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      A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia

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          Abstract

          Mixed dyslipidemia is characterized by increased low-density lipoprotein cholesterol (LDL-C) elevated triglycerides (TGs) and decrease high-density lipoprotein cholesterol (HDL-C). It is more common in diabetes and is associated with an increased risk of coronary artery disease. Monotherapy with statins or fibrates may not effectively control all lipid parameters. The atorvastatin-fenofibrate combination has been shown to have highly beneficial effect on lipid parameters in type 2 diabetes associated with combined hyperlipidemia (CHL). In an open-label study, we evaluated the efficacy of atorvastatin alone and in combination with fenofibrate in 60 types 2 diabetes mellitus patients associated with hyperlipidemia. Patients were randomly assigned to receive atorvastatin 10 mg (Group 1) or combination of atorvastatin 10 mg and fenofibrate 145 mg (Group 2) once daily for 12 weeks. The effect of drugs on lipid profile was evaluated before and after treatment. After 12 weeks, the reduction in total cholesterol (TC), TGs, LDL-C, VLDL-C was 28%, 20%, 37% and 20% in Group 1 ( P < 0.001 for all) as compared with 31%, 39%, 33% and 40% in Group 2 ( P < 0.001 for all). There was insignificant rise in HDL-C in Group 1 ( P = 0.71) and insignificant decrease in HDL-C ( P = 0.70) in Group 2. During the combination therapy, the decrease in TC, TGs and VLDL-C was greater than atorvastatin alone. The combination of atorvastatin with fenofibrate in type 2 diabetes patients with CHL may have a favorable effect on some major coronary artery disease risk factors.

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          Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994.

          To evaluate the prevalence and time trends for diagnosed and undiagnosed diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults by age, sex, and race or ethnic group, based on data from the Third National Health and Nutrition Examination Survey, 1988-1994 (NHANES III) and prior Health and Nutrition Examination Surveys (HANESs). NHANES III contained a probability sample of 18,825 U.S. adults > or = 20 years of age who were interviewed to ascertain a medical history of diagnosed diabetes, a subsample of 6,587 adults for whom fasting plasma glucose values were obtained, and a subsample of 2,844 adults between 40 and 74 years of age who received an oral glucose tolerance test. The Second National Health and Nutrition Examination Survey, 1976-1980, and Hispanic HANES used similar procedures to ascertain diabetes. Prevalence was calculated using the 1997 American Diabetes Association fasting plasma glucose criteria and the 1980-1985 World Health Organization (WHO) oral glucose tolerance test criteria. Prevalence of diagnosed diabetes in 1988-1994 was estimated to be 5.1% for U.S. adults > or = 20 years of age (10.2 million people when extrapolated to the 1997 U.S. population). Using American Diabetes Association criteria, the prevalence of undiagnosed diabetes (fasting plasma glucose > or = 126 mg/dl) was 2.7% (5.4 million), and the prevalence of impaired fasting glucose (110 to < 126 mg/dl) was 6.9% (13.4 million). There were similar rates of diabetes for men and women, but the rates for non-Hispanic blacks and Mexican-Americans were 1.6 and 1.9 times the rate for non-Hispanic whites. Based on American Diabetes Association criteria, prevalence of diabetes (diagnosed plus undiagnosed) in the total population of people who were 40-74 years of age increased from 8.9% in the period 1976-1980 to 12.3% by 1988-1994. A similar increase was found when WHO criteria were applied (11.4 and 14.3%). The high rates of abnormal fasting and postchallenge glucose found in NHANES III, together with the increasing frequency of obesity and sedentary lifestyles in the population, make it likely that diabetes will continue to be a major health problem in the U.S.
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            Diabetes trends in the U.S.: 1990-1998.

