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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 S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J - Pituitary (2009)

Bottom Line: 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 < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.Treatment was well tolerated by all patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Shlomo.melmed@cshs.org

ABSTRACT
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 < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 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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Related in: MedlinePlus

Study design showing the dose-titration schema. Dose-titration was based on serum levels of growth hormone (GH; ng/ml) and whether insulin-like growth factor-1 (IGF-1) levels were in the age-adjusted normalized range (N); A = GH > 2.5 or GH ≤ 2.5 + IGF-1 > N; B = GH ≤ 2.5 + IGF-1 ≤ N; C = 1 < GH ≤ 2.5 + IGF-1 ≤ N; D = GH ≤ 1 + IGF-1 ≤ N; E = GH > 1 or GH ≤ 1 + IGF-1 > N. *Only if 60 mg originally
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Fig1: Study design showing the dose-titration schema. Dose-titration was based on serum levels of growth hormone (GH; ng/ml) and whether insulin-like growth factor-1 (IGF-1) levels were in the age-adjusted normalized range (N); A = GH > 2.5 or GH ≤ 2.5 + IGF-1 > N; B = GH ≤ 2.5 + IGF-1 ≤ N; C = 1 < GH ≤ 2.5 + IGF-1 ≤ N; D = GH ≤ 1 + IGF-1 ≤ N; E = GH > 1 or GH ≤ 1 + IGF-1 > N. *Only if 60 mg originally

Mentions: Lan-Autogel was administered every 28 days by deep subcutaneous injection for 13 injections (Fig. 1). The study was conducted in four phases: the first was a washout phase for previously treated patients, followed by a double-blind phase, in which patients were randomized to one injection of Lan-Autogel 60, 90 or 120 mg or placebo. In the following single-blind phase, patients received three further injections at the same dose, and the placebo group was re-allocated to Lan-Autogel 60, 90 or 120 mg. In the final, open-label phase, doses could be titrated according to biochemical response, as assessed 28 days after the fifth and ninth injections (Fig. 1). At each titration step, the dose could increase or decrease by only one dose level (30 mg) and, once increased, the dose could not subsequently be reduced.Fig. 1


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 S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J - Pituitary (2009)

Study design showing the dose-titration schema. Dose-titration was based on serum levels of growth hormone (GH; ng/ml) and whether insulin-like growth factor-1 (IGF-1) levels were in the age-adjusted normalized range (N); A = GH > 2.5 or GH ≤ 2.5 + IGF-1 > N; B = GH ≤ 2.5 + IGF-1 ≤ N; C = 1 < GH ≤ 2.5 + IGF-1 ≤ N; D = GH ≤ 1 + IGF-1 ≤ N; E = GH > 1 or GH ≤ 1 + IGF-1 > N. *Only if 60 mg originally
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2807598&req=5

Fig1: Study design showing the dose-titration schema. Dose-titration was based on serum levels of growth hormone (GH; ng/ml) and whether insulin-like growth factor-1 (IGF-1) levels were in the age-adjusted normalized range (N); A = GH > 2.5 or GH ≤ 2.5 + IGF-1 > N; B = GH ≤ 2.5 + IGF-1 ≤ N; C = 1 < GH ≤ 2.5 + IGF-1 ≤ N; D = GH ≤ 1 + IGF-1 ≤ N; E = GH > 1 or GH ≤ 1 + IGF-1 > N. *Only if 60 mg originally
Mentions: Lan-Autogel was administered every 28 days by deep subcutaneous injection for 13 injections (Fig. 1). The study was conducted in four phases: the first was a washout phase for previously treated patients, followed by a double-blind phase, in which patients were randomized to one injection of Lan-Autogel 60, 90 or 120 mg or placebo. In the following single-blind phase, patients received three further injections at the same dose, and the placebo group was re-allocated to Lan-Autogel 60, 90 or 120 mg. In the final, open-label phase, doses could be titrated according to biochemical response, as assessed 28 days after the fifth and ninth injections (Fig. 1). At each titration step, the dose could increase or decrease by only one dose level (30 mg) and, once increased, the dose could not subsequently be reduced.Fig. 1

Bottom Line: 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 < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.Treatment was well tolerated by all patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Shlomo.melmed@cshs.org

ABSTRACT
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 < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 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.

Show MeSH
Related in: MedlinePlus