Recombinant Statin Drug (RSD) For Managing Metabolic Syndrome

Introduction to Metabolic Syndrome

Metabolic syndrome is a health condition which is initiated by insulin resistance and couple up with other metabolic disorders. Metabolic syndrome is diagnosed with elevated levels; of obesity, triglycerides, high blood pressure, and fasting glucose. There is an increased global prevalence of metabolic syndrome and this has led to the introduction of new medication approaches being developed to address the condition. Common medication approach is the use of the statin. They have tolerable effects on treating and managing dyslipidemia. However, with the shortcomings observed, new recombinant drug management has been formulated and thus this randomized study aimed at evaluating its effects on managing metabolic syndrome. This experimental study adopted randomized control double-blind study it passed three populations groups which include; normal population, control group, and treatment group. The recombinant drug was assessed with glucose, insulin, total cholesterol and triglyceride variables. The results of the study showed improved clinical outcome and highly significant effect of the drug with the key variables being assessed, with the levels of glucose (0.004), insulin (0.0001), total cholesterol (0.001), and triglycerides (0.002) significant at 95% CI. Thus with the results of this study, the new drug regime RSD has huge significant impacts on reducing lipid levels thus reducing the effects of metabolic syndrome.   

Metabolic syndrome also referred to as insulin resistance is a group of metabolic disorders which have its effects on glucose intolerance, resistance to insulin, dyslipidemia and glucose intolerance. A criterion for diagnosing metabolic syndrome follows a central obesity patient and raised triglycerides, decrease high blood pressure and elevated fasting glucose plasma. Metabolic syndrome is a serious public health issue due to its related global prevalence. The disorder has effects on the increased occurrence of hypertension, type II diabetes and heart-related diseases, (Hosseini-Esfahani et al., 2014 pp 106-108).

Metabolic syndrome prevalence often varies across the populations based on ethnicity, age, and gender. Studies undertaken in Tehran by Prevention and Metabolic Disorders Research Center found out that among 4018 subjects aged above 40 years, the prevalence of metabolic syndrome was found to be 51.4 %(Hadaegh, Shafiee, Ghasemi & Sarbakhsh, 2010). This high prevalence rate endangers huge population of Iran at elevated risks linked to cardiovascular. Among South Asians, metabolic syndrome predisposes patients with more and elevated occurrence of type 2 diabetes mellitus and coronary heart disease. Cardiovascular risk factors were initially supported with students undertaken in Europe, where reports of a high prevalence of metabolic syndrome occur, (Hadaegh et al., 2012 pp 430).

The Prevalence of Metabolic Syndrome

The associated clinical repercussions of the metabolic syndrome involve making changes on glucose and lipid homeostasis which play a role in the insensitivity. Insulin resistance can have an influence on the dyslipidemia state which has an enhanced level of hepatic glucogenesis, the output of glucose and low cholesterol secretion. The occurrence of postprandial suppression of adipose tissue has an effect on the adipose tissue lipolysis leading to increased levels of insulin sensitivity which has a subsequent effect on hyperinsulinemia, (Derakhashan & Balaee, 2010 pp 210).

Anthropogenic dyslipidemia has been linked to metabolic syndrome with low to high-density lipoprotein density, elevated triglyceride, and small low-density cholesterol. Further many patients have been observed to be having low density lipoproteins which increase risks of cardiovascular diseases.

Statin has been recognized as effective and best tolerable agents which are effective in treating and managing dyslipidemia. It is recognized as first-line therapy for reducing the levels of triglyceride and increasing the levels of high-density lipoprotein. Further, it has shown to reduce cardiovascular morbidity and mortality. Statin has been shown to have pleiotropic effects which reduce the oxidative stress and modulating responses, these factors have effects on improving risk factors liked to inflammatory response, (Fritschi & Richlin, 2004 pp 330).

Despite the benefits observed from statin therapy, many patients have been shown to fail to achieve the desired goals in the treatment phase. This can be attributed to inappropriate dosing effects of statin, leading to increased efficiency of myopathy and hepatoxicity. New drug development has been initiated to counter the effect of lipids and to lower the levels of insulin on metabolic syndrome patients. Diabetes has been linked as a factor in cardiovascular disease linked to lipoproteins density among the metabolic syndrome patients, (Kaur,2014 ).

With this new outcome of achieving the desired outcome, new recombinant Statin Drug, RSD, this experimental study aimed at testing the effectiveness of the drug on lowering the effect of metabolic syndrome. Thus the aim of this study aimed at evaluating the effects of RSD drug on metabolic syndrome. 

The study adopted a randomized double-blind parallel study evaluating the efficacy and effects of the new drug on metabolic syndrome. Ethical approval was approved and informed consent approval, the patients meeting the inclusion and exclusion criteria at enrolment of the study were recruited for 10 weeks on high-fat dietary plan. Eligible patients were randomized and received RSD  mg for  4 weeks.

Effects of Metabolic Syndrome on Homeostasis

Presence of concomitant medications such as azole, antifungal, vitamin k, systemic steroids and medication interacting with statin intake and metabolism were permitted from the study. Further those patients who took lipid-lowering medication were excluded from the study.

