scholarly journals Effects of Xuezhikang vs. Pravastatin on Triglyceride Level in Patients with Type 2 Diabetes Mellitus and Dyslipidemia: A Research Protocol for a Randomized Controlled Study

Author(s):  
Jin Xu ◽  
Xiao Du ◽  
Shilan Zhang ◽  
Qunyan Xiang ◽  
Liling Guo ◽  
...  

Abstract Background: Diabetes often accompanies with increase in triglyceride(TG) as well as small dense low density lipoprotein(sdLDL). Statins are difficult to completely correct this dyslipidemia. Xuezhikang, an extract of cholestin, is better than some statins in reducing TG. Under the condition of the similar decrease in LDL-cholesterol (LDL-C), it is not clear whether there is any difference in the effect of XZK and statins on TG reduction in patients with Type 2 DM(T2DM). Methods: An open-label multicenter study is planned to estimate the effects of Xuezhikang(1.2 g/d) and pravastatin(20 mg/d) on TG level and other blood lipids in T2DM patients with dyslipidemia and moderate to high risk of cardiovascular diseases. A total of 114 patients will be enrolled and randomly assigned (1:1 ratio) to accept Xuezhikang or pravastatin therapy for 6 weeks. The primary outcome measure is the change in fasting TG level after 6 weeks. The changes in other fasting lipids and postprandial lipids at 1, 2, 4 h after a nutritious breakfast will also be explored. The planned duration for enrollment is between November 2021 and December 2022. Conclusion: This study will evaluate the effect of 6-week treatment of Xuezhikang(1.2 g/d) and pravastatin(20 mg/d) on fasting TG level and other blood lipids in T2DM patients with dyslipidemia, which may provide a more optimized schedule for lipid control in patients with diabetes and dyslipidemia in primary prevention.

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kausik K. Ray ◽  
Stefano Del Prato ◽  
Dirk Müller-Wieland ◽  
Bertrand Cariou ◽  
Helen M. Colhoun ◽  
...  

Abstract Background Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778). Methods In DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C ≥ 100 mg/dL; n = 413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C ≥ 70 mg/dL; n = 441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin < 9% (DM-DYSLIPIDEMIA) or < 10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was ≥ 70 mg/dL (DM-INSULIN) or non-HDL-C was ≥ 100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these studies. Results This analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C < 100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA]; 65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB < 80 mg/dL (75.1% alirocumab/35.4% UC and 76.8% alirocumab/24.8% placebo, respectively) versus control at week 24 (all P < 0.0001). In pooling these studies, 66.4% (alirocumab) and 67.0% (control) of individuals reported treatment-emergent adverse events. The adverse event pattern was similar with alirocumab versus controls. Conclusions Among individuals with T2DM and ASCVD who had high non-HDL-C/LDL-C levels despite maximally tolerated statin, alirocumab significantly reduced atherogenic cholesterol and LDL-PN versus control. Alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov. NCT02642159. Registered 30 December 2015 and Clinicaltrials.gov. NCT02585778. Registered 23 October 2015


2019 ◽  
Author(s):  
Julius Chacha Mwita ◽  
Brian Godman ◽  
Tonya M Esterhuizen

Abstract Background There is evidence of statin benefit among patients with diabetes regardless of their cholesterol levels or prior cardiovascular disease history. Despite the evidence, there is under-prescription of statins in clinical practice. This study aimed to assess statin prescriptions and associated factors among patients with type 2 diabetes in Botswana. Methods The study was a secondary data analysis of 374 randomly selected type 2 diabetes patients at a specialised diabetes clinic at Gaborone Botswana. We assessed the proportion of statin-eligible patients who are prescribed statins and evaluated the adjusted associations between various factors and statin prescription. Results Overall, 356 (95.2%) participants were eligible for a statin prescription. Clinicians prescribed statins in 162 (45.5%%; 95% confidence interval [CI]: 40.4% - 50.7%)) of eligible participants, and only one (5.5%) ineligible participant. The probability of statin prescription was high in participants with high baseline low-density lipoprotein cholesterol (risk ratio [RR]: 1.49; 95%CI: 1.17 - 1.89), increasing duration of diabetes (RR: 1.01; 95%CI 1.00 - 1.03) and the presence of chronic kidney disease (RR: 1.35; 95%CI: 1.06 - 1.74). Conclusion Most patients with type 2 diabetes are not receiving statins. Clinicians did not consider most guideline-recommended indications for statin prescription. The findings call for improvement in diabetes quality of care by implementing evidence-based guideline recommendations. Key words: statin, type 2 diabetes mellitus, prescription and Botswana


