Abstract
PurposeOctreotide (OCT) has been successfully used for treatment of acromegaly and neuroendocrine tumors for more than 30 years. However, long-term safety of OCT has not been documented in placebo-controlled setting. This present analysis pooled safety data from two similarly-designed, randomized, and placebo-controlled studies to evaluate long-term safety of long-acting OCT (20, 30 mg); targeted post-hoc analyzes focused on cardiac, hepatic, and renal safety.MethodsTwo studies (NCT00131144, NCT001308450) were conducted in patients with diabetic retinopathy (OCT20 = 191, OCT30 = 348, placebo = 347). In this analysis, patients were stratified based on baseline glomerular filtration rate. Hepatic, cardiac, and renal adverse events (AEs) were identified by standardized MedDRA queries.ResultsMedian duration of exposure was >3.5 years. Most common AEs reported with OCT were diarrhea, cholelithiasis, hypoglycemia, nasopharyngitis, and hypertension. Incidence of cardiac events (QT prolongation and arrhythmia) with OCT20 and OCT30 were comparable to placebo (OCT20, RR = 1.11 [95% CI, 0.61–2.03]; OCT30, RR = 1.09 [95% CI, 0.70–1.68]). For ECG findings, changes in QTcF were similar in treatment groups, and outliers did not exceed 480 ms. Incidence of cardiac ischemia was lower with OCT than placebo (OCT20 = 12.6%, OCT30 = 10.6%, placebo = 15.3%). Incidence of liver-related AEs was higher with OCT30 than placebo (RR = 2.04 [95% CI, 1.28–3.26]); incidences were comparable with OCT20 and placebo (RR = 1.50 [95% CI, 0.69–3.25]). Overall incidences of renal AEs were comparable between treatment groups (OCT20 = 5.8%; OCT30 = 6.3%; placebo = 7.2%). Drug-related SAEs were reported more frequently with OCT (OCT20 = 7.9%; OCT30 = 10.1%; placebo = 3.5%); predominantly gallbladder-related, GI-related, and hypoglycemia.ConclusionsThe results from these long-term placebo-controlled studies confirm the established safety profile of long-acting OCT, in particular low risk of cardiac, hepatic and renal toxicity in a high-risk population.
Highlights
Octreotide (SMS 201–995, octreotide acetate, Sandostatin®, Novartis) is a somatostatin analogue (SSA) with a therapeutic use in pathophysiological states associated with excessive hormone production and secretion [1,2,3,4].With extensive clinical and real-world use over the past 30 years, octreotide is considered to have a favorable benefit-risk profile in acromegaly and neuroendocrine tumors [5,6,7,8]
Incidence of liver-related adverse events (AEs) was higher with OCT30 than placebo (RR = 2.04 [95% confidence intervals (CIs), 1.28–3.26]); incidences were comparable with OCT20 and placebo (RR = 1.50 [95% CI, 0.69–3.25])
Overall incidences of renal AEs were comparable between treatment groups (OCT20 = 5.8%; OCT30 = 6.3%; placebo = 7.2%)
Summary
Octreotide (SMS 201–995, octreotide acetate, Sandostatin®, Novartis) is a somatostatin analogue (SSA) with a therapeutic use in pathophysiological states associated with excessive hormone production and secretion [1,2,3,4].With extensive clinical and real-world use over the past 30 years, octreotide is considered to have a favorable benefit-risk profile in acromegaly and neuroendocrine tumors [5,6,7,8]. Octreotide (SMS 201–995, octreotide acetate, Sandostatin®, Novartis) is a somatostatin analogue (SSA) with a therapeutic use in pathophysiological states associated with excessive hormone production and secretion [1,2,3,4]. Octreotide has been shown to decrease the heart rate and prolong the QT interval, an important risk factor for ventricular arrhythmias. This may be perceived as a treatment risk, there is, some evidence that octreotide may have a beneficial cardiac effect in patients with acromegaly with a reduction, and in some cases, normalization of QT intervals [12] and with improvement of cardiac performance and hypertension [13, 14]
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