FDA Approves Second Drug in New Class of Cholesterol-Lowering Medications
FDA Approves Second Drug in New Class of Cholesterol-Lowering Medications
Trials showed Repatha slashed 'bad' LDL cholesterol levels in those who couldn't tolerate statins
"Familial hypercholesterolemia is not rare," he noted. "It affects about one in 300 to 500 people."
Of the trials covered in the Annals review, half involved people with familial hypercholesterolemia. Some of the other trials focused on people who'd quit statins because of the side effects.
However, that doesn't mean the new drugs are completely safe. Martin said the main concern that has arisen in trials of the new drugs is the potential for "neurocognitive effects." For example, some study patients reported problems such as confusion and trouble paying attention. But, Martin said, it's not clear yet whether the PCSK9 inhibitors are actually the cause.
For the Annals review, researchers led by Dr. Eliano Navarese, of Heinrich Heine University in Dusseldorf, Germany, pooled the results of 24 clinical trials involving more than 10,000 patients. Some compared a PCSK9 inhibitor to a placebo (an inactive treatment), while others used the cholesterol drug ezetimibe (Zetia) for comparison.
Overall, the researchers found, the new drugs cut LDL to a greater degree. They also lowered patients' risk of heart attack or death by about half.
Dr. Suzanne Steinbaum, a preventive cardiologist at Lenox Hill Hospital in New York City, told HealthDay that the results of the new cholesterol drugs were so far encouraging.
"For all those patients unable to take statins, finally there might be an option that can change [their] outcomes," said Steinbaum, who was not involved in the recent review.
But, she added, "we need to patiently wait for the next phase of trials to see whether the clinical outcomes are as promising as the initial studies suggest."
The new drugs have to be self-injected, which might put some people off. On the other hand, Martin said, the injections are done only once a month or every couple of weeks.
"Some people may prefer that to taking a pill every day," he said.
Then there's the cost. PCSK9 inhibitors are specialty drugs known as monoclonal antibodies, which are lab-altered versions of human antibodies. And they aren't cheap.
The new drugs could cost up to $12,000 a year per patient, according to a recent estimate by CVS Health, one of nation's largest pharmacy benefit managers.
Repatha is marketed by Amgen Inc., of Thousand Oaks, Calif.
FDA OKs Second in New Class of Cholesterol Drugs
Trials showed Repatha slashed 'bad' LDL cholesterol levels in those who couldn't tolerate statins
"Familial hypercholesterolemia is not rare," he noted. "It affects about one in 300 to 500 people."
Of the trials covered in the Annals review, half involved people with familial hypercholesterolemia. Some of the other trials focused on people who'd quit statins because of the side effects.
However, that doesn't mean the new drugs are completely safe. Martin said the main concern that has arisen in trials of the new drugs is the potential for "neurocognitive effects." For example, some study patients reported problems such as confusion and trouble paying attention. But, Martin said, it's not clear yet whether the PCSK9 inhibitors are actually the cause.
For the Annals review, researchers led by Dr. Eliano Navarese, of Heinrich Heine University in Dusseldorf, Germany, pooled the results of 24 clinical trials involving more than 10,000 patients. Some compared a PCSK9 inhibitor to a placebo (an inactive treatment), while others used the cholesterol drug ezetimibe (Zetia) for comparison.
Overall, the researchers found, the new drugs cut LDL to a greater degree. They also lowered patients' risk of heart attack or death by about half.
Dr. Suzanne Steinbaum, a preventive cardiologist at Lenox Hill Hospital in New York City, told HealthDay that the results of the new cholesterol drugs were so far encouraging.
"For all those patients unable to take statins, finally there might be an option that can change [their] outcomes," said Steinbaum, who was not involved in the recent review.
But, she added, "we need to patiently wait for the next phase of trials to see whether the clinical outcomes are as promising as the initial studies suggest."
The new drugs have to be self-injected, which might put some people off. On the other hand, Martin said, the injections are done only once a month or every couple of weeks.
"Some people may prefer that to taking a pill every day," he said.
Then there's the cost. PCSK9 inhibitors are specialty drugs known as monoclonal antibodies, which are lab-altered versions of human antibodies. And they aren't cheap.
The new drugs could cost up to $12,000 a year per patient, according to a recent estimate by CVS Health, one of nation's largest pharmacy benefit managers.
Repatha is marketed by Amgen Inc., of Thousand Oaks, Calif.