NEWS HIGHLIGHTS
Published Studies Related to Somavert (Pegvisomant)
A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long-acting octreotide in patients with acromegaly. [2009.10]
OBJECTIVE: For patients with acromegaly who are suboptimally controlled on long-acting octreotide (LAR), treatment options are to switch to pegvisomant monotherapy (PM) or add pegvisomant to LAR (P-LAR). Our objective was to evaluate if the safety and efficacy of these regimens differ... CONCLUSIONS: In patients suboptimally controlled on LAR, PM and P-LAR were equally well tolerated and effective in normalizing IGF-I, and overall clinical improvement was observed with both regimens. Thus, pegvisomant monotherapy and adjunctive therapy are equally viable options for the treatment of LAR-resistant acromegaly.
Quality of life in acromegalic patients during long-term somatostatin analog treatment with and without pegvisomant. [2008.10]
OBJECTIVE: The objective of the study was to assess whether weekly administration of 40 mg pegvisomant (PEG-V) improves quality of life (QoL) and metabolic parameters in acromegalic patients with normal age-adjusted IGF-I concentrations during long-acting somatostatin analog (SSA) treatment... CONCLUSION: Improvement in quality of life was observed without significant change in IGF-I after the addition of 40 mg pegvisomant weekly to monthly SSA therapy in acromegalic patients who had normalized IGF-I on SSA monotherapy. These data question the current recommendations in how to assess disease activity in acromegaly. Moreover, the findings question the validity of the current approach of medical treatment in which pegvisomant is used only when SSA therapy has failed to normalize IGF-I.
Pegvisomant for the treatment of gsp-mediated growth hormone excess in patients with McCune-Albright syndrome. [2006.08]
CONCLUSIONS: Pegvisomant effectively reduced IGF-I and IGFBP-3 levels in gsp-mediated GH excess but had no effect on fibrous dysplasia.
Glucose homeostasis and safety in patients with acromegaly converted from long-acting octreotide to pegvisomant. [2005.10]
CONTEXT: In clinical practice, patients with acromegaly may be switched from therapy with long-acting somatostatin analogs to pegvisomant. The effect of changing therapies on glucose homeostasis and safety has not been reported. OBJECTIVES: The objectives of this study were to monitor changes in IGF-I levels, glycemic control, and safety, particularly liver function and tumor size... CONCLUSIONS: Conversion from octreotide LAR to pegvisomant was safe and well tolerated. Improved glycemic control indicates that pegvisomant should be considered in patients with acromegaly and diabetes.
High levels of 150-kDa insulin-like growth factor binding protein three ternary complex in patients with acromegaly and the effect of pegvisomant-induced serum IGF-I normalization. [2004.02]
OBJECTIVE: To assess the effect of pegvisomant-induced serum insulin-like growth factor 1 (IGF-1) normalization on IGF binding proteins 1, 2, 3 (IGFBP-1, IGFBP-2 and IGFBP-3), total, non-bound (45 kDa) and 150-kDa ternary complex-associated IGFBP-3, and in vivo IGFBP-3 proteolysis in patients with active acromegaly... CONCLUSIONS: GH receptor blockade in patients with acromegaly lowers IGF-I and 150-kDa IGFBP-3 ternary complex formation. 50 kDa ternary complex formation (not in vivo IGFBP-3 proteolysis) is GH dependent and measurement of 150-kDa ternary complex-associated IGFBP-3 may provide useful information regarding treatment efficacy in patients with acromegaly.
Clinical Trials Related to Somavert (Pegvisomant)
Acute Application of Pegvisomant and Octreotide in Acromegaly [Completed]
The purpose of the study is to investigate the efficacy of an acute additional application of
the somatostatin analogue octreotide 100µg s. c. or the dopamine agonist cabergoline 0. 5mg
p. o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing
endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.
Pegvisomant And Sandostatin LAR Combination Study [Completed]
The purpose of this study is to compare the safety and tolerability of combination therapy
with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients [Completed]
Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of
weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and
insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during
long-term treatment with long-acting somatostatin analogs
Study Objectives:
1. To determine whether the addition of weekly pegvisomant administrations improves quality
of life
2. To determine whether the addition of weekly pegvisomant administrations improves insulin
sensitivity
Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to
the upper 25 centiles of normality during long-term treatment with monthly injections of a
long-acting somatostatin analogue Number of Subjects: 20
Procedures:
- Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i. m. or patients on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s. c. will be enrolled.
- For 4 months, all subjects will also receive weekly s. c. injections of either placebo or
a fixed dose of 40 mg pegvisomant
- After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant
or from pegvisomant to placebo
- Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and
quality of life (AcroQol ™/ PASQ™) will be assessed.
- Before and after 4 months of each treatment period, pituitary tumor size and insulin
sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months
Hypothesis:
•We postulate that co-administration of the growth hormone receptor antagonist pegvisomant
will improve QoL and insulin sensitivity
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors [Not yet recruiting]
Canadian Pegvisomant Compassionate Study In Acromegalic Patients [Completed]
The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with
acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the
safety and tolerability of SOMAVERT.
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