2019 ◽  
Author(s):  
Julius Chacha Mwita ◽  
Brian Godman ◽  
Tonya M Esterhuizen

Abstract Background There is evidence of statin benefit among patients with diabetes regardless of their cholesterol levels or prior cardiovascular disease history. Despite the evidence, there is under-prescription of statins in clinical practice. This study aimed to assess statin prescriptions and associated factors among patients with type 2 diabetes in Botswana. Methods The study was a secondary data analysis of 500 randomly selected type 2 diabetes patients at a specialised diabetes clinic at Gaborone, Botswana. We assessed the proportion of statin-eligible patients who are prescribed statins and evaluated the adjusted associations between various factors and statin prescription. Results Overall, 477(95.4%) participants were eligible for statin prescription. Clinicians prescribed statins in 217 (45.5%%) of eligible participants, and only one(4.4%) ineligible participant. The probability of statin prescription was high in participants with high baseline low-density lipoprotein cholesterol (risk ratio [RR]: 1.49; 95%CI: 1.17-1.89), increasing duration of diabetes(RR: 1.01; 95%CI 1.00-1.03) and the presence of chronic kidney disease(RR: 1.35; 95%CI: 1.06-1.74). Conclusion Most patients with type 2 diabetes in Gaborone are not receiving statins. Clinicians did not consider most guideline-recommended indications for statin prescription. The findings call for improvement in diabetes quality of care by implementing evidence-based guideline recommendations.


2011 ◽  
Vol 07 (01) ◽  
pp. 40
Author(s):  
Yu Kataoka ◽  
Kiyoko Uno ◽  
Stephen J Nicholls ◽  
◽  
◽  
...  

Cardiovascular disease is the leading cause of major morbidity and mortality in patients with type 2 diabetes. The recent focus on the apparent lack of cardiovascular benefit associated with glucose-lowering strategies has overshadowed the importance of targeting dyslipidemia for cardiovascular prevention in patients with diabetes. While lowering low-density lipoprotein (LDL) cholesterol is beneficial, diabetes is also characterized by hypertriglyceridemia, low levels of high-density lipoproteHDL-cholesterol and abundant levels of small, dense LDL particles. Accordingly, these factors represent additional targets for therapeutic modification in order to achieve more effective reductions in cardiovascular risk.


2018 ◽  
Vol 25 (2) ◽  
pp. 157-164
Author(s):  
◽  
Rajesh Kumar Meena ◽  
Sourabh Sharma ◽  
Soumya Sudharsan ◽  
Priyanka Kumari

