According to the U.S. Centers for Disease Control and Prevention, about 610,000 people die of heart disease in the United States every year. Heart disease is also the leading cause of death for both men and women.
Since high cholesterol is such a widespread problem, new medications have been in the works to help control and manage it. PCSK9 inhibitors are the newest line of medications in the war against cardiovascular disease.
These cholesterol-lowering injectable drugs work to increase your liver’s ability to remove “bad” LDL cholesterol from your blood and thus decrease your risk of heart attack or stroke.
Keep reading to get the latest on PCSK9 inhibitors, and how they could potentially benefit you.
About PCSK9 Inhibitors
PCSK9 inhibitors can be used with or without the addition of a statin, however they can help reduce LDL cholesterol by as much as 75 percent when used in conjunction with a statin drug.
This could be especially beneficial for those who can’t tolerate the muscle aches and other side effects of statins or those who simply can’t get their cholesterol under control by using statins alone.
The recommended starting dose is 75 mg injected once every two weeks. This dosage may be increased to 150 mg every two weeks if your doctor feels your LDL levels aren’t responding adequately to the smaller dose.
While the research and testing results with these injection drugs are still relatively new, they show great promise.
Newest Inhibitor Treatments
The U.S. Food and Drug Administration (FDA) recently approved Praluent (alirocumab) and Repatha (evolocumab), the first cholesterol-lowering injection treatments in the new class of PCSK9 inhibitors. They’re designed to be used in combination with statin therapy and dietary changes.
Praluent and Repatha are for adults with heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes high levels of LDL cholesterol in the blood, and those with clinical cardiovascular disease.
These drugs are antibodies that target a protein in the body called PCSK9. By inhibiting PCSK9’s ability to work, these antibodies are able to get rid of LDL cholesterol from the blood and decrease overall LDL cholesterol levels.
Trials and research have shown positive results for both Praluent and Repatha. In a recent trial on Repatha, participants with HeFH and others with high risk factors for heart attack or stroke lowered their LDL cholesterol by an average of 60 percent.
The most common reported side effects of Repatha were:
- upper respiratory tract infection
- back pain
- and bruising, redness, or pain at the injection site
Allergic reactions, including hives and rash, were also observed.
Another trial using Praluent also showed favorable results. These participants, who were already using statin therapy and had HeFH or increased risk of stroke or heart attack, saw a 36 to 59 percent drop in LDL cholesterol.
Side effects from Praluent use were similar to Repatha, including:
- pain and bruising at the injection site
- flu-like symptoms
- allergic reactions, such as hypersensitivity vasculitis
As is the case with most pharmaceutical advancements, these new injection drugs will come with a hefty price tag. While the cost for patients will depend on their insurance plan, wholesale costs start at $14,600 per year.
In comparison, brand name statin drugs cost only $500 to $700 per year, and those figures drop considerably if purchasing the generic statin form.
Analysts are expecting the drugs to advance to bestseller status in record time and bring in billions of dollars in new sales.
The Future of PCSK9 Inhibitors
Experiments are still ongoing as to the effectiveness of these injection drugs. Some health officials worry the new drugs pose the potential for neurocognitive hazards, due to some study participants reporting difficulties with confusion and the inability to pay attention.
Large clinical trials will be completed in 2017. Until then experts urge caution since the trials conducted thus far have been short-term, making it uncertain whether PCSK9 inhibitors can actually reduce the risk of heart disease and extend lives.