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Comparison of Lipid and Anti-inflammatory Levels Between Rosuvastatin Or Atorvastatin Daily vs. Thrice Weekly “Doubled-daily” Dosing*
456
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
of patients over 30 years of age in this trial. Future studies with a larger sample size are needed to validate the effects of SA on reducing 10 year Framingham CV risk and whether FRS is an appropriate estimator, given the younger age of these patients.
162 Hemoglobin and Lipid Assessment of Children in Iquitos, Peru* Samantha M. Ward, OMSII, Teresa Colelli, OMSII, Katelyn Wiseman, OMSIV, Lorenzo Lim, OMSIV, Sara Lang, OMSII, Jessica Jary, OMSII, Elise Craig, OMSII, Ruben K. Briceno, MD, Santiago Moises Benites Castillo, MD, Joe Gorz, DO, Gary Willyerd, DO, FACOEP, FAOD, Shane Sergent, DO, (East Lansing, MI)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Since 2009, we have been evaluating the prevalence of obesity in pediatric populations in Peru. Due to past Body Mass Index (BMI) studies and the prevalence of pediatric obesity, it was suspected that many children had high cholesterol levels. Additionally, it was suspected that many children were anemic due clinical presentations. However, it was not speculated that children would be both anemic and have high total cholesterol, as both are seldom presented together. In fact, it has been recognized that a relationship exists between anemia and hypocholesterolemia in humans. To confirm our suspicions, children between the ages of 9 and 13 were given the option to be evaluated with a fasting lipid panel and CBC to further asses their nutritional health. Objective/Purpose: Determine the prevalence of hypercholesterolemia and anemia in the pediatric population of Iquitos, Peru. Methods: A fasting lipid panel and a CBC were obtained from 14 children ages 9 to 13 years. Fasting cholesterol, triglyceride, HDL, LDL, glucose, hemoglobin, hematocrit, MCV, and MCH levels were taken and analyzed using standards set by the Children’s Hospital of Michigan. As
Table 1
defined by the National Heart, Lung and Blood institute, borderline hypercholesterolemia was diagnosed in children with cholesterol levels between 170mg/dl-199mg/dl and hypercholesterolemia was diagnosed in children with cholesterol levels .200mg/dl. Consistent with CDC guidelines, anemia was diagnosed in children with a hemoglobin of ,11.1g/dl. Results: Of the 14 children tested, five (35.7%) were hypercholesterolemic, seven (50%) were borderline hypercholesterolemic, and only two (14.2%) had normal cholesterol levels for their age. Additionally, eight (57.1%) of the 14 children were anemic. When only the eight anemic children were analyzed, four (50%) were hypercholesterolemic, three (37.5%) were borderline hypercholesterolemic and one (12.5%) was normal. Conclusions: These results suggest that there is a high prevalence of anemia and a very high prevalence of hypercholesterolemia in the pediatric population of Iquitos, Peru. Upon comparison, it appears that if a child is anemic, he is also likely to have elevated total cholesterol. This is different from the normal relationship between hypocholesterolemia and anemia. Further studies should be obtained to replicate these results with a larger population size and to determine the cause behind the anemia and hypercholesterolemia. 1 American Journal of Medical Science’’; The Relationship Between Iron Deficiency Anemia and Lipid Metabolism in Pre-Menopausal Women; Ozdemir, A. et al.; November 2007. 2 The Journal of Biological Chemistry’’; Cholesterol in Human Blood Under Pathological Conditions; Denis, W.; 1916.
