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Cheol Ryong Ku, Jae Won Hong, Eui Hyun Kim, Sun Ho Kim and Eun Jig Lee

Objective

Even in patients with cured acromegaly, GH deficiency (GHD) after transsphenoidal adenomectomy (TSA) adversely affects body composition and inflammatory biomarkers of cardiovascular risk. In this study, clinical parameters for predicting GHD after TSA in 123 cured acromegalic patients were investigated.

Design and methods

GH levels were measured at 6, 12, 18, 24, 48, and 72 h after TSA and serial insulin tolerance tests were conducted at 6 months, 2 years, and then every 2 years after TSA.

Results

GHD was found in 12 patients (9.8%) at 4.1 (range: 0.5–4.1) years after TSA. IGF1 levels were significantly lower at 6 months after TSA in GHD group than intact GH group (175.9 vs 316.8 μg/l, range: 32.0–425.0 and 96.9–547.3 respectively, P=0.008). Adenomas involving both sides of the pituitary gland were significantly more frequent in GHD patients (29.7 vs 83.3%; P=0.002). Furthermore, immediate postoperative 72-h GH levels after TSA were significantly lower (0.17 vs 0.45, range: 0.02–0.93 and 0.02–5.95 respectively, P=0.019) in GHD patients. In multiple logistic regression analysis, bilaterality of tumor involvement (odds ratio (OR)=10.678, P=0.003; 95% CI=2.248–50.728) and immediate postoperative 72-h GH level (OR=0.079, P=0.047; 95% CI=0.006–0.967) showed significant power for predicting GHD.

Conclusions

These data suggest that bilateral involvement of a pituitary adenoma and severely decreased immediate postoperative serum GH levels at 72 h after TSA may be independent risks factor for accelerated GHD in acromegalic patients.

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Cheol Ryong Ku, Thierry Brue, Katharina Schilbach, Stanislav Ignatenko, Sandor Magony, Yoon-Sok Chung, Byung-Joon Kim, Kyu Yeon Hur, Ho-Cheol Kang, Jung Hee Kim, Min Seon Kim, Aldona Kowalska, Marek Bolanowski, Marek Ruchala, Svetozar Damjanovic, Juraj Payer, Yun Jung Choi, Su Jin Heo, Tae Kyoung Kim, MinKyu Heo, Joan Lee and Eun Jig Lee

Objective

Hybrid Fc-fused rhGH (GX-H9) is a long-acting recombinant human growth hormone (GH) under clinical development for both adults and children with GH deficiency (GHD). We compared the safety, pharmacokinetics and pharmacodynamics of weekly and every other week (EOW) dosages of GX-H9 with those of daily GH administration in adult GHD (AGHD) patients.

Design

This was a randomized, open-label, active-controlled and dose-escalation study conducted in 16 endocrinology centers in Europe and Korea.

Methods

Forty-five AGHD patients with or without prior GH treatment were enrolled. Patients with prior GH treatments were required to have received the last GH administration at least 1 month prior to randomization. Subjects were sequentially assigned to treatment groups. Fifteen subjects were enrolled to each treatment group and randomly assigned to receive either GX-H9 or Genotropin (4:1 ratio). GX-H9 dosage regimens for Groups 1, 2 and 3 were 0.1 mg/kg weekly, 0.3 mg/kg EOW and 0.2 mg/kg EOW, respectively. All Genotropin-assigned subjects received 6 µg/kg Genotropin, regardless of treatment group. Main outcome analyses included measurements of serum insulin-like growth factor 1 (IGF-I), safety, pharmacokinetics, pharmacodynamics and immunogenicity.

Results

Mean GX-H9 peak and total exposure increased with an increase in dose after a single-dose administration. The mean IGF-I response was sustained above baseline over the intended dose interval of 168 h for the weekly and 336 h for the EOW GX-H9 groups. Safety profiles and immunogenicity were not different across the treatment groups and with Genotropin.

Conclusions

GX-H9 has the potential for up to twice-monthly administration.