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Medical and Financial Consequences of Using PCSK9 Inhibitors for Managing Hypercholesterolemia in Saudi Arabia: A
Yazed AlRuthia1, Khlood Khaled Almutairi2, Norah Abdulaziz Aljammaz2
1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.
Insights
Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors significantly reduced low-density lipoprotein cholesterol (LDL-C) and cardiovascular hospitalizations compared to statins plus ezetimibe. However, high costs necessitate price reductions for wider patient access.
Area of Science:
- Cardiology
- Pharmacoeconomics
- Public Health
Background:
- Hypercholesterolemia management is crucial for reducing cardiovascular disease (CVD) risks and healthcare costs.
- Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors are recommended for high-risk patients, but their cost-effectiveness in Saudi Arabia remains unclear.
- CVD prevalence is high in Saudi Arabia, making the evaluation of lipid-lowering therapies essential.
Purpose of the Study:
- To evaluate the costs and clinical outcomes of PCSK9 inhibitors compared to statins and ezetimibe in hypercholesterolemia management.
- To assess the effectiveness of PCSK9 inhibitors in reducing low-density lipoprotein cholesterol (LDL-C) and cardiovascular-related hospitalizations.
Main Methods:
- A multicenter retrospective study analyzed adult patients with hypercholesterolemia treated for at least 12 months.
- Outcomes measured included LDL-C reduction and cardiovascular hospitalizations.
- Direct medical costs were estimated using micro-costing and adjusted for confounders.
Main Results:
- PCSK9 inhibitors achieved greater mean LDL-C reductions (1.432 mmol/L) compared to statins plus ezetimibe (0.644 mmol/L).
- Cardiovascular-related hospitalizations were lower with PCSK9 inhibitors (0.645) versus the comparator group (0.808).
- Annual costs for PCSK9 inhibitors ranged from USD 4024 to USD 7559, with significant LDL-C reduction and hospitalization benefits observed in bootstrap analyses.
Conclusions:
- PCSK9 inhibitors demonstrated superior efficacy in lowering LDL-C and reducing cardiovascular hospitalizations in a real-world Saudi Arabian setting.
- The observed LDL-C reduction was more modest than in clinical trials, and high acquisition costs limit patient access.
- Significant price reductions for PCSK9 inhibitors are needed to improve their accessibility and cost-effectiveness for hypercholesterolemia management.
Abstract:
Background: Managing hypercholesterolemia is essential for reducing health risks and costs. Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors are recommended for patients with high low-density lipoprotein cholesterol (LDL-C) levels at risk for cardiovascular disease, especially those on maximum doses of statins and ezetimibe. However, their cost-effectiveness is unclear, particularly in Saudi Arabia, where cardiovascular disease is prevalent. The main objective of this study was to evaluate the costs and outcomes of PCSK9 inhibitors versus statins and ezetimibe. Methods: A multicenter retrospective study reviewed charts of adults (≥18 years) with hypercholesterolemia treated with PCSK9 inhibitors (evolocumab or alirocumab) for at least 12 months. Outcomes included LDL-C reduction and cardiovascular-related hospitalizations, with direct medical costs estimated via micro-costing and adjusted for confounders. Results: The analysis included 118 patients on PCSK9 inhibitors and 304 on statins plus ezetimibe. Mean LDL-C reductions were 1.432 mmol/L [95% CI: 0.964 to 1.899] for PCSK9 inhibitors and 0.644 mmol/L [95% CI: 0.464 to 0.823] for the other group. Cardiovascular-related hospitalizations averaged 0.645 for PCSK9 inhibitors compared to 0.808 for statins plus ezetimibe. The annual cost for PCSK9 inhibitors ranged from USD 4024 [95% CI: 3786.80 to 7947.91] to USD 7559 [95% CI: 7331.35 to 11,509.66]. In 99.13% and 98.78% of bootstrap distributions, PCSK9 inhibitors led to greater LDL-C reductions and fewer hospitalizations. Conclusions: The use of PCSK9 inhibitors for managing hypercholesterolemia was associated with a greater reduction in LDL-C levels and fewer cardiovascular-related hospitalizations. However, the more modest LDL-C reduction compared to clinical trials, combined with the high acquisition cost of PCSK9 inhibitors, underscores the need to provide significant price reductions to improve patient access to these lipid-lowering agents.
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