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

Prescription Trends of Oral Non-Statin Lipid‑Lowering Therapies and Their Effects on Low-Density Lipoprotein-Cholesterol

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.

Reference

  1. Katzmann JL, Sorio-Vilela F, Dornstauder E, Fraas U, Smieszek T, Zappacosta S, et al. Non-statin lipid-lowering therapy over time in very-high-risk patients: Effectiveness of fixed-dose statin/ezetimibe compared to separate pill combination on LDL-C. Clin Res Cardiol. 2020. doi: 10.1007/s00392-020-01740-8. Epub ahead of print. PMID: 32949286.
MAT-QA-2200070/V1/NOV2022