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LOWER: A Registry Evaluating Long-Term Lomitapide Use in Patients with Homozygous Familial Hypercholesterolemia†
Abstracts
Study Funding: This study was supported by an independent educational grant from AstraZeneca. Background/Synopsis: Research has identified clinical practice gaps in the management of diabetes, which include assessing and managing low-density lipoprotein cholesterol (LDL-C) levels as well as other lipid parameters. As part of a quality improvement, continuing medical education (CME)-based initiative on type 2 diabetes (T2D) management, lipid management was assessed in this population. Objective/Purpose: Conduct a baseline assessment survey to detect clinical practice gaps related to lipid management in patients with T2D. Methods: A baseline chart review was performed for 10 patients from each of 60 primary care physicians (total of 600 patients) that included data related to lipid parameters and statin use. Data were extracted for the time period May 1, 2013 to April 31, 2014, to provide one full year of patient chart information from the 10 random patients per provider. Results: Patients included in the baseline assessment were on average 54 years old (range 26 to 74), 47% were female, and had a median duration of T2D of 6.2 years (range 0 to 44). The most common comorbidities included obesity (74%), heart disease (14%) and peripheral neuropathy (11%). LDL-C: 21% had LDL-C ,70 mg/dL 55% had LDL-C ,100 mg/dL Patients with T2D and cardiovascular disease (CVD): 35% had LDL-C ,70 mg/dL and 65% had LDL-C ,100 mg/dL Statin utilization overall: 63% Among patients with statin use, 71% were moderateintensity, 16% high-intensity, 9% low-intensity, and 4% had unknown statin therapy (due to missing medication dosage documentation) Patients with T2D and CVD: 80% statin utilization Conclusions: This baseline assessment identified significant clinical practice gaps related to lipid management in patients with T2D, most notably: almost half of patients were not achieving LDL-C ,100mg/dl and more than 1/3 of physicians failed to have their T2D patients on a statin. Education should be used as a means to close these gaps and improve care for patients.
145 LOWER: A Registry Evaluating Long-Term Lomitapide Use in Patients with Homozygous Familial Hypercholesterolemia†
445 Amgen, and Eli Lilly; advisory board member for Amgen, Aegerion Pharmaceuticals, Sanofi, Novartis, and AstraZeneca; and receives research funding from Aegerion Pharmaceuticals. Study Funding: This study is sponsored by Aegerion Pharmaceuticals. Case Study Abstract: Homozygous familial hypercholesterolemia (HoFH) is a rare genetic disease characterized by high levels of low-density lipoprotein cholesterol (LDLC) and premature atherosclerosis. Lomitapide has been approved in the U.S., EU, and certain other countries as an adjunct to other lipid-lowering therapies to reduce LDL-C levels in adult patients with HoFH. Although lomitapide significantly reduced LDL-C levels in clinical trials, no studies have been performed to evaluate real-world use, particularly long-term safety, effectiveness, or patterns of use. Lomitapide Observational Worldwide Evaluation Registry (LOWER) is a large, long-term, prospective, observational registry conducted within the U.S., Canada, Europe, Asia, and Latin America. LOWER will enroll at least 300 adult lomitapide-treated patients, with all patients followed for a minimum of 10 years providing a minimum of 3,000 patient exposure years. In non-European countries, the registry will continue for 10 years from the date that the 300th patient is enrolled. In European countries, the registry will remain open indefinitely. The objectives of LOWER are to evaluate the occurrence of events of special interest, including hepatic and gastrointestinal events, tumors, events associated with coagulopathy, cardiovascular outcomes, and the occurrence and outcomes of pregnancy. LOWER will also provide data on long-term lipid control and adherence of prescribers to product label screening and monitoring recommendations. LOWER will provide clinically meaningful, real-world information on the clinical characteristics of patients with HoFH, including baseline characteristics, diagnostic criteria, and previous therapies. The registry was opened to enrollment in March 2014. As of Feb. 18, 2015, 82 patients were enrolled globally; enrollment of 300 patients is anticipated by March 2018.
