Ezetimibe/simvastatin vs simvastatin in coronary heart disease patients with or without diabetes

Abstract Background Treatment guidelines recommend LDL-C as the primary target of therapy in patients with hypercholesterolemia. Moreover, combination therapies with lipid-lowering drugs that have different mechanisms of action are recommended when it is not possible to attain LDL-C targets with statin monotherapy. Understanding which treatment or patient-related factors are associated with attaining a target may be clinically relevant. Methods Data were pooled from two multicenter, randomized, double-blind studies. After stabilization on simvastatin 20 mg, patients with coronary heart disease (CHD) alone and/or type 2 diabetes mellitus (T2DM) were randomized to ezetimibe 10 mg/simvastatin 20 mg (EZ/Simva) or simvastatin 40 mg. The change from baseline in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC/HDL-C ratio, triglycerides, and the proportion of patients achieving LDL-C Results EZ/Simva treatment (N = 93) resulted in significantly greater reductions in LDL-C, TC, and TC/HDL-C ratio and higher attainment of LDL-C Conclusion EZ/Simva is an effective therapeutic option for patients who have not achieved recommended LDL-C treatment targets with simvastatin 20 mg monotherapy. Trial Registration Clinical trial registration numbers: NCT00423488 and NCT00423579</p

Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics: a multicenter, randomized trial (the LEAD study)

Abstract Background The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM). Methods Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides was assessed. Results EZ + simva 10/20 mg produced a significantly greater change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2% vs -20.8%; p Conclusions These results demonstrate that EZ + simva 10/20 mg may provide a superior alternative for LDL-C lowering vs doubling the dose of simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, the combination therapy may provide an alternative treatment for patients who require further LDL-C reduction than they can achieve with simvastatin 20 mg alone.</p

Diagnostic yield of endoscopic ultrasound-guided tissue acquisition of solid pancreatic lesions after inconclusive percutaneous ultrasound-guided tissue acquisition

After a failed percutaneous ultrasound (US)-guided sampling, it is recommended that endoscopic ultrasound (EUS)-guided tissue acquisition (TA) be performed for non-resectable solid pancreatic lesions according to the European Federation of Societies for Ultrasound in Medicine and Biology. However, the diagnostic performance of EUS-guided TA in this setting is unknown

Reappraisal of factors impacting the cannulation rate and clinical efficacy of endoscopic minor papilla sphincterotomy

Background: We aimed to assess factors impacting the endoscopic minor papilla sphincterotomy (EMPS) success rate, clinical efficacy, and safety in a large cohort of patients with symptomatic pancreas divisum (PD). Methods: Retrospective study including patients with PD referred to the Pancreas Institute of Verona from May 2009 to May 2020 to undergo EMPS. The whole population was analyzed to assess EMPS technical success, defined as the rate of deep cannulation of the dorsal duct. Patients treated for recurrent pancreatitis (RP) with a minimum follow-up of 1 year were included to evaluate the clinical efficacy, defined as resolution or significant reduction of acute pancreatitis (AP) episodes. Safety was defined as the rate of procedure-related adverse events (AEs) according to an international lexicon. The effects of the main determinants on study outcomes were evaluated. Results: Overall, 106 patients were evaluated. Technical success was obtained in 87 (82.1%). The presence of pancreatic calcifications was associated with failure (p&nbsp;&lt;&nbsp;0.0001). Clinical efficacy was evaluated in 59 patients. Resolution/reduction of AP episodes after EMPS was observed in 93% of patients over a median follow-up of 49 months (IQR 37-92). Smoking habit was associated with AP recurrence (p&nbsp;=&nbsp;0.026). The overall AE rate was 14.9%, with post-ERCP pancreatitis as the most common complication (12.6%). Conclusions: In our study, performed at a tertiary center, EMPS showed satisfactory technical success and an acceptable safety profile. If confirmed by prospective multicenter studies, EMPS could become the standard of care for the treatment of RP in PD

Randomized trial comparing the fork-tip and the side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions

The aim of this study was to compare the performance of EUS-guided fine-needle biopsy using fork-tip (SharkCore, Medtronic, USA) or side-fenestrated (ProCore, Cook Medical, Limerick, Ireland) needles in patients with solid pancreatic lesions