163 Comparison of Lipid and Anti-inflammatory Levels Between Rosuvastatin Or Atorvastatin Daily vs. Thrice Weekly ‘‘Doubled-daily’’ Dosing* Carmelo V. Venero, MD, Madhur A. Roberts, MD, Patricia D. Crawley, MD, Dale C. Wortham, MD, (Knoxville, TN)
Lead Author’s Financial Disclosures: None
Comparison of lipid and anti-inflammatory levels between daily and thrice-weekly rosuvastatin or atorvastatin dosing Daily Dosing
Total cholesterol LDL cholesterol (mg/dL) Non-HDL Cholesterol (mg/dl) HDL cholesterol (mg/dL) Triglycerides (mg/dL) Apolipoprotein B (mg/dL) Apolipoprotein A (mg/dL) hs-CRP (mg/L) LpPLA2 (ng/mL)
144 77.8 99.7 44.5 132.8 74 136.1 2.9 154.9
6 6 6 6 6 6 6 6 6
26.3 18.6 21.3 14.6 58 13 24 5.1 39
Thrice-weekly Dosing 61.6 91.4 117.1 44.4 150.5 83.3 138.5 2.6 149.7
6 6 6 6 6 6 6 6 6
32 23.6 28 15.3 84 17 25 3.1 36
P Value ,0.001 , 0.001 ,0.001 0.89 0.04 ,0.001 0.23 0.7 0.35
Abstracts
457
Study Funding: None Background/Synopsis: Statins are generally well tolerated but some patients stop therapy due to adverse effects. Dosing rosuvastatin or atorvastatin thrice-weekly (TIW) is used in patients unable to tolerate daily statins and occasionally as the initial statin dosing regimen. Objective/Purpose: To compare the LDL-C and hsCRP levels achieved with rosuvastatin or atorvastatin daily use with levels reached with the same medication at a ‘‘double of the daily dose’’ used TIW. Methods: We performed a prospective, randomized, cross-over trial to compare LDL-C and hs-CRP levels between rosuvastatin or atorvastatin daily dose and its ‘‘doubled dose’’ used TIW. Consented patients continued their baseline rosuvastatin or atorvastatin and were randomized to their correspondent daily dose or a dose ‘‘double of the daily dose’’ but used TIW for 12 weeks. Laboratory testing was performed after initial 12 weeks and patients were subsequently crossed-over to the other corresponding group (daily statin to TIW and vice versa) for another 12-week period. The laboratory testing was repeated at the end of second 12-week period. We assessed the severity of muscle pain via a semi-quantitative questionnaire. Results: Forty-two patients consented to participate in the study. Rosuvastatin was used by 25 patients (59.5%) and atorvastatin by 17 patients (40.5%). The mean LDL-C on the daily regimen was 77.8 6 18.6 mg/dL whereas in the TIW regimen was 91.4 6 23.6 mg/dL (p , 0.001). Total cholesterol, non-HDL cholesterol, triglycerides, and Apolipoprotein B levels were also statistically different. HDLCholesterol and Apolipoprotein A levels were not different. The mean hs-CRP level on the daily regimen was 2.9 6 5.1 mg/L whereas in the TIW regimen was 2.6 6 3.1 mg/L (p5 0.70). The mean Lipoprotein-associated phospholipase A2 (Lp-PLA2) level on the daily regimen was 154.9 6 39 ng/ mL whereas in the TIW regimen was 149.7 6 36 ng/mL (p5 0.35). Glycemia, aminotransferase, and creatine
Table 1
phosphokinase levels were not statistically different. Only three patients (7%) had myalgias prior to the study. Two of these three patients reported myalgia to be definitively or somewhat better with TIW regimen. Three patients without baseline myalgia reported feeling definitively or somewhat better when taking TIW regimen. Conclusions: Rosuvastatin or atorvastatin dosed daily lowered LDL-C levels when compared to its correspondent ‘‘double daily dose’’ used thrice weekly. In contrast, hsCRP and Lp-PLA2 levels were not different between both regimens. Hardcore end-point clinical trial comparing both strategies is necessary before using thrice-weekly dosing as the initial statin dosing regimen.
164 Temporal Trends in Statin Therapy for Familial Hypercholesterolemia in U.S. Youth 2002 – 2012 Catherine J. McNeal, MD, PhD, Andrea Cassidy, PhD, MPH, Ying Fang-Hollingsworth, MPH, Joon Song, PhD, Sean Gregory, MBA, MS, PhD, Laurel Copeland, PhD, Justin Zachariah, MD, MPH, Eric Wright, PharmD, Jeffrey Tom, MD, MS, Jeffrey VanWormer, PhD, Fangfang Sun, MS, (Temple, TX)
Lead Author’s Financial Disclosures: None Study Funding: This study was funded by the Wilhelm Foundation.
Background/Synopsis: Since 1998, U.S. pediatric guidelines have recommended the addition of lipid-lowering medications (LLM) for youth age $ 10 years with a persistently elevated LDL-C . 190 mg/dL that does not respond to lifestyle changes, a cut point that is commonly associated with familial hypercholesterolemia (FH). If additional risk factors are present, LLM are also recommended for LDL-C . 160 mg/dL (one major risk factor) and for LDL-C . 130 mg/dL (two major risk factors). The preferred pharmaceutical treatment has evolved from bile
Demographic Characteristics in 2012
Site
Geisinger Health System
Henry Ford Health System
Kaiser Permanente
Marshfield Clinic
Scott&White
State Female (%) Age category 2-8 years (%) 9-11 years (%) 12-17 years (%) 18-21 years (%) Race/Ethnicity Non-Hispanic White Non-Hispanic Black Hispanic Asian, Other, Missing
Pennsylvania 49%
Michigan 51%
Hawaii 49%
Wisconsin 60%
Texas 49%
33% 16% 34% 17%
23% 14% 38% 25%
36% 16% 32% 17%
34% 15% 32% 19%
34% 16% 33% 17%
92% 3% 3% 2%
54% 42% 1% 3%
12% 1% 8% 79%
95% 1% 1% 3%
45% 5% 6% 43%
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
of patients over 30 years of age in this trial. Future studies with a larger sample size are needed to validate the effects of SA on reducing 10 year Framingham CV risk and whether FRS is an appropriate estimator, given the younger age of these patients.
