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.

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.

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

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.

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.

Reference

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.