Search

Background: Oral octreotide capsules (OOC; MYCAPSSA®) are approved in the US for individuals with acromegaly who responded to and tolerated treatment with injectable somatostatin receptor ligands (iSRLs). Add-on cabergoline therapy has shown effectiveness in patients previously inadequately controlled with iSRLS.1 The phase 3 MPOWERED trial assessed maintenance of response with OOC compared to iSRLs. Patients receiving OOC and ineligible for randomized controlled treatment (RCT) phase were eligible for a sub-study evaluating combination therapy with cabergoline, a dopamine agonist. Methods: Patients who fail to respond to 80 mg/d OOC for ≥2 weeks during the 26-week Run-in phase, or ineligible to enter the RCT on 80 mg/d OOC, due to inadequate biochemical control (insulin-like growth factor I [IGF-I] ≥1.3 × upper limit of normal [ULN] to Results: Of 146 patients enrolled in MPOWERED, 14 entered the combination sub-study, 9 having IGF-I ≥1.3 × ULN at sub-study start. Final cabergoline doses were 1 (n=5), 2 (n=3), 3 (n=1), and 3.5 mg (n=5) with 25.4-week (SD, 14.1) mean treatment duration. Week 36 IGF-I improved in most patients (n=12; 85.7%). Of 9 patients with IGF-I ≥1.3 × ULN at sub-study start, 5 (55.6%; 95% CI, 21.2%-86.3%) exhibited IGF-I decreased to predefined responder range ( Conclusion: We have shown for the first time the benefit of an all-oral combination treatment for acromegaly and avoidance of injection-related burdens. Addition of cabergoline to OOC yielded biochemical control improvement (IGF-I reduction) in patients inadequately controlled with OOC monotherapy. As both combination and OOC monotherapy safety profiles were similar, adjunctive cabergoline may be helpful in patients with acromegaly who do not achieve adequate biochemical control on OOC alone. 1Giustina A, et al. Nat Rev Endocrinol. 2014;10(4):243-248.

Aims. Insulin degludec (IDeg) is a novel insulin analogue that, following subcutaneous injection, forms soluble multihexamers, resulting in an ultra-long duration of action, which is two-fold longer than that of insulin glargine (IGlar). We present data from Russian cohorts of two multinational, open-label, treat-to-target phase 3 trials that investigated the efficacy and safety of IDeg and IGlar administered once daily.Materials and methods. The BEGIN Basal–Bolus Type 1 trial was a 52-week study comparing IDeg (n = 45) to IGlar (n = 16), both 100 U/mL, and in combination with insulin aspart in patients with type 1 diabetes (T1D). The BEGIN LOW VOLUME trial compared IDeg (200 U/mL; n = 27) to IGlar (100 U/mL; n = 28) over 26 weeks in insulin-naïve patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs. The primary outcome of both studies was the non-inferiority of IDeg to IGlar, as assessed by HbA1c level reduction at the trial end.Results. In patients with T1D, HbA1c level reductions at the trial end were 0.42% (IDeg) and 0.22% (IGlar). The rates of confirmed hypoglycaemia (plasma glucose level 3.1 mmol/L or severe) were lower in IDeg than in IGlar [17.83 vs. 22.87 events/patient/year exposure (PYE), respectively]. The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (2.24 vs. 4.77 events/PYE, respectively). Severe episodes occurred in 10% of patients in both treatment groups, with rates per PYE of 0.12 (IDeg) and 0.06 (IGlar). In patients with T2D, HbA1c levels decreased by 1.17% (IDeg) and 1.26% (IGlar) at the trial end. The rates of confirmed hypoglycaemia were comparable in IDeg and IGlar (0.52 vs. 0.44 events/PYE, respectively). The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (0.18 vs. 0.28 events/PYE, respectively). No severe episode occurred in either treatment group. In both studies, IDeg was well tolerated with no difference in safety between the two analogues investigated.Conclusions. In both T1D and T2D, IDeg provided similar glycaemic control to IGlar, with a lower risk of nocturnal hypoglycaemia.