1
and elevated Lp(a) is lacking. This is the first case study ex- amining the acute clinical benefits of LDL-a for a patient with CHD, cerebrovascular disease, and angina while hav- ing normal LDL-C but abnormally high levels of Lp(a). Purpose: To examine the acute clinical benefits of LDL-a in patients with angina having normal LDL-C but abnor- mally high levels of Lp(a). Methods: A 48-year-old female FH patient with a history of CHD (coronary artery bypass grafting and stents), pe- ripheral arterial disease (femoral/popliteal stent), cerebro- vascular disease (left endarterectomy) and unstable angina for the last 2 years despite intense antianginal medication (nitroglycerin transdermal, 0.6–0.8 mg/h patch, and sublin- gual, 0.6 mg/PRN) was referred to the Kansas University Atherosclerosis and LDL-a Center for further evaluation and treatment. The patient had an LDL-C of 62 mg/dL with an Lp(a) of 81 mg/dL (nL , 30) while taking vytorin, fenofibrate, and O-3-FA. On the basis of her known intoler- ance to niacin therapy and uncontrolled angina, it was de- cided to initiate LDL-a. Results: The first treatment of LDL-a (Liposorber; Kaneka, Osaka, Japan) improved laboratory values (Table) and com- pletely eradicated angina symptoms which resulted in the patient discontinuing her nitroglycerin therapy. Addition- ally, the patient claimed improvement of her PAD symp- toms. After 1 year of biweekly LDL-a therapy the patient has had no vascular events and continues to be angina pain free without the need of nitroglycerin. Conclusions: LDL-a can immediately improve symptoms of unstable angina. The etiology of its benefit may include changes to Lp(a). This case report forms the basis for future studies that may validate the use of LDL-a for lowering Lp(a) in patients with clinical symptoms of angina. 141 Predictors of Combination Therapy for the Treatment of Dyslipidemia in the Actual Clinical Practice-Setting Radhika Nair, PhD, Woodie Zachry, (Round Rock, TX) Synopsis: Several factors play a role in the selection of treatment for patients with dyslipidemia in the actual clin- ical-practice setting. Purpose: To determine the predictors for prescribing com- bination therapy versus monotherapy to control lipid abnor- malities in a clinical-practice setting. Methods: A retrospective claims database analysis was conducted with the use of i3 InVisionÔ Data Mart. Pa- tients with a lipid panel between January 2004 and March 2008 were selected and followed from the first occurrence (index date) of the following: low-density lipoprotein-C 60–180 mg/dL; high-density lipoprotein cholesterol ,55 mg/dL for women; high-density lipoprotein cholesterol ,50 mg/dL for men; and TG ,750 mg/dL. Additional in- clusion criteria were age 40–64 years, enrollment .179 days before and after index date, more than two diabetes medical claims, or more than 89 days’ supply of a pre- scription for diabetes treatment during the 6 months pre-in- dex, and no lipid-altering therapy during the 6-month pre- index period. Patients were classified into 4 groups based on treatment during the 6-month post-index period: Mono- therapy only, statin and fenofibrate combination therapy, other combination therapy (other than statin/fenofibrate combination), and no therapy. Logistic regression was used to identify demographic and clinical factors available in the claims data that predict for prescribing of combina- tion therapy. Results: A total of 141,595 patients met inclusion/exclusion criteria. The majority of the patients either did not receive any treatment (n 5 124,464) or were treated with monother- apy (n 5 16,559) during the 6-month post-index period. Only 181 patients received statin and fenofibrate combina- tion therapy at least once during the 6 months after index, whereas 391 patients received other combinations. A diagno- sis of chronic ischemic heart diseases (odds ratio [OR], 2.94, 95% confidence interval [95% CI], 1.38–6.28; P 5 .005) and dyslipidemia (OR, 1.68; 95% CI, 1.03–2.74; P 5 .037) before index date were associated with greater likelihood of treatment with statin and fenofibrate combination therapy than monotherapy. A diagnosis of stroke (OR, 2.16; 95% CI, 1.003–4.67) and chronic ischemic heart dis- ease (OR, 3.04; 95% CI, 1.81–5.12, P , .0001) before the index date were associated with greater likelihood of treat- ment with other combination therapy than a monotherapy or no treatment. Conclusions: Certain diagnoses, such as previous CVD event coupled with dyslipidemia, increase the likelihood of prescribing a combination therapy in diabetes patients in the actual clinical-practice setting. 142 The Treatment of Dyslipidemia in Actual Practice Settings That Use Similar Inclusion Criteria to the ACCORD Lipid Trial Radhika Nair, PhD, Woodie Zachry, (Round Rock, TX) Synopsis: Although clinical trials are a crucial source of in- formation, it is important to understand the applicability of Table Values, mg/dL Before apheresis After apheresis Percent change Total cholesterol 111 40 64 Triglycerides 195 88 47 HDL 27 18 34 LDL-C 62 12 81 Lp(a) 81 13 84 Fibrinogen 346 179 48 C-RP 2.63 0.95 64 218 Journal of Clinical Lipidology, Vol 4, No 3, June 2010

Predictors of Combination Therapy for the Treatment of Dyslipidemia in the Actual Clinical Practice-Setting