162 Hemoglobin and Lipid Assessment of Children in Iquitos, Peru* Samantha M. Ward, OMSII, Teresa Colelli, OMSII, Katelyn Wiseman, OMSIV, Lorenzo Lim, OMSIV, Sara Lang, OMSII, Jessica Jary, OMSII, Elise Craig, OMSII, Ruben K. Briceno, MD, Santiago Moises Benites Castillo, MD, Joe Gorz, DO, Gary Willyerd, DO, FACOEP, FAOD, Shane Sergent, DO, (East Lansing, MI)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Since 2009, we have been evaluating the prevalence of obesity in pediatric populations in Peru. Due to past Body Mass Index (BMI) studies and the prevalence of pediatric obesity, it was suspected that many children had high cholesterol levels. Additionally, it was suspected that many children were anemic due clinical presentations. However, it was not speculated that children would be both anemic and have high total cholesterol, as both are seldom presented together. In fact, it has been recognized that a relationship exists between anemia and hypocholesterolemia in humans. To confirm our suspicions, children between the ages of 9 and 13 were given the option to be evaluated with a fasting lipid panel and CBC to further asses their nutritional health. Objective/Purpose: Determine the prevalence of hypercholesterolemia and anemia in the pediatric population of Iquitos, Peru. Methods: A fasting lipid panel and a CBC were obtained from 14 children ages 9 to 13 years. Fasting cholesterol, triglyceride, HDL, LDL, glucose, hemoglobin, hematocrit, MCV, and MCH levels were taken and analyzed using standards set by the Children’s Hospital of Michigan. As
Table 1
defined by the National Heart, Lung and Blood institute, borderline hypercholesterolemia was diagnosed in children with cholesterol levels between 170mg/dl-199mg/dl and hypercholesterolemia was diagnosed in children with cholesterol levels .200mg/dl. Consistent with CDC guidelines, anemia was diagnosed in children with a hemoglobin of ,11.1g/dl. Results: Of the 14 children tested, five (35.7%) were hypercholesterolemic, seven (50%) were borderline hypercholesterolemic, and only two (14.2%) had normal cholesterol levels for their age. Additionally, eight (57.1%) of the 14 children were anemic. When only the eight anemic children were analyzed, four (50%) were hypercholesterolemic, three (37.5%) were borderline hypercholesterolemic and one (12.5%) was normal. Conclusions: These results suggest that there is a high prevalence of anemia and a very high prevalence of hypercholesterolemia in the pediatric population of Iquitos, Peru. Upon comparison, it appears that if a child is anemic, he is also likely to have elevated total cholesterol. This is different from the normal relationship between hypocholesterolemia and anemia. Further studies should be obtained to replicate these results with a larger population size and to determine the cause behind the anemia and hypercholesterolemia. 1 American Journal of Medical Science’’; The Relationship Between Iron Deficiency Anemia and Lipid Metabolism in Pre-Menopausal Women; Ozdemir, A. et al.; November 2007. 2 The Journal of Biological Chemistry’’; Cholesterol in Human Blood Under Pathological Conditions; Denis, W.; 1916.