Abstract Background: This study was conducted to evaluate left ventricular dysfunction in diabetics and to find correlation with glycemic control and biochemical parameters compared to non-diabetic population. Methods: Thirty type 2 diabetics and thirty nondiabetic controls were recruited. Age, sex, body mass index of the controls were matched. Results: Mean duration of diabetes mellitus in study population was 10.97± 4.01years. Among study population both cases and controls had ejection fraction >55%( no systolic dysfunction). Among cases(n=16) 53.3% were having mean E/A ratio <1 and(n=14) 46.67% were had mean E/A ratio >1. In controls all of them had mean E/A ratio above 1. This difference of mean E/A ratio among cases and controls was statistically significant (p<0.001). Among patients with diabetes, 9.09% cases with a HbA1cbetween 6-7%, 33.33% between 7.1-8%, respectively 100% of cases with HbA1c>8.1% had diastolic dysfunction the differences between groups being statistically significant (p<0.001). Low density lipoprotein( LDL) was weakly and negative correlated with E/A ratio (r = - 0.38) while fasting blood sugar (r = -0.53) respectively Hemoglobin A1c (r = -0.66) were moderately and negatively correlated. All these correlations were statistically significant. Conclusion: Subclinical diastolic dysfunction is prevalent among diabetic population. Diastolic dysfunction in patients with diabetes was correlated with FBS, HbA1C and LDL.


2020 ◽  
Author(s):  
Julius Chacha Mwita ◽  
Brian Godman ◽  
Tonya M Esterhuizen

Abstract Background There is evidence of statin benefit among patients with diabetes regardless of cholesterol levels or prior cardiovascular disease history. Despite the evidence, there is under-prescription of statins in clinical practice. This study aimed to assess statin prescriptions and associated factors among patients with type 2 diabetes in Botswana. Methods The study was a secondary data analysis of 500 randomly selected type 2 diabetes patients at a specialised diabetes clinic at Gaborone, Botswana. We assessed the proportion of statin-eligible patients who are prescribed statins and evaluated the adjusted associations between various factors and statin prescriptions. Results Overall, 477 (95.4%) participants were eligible for a statin prescription. Clinicians prescribed statins in 217 (45.5%) of eligible participants, and only one (4.4%) ineligible participant. The probability of a statin prescription was higher in participants with high baseline low-density lipoprotein cholesterol (risk ratio [RR]: 1.49; 95%CI: 1.17-1.89), increasing duration of diabetes (RR: 1.01; 95%CI 1.00-1.03) and the presence of chronic kidney disease (RR: 1.35; 95%CI: 1.06-1.74). Conclusion A large proportion with type 2 diabetes in Gaborone is not receiving statins. Clinicians did not consider most guideline-recommended indications for statin prescriptions. The findings call for improvement in diabetes quality of care by implementing evidence-based guideline recommendations. Keywords: statin, type 2 diabetes mellitus, prescription and Botswana


2002 ◽  
Vol 22 (7) ◽  
pp. 1168-1174 ◽  
Author(s):  
Karen Kornerup ◽  
Børge Grønne Nordestgaard ◽  
Bo Feldt-Rasmussen ◽  
Knut Borch-Johnsen ◽  
Kurt Svarre Jensen ◽  
...  

2021 ◽  
Author(s):  
Sabu Mandumpal Chacko ◽  
Priya Thambi Thekkekara

Diabetes mellitus (DM) is considered a risk factor for the development of coronary artery disease (CAD). Metformin, an anti-diabetic drug, has been shown to lower the cardiovascular events in pre-clinical and clinical studies. Many research articles suggests that metformin has a protective effect on CAD beyond its hypoglycemic effects. Patients with diabetes type 2 have an increased risk for cardiovascular disease and commonly use combination therapy consisting of the anti-diabetic drug metformin and a cholesterol-lowering statin. Statins have been found to be a safe and effective approach to reduce serum low density lipoprotein cholesterol (LDL-C) levels, which is the cornerstone for primary and secondary prevention of atherosclerosis. However, regular statin monotherapy in some patients may not be sufficient to achieve a therapeutic LDL-C. It has been reported that statins increased the incidence of new-onset diabetes in a dose dependent manner especially in women, the elderly, or in the presence of a family history of type 2 diabetes (T2D) and Asian ethnicity. The molecular mechanisms contributed to antioxidation, anti-inflammation, and anti-apoptosis. In this chapter, we aimed to investigate whether the combined administration of metformin and atorvastatin could achieve superior protective effects on different disease treatment purpose and to elucidate its molecular mechanisms of the combinations.


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