            To examine trends in diabetes prevalence in the U.S. This study was conducted via telephone surveys in states that participated in the Behavioral Risk Factor Surveillance System between 1990 and 1998. The participants consisted of noninstitutionalized adults aged 18 years or older. The main outcome measure was self-reported diabetes. The prevalence of diabetes rose from 4.9% in 1990 to 6.5% in 1998--an increase of 33%. Increases were observed in both sexes, all ages, all ethnic groups, all education levels, and nearly all states. Changes in prevalence varied by state. The prevalence of diabetes was highly correlated with the prevalence of obesity (r = 0.64, P<0.001). The prevalence of diabetes continues to increase rapidly in the U.S. Because the prevalence of obesity is also rising, diabetes will become even more common. Major efforts are needed to alter these trends.
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              Relation of gemfibrozil treatment and lipid levels with major coronary events: VA-HIT: a randomized controlled trial.

              A low plasma level of high-density lipoprotein cholesterol (HDL-C) is a major risk factor for coronary heart disease (CHD). A secondary prevention study, the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT), demonstrated that CHD events were significantly reduced during a median follow-up of 5.1 years by treating patients with the fibric acid derivative gemfibrozil when the predominant lipid abnormality was low HDL-C. To determine if the reduction in major CHD events with gemfibrozil in VA-HIT could be attributed to changes in major plasma lipid levels. Multicenter, randomized, double-blind, placebo-controlled trial conducted from September 1991 to August 1998. The Department of Veterans Affairs Cooperative Studies Program, in which 20 VA medical centers were participating sites. A total of 2531 men with a history of CHD who had low HDL-C levels (mean, 32 mg/dL [0.83 mmol/L] ) and low low-density lipoprotein cholesterol (LDL-C) levels (mean, 111 mg/dL [2.88 mmol/L]). Participants were randomly assigned to receive gemfibrozil, 1200 mg/d (n = 1264), or matching placebo (n = 1267). Relation of lipid levels at baseline and averaged during the first 18 months of gemfibrozil treatment with the combined incidence of nonfatal myocardial infarction and CHD death. Concentrations of HDL-C were inversely related to CHD events. Multivariable Cox proportional hazards analysis showed that CHD events were reduced by 11% with gemfibrozil for every 5-mg/dL (0.13-mmol/L) increase in HDL-C (P =.02). Events were reduced even further with gemfibrozil beyond that explained by increases in HDL-C values, particularly in the second through fourth quintiles of HDL-C values during treatment. During gemfibrozil treatment, only the increase in HDL-C significantly predicted a lower risk of CHD events; by multivariable analysis, neither triglyceride nor LDL-C levels at baseline or during the trial predicted CHD events. Concentrations of HDL-C achieved with gemfibrozil treatment predicted a significant reduction in CHD events in patients with low HDL-C levels. However, the change in HDL-C levels only partially explained the beneficial effect of gemfibrozil.
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                Author and article information

                Journal
                J Adv Pharm Technol Res
                J Adv Pharm Technol Res
                JAPTR
                Journal of Advanced Pharmaceutical Technology & Research
                Medknow Publications & Media Pvt Ltd (India )
                2231-4040
                0976-2094
                Jul-Sep 2013
                : 4
                : 3
                : 166-170
                Affiliations
                [1]Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka, India
                [1 ]Department of Pharmacology, Gandhi Medical College, Secunderabad, Andhra Pradesh, India
                Author notes
                Address for correspondence: Dr. Meenakshi Lella, Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka, India. E-mail: drmeenu81@ 123456yahoo.co.in
                Article
                JAPTR-4-166
                10.4103/2231-4040.116778
                3777308
                24083205
                65d3b5b5-ac1e-49d3-b4f2-b4ed5ea2cc4f
                Copyright: © Journal of Advanced Pharmaceutical Technology & Research

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Categories
                Original Article

                Pharmacology & Pharmaceutical medicine
                atorvastatin,fenofibrate,hyperlipidemia
                Pharmacology & Pharmaceutical medicine
                atorvastatin, fenofibrate, hyperlipidemia

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