ABSTRACT
Aim: Metabolic syndrome (MetS) and all its components are independently characterized by the presence of low-grade chronic inflammation. The study aimed at controlling inflammation using sulfasalazine 500mg, once a day treatment in comparison to placebo in MetS patients. Study Design: Double blind, randomized, placebo controlled study. Place and Duration of Study: Sadbhavna Medical and Heart Institute, Patiala; and, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, between January-November 2014. Methodology: 50 eligible subjects (Male / Female = 45/5, n=25/group), fulfilling the National Cholesterol education Program-Adult Treatment Panel (NCEP-ATP III) diagnostic criteria of MetS, were randomly assigned to once daily drug or placebo tablets for 20 weeks. Blood pressure, serum high sensitivity C-reactive protein (hsCRP), tumor necrosis factor–alpha (TNF-α), lipid profile, fasting plasma glucose and insulin levels, homeostatic model assessment-insulin resistance (HOMA-IR), endothelial-dependent flow-mediated dilation (FMD) of brachial artery, right common carotid artery’s intima-media thickness (IMT) and artery stiffness indices [(Young elastic modulus (YEM), stiffness index (SI) and carotid arterial compliance (CAC)] by Doppler Ultrasound were assessed at baseline and after 20 weeks treatment. Tolerability of drug was also measured using hematological and biochemical analysis. Statistical significance was accepted at p ≤.05. Results: FMD improved as 25.66±6.47% versus 12.41±3.22%, p<0.01; and insulin resistance (HOMA-IR) decreased as 7.05±3.48 versus 11.32±6.08, p<0.01, from baseline in drug group as compared to placebo group, whereas endothelium-independent vasodilatation (p=0.23) and baseline brachial artery diameter (p=0.95) remained unchanged in both the groups. Serum triglycerides (p=0.04), hsCRP (p<0.01) and TNF-α (p<0.01) levels were considerably altered, but there was no effect on carotid IMT, YEM, CAC and SI (all p≥0.05). Biochemical and hematological safety variables were significantly altered, but were still found with-in the normal limits. Conclusion: Thus, sulfasalazine may prevent cardiovascular disease risk in MetS patients by reducing insulin resistance and endothelial dysfunction via halting inflammatory process. Moreover, it was found tolerable.
ABSTRACT
Aim: The study was aimed to determine the association of adipose derived hormones, adiponectin, leptin, and adiponectin/leptin (A/L) ratio with presence and degree of atherosclerosis in metabolic syndrome patients. Study Design: Open label, pilot, case-control study. Place and Duration of Study: Sadbhavna Medical and Heart Institute, Patiala and, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, (INDIA), between January 2013 and December 2013. Methodology: Metabolic syndrome patients (n=55) with age ≥ 18 years, undergoing angiography for diagnosis and/or interventional treatment of atherosclerosis, and 25 matched control subjects were recruited. Evaluation of traditional and novel cardiovascular risk factors (adipose-derived hormones) and their association with angiographic-derived presence and degree of atherosclerosis indices (number of blocked vessels, severity index, and extent index) was carried out. Continuous variables were expressed as mean ± standard error mean and discrete variables were presented as frequencies and percentages. One way ANOVA was used to assess the difference b/w the groups characterized according to the number of vessels blocked. For each of the indices, the significant univariate predictors were entered into a forward stepwise multivariate regression model (model 1 and model 2) to determine the independent predictors. Statistical significance was accepted at P≤. 05. Results: The independent predictors of atherosclerosis for number of blocked vessels were low serum adiponectin and high total cholesterol level. For extent and severity index, low adiponectin level was the only significant and independent predictor. Leptin and A/L ratio could not prove as significant predictors (P≥. 05). Conclusion: Total cholesterol, adiponectin, leptin and A/L ratio might play a vital pathogenic role not only in the occurrence, but also in the severity, extent, number of vessels blocked complexity in metabolic syndrome patients.