Table of Contents
- Clinical trials overview
- Phase 3 studies in patient groups
- Phase 1 studies in healthy volunteers
- What the trials measure
- Who may take part
- Key points for patients
Clinical trials overview
The available studies on Rosuvastatin Calcium are testing different research questions in different groups of people.[1][2][3][4][5] Some trials look at prevention of heart and blood vessel problems, while others study how the medicine behaves in the body or compare one product with another.[1][3][4][5]
Phase 3 studies in patient groups
Three of the trials are Phase 3 studies, which means they are testing the treatment in larger groups and looking closely at how well it works and how safe it is.[1][2][3]
One Phase 3 trial is studying people with chronic inflammatory rheumatic diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus.[1] This study is testing a strategy for primary prevention, which means trying to stop the first major cardiovascular event before it happens.[1] The trial compares a strategy based on carotid ultrasound with the current strategy based on clinical guidelines.[1]
Another Phase 3 trial is in people with statin intolerance and high cardiovascular risk, including patients with previous cardiovascular disease or familial hypercholesterolemia.[2] This study uses an n=1 study design, which is a randomized, double-blind, cross-over trial with counseling on each patient’s own treatment results.[2] The goal is to see whether this approach increases statin use and lowers the use of PCSK9i compared with usual care after 12 months.[2]
The third Phase 3 study is the SAVER Trial in patients with venous thromboembolism, including pulmonary embolism and deep vein thrombosis.[3] It compares generic Rosuvastatin Calcium with placebo to see whether the treatment lowers the rate of symptomatic recurrent major venous thromboembolism during follow-up.[3]
Phase 1 studies in healthy volunteers
Two trials are Phase 1 studies, which are usually smaller and often focus on how a medicine is handled by the body or whether two products are similar.[4][5]
One completed Phase 1 trial studied healthy volunteers who received nirmatrelvir/ritonavir with Rosuvastatin Calcium in the setting of COVID-19 research.[4] The study looked at pharmacokinetics, meaning how the body absorbs and processes the medicine, and measured AUCinf and Cmax of rosuvastatin.[4]
The other completed Phase 1 trial was a bioequivalence study in healthy men and women under fasting conditions.[5] It compared a test capsule containing Rosuvastatin, amlodipine, and ramipril with separate reference products taken together.[5] The goal was to see whether the test product and the reference products gave similar exposure in the body.[5]
What the trials measure
The main outcome in the inflammatory rheumatic disease trial is the occurrence of a major cardiovascular event, including acute myocardial infarction, stroke, hospital admission for unstable angina, arterial revascularization for peripheral artery disease, or death due to cardiovascular disease.[1]
The statin-intolerance trial measures self-reported statin use 12 months after inclusion.[2] This helps show whether the counseling-based n=1 approach can improve long-term use of statins.[2]
The SAVER Trial measures symptomatic recurrent major venous thromboembolism, defined as proximal deep vein thrombosis or segmental or larger pulmonary embolism, from randomization until the end of follow-up.[3]
The Phase 1 drug-interaction study measures AUCinf and Cmax of rosuvastatin after multiple doses of nirmatrelvir/ritonavir.[4] The bioequivalence study measures AUC and Cmax and compares test-to-reference ratios, with acceptance limits of 80.00% to 125.00%.[5]
Who may take part
Each trial has a different target population, so participation depends on the study question.[1][2][3][4][5]
People with inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, or systemic lupus erythematosus may be considered for the prevention study.[1]
People with statin intolerance and high cardiovascular risk, including prior cardiovascular disease or familial hypercholesterolemia, are the target group for the n=1 study.[2]
People with venous thromboembolism, pulmonary embolism, or deep vein thrombosis are the focus of the SAVER Trial.[3]
Healthy volunteers took part in the Phase 1 studies, including both the drug-interaction study and the bioequivalence study.[4][5]
Key points for patients
These trials show that Rosuvastatin Calcium is being studied in several different ways, not just for one disease.[1][2][3][4][5]
Some studies are trying to prevent serious heart and blood vessel events, while others are testing whether the medicine can help after blood clots or improve long-term statin use in people who had trouble taking statins before.[1][2][3]
The Phase 1 studies are smaller and are mainly about body exposure and product comparison, which helps researchers understand how the medicine performs in controlled settings.[4][5]
