In a promising development , a drug injection is expected to replace the daily pill for controlling “bad” LDL cholesterol. The Inclisiran shot will be taken at the doctor’s office two or three times a year.
Researchers found that Inclisiran dramatically cuts LDL cholesterol levels by half or more. Early trials show that the drug’s effect lasts a range of four to six months.
Such long-lasting effects could provide a major advance in preventing heart disease, heart attack and stroke, by helping reduce hardening of the arteries, the researchers said.
The trial results were presented at the American Heart Association annual meeting in New Orleans. Another phase of research is needed before Inclisiran can receive U.S. Food and Drug Administration (FDA) approval.
Statin pills like Lipitor (atorvastatin) and Crestor (rosuvastatin) are the current gold standard for treating high cholesterol, but have their limits, heart doctors say.
When paired with a statin, a PCSK9 inhibitor called Repatha (evolocumab) reduced LDL cholesterol levels by nearly 60 percent more than statins alone, said lead researcher Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio.
The Repatha study involved 846 patients with coronary artery disease. Half received statins alone, and others received the PCSK9 inhibitor and statins. About 81 percent of patients taking Repatha and statins showed a reduction in arterial plaque volume, the results showed.
Drugs such as Repatha and Inclisiran spur the liver to flush more LDL cholesterol out of the bloodstream by blocking a protein called PCSK9.
Inclisiran is a next-level PCSK9 inhibitor, after Repatha, which works on a genetic level to prevent cells from producing PCSK9 in the first place, Ray said.
The Inclisiran clinical trial involved 500 people who were assigned to either a “control” group or one of four groups that received different doses of the drug.
One dose of Inclisiran at 300 milligrams or greater caused a 51 percent drop in LDL cholesterol that lasted at least 90 days, while two doses caused a 57 percent reduction that lasted up to six months, Ray reported.
Based on these results, Ray and his colleagues estimate patients would only need an Inclisiran injection two or three times a year to control their cholesterol.
Both trials are funded by the drug’s manufacturers, The Medicines Company for Inclisiran and Amgen Inc. for Repatha.
Data and conclusions presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.