Chanson P, Boerlin V, Ajzenberg C, Bachelot Y, Benito P, Bringer J, Caron P, Charbonnel B, Cortet C, Delemer B, Escobar-Jiménez F, Foubert L, Gaztambide S, Jockenhoevel F, Kuhn J M, Leclere J, Lorcy Y, Perlemuter L, Prestele H, Roger P, Rohmer V, Santen R, Sassolas G, Scherbaum W A, Schopohl J, Torres E, Varela C, Villamil F, Webb S M
Novartis Pharma AG, Clinical Research and Development, Basel, Switzerland.
Clin Endocrinol (Oxf). 2000 Nov;53(5):577-86. doi: 10.1046/j.1365-2265.2000.01134.x.
The most effective option for the medical treatment of patients with acromegaly is the use of somatostatin analogues. Long-acting depot formulations for intramuscular injection of two somatostatin analogues have recently become available: octreotide acetate LAR (Sandostatin LAR, Novartis Pharma AG) and lanreotide SR (Somatuline, Ipsen Biotech). We wished to compare efficacy of octreotide LAR and lanreotide SR in acromegalic patients.
A group of 125 patients with acromegaly (67 females; mean age, 47 years; 59 patients had previous pituitary irradiation) from 26 medical centres in France, Spain and Germany were studied. Before the study, all patients had been treated with intramuscular injections of lanreotide SR (mean duration, 26 months) at a dose of 30 mg which was injected every 10 days in 64 and every 14 days in 61 patients, respectively. All patients were switched from lanreotide SR to intramuscular injections of 20 mg of octreotide LAR once monthly for three months. In order to obtain efficacy and safety data of lanreotide SR under study conditions, it was decided to randomly assign at day 1, in a 3 : 1 ratio, the time point of the treatment switch; 27 of the patients were randomly assigned to continue the lanreotide SR treatment for the first 3 months of the study (group A); they were on octreotide LAR 20 mg from month 4-6. The other 98 patients were assigned to be switched to treatment with octreotide LAR 20 mg at day 1 (group B). In group B patients, octreotide LAR treatment was continued until month 6, with an adjustment of the dose based on GH levels obtained at month 3.
The mean GH concentration decreased from 9.6 +/- 1.3 mU/l at the last evaluation on lanreotide SR to 6.8 +/- 1.0 mU/l after three injections of octreotide LAR (P < 0.001). The percentages of patients with mean GH values < or = 6.5 mU/l (2.5 microg/l) and < or = 2.6 mU/l (1.0 microg/l) at the last evaluation on lanreotide SR were 54% and 14%, and these values increased after 3 months treatment with octreotide LAR to 68% and 35% (P < 0.001), respectively. IGF-I levels were normal in 48% at the last evaluation on lanreotide SR and in 65% after 3 months on octreotide LAR (P < 0.001). Patients with pre-study pituitary irradiation had lower mean GH and IGF-I concentrations. But the effects of the treatment change did not differ between the irradiated and the nonirradiated patients. In general both drugs were well tolerated.
Octreotide LAR 20 mg administered once monthly was more effective than lanreotide SR 30 mg administered 2 or 3 times monthly in reducing GH and IGF-I in patients with acromegaly.
对于肢端肥大症患者，最有效的药物治疗选择是使用生长抑素类似物。最近，两种用于肌肉注射的长效生长抑素类似物已上市：醋酸奥曲肽长效注射剂（善龙，诺华制药公司）和缓释兰瑞肽（索马杜林，益普生生物技术公司）。我们希望比较奥曲肽长效注射剂和缓释兰瑞肽对肢端肥大症患者的疗效。
对来自法国、西班牙和德国26个医疗中心的125例肢端肥大症患者（67例女性；平均年龄47岁；59例患者曾接受垂体放疗）进行了研究。研究前，所有患者均接受了肌肉注射缓释兰瑞肽治疗（平均疗程26个月），剂量为30mg，其中64例患者每10天注射一次，61例患者每14天注射一次。所有患者均从缓释兰瑞肽改为每月肌肉注射一次20mg奥曲肽长效注射剂，共三个月。为了获取研究条件下缓释兰瑞肽的疗效和安全性数据，决定在治疗转换时间点（第1天）按3:1的比例随机分组；27例患者被随机分配在研究的前3个月继续使用缓释兰瑞肽治疗（A组）；他们在第4至6个月使用20mg奥曲肽长效注射剂。其他98例患者在第1天被分配改为使用20mg奥曲肽长效注射剂治疗（B组）。B组患者持续使用奥曲肽长效注射剂治疗至第6个月，并根据第3个月时的生长激素水平调整剂量。
在最后一次评估缓释兰瑞肽时，生长激素平均浓度为9.6±1.3mU/l，在注射三次奥曲肽长效注射剂后降至6.8±1.0mU/l（P<0.001）。在最后一次评估缓释兰瑞肽时，生长激素平均水平≤6.5mU/l（2.5μg/l）和≤2.6mU/l（1.0μg/l）的患者百分比分别为54%和14%，在使用奥曲肽长效注射剂治疗3个月后，这些值分别增至68%和35%（P<0.001）。在最后一次评估缓释兰瑞肽时，48%的患者胰岛素样生长因子-I水平正常，在使用奥曲肽长效注射剂3个月后，这一比例为65%（P<0.001）。研究前接受垂体放疗的患者生长激素和胰岛素样生长因子-I的平均浓度较低。但放疗患者和未放疗患者治疗变化的效果没有差异。总体而言，两种药物耐受性良好。
对于肢端肥大症患者，每月注射一次20mg奥曲肽长效注射剂在降低生长激素和胰岛素样生长因子-I水平方面比每月注射2或3次30mg缓释兰瑞肽更有效。
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