Issue: February 2017
December 01, 2016
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Lanreotide not harmful for HbA1c, lipid levels in acromegaly

Issue: February 2017
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Lanreotide autogel did not increase lipid or glucose levels in patients with acromegaly, researchers conducting an open-label phase 3b study found.

The researchers reported that only a small minority of patients showed deteriorating glucose control.

“Long-acting formulations of somatostatin analogues (SSAs), such as lanreotide, are recommended first-line treatments for acromegaly after surgery or when surgery is inappropriate,” Phillippe J. Caron, of the department of endocrinology and metabolic diseases at CHU Larrey, Toulouse, France, and colleagues wrote. “Whereas SSA treatment counteracts disease-related lipid abnormalities and reduces cardiovascular risk, it has sometimes been implicated in the exacerbation of impaired glucose tolerance and the development of type 2 diabetes in acromegaly. … With the advent of somatostatin multirecepter ligands, therefore, and given potential concerns over glycemic disruption with SSAs still not entirely dispelled, further data are needed on the metabolic effects of established SSAs, such as lanreotide autogel.”

Caron and colleagues performed a 48-week open-label study that included 90 adults with untreated pituitary macroadenoma, mean growth hormone levels >1 µg/L and elevated insulin-like growth factor-1 levels (PRIMARYS study). Participants received 120 mg of lanreotide autogel by subcutaneous injection every 4 weeks for 48 weeks at 27 endocrinology centers across Europe between May 20, 2008, and Feb. 13, 2012. Researchers recorded data on HbA1c and hormone levels at baseline, weeks 12 and 24 and end of study. Researchers also collected data on fasting lipid levels at baseline and end of study.

Mean participant age was 49.5 years; mean IGF-1 was 810 µg/L, and mean GH was 15 µg/L. Among the cohort, 24 (27%) patients had diabetes, 15 (62.5%) of whom were prescribed diabetes medications at baseline. At all times, the researchers wrote, mean HbA1c was stable, decreasing from 6.3% at baseline (n = 87) to 6.1% at 48 weeks (n = 62). Patients without diabetes showed slight increases in HbA1c from baseline to weeks 12 and 24 (week 12: 0.12% [95% CI, 0.05; 0.19], n = 61; week 24: 0.13% [95% CI, 0.03; 0.23], n = 55), but the increase was not considered clinically relevant, according to the researchers. No significant changes were observed in fasting lipids among patients with diabetes. In participants without diabetes, observed improvements in triglycerides and HDL-cholesterol were unlikely to be clinically relevant, according to the researchers.

“In conclusion, although acromegaly itself can contribute to impaired glucose tolerance and diabetes onset, lanreotide autogel 120 mg every 4 weeks in the PRIMARYS study had no detrimental impact on glucose homeostasis in the majority of patients, while, for a small proportion of individuals, it was associated with some worsening,” the researchers wrote. “In addition, a minor positive influence on lipid profiles was observed, suggesting that detrimental metabolic effects are not a major consideration when initiating long-term lanreotide treatment at the highest recommended dose in acromegaly.” – by Andy Polhamus

Disclosure: Caron reports fees from Ipsen and Novaris. Please see the full study for a complete list of all other researchers’ relevant financial disclosures.