Prescription Trends of Oral Non-Statin LLTs and Their Effects on LDL-C

Key Takeaway

• This large cohort study provides:
  • Definitive information regarding trends in LLT prescriptions in Germany over a period of 5 years
  • Practical strategies to improve LDL-C goal achievement for ASCVD prevention
• Increase in prescription for high-potency statins (atorvastatin and rosuvastatin) and ezetimibe was noted over the duration of the study period.
• Higher prescription of non-statin LLTs was observed in patients treated by cardiologists vs GPs.
• A higher reduction in LDL-C was seen with FDC of statin/ezetimibe in comparison to separate pills; however, a large proportion of patients still remained with uncontrolled LDL-C levels.

Why This Matters

• Statins are recommended by the ESC and EAS as first-line therapy for LDL-C reduction.
• However, in patients on statin monotherapy with substantially higher LDL-C levels than the recommended goals or with statin intolerance, poor management of LDL-C levels are observed, further substantiating a need for addition of a non-statin LLT such as ezetimibe to reduce LDL-C.
• Real-world data analyzed in this study provides trends in prescription of oral non-statin LLT that may further help identify opportunities to improve the low rates of LDL-C target attainment.

Study Design

• This was a retrospective analysis using cross-sectional data obtained from the IMS^® Disease Analyzer of outpatients at very-high cardiovascular risk treated by GPs and cardiologists, and prescribed LLT in Germany*.

• Inclusion Criteria:
  • Patients >18 years of age 
  • Very-high cardiovascular risk^† 
  • At least two prescriptions of the same oral LLT within one calendar year 
  • Taking LLT for at least 21 days

• Study Goals: 
  • To analyze prescription trends of oral non-statin LLT in Germany 
  • To analyze trends in the prescription of statin/ezetimibe FDC or separate pills 
  • To compare statin/ezetimibe FDC and separate pills in a large cohort of patients at very-high cardiovascular risk in reducing LDL-C

• Outcomes of Interest: 
  • Prescription trends in LLTs 
  • Prescription trends of ezetimibe on top of statin therapy 
  • Effect of statin/ezetimibe FDC or separate pills on LDL-C

Key Results

• Overall, 311,242 patients were included in the analyses.
  • Baseline Characteristics: Similar across patients
  • Prevalence of ASCVD: Higher in patients prescribed ezetimibe (monotherapy or in combination with statins as FDC or in separate pills) and lower in patients prescribed fibrates vs statin monotherapy

Prescription Trends in LLTS

• Statin Monotherapy (GPs vs Cardiologists): 91.6% vs 79%
• Increase in Prescription Rates (2013 to 2018):
  • Atorvastatin and rosuvastatin (patients treated by GPs vs cardiologists):
    • In 2013: 10.4% and 25.8%
    • In 2018: 34.7% and 58.3%
  • Simvastatin (patients treated by GPs vs cardiologists):
    • In 2013: 81.0% and 64.0%
    • In 2018: 60.0% and 37.0%
• Non-statin LLTs (2013-2018):
  • GPS:
    • In 2013: 4.6%
    • In 2018: 3.6
  • Cardiologists:
    • In 2013: 7.2%
    • In 2018: 5.7%
  • No change in prescription rates for non-statin LLTs from 2013 to 2018.
  • Higher in patients treated by cardiologists vs GPs
• Prescription of Ezetimibe:
  • Patients receiving ezetimibe in 2018 (patients treated by GPs vs cardiologists): 76.1% vs 92.8%
  • Steady increase over the study period
  • Prescribed with statin in majority of the cases

Effect of Statin/ezetimibe Fdc or Separate Pills on LDL-C

• Reduction in LDL-C By Addition of Ezetimibe in Patients on Statin Therapy
  • 23.8% (32.3 mg/dL)
  • Addition of ezetimibe in patients on statin, reduced LDL-C by an additional 23.8%.
• Mean LDL-C Reduction With Statin + Ezetimibe
  • FDC: 28.4% (40.0 mg/dL) 
  • Separate Pills: 19.4% (27.5 mg/dL)
  • Reduction was considerably larger for FDC when statin and ezetimibe were prescribed in combination.
• Patients Reaching LDL-C Level of <70 mg/dL With Statin + Ezetimibe
  • FDC vs Separate Pills): 31.5%
  • Separate Pills: 21.0%
  • Larger reduction of LDL-C resulted in better LDL-C control.

Limitations

• Data not available on medication adherence that would strengthen study conclusion.
• Reasons for physicians prescribing FDC or separate pills could not be derived from the data, potentiating confounding related to the prescribing individuals.

* Between 2013 and 2018.
^† As per 2016 ESC/EAS guidelines.