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Lovastatin

Clinical trials investigating Lovastatin are studying people at risk of cardiovascular disease who may receive statins. The main aim is to evaluate safety, effectiveness, and cost-effectiveness, including whether gene testing can help reduce muscle-related problems from statin treatment.

Table of Contents

Trial overview

This clinical trial is authorised and is designed to study a gene analysis strategy in people at risk of cardiovascular disease who may receive statins.[1] The brief summary says the goal is to assess whether preemptive genotyping can reduce statin-associated musculoskeletal adverse events.[1]

Who is being studied

The trial includes patients at risk of cardiovascular disease who are suitable for high- or moderate-intensity statin treatment.[1] This means the study is focused on people who may need statins as part of their heart and blood vessel risk care.[1]

What is being tested

The main idea being tested is a gene analysis strategy, also described as preemptive genotyping.[1] Genotyping means looking at a person’s genes before treatment to see whether the result can help lower the chance of muscle-related problems from statin therapy.[1]

The study also evaluates safety and cost-effectiveness.[1] Cost-effectiveness means whether the strategy gives useful results for the money spent.[1]

Trial phase and size

This is a Phase 3 study with an enrollment of 216 participants.[1] Phase 3 trials usually study a treatment strategy in a larger group to better understand how well it works and how safe it is, and this trial follows that pattern.[1]

Main outcomes being measured

The primary outcome is a combined measure that includes clinically relevant statin-associated musculoskeletal symptoms or a serum CPK level greater than three times the upper limit of normal for each site’s laboratory.[1] A musculoskeletal symptom is a problem affecting muscles, bones, or joints, and CPK is a blood marker that can rise when muscle is injured or irritated.[1]

The musculoskeletal symptom part of the outcome is defined using two scores: a SAMS-CI score of 7 or higher and an NPRS score of 3 or higher.[1] These are scoring tools used to measure how likely symptoms are related to statin treatment and how strong the pain is.[1]

Statin options listed in the trial

Although the trial focuses on Lovastatin in the overall article topic, the source record lists several statins used in the study plan.[1] These include rosuvastatin, pravastatin, pitavastatin, simvastatin, fluvastatin, lovastatin, and atorvastatin.[1]

  • Rosuvastatin and atorvastatin are listed as treatment options in the trial record.[1]
  • Pravastatin, pitavastatin, simvastatin, and fluvastatin are also included in the intervention list.[1]
  • Lovastatin appears directly in the intervention list as one of the statin treatments being considered.[1]
Trial ID Phase Condition studied Status Enrollment
2023-509418-12-00 Phase 3 Patients at risk of cardiovascular disease susceptible of receiving high or moderate-intensity doses of statins Authorised 216

FAQ

  • What are the Lovastatin trials trying to find out? The trial is looking at whether a gene testing strategy can reduce statin-related muscle problems. It also evaluates safety and cost-effectiveness.
  • Who can take part in the study? The study includes patients at risk of cardiovascular disease who are suitable for high- or moderate-intensity statin treatment. This means people who may need statins to lower their heart and blood vessel risk.
  • What phase is the Lovastatin trial? The trial is a Phase 3 study. Phase 3 trials usually test a treatment strategy in a larger group of people to better understand how well it works and how safe it is.
  • What condition is being studied? The study focuses on cardiovascular disease risk and statin-associated muscle symptoms. It is designed for people who may develop muscle-related side effects during statin treatment.
  • What outcome is the trial measuring? The main outcome is a combined measure of muscle symptoms or a high creatine phosphokinase (CPK) blood level. CPK is a muscle enzyme, and a high level can suggest muscle injury.

Ongoing Clinical Trials on Lovastatin

  • Study on the Effectiveness and Safety of Atorvastatin, Simvastatin, and Fluvastatin in Patients at Risk of Cardiovascular Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Cardiovascular disease: Diseases of the heart and blood vessels. In this trial, the study population includes people at risk of this condition.
  • Statin: A group of medicines used in the trial as the treatment being studied. The study compares different statin options in people at risk of heart disease.
  • High-intensity dose: A stronger treatment dose used when a larger effect is needed. The trial includes people who may receive high-intensity statin treatment.
  • Moderate-intensity dose: A middle-strength treatment dose. The trial also includes people who may receive this level of statin treatment.
  • Gene analysis strategy: A plan that uses genetic testing to help guide treatment decisions. In this trial, it is being tested to see if it can lower muscle-related side effects.
  • Safety: How well a treatment is tolerated and whether it causes unwanted effects. This trial includes safety as one of its goals.
  • Efficacy: How well a strategy works. Here it means whether gene testing helps prevent statin-related muscle problems.
  • Cost-effectiveness: A measure of whether a strategy gives good value for the cost. The trial checks whether the gene analysis strategy is worth using.
  • Statin-associated musculoskeletal symptom: A muscle or joint symptom linked to statin treatment. The trial defines this with specific score cutoffs.
  • CPK: Creatine phosphokinase, a blood test that can rise when muscle is irritated or injured. The trial uses a high CPK level as part of its main outcome.

References

  1. https://clinicaltrials.gov/study/NCT03242499
  2. https://clinicaltrials.gov/study/NCT00580970
  3. https://clinicaltrials.gov/study/NCT00285857
  4. https://clinicaltrials.gov/study/NCT01478828
  5. https://clinicaltrials.gov/study/NCT02563860
  6. https://clinicaltrials.gov/study/NCT00352599
  7. https://clinicaltrials.gov/study/NCT02680379
  8. https://clinicaltrials.gov/study/NCT00243880
  9. https://clinicaltrials.gov/study/NCT01346670
  10. https://clinicaltrials.gov/study/NCT01110642