163 Comparison of Lipid and Anti-inflammatory Levels Between Rosuvastatin Or Atorvastatin Daily vs. Thrice Weekly ‘‘Doubled-daily’’ Dosing* Carmelo V. Venero, MD, Madhur A. Roberts, MD, Patricia D. Crawley, MD, Dale C. Wortham, MD, (Knoxville, TN)
Lead Author’s Financial Disclosures: None
Comparison of lipid and anti-inflammatory levels between daily and thrice-weekly rosuvastatin or atorvastatin dosing Daily Dosing
Total cholesterol LDL cholesterol (mg/dL) Non-HDL Cholesterol (mg/dl) HDL cholesterol (mg/dL) Triglycerides (mg/dL) Apolipoprotein B (mg/dL) Apolipoprotein A (mg/dL) hs-CRP (mg/L) LpPLA2 (ng/mL)
144 77.8 99.7 44.5 132.8 74 136.1 2.9 154.9
6 6 6 6 6 6 6 6 6
26.3 18.6 21.3 14.6 58 13 24 5.1 39
Thrice-weekly Dosing 61.6 91.4 117.1 44.4 150.5 83.3 138.5 2.6 149.7
6 6 6 6 6 6 6 6 6
32 23.6 28 15.3 84 17 25 3.1 36
P Value ,0.001 , 0.001 ,0.001 0.89 0.04 ,0.001 0.23 0.7 0.35
Abstracts
457
Study Funding: None Background/Synopsis: Statins are generally well tolerated but some patients stop therapy due to adverse effects. Dosing rosuvastatin or atorvastatin thrice-weekly (TIW) is used in patients unable to tolerate daily statins and occasionally as the initial statin dosing regimen. Objective/Purpose: To compare the LDL-C and hsCRP levels achieved with rosuvastatin or atorvastatin daily use with levels reached with the same medication at a ‘‘double of the daily dose’’ used TIW. Methods: We performed a prospective, randomized, cross-over trial to compare LDL-C and hs-CRP levels between rosuvastatin or atorvastatin daily dose and its ‘‘doubled dose’’ used TIW. Consented patients continued their baseline rosuvastatin or atorvastatin and were randomized to their correspondent daily dose or a dose ‘‘double of the daily dose’’ but used TIW for 12 weeks. Laboratory testing was performed after initial 12 weeks and patients were subsequently crossed-over to the other corresponding group (daily statin to TIW and vice versa) for another 12-week period. The laboratory testing was repeated at the end of second 12-week period. We assessed the severity of muscle pain via a semi-quantitative questionnaire. Results: Forty-two patients consented to participate in the study. Rosuvastatin was used by 25 patients (59.5%) and atorvastatin by 17 patients (40.5%). The mean LDL-C on the daily regimen was 77.8 6 18.6 mg/dL whereas in the TIW regimen was 91.4 6 23.6 mg/dL (p , 0.001). Total cholesterol, non-HDL cholesterol, triglycerides, and Apolipoprotein B levels were also statistically different. HDLCholesterol and Apolipoprotein A levels were not different. The mean hs-CRP level on the daily regimen was 2.9 6 5.1 mg/L whereas in the TIW regimen was 2.6 6 3.1 mg/L (p5 0.70). The mean Lipoprotein-associated phospholipase A2 (Lp-PLA2) level on the daily regimen was 154.9 6 39 ng/ mL whereas in the TIW regimen was 149.7 6 36 ng/mL (p5 0.35). Glycemia, aminotransferase, and creatine
Table 1
phosphokinase levels were not statistically different. Only three patients (7%) had myalgias prior to the study. Two of these three patients reported myalgia to be definitively or somewhat better with TIW regimen. Three patients without baseline myalgia reported feeling definitively or somewhat better when taking TIW regimen. Conclusions: Rosuvastatin or atorvastatin dosed daily lowered LDL-C levels when compared to its correspondent ‘‘double daily dose’’ used thrice weekly. In contrast, hsCRP and Lp-PLA2 levels were not different between both regimens. Hardcore end-point clinical trial comparing both strategies is necessary before using thrice-weekly dosing as the initial statin dosing regimen.
164 Temporal Trends in Statin Therapy for Familial Hypercholesterolemia in U.S. Youth 2002 – 2012 Catherine J. McNeal, MD, PhD, Andrea Cassidy, PhD, MPH, Ying Fang-Hollingsworth, MPH, Joon Song, PhD, Sean Gregory, MBA, MS, PhD, Laurel Copeland, PhD, Justin Zachariah, MD, MPH, Eric Wright, PharmD, Jeffrey Tom, MD, MS, Jeffrey VanWormer, PhD, Fangfang Sun, MS, (Temple, TX)
Lead Author’s Financial Disclosures: None Study Funding: This study was funded by the Wilhelm Foundation.
Background/Synopsis: Since 1998, U.S. pediatric guidelines have recommended the addition of lipid-lowering medications (LLM) for youth age $ 10 years with a persistently elevated LDL-C . 190 mg/dL that does not respond to lifestyle changes, a cut point that is commonly associated with familial hypercholesterolemia (FH). If additional risk factors are present, LLM are also recommended for LDL-C . 160 mg/dL (one major risk factor) and for LDL-C . 130 mg/dL (two major risk factors). The preferred pharmaceutical treatment has evolved from bile
Demographic Characteristics in 2012
Site
Geisinger Health System
Henry Ford Health System
Kaiser Permanente
Marshfield Clinic
Scott&White
State Female (%) Age category 2-8 years (%) 9-11 years (%) 12-17 years (%) 18-21 years (%) Race/Ethnicity Non-Hispanic White Non-Hispanic Black Hispanic Asian, Other, Missing
Pennsylvania 49%
Michigan 51%
Hawaii 49%
Wisconsin 60%
Texas 49%
33% 16% 34% 17%
23% 14% 38% 25%
36% 16% 32% 17%
34% 15% 32% 19%
34% 16% 33% 17%
92% 3% 3% 2%
54% 42% 1% 3%
12% 1% 8% 79%
95% 1% 1% 3%
45% 5% 6% 43%