NEW YORK: As many as one in five individuals- about 64 million in the US- have elevated amounts of a small atom in their body that can significantly increase the risk of heart attacks and stroke. But few know about it, and some specialists check for it, because there was not much to get done. Neither eating nor training help. There have been no medication.
But that may quickly change.
On Sunday, at the annual meeting of the American College of Cardiology, cardiologists announced that an experimental drug made by Eli Lilly, lepodisiran, could lower levels of the particle, Lp ( a ), by 94 % with a single injection. The results lasted for six months and there were no major side effects, said the post instantly published in the’ New England Journal of Medicine’.
At least four other companies are also testing drugs that block the body’s production of Lp ( a ), a mix of lipids and a protein. The first will be a review of a Novartis medicine, injected regular, with benefits expected in 2026. However, these medications are still in stage 2 clinical tests and are times away from making it to the business.
Moreover, it isn’t yet confirmed that reducing Lp ( a ) levels also reduces the risk of heart attacks. Doctors are optimistic as they remember a lesson learned from assuming that altering a risk factor can change risk: They when were passionate about medication that raised rates of HDL- the” good cholesterol” associated with lower rates of heart disease- but the medications didn’t help.
Treatments targeting Lp ( a ) have been a long time coming. It was identified in 1974 as a risk factor for heart disease that is controlled by genes more than life or setting.
People with elevated levels of Lp ( a ) have a 25 % increased risk of a heart attack or a stroke, the risk doubles at very high levels.
Cardiologists say patients with no obvious reason for having a heart attack- non-smoker, normal blood pressure and cholesterol-have high levels of Lp ( a ). The same goes for young persons having heart problems, said Cleveland Clinic’s Dr Steven Nissen, the intellectual leader for the Lilly test. ” If you go into the coronary care unit and see someone who is 40 years old with an acute myocardial infarction, you need to know the level of their Lp ( a )”, he said. It’s likely to be over 250 nanomoles per litre instead of 75.
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The excitement surrounding Elli Lilly’s novel drug candidate is understandable as it’s the first with the potential to suppress production of Lipoprotein ( a ) or Lp ( a ) — a protein-fat molecule in blood that increases the risk of heart attack and stroke. But this euphoria should be tempered with a few caveats:
- The drug’s development is in phase 2 — the halfway point in a four-phase clinical trial journey.
- The process is stringent — only about 10 % of applications for trial finally receive FDA approval, and can take a decade and huge investments.
- Success rate for progression from phase 2 to 3 trials is 30-40 %.
- Phase 2 trials involve only a few hundred participants and are aimed at determining a drug’s effectiveness and appropriate dosage levels.
- Phases 3a and 3b would be more interesting as they underline a medication’s safety and effectiveness over a large sample involving thousands of participants.
A senior Mumbai-based physician said numerous drugs and clinical trials in phase 2 “flatter only to deceive” and often raise false expectations among patients. Definitive answers will emerge only through time and comprehensive trials.
