Is the New Class of Cholesterol-Lowering Drugs For You?

The quick answer to ‘Am I a candidate for one of the two new PCSK9 cholesterol-lowering drugs?’ is Probably Not (unless you have FH or have heart disease / have had a heart attack.)

The reason? Two, actually. First, this totally new class of (injectable) cholesterol-lowering drugs is approved ONLY for those with high cardiac risk. And secondly, clinical study results with key safety data won’t be available for YEARS.

The two new drugs, Praluent and Repatha, were approved this past summer by the FDA only for those with a serious, genetically inherited disease that causes very high LDL (bad) cholesterol called Familial Hypercholsterolemia (FH) and/or for those who have heart disease / have suffered a heart attack. Said differently, this new class of drugs is NOT for those with “regular” high cholesterol — and that’s key because these drugs have potentially serious (neurological and other) side effects which won’t be fully known until clinical results are released in 2017.

As reported by CNN’s FDA Approves Second In New Class of Cholesterol Lowering Drugs:

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” Dr. John Jenkins, director of the FDA Office of New Drugs, Center for Drug Evaluation and Research, said in a news release.”

A similar CNN article, FDA Approves New Cholesterol Lowering Drug, explains:

“It focuses on those who’ve truly had clinical disease or those who start out with such high levels of LDL they can’t get anywhere near where they should be and I think those are the most at-risk people,” said Dr. Donald A. Smith, associate professor of medicine and cardiology at Mount Sinai Hospital in New York.”

So, yes, this new class of drugs is amazing news for those with FH and those with cardiac disease who cannot tolerate statins. These folks should run, not walk, to their cardiologists. But for the rest of us, Repatha and Praluent are drugs we can ask our internists and cardiologists about at our next appointments, not race there with questions now.

What’s fascinating frustrating to me about these new drugs is that there is a lack of clarity from the American Heart Association (AHA) and the American College of Cardiologists about how this new class of drugs fits in with their 2013 “New Guidelines” for treating high cholesterol.  Indeed, in ‘Understanding The New Guidelines,’ the new class of drugs is not even mentioned. I find this exasperating – this is an ONLINE instrument and should be current. I found exactly one article on AHA’s site (their blog, actually) called FDA Approves New Cholesterol Drug. In a nutshell, what the AHA said about the new class of drugs is that MAYBE WE SHOULD THINK ABOUT IT VIS-A-VIS OUR GUIDELINES? (emphasis mine, obviously.)

Seriously? That’s it, AHA? Very disappointing. Here’s a quote from that article:

“The AHA revised its scientific guidelines about cholesterol in 2013. They de-emphasize the setting of specific LDL targets and recommend statin use for all at-risk patients with elevated LDL. The recommendations also suggest statin treatment for people who don’t have cardiovascular disease but who by using an at-risk estimator tool are determined to have at least a 7.5 percent risk of developing it over a decade.

Now with the possibility of having ultra-low levels of LDL, Eckel, who sat on that guideline-writing panel, said it is unclear whether there will be a move soon to rewrite the guideline to take into account the developments with PCSK9 inhibitors.

“Some people feel the guideline could be re-written now and others believe it should wait until the PCSK9 outcome trials are completed,” he said.”

(NOTE: ‘he’ refers to “Dr. Robert H. Eckel, an endocrinologist and professor at the University of Colorado Anschutz Medical Campus and director of the medical school’s Lipid Treatment Clinic” who sat on the AHA/ACC new guidelines panel.) 

This equivocating statement (and no real guidance at all) is the sum total of what I could find in terms of opinion from the American Heart Association about this new class of drugs. One can only hope they are providing more to doctors and cardiologists, but I doubt it. Which leaves doctors deciding on treatment based on information presented by (necessarily biased) drug companies. Because you can be sure reps from Amgen and Sanofi are banging down the doors of US cardiologists.

