Deutsche medizinische Wochenschrift
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Dtsch. Med. Wochenschr. · Aug 2024
Randomized Controlled Trial[Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2].
The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. ⋯ The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.
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Dtsch. Med. Wochenschr. · Jun 2023
Randomized Controlled Trial[Endovascular Therapy for Peripheral Artery Disease - Therapeutic Options for Treatment of Severe Calcification].
Calcified lesions are a major limitation of endovascular therapy of peripheral artery disease. Recently published studies evaluating the impact of lithotripsy (Disrupt III) and directional atherectomy (REALITY) as vessel preparation devices for calcified femoro-popliteal lesions prior to the final treatment with drug-coated balloons (DCB). Disrupt III, a randomized controlled trial comparing lithotripsy and regular balloon angioplasty for vessel preparation prior to DCB, and REALITY, a single-arm study of directional atherectomy prior to DCB angioplasty resulted in low provisional stent and dissection rates. ⋯ Importantly, both vessel preparation strategies resulted in a low rate of post-procedural residual stenosis of >30%, the major predictor for loss of patency following DCB angioplasty in long-term. Lithotripsy is an emerging therapy concept for vessel preparation of calcified pelvic arteries prior to trans-femoral aortic valve implantation. In summary, vessel preparation of calcified arterial lesions by improving vessel compliance or reducing the plaque load represent promising technical methods reducing provisional stent rates and improving longer-term outcomes.
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Dtsch. Med. Wochenschr. · Apr 2013
Randomized Controlled Trial Multicenter Study Comparative Study[Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride].
Progressive deterioration of glycaemic control in type 2 diabetes mellitus (T2DM) often requires treatment intensification. Dapagliflozin increases urinary glucose excretion by selective inhibition of renal sodium-glucose cotransporter 2 (SGLT2). We assessed the efficacy, safety and tolerability of dapagliflozin added to glimepiride in patients with uncontrolled T2DM. ⋯ Dapagliflozin added to glimepiride in patients with T2DM uncontrolled on sulphonylurea monotherapy significantly improved HbA1c, reduced weight and was generally well tolerated, although events suggestive of genital infections were reported more often in patients receiving dapagliflozin.
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Dtsch. Med. Wochenschr. · Apr 2013
Randomized Controlled Trial Multicenter Study Comparative Study[Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin].
Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2, may improve glycemic control with a lower dose of insulin and attenuate the associated weight gain in patients with inadequate control despite high doses of insulin. ⋯ Dapagliflozin improves glycemic control, stabilizes insulin dosing, and reduces weight without increasing major hypoglycemic episodes in patients with inadequately controlled type 2 diabetes mellitus.
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Dtsch. Med. Wochenschr. · Apr 2013
Randomized Controlled Trial Multicenter Study Comparative Study[Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin].
Although initially effective, sulfonylureas are associated with poor glycemic durability, weight gain, and hypoglycemia. Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycemia by increasing urinary glucose excretion independent of insulin and may cause fewer of these adverse effects. We compared the efficacy, safety, and tolerability of dapagliflozin with the sulfonylurea glipizide in patients with type 2 diabetes inadequately controlled with metformin monotherapy. ⋯ Despite similar 52-week glycemic efficacy, dapagliflozin reduced weight and produced less hypoglycemia than glipizide in type 2 diabetes inadequately controlled with metformin. Long-term studies are required to further evaluate genital and urinary tract infections with SGLT2 inhibitors.