The study involved patients aged 18 years and above qualified for the study. Metabolic syndrome in the study was defined with the following key parameters; abdominal obesity having >102cm; men and >88cm for women, TG ≥1.60mmol; HDL-C lower than 1.03 mol/L for men while female <1.30 for women. Blood pressure ranged between ≥130/85 and fasting blood glucose index of ≥6.12mmol/L. Further, the patients need to have LDL-C of 3.35 mmol with additional risks factors of diabetes. The exclusion criteria process followed a history of usage of lipid-lowering agents and known history of known hypercholesteremia and sensitivity of statin.

Assessments of lipids, glucose were measured for the patients. Lipid levels were measured using enzymatic determination of total serum cholesterol kit which is commercially available, HDL was assessed using isolation of high density by the use of polyethylene. The results were analyzed using mean difference. 

The results on glucose levels, insulin, and total cholesterol were assessed after the four weeks the following results were obtained;

Baseline information of the patients

Figure 1Mean variables range 

Assessment variables change 

Figure 2Mean percentage change after the treatment phase 

The recombinant statin drug RSD has an effect on the levels of cholesterols. Further, they have pleiotropic effects which are effective in lowering cholesterol levels and having a beneficial effect on metabolic syndrome, (Cederberg et al., 2015). Statin has been shown to demonstrate a 50% reduction of low-density lipoprotein. The results of this study indicate that the recombinant drug has positive effects on reducing triglyceride factors which are major contributors of LDL. There is a significant difference in the values obtained from the three distinct groups of the study.

The results showed that the new recombinants drug is effective and shows statistical significance on the levels of glucose (0.004), insulin (0.0001), total cholesterol (0.001), and triglycerides (0.002). The drug shows an effective way of lowering the cholesterol levels of the patients. Further, it reduces the effect of low-density lipoproteins in the body.

Adjuvant Statin has been demonstrated to improve the levels of low-density lipoproteins. These findings are consistent with research undertaken on the use of statin alone, (Meike et al., 2015). Combined new drug therapy referred to RSD has been demonstrated to have a positive outcome due to reducing the factors associated with a reduction of other related factors such as glucose, insulin levels, total cholesterol, and triglycerides levels. As observed from table 2, there are significant differences in the parameters assessed on the mean level.  

Statin Treatment for Dyslipidemia Management

Other factors assessed such as triglyceride and total cholesterol was reduced and found out to be reduced b the treatment regiment applied. Studies undertaken have shown the statin alone often reach the limits of lipid levels; however, with this study, other factors were significantly reduced. 

Conclusion

Recombinant drug RSD has shown to have tremendous effects on the metabolic syndrome factors. The randomized controlled trial has shown significant benefits of the drug in reducing the levels of glucose, insulin, triglycerides and total cholesterol of patients. The treatment has beneficial effects on patients which are suffering from coronary heart disease with failure to obtain the optimum levels of low-density lipoproteins. In this experiment factors associated with CHD were found to be reduced by the new drug regimen. Thus the new drug is effective in managing patients with metabolic syndrome.  

References

Cederberg, H., Stan?áková, A., Yaluri, N., Modi, S., Kuusiso, J. and Laakso, M., 2015. Increased risk of diabetes with statin treatment is associated with impaired insulin sensitivity and insulin secretion: a 6-year follow-up study of the METSIM cohort. Diabetologia, 58(5), pp.1109-1117.

Derakhshan, R. and Balaee, P., 2010. Evaluation of abdominal obesity prevalence in diabetic patients and relation with other factors of metabolic syndrome. Iranian Journal of Endocrinology and Metabolism, 12(3), pp.208-212.

Fritschi, C. and Richlin, D., 2004. The metabolic syndrome—early action to decrease risks for cardiovascular disease. Aaohn Journal, 52(8), pp.320-322.

Hadaegh F, Shafiee G, Ghasemi A, Sarbakhsh P, Azizi F. Impact of metabolic syndrome, diabetes, and prediabetes on cardiovascular events: Tehran lipid and glucose study. Diabetes research and clinical practice. 2010 Mar 1;87(3):342-7.

Hadaegh, F., Zabetian, A., Khalili, D., Nadarkhani, M., James, W.P.T. and Azizi, F., 2012. A new approach to compare the predictive power of metabolic syndrome defined by a joint interim statement versus its components for incident cardiovascular disease in Middle East Caucasian residents in Tehran. J Epidemiol Community Health, 66(5), pp.427-432.

Hosseini-Esfahani, F., Mirmiran, P., Daneshpour, M.S., Mehrabi, Y., Hedayati, M., Zarkesh, M. and Azizi, F., 2014. Western dietary pattern interaction with an APOC3 polymorphism in the risk of metabolic syndrome: Tehran lipid and glucose study. Lifestyle Genomics, 7(2), pp.105-117.

Kaur, J., 2014. A comprehensive review of metabolic syndrome. Cardiology research and practice, 2014.

Meikle, P.J., Wong, G., Tan, R., Giral, P., Robillard, P., Orsoni, A., Hounslow, N., Magliano, D.J., Shaw, J., Curran, J.E. and Blangero, J., 2015. Statin action favors normalization of the plasma lipidome in the atherogenic mixed dyslipidemia of metabolic syndrome: Potential relevance to statin-associated dysglycemia. Journal of lipid research, pp.jlr-P061143.

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