Bad cholesterol is also known as LDL-C. Having too much bad cholesterol can cause sticky plaques to build up inside your blood vessels. Over time, this buildup narrows your blood vessels and blocks blood flow. If a plaque breaks, it can trigger a blood clot. This can lead to serious heart or blood vessel problems, like a heart attack or stroke.
Lipfendra belongs to a class of drugs called PCSK9 inhibitors. PCSK9 is a protein in your body that binds to the parts of your liver cells (LDLRs) that clear bad cholesterol. By blocking this protein, Lipfendra helps keep the LDLRs in your liver more active. This allows your body to pull more bad cholesterol out of your blood and break it down.
The FDA has approved other medicines that block PCSK9, but these other medicines must be given as shots. Lipfendra is the first one that you can take as a pill by mouth.
What Do the Studies Show?
The FDA approved this medicine based on two clinical trials with a total of 3,207 adults. All of the patients in these studies already had high cholesterol and were taking standard cholesterol-lowering pills, called statins. In both studies, patients received either Lipfendra or a placebo pill, which contained no medicine. The main goal was to see how far the levels of bad cholesterol dropped after 24 weeks of treatment.
The first trial, called CORALreef Lipids, included 2,904 patients. These patients had high cholesterol and either a history of heart disease or a high risk of developing it. At the start of the study, their average bad cholesterol level was 96 mg/dL. After 24 weeks, those taking Lipfendra lowered their bad cholesterol by 56% compared to those taking a placebo.
The second trial, called CORALreef HeFH, included 303 patients with the inherited form of high cholesterol (HeFH). At the start of the study, their average bad cholesterol level was 119 mg/dL. After 24 weeks, the patients taking Lipfendra lowered their bad cholesterol by 59% compared to those taking a placebo.
A larger study is still going on to find out if this medicine can also lower the risk of major heart and blood vessel events, like heart attacks or strokes, over time.
What Else Should I Know?
Lipfendra is a pill that you swallow once a day. You should take it in the morning on an empty stomach with water, black coffee, or plain tea. Make sure to swallow the pill whole, and do not split, crush, or chew it. After taking the pill, you must wait at least 30 minutes before eating food or drinking other types of beverages.
In the trials, Lipfendra was generally safe. In the first trial, the number of side effects was similar for the medicine and the placebo. In the trial for the inherited form of high cholesterol, the most common side effects were diarrhea and dizziness. These side effects occurred in less than 10% of the people taking Lipfendra.
Make sure your health care provider knows about all the medicines or supplements you take. You should also talk to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding. If you find out that you are pregnant, you may need to stop taking Lipfendra. Because of the way the medicine works, it may harm a fetus.
