ABSTRACT
Globally liver disorders are major cause of illness death and death. Oxidative stress plays a critical role in the progression of alcoholic and nonalcoholic related diseases. The aim of the present study was to evaluate the efficacy and tolerability of fixed dose combination (FDC) of silymarin, alpha lipoic acid, N-acetyl cysteine and selenium in the management of liver disorders. This was an observational, non-randomized, open label, non-comparative, multi-centric post-marketing surveillance study. The above mentioned FDC was administered to 15 patients diagnosed with alcoholic or viral hepatitis for three months. Evaluation of liver function tests (LFT) were carried out at baseline and at the end of 3rd month of the treatment. Significant changes were observed in the LFT parameters at the end of three months of this study. aspartate aminotransferase (AST): (Mean ± SEM) 369.9 ± 128.0 to 97.00 ± 34.27 U/L, (p < 0.0001); alanine aminotransferase (ALT): 652.93 ± 214.57 to 194.40 ± 82.51 U/L, (p < 0.03); Alkaline phosphatase: 197.47 ± 25.57 to 151.60 ± 17.92 U/L, (p < 0.0059); Gamma glutamyl transferase: 156.67 ± 49.80 to 87.33 ± 22.94 U/L, (p < 0.0490); Total bilirubin: 3.44 ± 0.76 to 1.66 ± 0.57 mg/dL, (p < 0.0192) and bilirubin direct: 2.13 ± 0.58 to 1.00 ± 0.50 mg/dL, (p < 0.0273). Two patients reported mild gastrointestinal adverse events (nausea, bloating). This FDC was therapeutically effective under the circumstances of elevated oxidative stress and produces significant reduction in LFT parameters in alcoholic and viral hepatitis patients.
ABSTRACT
Anti-diabetic therapy initiated should be directed towards the target, both fasting and as well as postprandial hyperglycaemia. Despite the introduction of new agents efforts for better management of diabetes are disappointing and the control of blood glucose levels remains unsatisfactory. The aim of the present study was to evaluate the safety and efficacy of triple drug fixed dose combination (FDC) of Voglibose, Glimepiride and Metformin in type 2 diabetes mellitus. The study was post marketing surveillance (PMS) non-randomized, open, non-comparative and multi centric study. The above mentioned FDC was administered to 118 type 2 diabetic patients once daily for 3 months. Baseline values were recorded for glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and post prandial blood glucose/hyperglycaemia (PPHG) level. There was significant decrease in HbA1c value (8.69 ± 1.81 % vs. 6.475± 0.39 %, P<0.0001); FPG (206.5±73.76 mg/dl vs. 112.7 ± 25.73mg/dl, P<0.0001) and PPHG level (244.7 ± 69.95 mg/dl vs. 141.7 ± 22.64 mg/dl, P<0.0001) after 3 month of the treatment from the baseline. The triple drug FDC of Voglibose, Glimepiride and Metformin significantly decreased the HbA1c, FPG and PPHG levels at the end of the treatment. Investigators observed good clinical effectiveness without any adverse effect reported.
ABSTRACT
Despite many therapeutic options available only one-third of hypertensive patients achieve target Blood pressure (BP). The present study was undertaken to evaluate the efficacy and safety of triple drug, fixed dose combination of Telmisartan 40 mg + Amlodipine 5 mg + Hydrochlorothiazide 12.5mg, in the management of hypertensive patients with or without co-morbidities. A total of 60 patients were enrolled on the basis of mean seated cuff systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg in this post-marketing surveillance (PMS) study. Patients were prescribed triple drug fixed dose combination for 120 days. In all groups (diabetic hypertensive, Dyslipidemic hypertensive and hypertension without any complication) there was statistically significant decrease (p<0.0001) in systolic blood pressure (SBP) from the baseline to 30th, 60th and 120th days of the treatment. Diastolic BP (DBP) was significantly decreased (p<0.0001) from the baseline just after 15th day of the treatment and on subsequent days of observation. 50% of diabetic hypertensive patients and 78.5% of hypertensive patients with dyslipidaemia achieved the Joint national committee VII (JNC VII) recommended goal (130/80mm Hg) at the end of study period of 120 days. Similarly in patients with hypertension without complication, 81.3% achieved the JNC VII recommended goal (140/90mm Hg) at the end of the study period. Triple drug fixed dose combination therapy of Telmisartan, Amlodipine and hydrochlorothiazide has been shown to be an effective, safe and convenient treatment strategy in controlling the blood pressure and achieving the desired blood pressure goal.
ABSTRACT
Hypertension is a major health problem in India. Different clinical studies have reported that reducing the blood pressure can substantially decrease cardiovascular risk and all cause mortality. This study was conducted to evaluate the efficacy and safety of triple drug fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorthiazide 12.5mg. 41 hypertensive patients having systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥100 mmHg who were uncontrolled on dual drug therapy with Telmisartan-Amlodipine or Telmisartan-Hydrochlorothiazide combinations were enrolled in this study. The treatment period was of 120 days and patients were administered once daily fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorthiazide 12.5mg. Patients were evaluated on 15th, 30th, 60th and 120th days of treatment. There was statistically significant (p60 years and <60 years achieved the JNC VIII recommended target goal respectively. This triple drug fixed dose combination of Telmisartan, Amlodipine and hydrochlorothiazide was found to be effective and safe option for the optimal management of hypertension without any safety concern.