How Amgen & HealthVerity found treatment gaps in high-risk diabetes care

Amgen’s new retrospective study, VESALIUS-REAL, examines how lipid-lowering therapy (LLT) is being used in clinical practice for patients with high-risk diabetes.¹ The study draws on Verified de-identified medical and pharmacy claims from 2016 to 2022, sourced from HealthVerity Marketplace. These findings offer important insights into treatment gaps and opportunities in cardiovascular care. And they’re not the only big players taking advantage of real-world data from HealthVerity to drive decisions about treatment patterns.

This research aligns with the ongoing VESALIUS-CV clinical trial (NCT03872401), which is evaluating the effect of evolocumab, a PCSK9 inhibitor, in patients at elevated cardiovascular risk who have not had a prior heart attack or stroke. While VESALIUS-CV continues to generate evidence in a clinical setting, VESALIUS-REAL focuses on what is happening in everyday patient care.

Closing the treatment gap: Insights for pharma and life sciences teams

For pharmaceutical manufacturers and life sciences organizations focused on cardiovascular innovation, VESALIUS-REAL offers several key takeaways:

• Identifies real-world therapeutic gaps
  Many high-risk patients remain untreated or undertreated despite elevated LDL-C levels and clear guideline recommendations.
  
  
• Highlights missed opportunities for early intervention
  Patients who have not yet experienced a major event represent an ideal window for proactive care, especially with effective LLT options available.
  
  
• Supports strategic decision-making
  Findings can help medical affairs, HEOR, and commercial teams understand real-world barriers to adoption and optimize education, access, and messaging strategies.
  
  
• Reveals actionable population segments
  By focusing on high-risk diabetes patients without prior cardiovascular events, the study pinpoints a large, under-addressed cohort with unmet needs.
  
  
• Underscores the value of real-world data
  Access to comprehensive, stable, and privacy-compliant datasets like those in HealthVerity Marketplace allows teams to uncover insights that go beyond clinical trial environments.
  
  

Study design and population overview

The VESALIUS-REAL study used HealthVerity Marketplace to identify a large, representative patient population across the United States. The inclusion criteria and methodology reflect a rigorous approach to capturing real-world patterns of care:

• Data source:
  De-identified medical and pharmacy claims from 2016 to 2022 from HealthVerity Marketplace
  
  
• Patient population:
  
  
  • Adults aged 50 years or older
  • Diagnosed with diabetes mellitus (DM) with either microvascular complications or chronic insulin use
  • LDL-C ≥ 90 mg/dL at baseline
  • No prior myocardial infarction or stroke
  • May also have coronary artery disease, cerebrovascular disease, or peripheral artery disease.

• Index date:
  Defined as the earliest date a patient met all inclusion criteria
  
  
• Follow-up period:
  One year post-index for patients with recorded LDL-C values
  
  
• LLT intensification definition:
  
  • Increase in statin dose
  • Switch to a more intensive LLT
  • Addition of another LLT drug class

Key findings on lipid-lowering treatment gaps

Among the 103,981 patients with high-risk diabetes, many were not receiving appropriate lipid-lowering treatment. The prevalence of comorbid conditions among the study population was notable. Coronary artery disease (CAD) was present in 11% of patients, while 4% had cerebrovascular disease (CeVD) and 5% had peripheral artery disease (PAD).

• 81% had LDL-C > 70 mg/dL
• Only 48% were receiving any LLT
• Among those not on LLT at index, just 36% initiated therapy within one year
• LLT intensification occurred in only 24% of patients

Figure 1: Despite elevated LDL-C, most high-risk diabetes patients remain untreated or under-treated. N=37,072 patients. LLT = lipid-lowering therapy

These results indicate a clear gap between guideline-based care and actual practice, underscoring the need for earlier intervention, greater therapy adoption, and improved follow-through in the management of cardiovascular risk among high-risk diabetes patients.

Commercial implications for cardiovascular therapies

The data reveal a significant opportunity for pharmaceutical companies working in the lipid management space:

• Many patients who qualify for treatment remain unmanaged, representing a missed chance to prevent major cardiovascular events.
  
  
• Educating providers about timely intervention could improve both health outcomes and therapy adoption.
  
  
• Real-world insights can inform segmentation, messaging, and go-to-market strategies for cardiovascular brands, including statins and PCSK9 inhibitors.
  
  

Improve cardiovascular outcomes with real-world data you can trust

Bridging the gap between evidence and practice requires a real-world understanding of how patients are actually treated. HealthVerity Marketplace makes this level of insight possible through its broad data coverage and long-term stability.

For life sciences organizations aiming to improve cardiovascular outcomes and reach high-risk populations, real-world studies like VESALIUS-REAL provide the foundation to act with precision and confidence.

To explore datasets like those used in this study, or design your next real-world research initiative, visit the HealthVerity Marketplace. With Verified coverage, transparency, and stability, it supports your study at every stage.

Or explore another use-case: how Gilead used HealthVerity RWD to find treatments that protect against liver disease in HIV/HBV patients. 

References

1. Chan Q, Sakhuja S, Ochs A, et al. 1315-p: lipid-lowering therapy patterns of high-risk cardiovascular patients without prior myocardial infarction or stroke—vesalius-real—results from patients with high-risk diabetes in the u. S. Diabetes. 2025;74(Supplement_1):1315-P.