Article ; Online: Safety and efficacy of very low LDL-cholesterol intensive lowering: a meta-analysis and meta-regression of randomized trials.
European heart journal. Cardiovascular pharmacotherapy
2023 Volume 9, Issue 2, Page(s) 138–147
Abstract: Aims: We performed a study-level meta-analysis to provide more robust evidence on safety of very low LDL-cholesterol (LDL-C) levels.: Background: Concerns on the safety of LDL-C values achieved with potent lipid-lowering therapies have been raised.!## ...
Abstract | Aims: We performed a study-level meta-analysis to provide more robust evidence on safety of very low LDL-cholesterol (LDL-C) levels. Background: Concerns on the safety of LDL-C values achieved with potent lipid-lowering therapies have been raised. Methods and results: We searched randomized trials reporting clinical outcomes with intensive lipid-lowering treatments leading to very low (<40 mg/dL) LDL-C levels vs. a control group with higher LDL-C levels. Only studies with follow-up duration ≥ 3 months were considered. Primary endpoint was the incidence of various safety measures. A total of 10 randomized trials were overall included, with 38 427 patients being in the very low LDL-C group vs. 70 668 in the control group. Median follow-up duration was 28.8 months. The incidence of all safety outcomes was similar in the two groups: non-cardiovascular death: OR 1.13, 95% CI 0.87-1.45; P = 0.36; any adverse events: OR 1.00, 0.90-1.11, P = 0.94; adverse events leading to drug discontinuation: OR 1.00, 0.87-1.15, P = 0.99; cancer: OR 1.02, 0.95-1.10, P = 0.57; haemorrhagic stroke OR 0.89, 0.66-1.20, P = 0.44; new-onset diabetes: OR 1.16, 0.91-1.47, P = 0.23; neurocognitive disorders: OR 0.97, 0.91-1.04, P = 0.41; haepatobiliary disorders: OR 0.99, 0.83-1.18, P = 0.93; muscle disorders: OR 0.94, 0.77-1.13, P = 0.49; cataract: OR 1.28, 0.78-2.10, P = 0.34. The rates of major adverse cardiovascular events were significantly lower in the very low LDL-C group: OR 0.82, 0.72-0.94, P = 0.005. Conclusion: This meta-analysis indicates that very low LDL-C levels on intensive lipid-lowering treatments are not associated with any adverse event and maintain a persistent reduction of cardiovascular events. |
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MeSH term(s) | Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Cholesterol, LDL ; Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/chemically induced ; Randomized Controlled Trials as Topic ; Cholesterol |
Chemical Substances | Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Cholesterol, LDL ; Cholesterol (97C5T2UQ7J) |
Language | English |
Publishing date | 2023-01-20 |
Publishing country | England |
Document type | Meta-Analysis ; Journal Article |
ZDB-ID | 2808613-2 |
ISSN | 2055-6845 ; 2055-6837 |
ISSN (online) | 2055-6845 |
ISSN | 2055-6837 |
DOI | 10.1093/ehjcvp/pvac049 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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