This study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS DEPICT-1 (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) was a randomized (1:1:1), double-blind, placebo-controlled phase 3 study of dapagliflozin 5 mg and 10 mg in patients with type 1 diabetes (HbA 1c 7.5-10.5% [58-91 mmol/mol]) (NCT02268214). The results of the 52-week study, consisting of the 24-week short-term and 28-week extension period, are reported here. RESULTS Of the 833 patients randomized into the study, 708 (85%) completed the 52-week study. Over 52 weeks, dapagliflozin 5 mg and 10 mg led to clinically significant reductions in HbA 1c (difference vs. placebo [95% CI] 20.
BackroundThe treatment of wide neck bifurcation aneurysms remains challenging despite the introduction of new techniques (Y stenting, waffle cone technique, or flow diverter stents). The Woven EndoBridge (WEB) device is an innovative solution for this type of cerebral aneurysm. A new WEB 17 is now available and has been designed to offer smaller sized devices to optimize navigability and delivery.MethodsBetween February 2017 and April 2018 all patients treated with the WEB 17 device in our center were retrospectively reviewed. 25 patients with 28 non-ruptured aneurysms were identified and analyzed. Three patients with two aneurysms both treated with the WEB device were identified.ResultsThe device was successfully deployed in all cases. Procedure related morbidity was 4% and mortality was 0%. In one case, a delayed postprocedural thromboembolic event occurred owing to device protrusion. Technical success, complications, angiographic outcomes, procedural data, and follow-ups are reported. The modified Rankin Scale score at discharge was 0 for 24 patients (96%). At the 3, 6, or 9 month follow-up, angiograms were taken of 21 of the 25 patients (84%) (24 of 28 aneurysms had been controlled); 3 patients (3 aneurysms) did not receive angiographic follow-up at the time of submission of this work. Complete occlusion was achieved in 22 of 24 aneurysms (91.66%), and 2 of 24 aneurysm (8.33%) showed a neck remnant.ConclusionsThe WEB 17 is safe and technically feasible, according to this retrospective single center analysis. For very small bifurcation aneurysms, the WEB 17 seems to have lower complication rates than stent assisted techniques. However, further studies are needed to evaluate the complication rate and long term efficiency.
BackgroundWoven EndoBridge (WEB) deployment remains challenging in aneurysms with a complex shape or orientation.ObjectiveTo show that embolization of wide-neck bifurcation aneurysms using the WEB device balloon remodeling-assisted technique is a feasible and elegant endovascular solution compared with other techniques, such as balloon remodeling or stent-assisted coiling.Materials and methods10 cases (10 aneurysms in 9 patients) of balloon remodeling-assisted WEB treatment of unruptured complex bifurcation aneurysms were treated in our institution and retrospectively analyzed. Details of clinical presentations, technical details, perioperative and postoperative complications, and outcomes were collected. Immediate and long-term angiographic results were also evaluated.ResultsAneurysms included six middle cerebral artery aneurysms, one anterior communicating artery aneurysm, one posterior communicating artery aneurysm, one basilar artery aneurysm, and one T-shaped carotid aneurysm. Mean dome width was 6.55 mm, mean neck size 4.5 mm, mean height 4.79 mm, and mean dome-to-neck ratio was 1:1.46. Treatment was performed exclusively with the balloon remodeling-assisted WEB technique in all cases. The device was successfully deployed in every case. Periprocedural thromboembolic or hemorrhagic events did not occur. The modified Rankin Scale score at discharge was 0 for all patients. At mid-term or long-term angiographic follow-up, adequate occlusion was observed in 7 aneurysms from 8 controlled cases (87.5%), and one patient (2 aneurysms) did not have angiographic follow-up.ConclusionThe balloon remodeling-assisted WEB technique seems to be a safe and effective solution for endovascular treatment of unruptured wide-neck bifurcation aneurysms with specific complex anatomy. However, further studies are needed to evaluate the rate of complications and long-term efficacy.
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