Personally, I’m confused. Every single adult in my family takes statins to lower cholesterol. ALL of them.  But I’m trying not to; I’m trying to manage my risk with lifestyle and diet. And following the American Heart Association’s guidance, I should not be taking statins (my results from the AHA ‘risk calculator’ are below. And clearly I’m not a candidate for the PCSK9 drugs as I don’t have FH nor have had a heart disease event, yet. And further, my advanced lipid panel testing also confirms I am not at great cardiac risk.

But what if they’re wrong? What if the AHA changes the guidelines again and I waste two years not taking statins? Or find out that everyone should be taking PCSK9 to lower cholesterol dramatically?

Dr. Mercola doesn’t think that will happen. In his FDA Approves Potentially Disastrous Cholesterol-Lowering Drug, he argues this new class of drugs is likely to be widely prescribed before it’s safety is known, and that there are early indicators of safety issues.

But I’m left wondering.  Luckily I have a follow up appointment with my cardiologist in December, so I’ll ask him what he thinks of the 2013 Guidelines now that two PCSK9 drugs have been approved. I plan to ask if he thinks I should continue to follow AHA/ACC guidelines or consider further tests or treatment.

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RESOURCE: CALCULATING YOUR CARDIOVASCULAR RISK:

If you haven’t used the AHA/ACC’s  2013 CV Risk Calculator, you should. It’s free, online (or an app) and is simple to use – all you need are your cholesterol results and your blood pressure (both my internist and my cardiologist used this app during my appointment). Click on the link and fill in the very few boxes and you’ll get a personalized result.

For reference, here’s a summary of my personal inputs and result/recommendation.

“Based on the data entered (assuming no clinical ASCVD and LDL-C 70-189 mg/dL):

  • “Total Cholesterol: 240
  • HDL-Cholesterol: 88
  • Systolic Blood Pressure: 130
  • Hypertension Treatment: No
  • Diabetes: No
  • Smoker: No

Not In Statin Benefit Group Due To 10-Year ASCVD Risk <5%   (THIS IS MY RECO)

In individuals for whom after quantitative risk assessment a risk-based treatment decision is uncertain, additional factors may be considered to inform treatment decision making. These factors may include primary LDL-C ≥160 mg/dL or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first degree male relative or <65 years of age in a first degree female relative, high-sensitivity C-reactive protein ≥2 mg/L, CAC score ≥300 Agatston units or ≥75 percentile for age, sex, and ethnicity, ankle-brachial index <0.9, or elevated lifetime risk of ASCVD. Additional factors may be identified in the future. (IIb C)

Lifestyle Recommendations

AHA/ACC guidelines stress the importance of lifestyle modifications to lower cardiovascular disease risk. This includes eating a heart-healthy diet, regular aerobic exercises, maintenance of desirable body weight and avoidance of tobacco products.”

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Do You Have FH?

The cholesterol-watching world is filled to the brim with acronyms and easily confused verbiage.  Who can remember what LDL and HDL stand for – much less which is the good and which is the bad cholesterol?  And then there’s Apo-B and LDL particle size to boot. But today I learned one that was total news to me: FH.

Turns out, FH stands for Familial Hypercholesterolemia which, in a nutshell, is very high LDL (bad) cholesterol that is caused by genetics. A more complete definition is given on The FH Foundation website:

FHlogo“FH is short for Familial Hypercholesterolemia. It is an inherited disorder that leads to aggressive and premature cardiovascular disease. This includes problems like heart attacks, strokes, and even narrowing of our heart valves. For individuals with FH, although diet and lifestyle are important, they are not the cause of high LDL. In FH patients, genetic mutations make the liver incapable of metabolizing (or removing) excess LDL. The result is very high LDL levels which can lead to premature cardiovascular disease (CVD).”

I was amazed to find there’s a site – indeed, an entire foundation – dedicated to high cholesterol caused by genetics.  And a bit miffed – because I know my high cholesterol is genetic… so I can’t believe I didn’t know about this very useful source of information.

