Pharmacokinetics and efficacy of the long-acting somatostatin analogue somatuline in acromegaly

Mr, Johnson; Hs, Chowdrey; Thomas, François; C, Grint; Lightman, Stafford L.

doi:10.1530/eje.0.1300229

Cited by 37 publications

(17 citation statements)

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“…However, individual variations do occur, with GH levels remaining suppressed in 50% of patients at day 17 and in 37% of patients at day 22, although at both time points the levels were . 10 mU/l (Johnson et al, 1994). Our results of 45% of patients achieving a mean GH , 5 mU/l at 10 days are in line with other series, although unlike these our patients were not all preselected by their prior responsiveness to subcutaneous octreotide (Giusti et al, 1996;Caron et al, 1997).…”

Section: Discussionsupporting

confidence: 90%

Optimal dosage interval for depot somatostatin analogue therapy in acromegaly requires individual titration

Jenkins

Akker

Chew

et al. 2000

Clinical Endocrinology

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There is marked variability in individual patient responses to depot somatostatin analogues. The establishment of optimal drug intervals requires careful assessment. For octreotide LAR many patients may be as adequately controlled with 6 weekly injections as with 4 weekly injections. It is important to measure serum GH profiles at intervals after initiating therapy with these drugs to individualize doses for each patient and hence minimize cost.

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Section: Discussionsupporting

confidence: 90%

Optimal dosage interval for depot somatostatin analogue therapy in acromegaly requires individual titration

Jenkins

Akker

Chew

et al. 2000

Clinical Endocrinology

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“…The somatostatin analogue lanreotide (Somatuline ® , Ipsen) has demonstrated efficacy in the medical management of acromegaly [8–11]. Somatuline Autogel ® (Lan-Autogel) (marketed as Somatuline Depot ® in the US) is a prolonged-release, supersaturated formulation of lanreotide, which is available in sterile, ready-to-use syringes.…”

Section: Introductionmentioning

confidence: 99%

Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel® therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension

Melmed

Cook

Schopohl³

et al. 2009

Pituitary

119

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The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks’ treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels ≤ 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level ≤ 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.

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“…Promising results seem to be emerging from recent studies with the longacting octreotide formulation [11][12][13]. Another somatostatin analogue, lanreotide, is available in slow-release (SR) formulation, and studies have been carried out on acromegalic patients selected on the basis of their previous responsiveness to octreotide therapy [14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

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

Giusti

Ciccarelli

Dallabonzana

et al. 1997

Eur J Clin Investigation

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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.

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Pharmacokinetics and efficacy of the long-acting somatostatin analogue somatuline in acromegaly

Cited by 37 publications

References 0 publications

Optimal dosage interval for depot somatostatin analogue therapy in acromegaly requires individual titration

Optimal dosage interval for depot somatostatin analogue therapy in acromegaly requires individual titration

Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel® therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension

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

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