Treatment with Signifor (pasireotide) for one year reduces the risk for heart disease and diabetes in patients with Cushing’s disease, by improving visceral adiposity index (VAI) scores and adipose tissue dysfunction, according to a multi-center study.
However, Signifor did not prevent an increase in cases of diabetes, or change heart disease risk scores, likely because of the study’s short duration, researchers explained.
The study, “Pasireotide treatment reduces cardiometabolic risk in Cushing’s disease patients: an Italian, multicenter study,” was published in the journal Endocrine.
Signifor is a class of medications called somatostatin analogues. Somatostatin is a hormone that is responsible for controlling many processes in the body, by blocking the action of other hormones.
Patients with Cushing’s disease experience changes in metabolism that can lead to death due to heart disease. Visceral adipose tissue dysfunction is a condition involving fat tissue surrounding the liver and pancreas, resulting in a lack of response to insulin. Insulin resistance can lead to diabetes. The visceral adiposity index, which measures the degree of dysfunction, is an indirect evaluation of cardiometabolic risk (risk of heart disease and diabetes).
This study measured the visceral adiposity index and visceral adipose tissue dysfunction, monitored blood cholesterol and sugar, waist and body mass index (a measure of obesity based on body measurements), and Framingham and ASCVD scores after six and 12 months of Signifor treatment.
The Framingham Risk Score is a measure of the 10-year risk of cardiovascular disease and the atherosclerotic cardiovascular risk (ASCVD) score assesses the risk of cardiovascular disease on the whole.
The study included 16 patients with Cushing’s disease who already had been successfully treated with Signifor for at least 12 months.
Before starting pasireotide treatment, visceral adipose tissue dysfunction was present in seven of the 16 patients. After 12 months of treatment, the 24-hour urinary-free cortisol levels, body mass index, waist circumference, cholesterol, triglycerides, visceral adiposity index, and visceral adipose tissue dysfunction severity were decreased significantly, compared to baseline.
At this point, visceral adipose tissue dysfunction was present in only one patient, compared to seven at the beginning of the study. However, the number of patients with diabetes mellitus and high blood sugar levels had increased significantly. Framingham and ASCVD risk scores were not significantly different from pre-treatment values.
Overall, while visceral adiposity index scores decreased in the patients, Framingham and ASCVD risk scores did not change and the number of patients with diabetes increased.
“Twelve-month pasireotide treatment significantly reduces [visceral adipose index] and [visceral adipose tissue dysfunction] in CD patients. These positive effects on cardiometabolic risk occur despite no change in Framingham and ASCVD risk scores and the increase in the prevalence of diabetes mellitus,” the investigators concluded.
Several of the authors received funding from Novartis, Signifor’s maker.