21 Jun Lower LDL-C Cholesterol May Not Always Be Better
MedicalResearch.com Interview with:
Morton Leibowitz, M.D., FACC, Senior Physician
Clalit Research Institute
Clinical Associate Professor of Medicine/Cardiology
NYU School of Medicine
MedicalResearch.com: What is the background for this study? What is known (and not known) about this subject?
Dr. Leibowitz: Statins are upheld as effective treatments in LDL-C lowering and secondary prevention of major cardiovascular events.
Results from recent clinical trials of statins in combination with adjunctive medications for secondary prevention have led to renewed emphasis on a concept that “lower is better” for targeting LDL-C in high-risk patients. Recent meta-analyses have suggested and guidelines have incorporated that intensive statin treatment is recommended for secondary prevention of future cardiac events.
However, on the question “how low is low enough?” for LDL levels in the management of Ischemic Heart Disease patient – the jury is still out.
Past studies do suggest that there is a lower threshold to the beneficial impact of lowering LDL-C, however there still remains uncertainty about what the optimal target is. Some guidelines have suggested a target of LDL below 70 for the group at high-risk for cardiac events, while other guidelines maintain the previously target value of below 100 for these patients. This decision whether indeed “lower is better” has considerable impact on physicians prescription decision-making, and is thus of timely importance.
To address this question, one whould need a very large longitudinal dataset of real-world data on actual prescription, dispensing, laboratory and clinical outcomes data, on tens of thousands of patients for over 5 years. Such databases are available at Clalit Health Services, Israel’s largest healthcare payer/provider, that has 100% Electronic Medical Records for well over a decade. The Clalit Research Institute has created such a retrospective cohort to address this policy question.
MedicalResearch.com: What did this study show?
Dr. Leibowitz: This study’s findings among more than 30,000 individuals with pre-existing ischemic heart disease and high compliance to statin medications, show that treating to below 100mg/dl LDL levels has a significant protective association on cardiovascular outcomes, while lowering LDL-C levels to below 70mg/dl does not confer any further protection
The findings of no benefit with LDL-C lower than 70mg/dl as compared with 70-100 remain consistent in our study after sub-group and multiple sensitivity analyses, including among ischemic heart disease patients who were only ≥50% adherent to their statin medication.
The findings of this community-based study are not necessarily applicable to patients who have had a recent cardiac event.
MedicalResearch.com: What does this mean for clinical practice?
Dr. Leibowitz: This study further supports previous evidence that there are significant protective effects of lowering LDL-C levels to below 100mg/dl, and suggests what a target threshold for long-term statin treatment management may be for secondary prevention – between 70-100 mg/dl.
When weighing necessary treatment options in community-based clinical practice, this study’s data do not indicate any generalized clinical advantage to achieving LDL-C levels lower than 70mg/dl compared to 70-100 mg/dl.
It is important to notice the study limitations. This study’s results do not exclude the possibility that certain sub-populations will benefit from more intensive statin treatment to achieve lower LDL-C levels; this warrants further investigation to identify whether such sub groups exist.
Our study demonstrates that physicians treating patients with ischemic heart disease and elevated levels of cholesterol with statins have to insure that patients meet a target of less than 100mg/dl to prevent future events. There is, however, no evidence at present that increasing the intensity of treatment to lower LDL levels further adds benefit. These results are relevant to family doctors, internists, and cardiologists and all who consider potentially treating LDL levels more aggressively.
Prof Ran Balicer, Director of the Clalit Research Institute and paper author, states that “This is among the largest cohorts to study this issue, and it suggests that treatment with statins is very important for patients with ischemic heart disease; if their LDL levels are controlled at below 100 mg/dl, a substantial proportion of future heart disease complications can be prevented. Yet the study also suggests that lower is not always better – not all high-risk patients should be targeted for lower values of LDL, below 70 mg/dl. At Clalit, therefore, we keep our longstanding policy of targeting these Ischemic Heart Disease patients to LDL levels of 70-100, and these guidelines concur with the March 2016 Expert Consensus Panel of the American College of Cardiology.
MedicalResearch.com: What should the take-home message be?
Dr. Leibowitz: The most significant observation and take home message is, as indicated in the statement, “When weighing necessary treatment options in community-based clinical practice, this study’s data do not indicate any generalized clinical advantage to achieving LDL-C levels lower than 70mg/dl compared to 70-100 mg/dl.”
Patients’ statin dosage has to be set based on the full medical profile of the patient including tolerance of statins, percentage reduction of LDL achieved with statins and clinical stability and is in conformity with the most recent guidelines issued by ACC: 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk.
Our present study addressed the question of LDL targets and does not support the principle that all patients with established ischemic heart disease be titrated to LDL levels less than 70mg/dl..
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Citation:
Leibowitz M, Karpati T, Cohen-Stavi CJ, et al. Association Between Achieved Low-Density Lipoprotein Levels and Major Adverse Cardiac Events in Patients With Stable Ischemic Heart Disease Taking Statin Treatment. JAMA Intern Med. Published online June 20, 2016. doi:10.1001/jamainternmed.2016.2751.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on June 22, 2016 by Marie Benz MD FAAD