Are Pricey New Cholesterol Drugs Worth the Money?

Consumer Reports
Steve Mitchell
January 19, 2016

Praulent and Repatha can dramatically lower your cholesterol—but aren't proven to prevent heart attack or save lives

You may have heard about two expensive new cholesterol-­lowering drugs: alirocumab (Praluent) and evolocumab (Repatha). Both are injectables recently approved by the Food and Drug Administration and are expected to cost $1,100 to $1,200 per month. That compares with about $48 per year for commonly prescribed cholesterol-­lowering statin drugs such as generic lovastatin, pravastatin, and simvastatin.

Those new drugs, called PCSK9 inhibitors, can dramatically reduce LDL (bad) cholesterol—even in people who’ve been unable to sufficiently lower their LDL with the maximum dose of a statin. But it’s not yet known whether that translates into a reduced risk of heart attack, stroke, or premature death—and that question won’t be answered until ongoing studies have been completed.

In addition, because the medications are so new, their long-term safety is unknown. The most common side effects seen so far include pain at the injection site and symptoms similar to those of a cold or the flu. Serious allergic reactions have occurred as well.

So should you ask your doctor about adding one of the new cholesterol drugs to your regimen? For now, the drugs are approved only for people with a genetic condition that causes extremely high LDL levels, and those who have already had a heart attack or stroke and can’t get their LDL levels down despite high-dose statins and a serious effort to make lifestyle changes.

If you fall into one of those categories, ask your doctor whether you should wait until more is known about the drugs, or whether they make sense for you to try now. Other people should definitely wait.

Be aware that if you do start either of the new cholesterol drugs now, your health insurance may cover the costs only if you take it for one of the FDA’s approved uses. And it’s still unclear whether Medicare will cover the drugs.

Both Sanofi (the maker of Praluent) and Amgen (which makes Repatha) told us that they have programs that can lower out-of-pocket costs for some people. But there are eligibility restrictions—you can’t be on Medicare or Medicaid, for example. And depending on the program, you may have to give the pharmaceutical company information such as your medical history and doctor’s name.

For more on cholesterol medications, see our free Best Buy Drugs report on statins.

Editor's Note: This article also appeared in the February 2016 issue of Consumer Reports On Health.

This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

Should You Mix Those Two Drugs?

Should You Mix Those Two Drugs? Ask Dr. Google


by Sean Treacy on 6 March 2013, 6:30 PM

Analyzing queries made to Google, Bing, and other search engines can reveal the potentially dangerous consequences of mixing prescriptions before they are known to the Food and Drug Administration (FDA), according to a new study. Such data mining could even expose medical risks that slip through clinical trials undetected.

Pharmaceuticals often have side effects that go unnoticed until they're already available to the public. This is especially true of side effects that emerge when two drugs interact, largely because drug trials try to pinpoint the effects of one drug at a time. Physicians have a few ways to hunt for these hidden risks, such as reports to FDA from doctors, nurses, and patients. One study, in 2011, data-mined those FDA reports and uncovered a hidden drug interaction: When taken together, the antidepressant paroxetine and the cholesterol suppressant pravastatin cause hyperglycemia, or high blood sugar. After verifying that finding with experiments, the researchers behind the study wondered what other information sources were left untapped.

Enter search engines. Much like Google Flu Trends reveals influenza outbreaks by tracking flu-related search terms, search queries about drug combinations and possible side effects—say, "paroxetine," "pravastatin," and "hyperglycemia"—might enable researchers to identify unanticipated downsides to medications, says bioinformatics researcher Nigam Shah of Stanford University in Palo Alto, California. "If a lot of people are concerned about a symptom, that in itself is valuable information."

Although many bad reactions to drugs never get reported to doctors, people talk about what's bothering them all the time on a casual basis to their friends or online, notes computational biologist Nicholas Tatonetti of Columbia University, who was also involved with the study. "They don't really know," he says. "They're just reporting on their symptoms, which is just a normal thing that humans love to do."

So the researchers turned to Microsoft, which gets permission from many Internet Explorer users to collect Google, Bing, and Yahoo! search queries for research. Microsoft provided a database containing 82 million search engine queries from 6 million unique users from 2010. The research team looked for users who queried "paroxetine" and "pravastatin," or each drug alone, to determine if the same users also looked for "hyperglycemia" or other terms describing hyperglycemic symptoms. For example, they may have looked for "dry mouth" or its technical term, "xerostomia."

Before anyone knew about the drug combination's side effects, one out of 10 people searching for both drugs also looked for terms related to hyperglycemia—about twice as often as did people looking up paroxetine or pravastatin alone, the team reports today in the Journal of the American Medical Informatics Association. The researchers then looked for 62 other drug pairings, half known to cause hyperglycemia and the other half known not to. They found that the data-mining procedure correctly predicted whether the drug combo did or did not cause hyperglycemia about 81% of the time.

The findings add yet another resource for scientists to find clues to drug risks, Shah says, and this one can be monitored in real time. One hope, he notes, is that search engine companies could analyze the data and ship the results to FDA, which would then screen the information and alert doctors of new potential risks. "This is information, we have access to it. As a society we're sitting on it," he says. "We could use it to assist the FDA, which currently relies on the reported sources."

The new study is "exciting" because the field is so new, says biomedical informatics researcher Hojjat Salmasian of Columbia University, who was not involved with the work. "We don't know how much potential it has," he says. "But based on the results that have been published so far in this study and other similar studies, it seems like this is a very important field to explore."