Statin+

Cardiovascular disease (CVD) remains the leading cause of death worldwide, despite being largely preventable through lifestyle changes and effective medical therapies. It is estimated that up to 90% of CVD-related deaths could be avoided with appropriate prevention and treatment.

Statins are the cornerstone of lipid-lowering therapy and among the most widely prescribed medications globally. They have been proven to reduce cardiovascular events and mortality in high-risk individuals. However, statins are also associated with side effects such as muscle pain, liver enzyme elevations, and increased risk of diabetes, which can limit long-term adherence.

The Statin+™ platform is designed to advance statin therapy by pairing statins with a complementary, FDA-approved small molecule. This innovative combination aims to provide a safer, more effective option for both current statin users and those who have discontinued or cannot tolerate standard statin therapy.

While statins remain the cornerstone of cardiovascular risk reduction, their use is often limited by tolerability and metabolic side effects.

Common adverse effects include:

• Muscle symptoms such as pain, weakness, or fatigue
• Elevated liver enzymes indicating hepatic stress
• Increased risk of new-onset diabetes mellitus
• Cognitive and peripheral effects, including neuropathy and memory changes
• Gastrointestinal and sexual dysfunction in some patients

In observational studies, 10–15% of patients experience muscle-related symptoms—most often mild pain—but these can lead to treatment discontinuation. A systematic review found a 2–17% relative increase in diabetes risk among statin users.

Importantly, nearly half of first-time statin patients discontinue therapy within the first year, most often due to perceived or actual side effects. Many must then be re-challenged on alternative statins or reduced doses, increasing both clinical risk and healthcare costs.

The Statin+™ platform is a next-generation therapeutic approach designed to enhance the clinical performance of all statins through combination with a proven, FDA-approved small molecule.

This fixed-dose combination concept is intended to deliver synergistic benefits, including:

• Improved lipid-lowering efficacy
• Reduction in arterial plaque formation
• Mitigation of common statin-associated side effects

Because the Statin+™ framework applies broadly across the statin class, it supports a scalable pipeline of differentiated cardiovascular products that build on decades of established safety and efficacy.

For more information about the Statin+™ platform and ongoing clinical development programs, please contact us.