Endocr Pract. 2018 Jun;24(6):542-547. doi: 10.4158/EP-2017-0195.
The present study aimed to evaluate the efficacy of add-on therapy of cabergoline versus raloxifene to long-acting somatostatin analogues (SAs) in patients with inadequately controlled acromegaly.
This was a prospective, randomized open label clinical trial. Forty-four patients (22 per group) completed the study; where participants received either cabergoline (3 mg/week) or raloxifene (60 mg twice daily) add-on therapy for 12 weeks in a parallel manner. The primary outcome was the rate of reduction in serum insulin-like growth factor 1 (IGF-1) from baseline. Secondary outcomes comprised normalization of serum IGF-1 for age and sex.
Serum IGF-1 was significantly decreased in both the cabergoline (40.3 ± 25.6%, P<.001) and raloxifene (31.5 ± 24.6%, P<.001) groups, with no significant difference between arms ( P>.05). Normalization in serum IGF-1 values occurred in 40.9% of patients who were on cabergoline compared to 45.5% of those receiving raloxifene ( P = .76). The subsequent logistic regression analysis highlighted baseline IGF-1 as a significant predictor of IGF-1 normalization (odds ratio, 0.995; 95% confidence interval, 0.990-0.999; P = .02). Using the receiver operating characteristic (ROC) curve analysis for the entire group, the baseline IGF-1 value of 1.47 the upper limit of normal (ULN) was the best cut-off point to identify patients with normal IGF-1 at the end of the study (sensitivity: 52.6%, specificity: 84.0%, Yoden's index: 0.366). Full biochemical control of acromegaly was achieved in 22.7% of patients in the cabergoline group compared to 13.6% of those in the raloxifene group ( P = .43).
Cabergoline and raloxifene add-on therapy could effectively decrease serum IGF-1 level in patients with inadequately controlled acromegaly. The efficacy profiles of both drugs are comparable.
DA = dopamine agonist; FBG = fasting blood glucose; GH = growth hormone; IGF1 = insulin-like growth factor-1; IQR = interquartile range; OR = odds ratio; ROC = receiver operating characteristic; SA = somatostatin analogue; SERM = selective estrogen modulator receptor; ULN = upper limit of normal.
本研究旨在评估卡麦角林与雷洛昔芬作为长效生长抑素类似物（SAs）附加治疗药物在控制不佳的肢端肥大症患者中的疗效。
这是一项前瞻性、随机开放标签临床试验。44 名患者（每组 22 名）完成了研究；其中参与者以平行的方式分别接受卡麦角林（3mg/周）或雷洛昔芬（60mg 每日 2 次）附加治疗 12 周。主要结局是血清胰岛素样生长因子 1（IGF-1）从基线的降低率。次要结局包括血清 IGF-1 按年龄和性别正常化。
卡麦角林组（40.3±25.6%，P<.001）和雷洛昔芬组（31.5±24.6%，P<.001）血清 IGF-1 均显著降低，两组间无显著差异（P>.05）。与接受雷洛昔芬的患者相比，接受卡麦角林治疗的患者中有 40.9%的血清 IGF-1 值正常化，而接受雷洛昔芬的患者中有 45.5%（P =.76）。随后的逻辑回归分析强调了基线 IGF-1 是 IGF-1 正常化的重要预测因子（比值比，0.995；95%置信区间，0.990-0.999；P =.02）。使用整个组的接收器工作特征（ROC）曲线分析，基线 IGF-1 值为 1.47 上限正常值（ULN）是识别研究结束时 IGF-1 正常的最佳截断值（敏感性：52.6%，特异性：84.0%，Yoden 指数：0.366）。卡麦角林组有 22.7%的患者达到肢端肥大症的完全生化控制，而雷洛昔芬组有 13.6%（P =.43）。
卡麦角林和雷洛昔芬附加治疗可有效降低控制不佳的肢端肥大症患者的血清 IGF-1 水平。两种药物的疗效相似。