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Table

Values, mg/dLBeforeapheresis

Afterapheresis

Percentchange

Total cholesterol 111 40 64Triglycerides 195 88 47HDL 27 18 34LDL-C 62 12 81Lp(a) 81 13 84Fibrinogen 346 179 48C-RP 2.63 0.95 64

218 Journal of Clinical Lipidology, Vol 4, No 3, June 2010

and elevated Lp(a) is lacking. This is the first case study ex-amining the acute clinical benefits of LDL-a for a patientwith CHD, cerebrovascular disease, and angina while hav-ing normal LDL-C but abnormally high levels of Lp(a).Purpose: To examine the acute clinical benefits of LDL-ain patients with angina having normal LDL-C but abnor-mally high levels of Lp(a).Methods: A 48-year-old female FH patient with a historyof CHD (coronary artery bypass grafting and stents), pe-ripheral arterial disease (femoral/popliteal stent), cerebro-vascular disease (left endarterectomy) and unstable anginafor the last 2 years despite intense antianginal medication(nitroglycerin transdermal, 0.6–0.8 mg/h patch, and sublin-gual, 0.6 mg/PRN) was referred to the Kansas UniversityAtherosclerosis and LDL-a Center for further evaluationand treatment. The patient had an LDL-C of 62 mg/dLwith an Lp(a) of 81 mg/dL (nL , 30) while taking vytorin,fenofibrate, and O-3-FA. On the basis of her known intoler-ance to niacin therapy and uncontrolled angina, it was de-cided to initiate LDL-a.Results: The first treatment of LDL-a (Liposorber; Kaneka,Osaka, Japan) improved laboratory values (Table) and com-pletely eradicated angina symptoms which resulted in thepatient discontinuing her nitroglycerin therapy. Addition-ally, the patient claimed improvement of her PAD symp-toms. After 1 year of biweekly LDL-a therapy the patienthas had no vascular events and continues to be anginapain free without the need of nitroglycerin.Conclusions: LDL-a can immediately improve symptomsof unstable angina. The etiology of its benefit may includechanges to Lp(a). This case report forms the basis for futurestudies that may validate the use of LDL-a for loweringLp(a) in patients with clinical symptoms of angina.

141

Predictors of Combination Therapy for the Treatment ofDyslipidemia in the Actual Clinical Practice-Setting

Radhika Nair, PhD, Woodie Zachry, (Round Rock, TX)

Synopsis: Several factors play a role in the selection oftreatment for patients with dyslipidemia in the actual clin-ical-practice setting.

Purpose: To determine the predictors for prescribing com-bination therapy versus monotherapy to control lipid abnor-malities in a clinical-practice setting.Methods: A retrospective claims database analysis wasconducted with the use of i3 InVision� Data Mart. Pa-tients with a lipid panel between January 2004 and March2008 were selected and followed from the first occurrence(index date) of the following: low-density lipoprotein-C60–180 mg/dL; high-density lipoprotein cholesterol ,55mg/dL for women; high-density lipoprotein cholesterol,50 mg/dL for men; and TG ,750 mg/dL. Additional in-clusion criteria were age 40–64 years, enrollment .179days before and after index date, more than two diabetesmedical claims, or more than 89 days’ supply of a pre-scription for diabetes treatment during the 6 months pre-in-dex, and no lipid-altering therapy during the 6-month pre-index period. Patients were classified into 4 groups basedon treatment during the 6-month post-index period: Mono-therapy only, statin and fenofibrate combination therapy,other combination therapy (other than statin/fenofibratecombination), and no therapy. Logistic regression wasused to identify demographic and clinical factors availablein the claims data that predict for prescribing of combina-tion therapy.Results: A total of 141,595 patients met inclusion/exclusioncriteria. The majority of the patients either did not receiveany treatment (n 5 124,464) or were treated with monother-apy (n 5 16,559) during the 6-month post-index period.Only 181 patients received statin and fenofibrate combina-tion therapy at least once during the 6 months after index,whereas 391 patients received other combinations. A diagno-sis of chronic ischemic heart diseases (odds ratio [OR], 2.94,95% confidence interval [95% CI], 1.38–6.28; P 5 .005) anddyslipidemia (OR, 1.68; 95% CI, 1.03–2.74; P 5 .037)before index date were associated with greater likelihoodof treatment with statin and fenofibrate combinationtherapy than monotherapy. A diagnosis of stroke (OR,2.16; 95% CI, 1.003–4.67) and chronic ischemic heart dis-ease (OR, 3.04; 95% CI, 1.81–5.12, P , .0001) before theindex date were associated with greater likelihood of treat-ment with other combination therapy than a monotherapyor no treatment.Conclusions: Certain diagnoses, such as previous CVDevent coupled with dyslipidemia, increase the likelihoodof prescribing a combination therapy in diabetes patientsin the actual clinical-practice setting.

142

The Treatment of Dyslipidemia in Actual PracticeSettings That Use Similar Inclusion Criteria to theACCORD Lipid Trial

Radhika Nair, PhD, Woodie Zachry, (Round Rock, TX)

Synopsis: Although clinical trials are a crucial source of in-formation, it is important to understand the applicability of