Growth Hormone Deficiency after Treatment of Acromegaly: A Randomized, Placebo-Controlled Study of Growth Hormone Replacement

Abstract

This is the first randomized, placebo-controlled study of the effects of GH replacement therapy on body composition and cardiovascular end points in patients who have developed GH deficiency after treatment for acromegaly, a disease complicated by metabolic and body composition alterations and increased cardiovascular risk. GH replacement decreased visceral adipose tissue, increased fat-free mass, decreased hsCRP, and improved quality of life in patients with GHD after cure of acromegaly, with minimal side effects and without an increase in insulin resistance.

Effect of long-term GH replacement therapy on cardiovascular outcomes in GH-deficient patients previously treated for acromegaly: a sub-analysis from the Dutch National Registry of Growth Hormone Treatment in Adults

“…However, whether the increased rate of vascular events was due to the impaired metabolic profile or other patient characteristics at baseline or due to GH treatment itself could not be addressed properly due to the small study population and relatively short follow-up in that study. Thereafter, this safety concern is restated by others, but could not be verified or retested (17,18). Recently, Tritos et al (28) have found a comparable safety profile in patients with previous acromegaly and NFPA, with the exception of an elevated cardiovascular mortality rate.…”

“…To date, ten studies (Table 4) investigated the characteristics of GHD and/or the effect of GH treatment on cardiovascular outcome measures in GHD patients after treatment for acromegaly (6,15,16,17,18,19,20,26,27,28). In three studies, patients who were GH sufficient after treatment for acromegaly or active acromegaly were used as controls.…”

“…In an observational (KIMS) study on GH replacement, a higher prevalence of stroke was reported at baseline; however, the group with previous acromegaly harbored more subjects who received cranial radiotherapy in the past (26). Six studies investigated the effect of GH treatment in GHD after acromegaly (17,18,19,20,26,28), with only one randomized placebo-controlled trial (18). Positive effects of GH treatment on body composition and lipid profile have been reported (17,18,20,28).…”

“…Six studies investigated the effect of GH treatment in GHD after acromegaly (17,18,19,20,26,28), with only one randomized placebo-controlled trial (18). Positive effects of GH treatment on body composition and lipid profile have been reported (17,18,20,28). The study by both van der Klaauw et al (19) and the Pfizer-owned KIMS database (26) demonstrated no significant effect on cardiovascular risk factors after 6 and 12 months.…”

“…GH treatment has been demonstrated to show improvement in the metabolic parameters in acromegalic patients with GHD (17,18). However, contradicting results are also published (19), and longterm data are lacking.…”