One‐year follow‐up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel<sup>®</sup>

Caron, P.; Bex, Mieke; Cullen, D. R.; Feldt‐Rasmussen, Ulla; Picón, Antonio; Pynka, Sławomir; Rácz, Kàroly; Schopohl, Jochen; Tabarin, Antoine; Välimäki, Matti

doi:10.1111/j.1365-2265.2004.02045.x

Cited by 84 publications

(87 citation statements)

References 27 publications

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“…There are, at present, only a few papers examining the effects of L-Autogel in acromegaly (18,19) and a larger number on the effects of octreotide LAR (7, 14, 16, 22 -25). The present study shows that both somatostatin analogues were well tolerated and similarly effective in the treatment of acromegaly, with minor differences that may alternatively favour one or the other depot formulation.…”

Section: Discussionmentioning

confidence: 99%

“…L-Autogel is a new, long-acting aqueous preparation of lanreotide which is administered by deep subcutaneous injections every 4 weeks and provides a consistent drug release over this time period (18,19). A previous clinical study has shown that this new formulation is at least as effective and well tolerated as lanreotide SR given every 10 -14 days intramuscularly (18).…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

Alexopoulou¹,

Abrams

Verhelst

et al. 2004

European Journal of Endocrinology

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Objective: This open label, multicentre study was designed to evaluate the efficacy and tolerability of lanreotide Autogel (L-Autogel) in acromegalic patients over a 24-week period. The outcome of treatment with this new, long-acting, aqueous formulation of lanreotide was also compared with the patients' previous treatment with octreotide long acting repeatable (LAR). Design and methods: Twenty-five acromegalic patients (13 males, mean age 51^12 years) were switched from octreotide LAR (20-40 mg/4 weeks for at least 6 months) to L-Autogel, given deep subcutaneously at a fixed dose of 90 mg/4 weeks. After 12 weeks, the dose of L-Autogel was titrated according to patients' mean GH and IGF-I levels at week 8. It was increased to 120 mg/4 weeks if GH . 2.5 mg/l or if IGF-I was above the age-adjusted normal range. It was reduced to 60 mg/4 weeks if mean GH , 1 mg/l and IGF-I was within the normal range. If the values did not fall within these ranges, the dose remained unchanged at 90 mg. Results: After 24 weeks of treatment with L-Autogel (final doses 60 mg in 3 patients, 90 mg in 4 patients and 120 mg in 18 patients), mean serum GH (2.9^2.4 mg/l) and IGF-I concentrations (332^193 mg/l) remained statistically unchanged when compared with baseline values under octreotide LAR (GH 2.4^1.8 mg/l and IGF-I 337^201 mg/l, non significant (NS)). There was a significant improvement of the acromegalic symptom score over the study period, from 4.8^3.4 to 2.8^2.5 (P , 0.001) and a small but significant reduction in the residual pituitary tumour volume (P , 0.05). Local side-effects were observed less frequently and no technical problems were encountered with the L-Autogel injections, as opposed to treatment with octreotide LAR (60 difficult injections/150 (P , 0.001)). Conclusions: L-Autogel appears to be as effective as octreotide LAR in lowering GH and IGF-I concentrations in acromegalic patients. This treatment was also well tolerated by the patients, giving fewer local side-effects and technical problems with injections. These advantages may improve the long-term acceptability of medical treatment in acromegaly.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

Alexopoulou¹,

Abrams

Verhelst

et al. 2004

European Journal of Endocrinology

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“…During SSA treatment, improvement of joint and soft tissue symptoms as well as headache and perspiration frequently occurs (Caron et al 2004, Mercado et al 2007). …”

Section: Medical Treatmentmentioning

confidence: 99%

60 YEARS OF NEUROENDOCRINOLOGY: Acromegaly

Căpățînă¹,

Wass²

2015

Journal of Endocrinology

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Acromegaly (ACM) is a chronic, progressive disorder caused by the persistent hypersecretion of GH, in the vast majority of cases secreted by a pituitary adenoma. The consequent increase in IGF1 (a GH-induced liver protein) is responsible for most clinical features and for the systemic complications associated with increased mortality. The clinical diagnosis, based on symptoms related to GH excess or the presence of a pituitary mass, is often delayed many years because of the slow progression of the disease. Initial testing relies on measuring the serum IGF1 concentration. The oral glucose tolerance test with concomitant GH measurement is the gold-standard diagnostic test. The therapeutic options for ACM are surgery, medical treatment, and radiotherapy (RT). The outcome of surgery is very good for microadenomas (80-90% cure rate), but at least half of the macroadenomas (most frequently encountered in ACM patients) are not cured surgically. Somatostatin analogs are mainly indicated after surgical failure. Currently their routine use as primary therapy is not recommended. Dopamine agonists are useful in a minority of cases. Pegvisomant is indicated for patients refractory to surgery and other medical treatments. RT is employed sparingly, in cases of persistent disease activity despite other treatments, due to its long-term side effects. With complex, combined treatment, at least three-quarters of the cases are controlled according to current criteria. With proper control of the disease, the specific complications are partially improved and the mortality rate is close to that of the background population.

