August 08, 2013
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GH replacement could delay progression of chronic HF

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New preliminary data demonstrate that growth hormone replacement therapy improved exercise and cardiac performance of patients with chronic heart failure and growth hormone deficiency.

Antonio Cittadini, MD, and colleagues conducted a single-blind study to investigate whether patients with both chronic heart failure (HF) and GH deficiency assigned GH replacement therapy could experience delays in the progression of chronic HF.

The findings suggest that “correction of [growth hormone] deficit improves exercise and cardiac performance of [chronic HF] patients in an enduring way,” the researchers wrote.

The researchers screened participants from a previous controlled, single blind, single-center study for GH deficiency. Of the 158 participants screened, 63 had GH deficiency and 56 were subsequently enrolled in the trial. Twenty-eight patients were randomly assigned standard therapy for chronic HF plus subcutaneous somatropin (rDNA origin; Saizen, Merck-Serono) at a dose of 0.012 mg/kg every second day. The other 28 patients were assigned standard therapy for chronic HF alone.

Follow-up was 4 years, and 17 patients in the GH group and 14 in the control group completed the study. The primary endpoint was peak oxygen consumption (VO2) because “it is a strong, independent predictor of [chronic HF] progression,” according to the study background. Peak VO2 improved in the GH group over 4 years, but not in the control group. The treatment effect was 7.1 ± 0.7 mL/kg/min in the GH group, which beat the researchers’ projected improvement of 4 mL/kg/min, vs. –1.8 ± 0.5 mL/kg/minin the control group (P<.001).

LV ejection fraction increased by 10 ± 3% in the growth-hormone group, but decreased by 2 ± 5% in the control group (P<.001). LV end-systolic volume index decreased by 22 ± 6 mL/m2 in the growth-hormone group and increased by 8 ± 3 ml/m2 in the control group (P<.001).

“The improvements in LV end-systolic volume and ejection fraction were [as] equally relevant [as improvements in peak VO2]; both are consolidated predictors of survival,” Cittadini and colleagues wrote.

The only adverse events reported by the GH group were two cases of arthralgia.

Given the limitations of a small study of this design with a large dropout rate, the association should be studied further in a large, multicenter, placebo-controlled, double blind trial, according to the researchers.

Disclosure: The study was funded in part by Ipsen and Merck Serono. One researcher is an employee of Merck-Serono. The other researchers report no relevant financial disclosures.