias, headache, digital paraesthesias and hyperhidrosis. Soft-tissue changes were documented by significant (P < 0.001) decreases in finger size. In 52 (91%) patients without overt diabetes, a slight but significant increase in integrated glycaemia (P < 0.001) was noted, while integrated insulin levels were reduced (P < 0.001). Of 33 (58%) patients with normal basal ultrasound examination of the gall bladder, three (9%) had developed asymptomatic gall stones or biliary sludge after 12 months. Adverse events were generally mild. They frequently (52%) occurred after the first SR lanreotide administration; only 28% were recurrent and 20% appeared for the first time during therapy. SR lanreotide is an effective treatment in most unselected acromegalic patients. Tolerance towards the drug is high. Subjective benefits seem to override the simple biochemical control of the disease. Glucose homeostasis more than the incidence of gall stones seems to require monitoring on therapy. SR lanreotide is clearly advantageous in improving patient compliance with medical treatment for acromegaly.

Slow-release lanreotide and octreotide LAR in the medical therapy of acromegaly

“…Larger patient populations may be required in order to make a more meaningful comparison. Moreover, as already reported in other clinical studies with SR lanreotide (2,5), our data support the effectiveness of octreotide LAR in normalising IGF-I levels in a large percentage of patients. Finally, it must be considered that long-acting somatostatin analogues improve patient compliance with medical therapy for acromegaly.…”

“…Octreotide (1), slow-release (SR) lanreotide (2) and octreotide LAR (3) are currently administered before surgery or in patients in whom surgery and/or radiotherapy have failed to restore normal growth hormone (GH)/insulin-like growth factor-I (IGF-I) levels. Cozzi et al (4) have recently shown that octreotide LAR, a somatostatin analogue to be administered at 28-day intervals, seems to be more efficacious than SR lanreotide, a somatostatin analogue administered at intervals ranging from 10 to 14 days.…”

Effects of high-dose octreotide LAR on glucose metabolism in patients with acromegaly inadequately controlled by conventional somatostatin analog therapy

“…Furthermore, glycometabolic status of our patients at the study entry was that expected based on epidemiological data (2, 3) as well as on meta-analytic evaluations suggesting a minor clinical impact of conventional somatostatin schedule on glucose metabolism (10). It cannot be excluded that any side effect of SSA on glucose metabolism had been established in sensitive patients during the first period of SSA treatment, such that an increase in dose as employed in the present paper would be less likely to promote additional deterioration (20,21). In fact, this trial included only patients partially sensitive to SSAs.…”

Population Pharmacokinetic Analysis of Lanreotide Autogel® in Healthy Subjects

“…[1] An earlier extended-release lanreotide formulation based subjects. The study was conducted according to the Declaration of on microparticles of lactide-glycolide copolymer allowed the reHelsinki and Good Clinical Practice guidelines.…”