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Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.

2017-05-09

The mean age of the patients was 56.0 +/- 10.3 years. 79.0 percent were male and 62.9 percent had hypertension, 39 percent had diabetes mellitus with a mean HBA1c of 7.7 percent. 58.1 percent had a history of myocardial infarction. The median simvastatin equivalent dose was 40 (range 5-80) mg. Duration of ezetimibe treatment was 102 +/- 60 days. We observed improvements in total cholesterol (TC) (from 5.31 +/- 1.02 to 4.33 +/- 1.11 mmol/l, 16.4 percent reduction, p-value less than 0.0005), low density lipoprotein (LDL) (from 3.43 +/- 0.87 to 2.52 +/- 0.95 mmol/l, 24.0 percent reduction, p-value less than 0.0005) and TC to LDL ratio (from 4.92 +/-1.42 to 4.03 +/-1.16, 16.2 percent reduction, p-value less than 0.0005). The percentage improvement of lipid profile was comparable to that of the published data based on 10-mg dosing.

The aim of the study was to compare the effect of two different hypolipidemic therapies on the structure of erythrocyte membranes.

For accurate assessment of AS severity, pressure recovery adjustment of AVA must be routinely performed. Estimation of pressure recovery at the sinotubular junction is suggested.

The prevalence of severe stenosis increased with the AVAindex criterion compared to AVA from 71% to 80% in the retrospective cohort, and from 29% to 44% in SEAS (both p<0.001). Overall, the predictive accuracy for aortic valve events was virtually identical for AVA and AVAindex in the SEAS population (mean follow-up of 46 months; area under the receiver operating characteristic curve: 0.67 (95% CI 0.64 to 0.70) vs. 0.68 (CI 0.65 to 0.71) (NS). However, 213 patients additionally categorised as severe by AVAindex experienced significantly less valve related events than those fulfilling only the AVA criterion (p<0.001).

Fixed-dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS.

There is limited research detailing low-density lipoprotein cholesterol (LDL-C) trends over the long term in children on various lipid-lowering medications.

We compared the results of a hypothesis-generating analysis of the incidence of cancer in the SEAS trial of ezetimibe plus simvastatin in 1873 patients (mean follow-up after ezetimibe or matching placebo was begun, 4.1 years) with a hypothesis-testing analysis of cancer data from the two large ongoing trials of this regimen: the Study of Heart and Renal Protection (SHARP) (NCT00125593) with 9264 patients (mean follow-up, 2.7 years) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) (NCT00202878), currently with 11,353 patients (mean follow-up, 1.0 year).

Curcumin is a polyphenol and the one of the principle curcuminoids of the spice turmeric. Its antioxidant, anti-cancer and anti-inflammatory effects have been intensively studied. Previous in vivo studies showed that administration of curcumin also decreased cholesterol levels in the blood, and the effects were considered to be related to upregulation of LDL receptor. However, since plasma cholesterol levels are also influenced by the uptake of cholesterol in the gut, which is mediated by a specific transporter Niemann-Pick Cl-like 1 (NPC1L1) protein, the present study is to investigate whether curcumin affects cholesterol uptake in the intestinal Caco-2 cells.

Niacin may reduce cardiovascular events as monotherapy; however, recent trials in combination with statins have failed to show a benefit. Trials with omega-3 FAs have failed to demonstrate significant reductions in cardiovascular outcomes. Fibrates may improve cardiovascular outcomes as monotherapy; however, trials in combination with statins have failed to show a benefit, except in those with elevated triglycerides (>200 mg/dL) or low HDL-C (<40 mg/dL). There is a lack of data that evaluates bile acid sequestrant in combination with statin therapy on reducing cardiovascular events. Ezetimibe-statin combination therapy can reduce cardiovascular outcomes in those with chronic kidney disease and following vascular surgery or acute coronary syndrome. Long-term effects of emerging nonstatin therapies (CETP and PCSK9 inhibitors) are currently being evaluated in ongoing Phase III trials.

A total of 7427 patients were included in the study. A total of 3226 patients attained a LDL-C less than 70 mg/dL. The majority (92.4%) attaining goal were receiving statin monotherapy or in combination compared with 81.3% not at goal (P < .001). More than one-half attained goal on statin monotherapy with 70.7% at moderate- to high-potency doses and 87.4% on generically available statin. Nearly one-third attaining goal received statin in combination. Ezetimibe (70.6%) was most frequently used with statin. Factors independently associated with failure to attain a LDL-C less than 70 mg/dL were age younger than 65 years, patients not receiving statin, a history of creatine kinase elevation, and female sex.