146 Statin-Induced Myopathy in Patients with Familial Hypercholesterolemia Htet Khine, MD, Wei Yuet, PharmD, Zahid Ahmad, MD, Beverly Huet, MS, (Dallas, TX)
James A. Underberg, MD, FNLA, John Kastelein, MD, Dominique Larrey, Lukas Makris, Charles Schwamlein, Dirk Blom, (New York, NY)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Patients with familial hyper-
Lead Author’s Financial Disclosures: Dr. Under-
cholesterolemia (FH) require high potency statins, a major risk factor for statin-induced myopathy, due to elevated low-density lipoprotein-cholesterol (LDL-C) levels. For FH
berg was a speaker for Genzyme, Merck, AstraZeneca, Amarin, Sanofi, and Kowa; consultant to Liposcience,
Study Funding: This study was supported by an independent educational grant from AstraZeneca. Background/Synopsis: Research has identified clinical practice gaps in the management of diabetes, which include assessing and managing low-density lipoprotein cholesterol (LDL-C) levels as well as other lipid parameters. As part of a quality improvement, continuing medical education (CME)-based initiative on type 2 diabetes (T2D) management, lipid management was assessed in this population. Objective/Purpose: Conduct a baseline assessment survey to detect clinical practice gaps related to lipid management in patients with T2D. Methods: A baseline chart review was performed for 10 patients from each of 60 primary care physicians (total of 600 patients) that included data related to lipid parameters and statin use. Data were extracted for the time period May 1, 2013 to April 31, 2014, to provide one full year of patient chart information from the 10 random patients per provider. Results: Patients included in the baseline assessment were on average 54 years old (range 26 to 74), 47% were female, and had a median duration of T2D of 6.2 years (range 0 to 44). The most common comorbidities included obesity (74%), heart disease (14%) and peripheral neuropathy (11%). LDL-C: 21% had LDL-C ,70 mg/dL 55% had LDL-C ,100 mg/dL Patients with T2D and cardiovascular disease (CVD): 35% had LDL-C ,70 mg/dL and 65% had LDL-C ,100 mg/dL Statin utilization overall: 63% Among patients with statin use, 71% were moderateintensity, 16% high-intensity, 9% low-intensity, and 4% had unknown statin therapy (due to missing medication dosage documentation) Patients with T2D and CVD: 80% statin utilization Conclusions: This baseline assessment identified significant clinical practice gaps related to lipid management in patients with T2D, most notably: almost half of patients were not achieving LDL-C ,100mg/dl and more than 1/3 of physicians failed to have their T2D patients on a statin. Education should be used as a means to close these gaps and improve care for patients.
145 LOWER: A Registry Evaluating Long-Term Lomitapide Use in Patients with Homozygous Familial Hypercholesterolemia†
445 Amgen, and Eli Lilly; advisory board member for Amgen, Aegerion Pharmaceuticals, Sanofi, Novartis, and AstraZeneca; and receives research funding from Aegerion Pharmaceuticals. Study Funding: This study is sponsored by Aegerion Pharmaceuticals. Case Study Abstract: Homozygous familial hypercholesterolemia (HoFH) is a rare genetic disease characterized by high levels of low-density lipoprotein cholesterol (LDLC) and premature atherosclerosis. Lomitapide has been approved in the U.S., EU, and certain other countries as an adjunct to other lipid-lowering therapies to reduce LDL-C levels in adult patients with HoFH. Although lomitapide significantly reduced LDL-C levels in clinical trials, no studies have been performed to evaluate real-world use, particularly long-term safety, effectiveness, or patterns of use. Lomitapide Observational Worldwide Evaluation Registry (LOWER) is a large, long-term, prospective, observational registry conducted within the U.S., Canada, Europe, Asia, and Latin America. LOWER will enroll at least 300 adult lomitapide-treated patients, with all patients followed for a minimum of 10 years providing a minimum of 3,000 patient exposure years. In non-European countries, the registry will continue for 10 years from the date that the 300th patient is enrolled. In European countries, the registry will remain open indefinitely. The objectives of LOWER are to evaluate the occurrence of events of special interest, including hepatic and gastrointestinal events, tumors, events associated with coagulopathy, cardiovascular outcomes, and the occurrence and outcomes of pregnancy. LOWER will also provide data on long-term lipid control and adherence of prescribers to product label screening and monitoring recommendations. LOWER will provide clinically meaningful, real-world information on the clinical characteristics of patients with HoFH, including baseline characteristics, diagnostic criteria, and previous therapies. The registry was opened to enrollment in March 2014. As of Feb. 18, 2015, 82 patients were enrolled globally; enrollment of 300 patients is anticipated by March 2018.
146 Statin-Induced Myopathy in Patients with Familial Hypercholesterolemia Htet Khine, MD, Wei Yuet, PharmD, Zahid Ahmad, MD, Beverly Huet, MS, (Dallas, TX)
James A. Underberg, MD, FNLA, John Kastelein, MD, Dominique Larrey, Lukas Makris, Charles Schwamlein, Dirk Blom, (New York, NY)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Patients with familial hyper-
Lead Author’s Financial Disclosures: Dr. Under-
cholesterolemia (FH) require high potency statins, a major risk factor for statin-induced myopathy, due to elevated low-density lipoprotein-cholesterol (LDL-C) levels. For FH
berg was a speaker for Genzyme, Merck, AstraZeneca, Amarin, Sanofi, and Kowa; consultant to Liposcience,