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“…Caucasian men interval of at least 28 days. [3] This formulation, supplied as a and women fulfilling the following criteria were included: age ready-to-use preparation (of 60, 90 or 120 mg) in pre-filled between 18 and 45 years; bodyweight within 10% of the ideal polypropylene syringes, has good effectiveness and is well toleratheight/frame; normal physical and laboratory test results; women ed in patients; the main side-effects, which are of a gastrointestinal with a negative pregnancy test who were not breastfeeding and nature, [4][5][6] have been similarly reported with other somatostatin who were using appropriate contraceptive methods; willingness analogues given at therapeutic doses. [7] and ability to understand and sign an approved informed consent A population model has recently been developed that relates form.…”

Section: Introductionmentioning

confidence: 99%

Population Pharmacokinetic Analysis of Lanreotide Autogel® in Healthy Subjects

Trocóniz¹,

Cendros²,

Peraire³

et al. 2009

Clinical Pharmacokinetics

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Abstractneuroendocrine tumours. The objective of this study was to develop a pharmacokinetic model for the sustainedrelease formulation lanreotide Autogel ® after deep subcutaneous administration in healthy subjects, and to explore the potential effect of covariates, especially sex and dose. Subjects and methods:This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects. Healthy Caucasian subjects aged 18-45 years were included. Subjects received a rapid intravenous bolus of 7 µg/kg of an immediate-release formulation of lanreotide (lanreotide IRF). After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel ® at a dose of 60, 90 or 120 mg. Pharmacokinetic and statistical analysis: Blood samples for lanreotide determination were obtained during the first 12 hours after the intravenous bolus injection and during the 4-to 7-month follow-up period after deep subcutaneous administration of lanreotide Autogel ® . Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM ® version VI software. The model was validated externally using data from patients with acromegaly. Results: In total, 50 healthy subjects (24 women and 26 men) received a single intravenous dose of lanreotide IRF. Of these, 38 subjects (18 women and 20 men) received a single subcutaneous dose of lanreotide Autogel ® 3 days after intravenous lanreotide IRF. The disposition of lanreotide was described by a three-compartment open model. The estimates of the total volume of distribution and serum clearance were 15.1 L and 23.1 L/h, respectively. The estimates of interindividual variability were <40%. To evaluate lanreotide Autogel ® pharmacokinetics, the absorption rate was modelled to decrease exponentially as a function of the natural logarithm of time. The absolute bioavailability after deep subcutaneous administration of lanreotide Autogel ® was 63%. The rate of absorption and bioavailability of lanreotide Autogel ® were independent of the administered dose in the range from 60 to 120 mg, and no significant effect of covariates (sex, dose, age or bodyweight) was found (p > 0.05). Conclusions: Population analysis allows a full description of the disposition of lanreotide after rapid intravenous bolus administration of lanreotide IRF (7 µg/kg) and the pharmacokinetics of lanreotide Autogel ® after a single deep subcutaneous injection (60, 90 or 120 mg) in healthy subjects. The model-based simulations provide support for the feasibility of extending the dosing interval for lanreotide Autogel ® to 56 days when given at 120 mg. The absorption profile of lanreotide Autogel ® was independent of the dose and was not affected by sex. Backgroundmeters, the design included a rapid intravenous bolus injection of an immediate-release formulation of lanreotide (lanreotide IRF).

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One‐year follow‐up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel^®

Abstract: Dose titration of lanreotide Autogel improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel or lanreotide microparticles. Titrated long-term lanreotide Autogel treatment is well tolerated.

Cited by 84 publications

References 27 publications

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

60 YEARS OF NEUROENDOCRINOLOGY: Acromegaly

Population Pharmacokinetic Analysis of Lanreotide Autogel® in Healthy Subjects

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One‐year follow‐up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®

Abstract: Dose titration of lanreotide Autogel improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel or lanreotide microparticles. Titrated long-term lanreotide Autogel treatment is well tolerated.

Cited by 84 publications

References 27 publications

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

60 YEARS OF NEUROENDOCRINOLOGY: Acromegaly

Population Pharmacokinetic Analysis of Lanreotide Autogel® in Healthy Subjects

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Product

Resources

About

One‐year follow‐up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel^®