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Dana Holováčová, Martin Kužma, Zdenko Killinger and Juraj Payer

Background

The purpose of this study was to assess changes in the cross-sectional area (CSA) of nervus medianus by ultrasound in newly diagnosed primary hypothyroid patients after thyroxine replacement treatment.

Patients and methods

The cohort comprised 30 patients with newly diagnosed primary autoimmune hypothyroidism. These were subsequently compared with 30 controls, matched for sex, BMI and age. Ultrasound evaluation, including measurement of CSA at the level of the pisiform bone or tunnel inlet was performed at baseline and after 3months. A CSA threshold of more than 10mm2 was considered pathological.

Results

CSA was increased in patients compared with controls (9.8±0.7mm2 vs 7.2±1.1mm2; P<0.001). Thyroxin substitution increased fT4 levels (baseline, 11.0±0.6pmol/L vs 15.5±0.4pmol/L; P<0.001) and decreased TSH (baseline, 23.9±6.0mIU/L vs 2.7±0.2mIU/L; P<0.001). Thyroxine treatment decreased CSA to 8.4mm2±0.3mm2 (P=0.033). Before treatment, four patients experienced distal paresthesia in the median nerve distribution area. Increased CSA pathognomonic for carpal tunnel syndrome found in two symptomatic patients normalized after 3months. No clinical symptoms were observed after 3months. A positive correlation was found between TSH and CSA (R=0.155, P=0.05) before treatment.

Conclusion

Our study demonstrates that increase in median nerve CSA caused by primary autoimmune hypothyroidism can be fully reversible after achieving target levels of TSH and fT4.

Open access

Christian J Strasburger, Peter Vanuga, Juraj Payer, Marija Pfeifer, Vera Popovic, László Bajnok, Miklós Góth, Veˇra Olšovská, L‘udmila Trejbalová, Janos Vadasz, Eyal Fima, Ronit Koren, Leanne Amitzi, Martin Bidlingmaier, Oren Hershkovitz, Gili Hart and Beverly M K Biller

Objective

Growth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This study’s objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once-weekly in GHD adults.

Design

54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18.5%, 37%, 55.5% or 123.4% of individual cumulative weekly molar hGH dose. The study included 2 stages: Stage A assessed the effectiveness and PK/PD profiles of the 4 dosing regimens of MOD-4023. Stage B was an extension period of once-weekly MOD-4023 administration (61.7% molar hGH content) to collect further safety data and confirm the results from Stage A.

Results

Dose-dependent response was observed for both PK and PD data of weekly MOD-4023 treatment. Insulin-like growth factor I (IGF-I) SDS levels were maintained within normal range. The 18.5% cohort was discontinued due to low efficacy. MOD-4023 was well tolerated and exhibited favorable safety profile in all dose cohorts. The reported adverse events were consistent with known GH-related side effects.

Conclusions

Once-weekly MOD-4023 administration in GHD adults was found to be clinically effective while maintaining a favorable safety profile and may obviate the need for daily injections. Weekly GH injections may improve compliance and overall outcome. The promising results achieved in this Phase 2 study led to a pivotal Phase 3 trial, which is currently ongoing.

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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.