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Today’s Statin Debate Bears Lessons For Tomorrow’s Cholesterol Drugs

 
• By Emily Hayes

Clinicians recently took to the pages of the Journal of the American Medical Association to argue the appropriateness of using statin therapy as primary prevention in patients who are not already at high risk for a cardiovascular event. Such scrutiny comes as NIH prepares to issue new treatment guidelines to a market newly saturated with popular generic options, and as pharmaceutical companies assess how best to approach the dyslipidemia field.

A recent debate in the Journal of the American Medical Association over whether statins are worthwhile for use in non-high risk patients highlights some of the hurdles new cholesterol drugs could face in gaining acceptance in the post-Lipitor era.

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

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