Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- GH and IGF-I levels after 4, 6, 10, 12 months therapy.
研究概览
简要总结
The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important.
Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed.
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days.
Aim
The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.
详细描述
Introduction The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important (1).
Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone (1). In most patients, additional medical therapy is therefore needed.
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels (2, 3, 4, 5). Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days.
Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.
Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients which receive octreotide LAR can be included;
- •New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated;
- •As long as they do not fit in the exclusion criteria.
排除标准
- •Which had not given their consent after they received standard information about the study;
- •Current malign disease;
- •Somatostatin analogues intolerance;
- •Elevation of lever enzymes;
- •Pregnancy.
结局指标
主要结局
GH and IGF-I levels after 4, 6, 10, 12 months therapy.
次要结局
未报告次要终点