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Beomseok Suh, Dong Wook Shin, Youngmin Park, Hyunsun Lim, Jae Moon Yun, Sun Ok Song, Jin-ho Park, Belong Cho and Eliseo Guallar

Objective: Many thyroid cancer patients are exposed to long-term thyroid stimulating hormone (TSH) suppression, in many cases as lifetime treatment, and are consequently subjected to risk for cardiovascular disease. We investigated incidence of coronary heart disease (CHD) and ischemic stroke among thyroid cancer patients compared to matched control subjects.

Design: Retrospective cohort study

Methods: A total of 182,419 subjects who received thyroidectomy for thyroid cancer during 2004-2012 were selected from the Korean National Health Insurance data, which covers approximately 97% of the entire Korean population. Propensity score matching was used to select non-cancer controls. Cox proportional hazards regression analysis was used to determine relative risk of coronary heart disease, and ischemic stroke. Mean follow-up was 4.32 years.

Results: Thyroid cancer patients had elevated risk for CHD and ischemic stroke with HR 1.15 (95% CI 1.10-1.22), and 1.15 (1.09-1.22), respectively. This risk was marked in those who took higher dosage of levothyroxine (HR 1.47, 95% CI 1.34-1.60 for CHD and HR 1.56, 95% CI 1.42-1.72 for ischemic stroke among those who took ≥170mcg/d). Atrial fibrillation risk was dose-dependently associated with levothyroxine dosage; however, it comprises only a small proportion of ischemic stroke incidence (4.4%, 128/2914).

Conclusions: The risk for CHD and ischemic stroke was higher in thyroid cancer patients who received thyroidectomy, and the dosage of levothyroxine administered appears to play a major role. More caution is suggested for the screening and treatment of thyroid cancer and subsequent TSH suppression therapy, as well as proper management for cardiovascular disease prevention.

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Jin Soon Hwang, Hae Sang Lee, Woo Yeong Chung, Heon-Seok Han, Dong-Kyu Jin, Ho-Seong Kim, Cheol-Woo Ko, Byung-Churl Lee, Dae-Yeol Lee, Kee-Hyoung Lee, Jeh-Hoon Shin, Byung-Kyu Suh, Han-Wook Yoo, Hyi-Jeong Ji, Jin-Hwa Lee, Yoon Ju Bae, Duk-Hee Kim and Sei Won Yang

Purpose

The purpose of this study was to investigate the efficacy and safety of LB03002, a sustained-release human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD).

Methods

A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period.

Results

The mean (s.d.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HV at 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events.

Conclusion

Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.