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Provident Perspective Volume 1, Issue 2 Provident NewsNew Team Members:
AnnouncementsClinical Research Site Opens in Bloomington, Indiana. Our newest Provident Clinical Research site opened its doors on August 1st, 2005! This research clinic is located at 1000 West 1st Street in Bloomington, Indiana, next door to Bloomington Hospital. The center is integrated with Bloomington Cardiology with 2500 square feet dedicated to clinical study conduct. Contact us by telephone at 812.961.2345 or fax us at 812.961.1525. Administrative Office Moves to New Address. Please note that we have moved our administrative offices to: Recent and Upcoming Publications and PresentationsAbstracts/PresentationsJuly 8, 2005. RA Shalwitz, MH Davidson, H Bays, E Stein, KC Maki, R Doyle, D Kling. Treatment of Dyslipidemia in Patients with the Metabolic Syndrome: A Target Triglyceride Level is Necessary to Produce Shifts in LDL Particle Size. National Lipid Association's Annual Scientific Sessions, Chicago, Illinois. July 8, 2005. MH Davidson, H Bays, E Stein, KC Maki, D Kling, R Doyle, R Shalwitz. Enhanced Response to Fenofibrate in Hypertriglyceridemic Women with the Metabolic Syndrome. National Lipid Association's Annual Scientific Sessions, Chicago, Illinois. September 23, 2005. Kevin C. Maki, PhD. Meta-analysis as a Tool in Nutrition and Medicine. American College of Nutrition Scientific Sessions, Kiawah Island, South Carolina. Note: Dr. Paul Jacques from Tufts University kindly gave this presentation because Dr. Maki was unable to attend due to illness. September 30, 2005. Kevin C. Maki, PhD. Use of Omega-3 Ethel-esters in the Management of Very High Triglyceride Levels. Reliant Pharmaceuticals’ Omacor® Launch Meeting, Detroit, Michigan. October 16, 2005. Kevin C. Maki, Tia M. Rains, Valerie N. Kaden, Judy Quinn, Michael H. Davidon. Effects of a Longer-term Modified Carbohydrate Diet vs. a Low-fat, Portion-controlled Diet on Weight Loss/Weight Maintenance in Overweight or Obese Men and Women. North American Association for the Study of Obesity, Vancouver, Canada. PublicationsDavidson M, Maki KC, Pearson T, Pasternak R, Deedwania P, McKenney J, Fonarow G, Maron D, Ansell B, Clark L, Ballantyne C. Results of the National Cholesterol Education (NCEP) Program Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II survey and implication for treatment under the recent NCEP Writing Group recommendations. Am J Cardiol. 2005;96:556-563. LaPuma J, Szapary P, Maki KC. Predictors of physician overweight and obesity in the USA: an empiric analysis. Nutrition & Food Science. 2005;35:315-319. Maki KC, Davidson MH, Galant R. Non-HDL cholesterol: The forgotten therapeutic target. Am J Cardiol. 2005; (in press). Clark LT, Maki KC, Galant R, Maron DJ; Pearson TA; Davidson MH. Ethnic differences in achievement of cholesterol treatment goals: results from the National Cholesterol Education Program Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II. J Gen Intern Med. 2005; (in press). Maki KC, Davidson MH, Dicklin MR. A comparison of Canadian and United States guidelines for lipid management using data from the National Cholesterol Education Program Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II. Can J Cardiol. 2005; (in press) In the LiteratureDavidson MH, Maki KC, Pearson TA, et al. Results of the National Cholesterol Education Program (NCEP) Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II Survey and Implications for Treatment Under the Recent NCEP Writing Group Recommendations. Am J Cardiol 2005;96:556-563. NEPTUNE II was a national survey of lipid management in clinical practice completed in 2003. A group of 376 physicians (83% primary care, 17% cardiologists or endocrinologists) who were high-prescribers of lipid-altering medications each enrolled 10-20 consecutive patients receiving lipid management, in order to provide information on the achievement of the NCEP Adult Treatment Panel III (ATP III) treatment goals in clinical practice. NEPTUNE II was very similar in design to the Lipid Treatment Assessment Program (L-TAP) that was completed in 1997, while the ATP II recommendations were in force. Of the 4885 patients evaluated for NEPTUNE II, 67% had achieved their LDL cholesterol goal, which was a major improvement compared with L-TAP, in which only 38% had achieved goal. Also, only 18% of those with coronary heart disease (CHD) had met their LDL cholesterol target in L-TAP, whereas 62% had in NEPTUNE II. While these results are very encouraging, several treatment gaps were evident. LDL cholesterol goal achievement among patients with CHD risk equivalents was far from optimal: 55% for those with diabetes and 40% for those with other CHD risk equivalents. Also, achievement of combined LDL and non-HDL cholesterol goals among the 25% of the sample with elevated triglycerides (200+ mg/dL) was low, ranging from 64% among those with 0 or 1 risk factor to 27% among those with CHD and risk equivalents. Of the 2708 patients with CHD and risk equivalents, a large majority (75%) could be classified as being at “very high risk” according to the 2004 NCEP Working Group recommendations, which would qualify them for the optional LDL cholesterol treatment goal of <70 mg/dL. Factors associated with greater likelihood of LDL cholesterol goal achievement included having a greater number of major CHD risk factors, older age, use of drug therapy, use of a statin drug (particularly Lipitor and Zocor) and treatment by a subspecialist. High risk women, current smokers and those with minority ethnicity were less likely to have achieved their LDL cholesterol goal. Dr. Maki’s comment. The results from NEPTUNE II illustrate the fact that large strides have been made in lipid management during the last few years. However, evidence continues to accumulate showing that lowering the concentrations of cholesterol carried by atherogenic particles (LDL and VLDL) to levels well below those previously considered “normal” reduces cardiovascular events. Although the frequencies of goal achievement were substantially higher in NEPTUNE II compared to L-TAP, substantial room remains for improvement. In particular, those with CHD or risk equivalents, elevated triglycerides, high-risk women and people of color should be targeted for more effective lipid management. This is especially true in view of recently published data showing that aggressive lipid lowering improves outcomes, even in the range of LDL cholesterol values lower than 100 mg/dL. Substantial changes in lipid management will be needed if the new, optional lipid goals (e.g., LDL cholesterol <70 mg/dL for those at “very high” CHD risk) outlined by the NCEP Working Group in 2004 are implemented on a large scale. About ProvidentProvident has a team of research professionals with extensive experience in the design and conduct of clinical trials to evaluate pharmaceuticals, medical and functional foods, dietary supplements and medical devices. For more information, visit our web site: http://www.providentcrc.com. Or, contact us directly: Tia Rains: trains@providentcrc.com, Director of Medical Writing / Principal Scientist |
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