And it’s important – because FH is a serious condition and essentially requires choleterol-lowering medication or other intervention:

“Nearly 100% of people with FH will require cholesterol-lowering medications. For some people with FH, more aggressive measures are needed, including LDL-apheresis (a very simple procedure in which LDL-C cholesterol is removed from the blood on a weekly or biweekly basis.)

The American Academy of Pediatrics recommends that if a family has a pattern of early heart attacks or heart disease defined as before age 55 for men and 65 for women, children in that family should have cholesterol testing after the age of 2 years and before age 10.”

All this very sobering information compelled me to track down the excel spreadsheet I use to track my cholesterol results over time.  I was quite pleased to discover that although my high cholesterol is largely caused by genetics, it does not look like I have FH. In my most recent test, I’d brought my LDL (bad) cholesterol down through diet and exercise to 132 (under 130 was the goal before new guidelines were established).  And according to The FH Foundation website, FH is suspected when untreated LDL is above 190 (or 160 in children).

Whew.  Good news for me on the FH front.

Not so good news for me to ‘discover’ that my last cholesterol test was in March 2013.  Um, more than a year and a half ago.  It seems I have “forgotten” to keep track of my cholesterol levels.  Probably because I spent a lot of time this past year at Shake Shack.

So next week, at my annual ob/gyn appointment, I’ll take the blood test order my doctor always gives me and use it to have my cholesterol tested.

And if you have high LDL cholesterol that has not declined with diet and exercise and/or a family history of early heart disease / heart attacks, consider learning more about FH at The FH Foundation site and discuss with your doctor.

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Chewable Lipitor – Pfizer Targeting Kids with Cholesterol

Lipitor, Pfizer’s blockbuster cholesterol-lowering statin medication, has been approved for use in children with heterozygous familial hypercholesterolemia in the US since 2002, according to Pharmafile. (FH is an “inherited disorder that leads to aggressive and premature cardiovascular disease”). And those with FH are likely in great need of Lipitor.

But FH is a pretty rare disease.  And Pfizer’s putting a lot of effort into chewable Lipitor.

Why?

Is Pfizer is positioning itself to profit – at the expense of children – by inducing pediatricians to more broadly prescribe Lipitor for children?

Perhaps.  And that is very distressing.

Pfizer gained approval in the EU to market a grape-flavored, lower-dose, chewable form of Lipitor — in exchange for patent extension of regular Lipitor (read, short-term profit). Indeed, according to Andrew Jack of the Financial Times,

“Pfizer could earn $800m after European Union countries extended exclusive rights to sell its top-selling drug Lipitor until summer next year, in exchange for tests that will provide a slightly modified form of the medicine to just a few thousand children.”

So Pfizer used the EU’s controversial pediatric regulations, “which were introduced in 2007 with the offer of extended exclusivity as a financial incentive to encourage drug companies to ensure they expanded testing of experimental medicines to include children,” for short-term financial gain.

Typical big pharma move. Totally legal. Much debate about ethics.

More worrisome is what could come down the road.

For there is potential for Pfizer to use the same agressive marketing tactics they have employed to induce over-medication of adult Americans with high cholesterol and no other heart disease risk factors…now with KIDS.

Of course, for those with FH who have a serious need for a statin to reduce cholesterol, that a chewable, grape-flavored version of Lipitor is available in the EU is good news.

But if chewable Lipitor for kids gets approved in the US, who will make sure that Pfizer won’t repeat the marketing strategy that’s been so successful with adults? Who will make sure they don’t resort to scare tactics to convince people – parents of KIDS with high cholesterol — that Lipitor is indicated when it perhaps is not?

Let’s hope if chewable Lipitor ever arrives in the US (and if it stays in the EU) that it’s limited to those who really need it – those with FH.  And that Pfizer will not look to profit on the backs of children who have high cholesterol but no other risk factors.

For more information on the risks and guidelines for cholesterol for children, see my recently published article on Answers.com, High Cholesterol in Children.

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