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A new strategy for further lowering LDL-cholesterol

MD-FM Thursday March 27, 2014 

 


SARAH:

MD-FM, the latest medical news from around the world, here’s Peter Goodwin.

 

SEGMENT 1: HYPERLIPIDEMIA: Evolocumab significantly reduces LDL cholesterol


PETER:

Hello and, to begin with, for patients with hyperlipidemia, 52 weeks of the statin alternative evolocumab significantly reduced LDL cholesterol levels and that was whether the drug was added to diet alone, low or high-dose atorvastatin with or without ezetimibe. Sarah Maxwell has the details…

 

SARAH:

Yes, that’s the result of a study, published in the New England Journal of Medicine, that compared the anti-PCSK9 monoclonal antibody to placebo in 900 patients with a range of cardiovascular risks. LDL cholesterol was lowered by 57 per cent with evolocumab and it was well tolerated:

 

BLOM:

The drug works well, across a very wide spectrum of background cardiovascular risks that require treatment. The effect is maintained, so we looked at the week 12 versus the week 52 data and there was no loss of efficacy over the drug. And then obviously it provides us with further safety information in a double-blind fashion.

 

SARAH:

That was lead study author Dirk Blom, head of the division of lipidology at the University of Cape Town, South Africa.

 

PETER:

These results sound encouraging but evolocumab’s not actually approved yet is it… But which patients could we potentially see it being considered for in the future?

 

SARAH:

Well, there’s a lot of data on the way from other studies looking at evolocumab in different settings, and the hope is that it could provide a new early treatment option for some patients including those who can’t have statins…

 

BLOM:

We would really be looking at patients with heterozygous-familial hypercholesterolemia, who have very high baseline LDL cholesterols and cant get close to target with the currently available therapy and then statin intolerant patients. So these would be groups of patients that one may be treating earlier with the drug if it is approved while we’re waiting for cardiovascular outcome data because they have the largest need for new and alternative therapies.


SARAH:

Dirk Blom, from the University of Cape Town.

 

 

SEGMENT 2: Millions affected by new US hypertension guidelines

 

PETER:

How many Americans have been impacted by the latest –and slightly controversial –changes to the hypertension management guidelines? The estimate is tens of millions, according to a study reported in JAMA, which also looked into how many people have been re-classified from having high-blood pressure –by old guidelines –to now having ok or at goal BP...

 

SARAH:

Yes, the blood pressure threshold for adults over the age of 60, was raised from 140 over 90, to 150 over 90 by the new guidelines released in February. Another major change was in recommended goals for adults with diabetes and chronic kidney disease, for whom the target used to be lower than the general population but is now back up to the same goal as everybody else. The study identified two groups affected by the new guidelines:

 

NAVAR-BOGGAN:

We estimated that about 13,5 million adults, including one in five of every adult over the age of 60, under the old more stringent guidelines, were considered to have uncontrolled blood pressure and, under the new guidelines, their blood pressure would be considered at goal. This includes five million adults who were not on blood pressure therapy but, under the old guidelines, had high blood pressure and would have been recommended to start treatment. Under the new guidelines those 5.8 million adults are now considered controlled and would not need to start medication. The second group would be the adults who were doing well under the old guidelines, being treated for high blood pressure, and meeting the older more stringent targets. So there’s about 14 million of those adults, and this includes one in four adults over the age of 60 who, under the old guidelines, were recommended to have a lower blood pressure and were taking medication and achieving that.

 

SARAH:

That was lead author Ann Marie Navar-Boggan, from Duke University Medical Center.

 

PETER:

Some of the authors of the new guidelines actually came out saying they didn’t agree with the changes in the recommendations for the over 60’s, didn’t they? So what should we all make of this lack of consensus?

 

SARAH:

Well, the authors suggest dealing with each patient on an individual basis rather than a one-size-fits-all approach:

 

NAVAR-BOGGAN:

I think it’s a good time for doctors and patients to connect and really discuss the risks and benefits of blood pressure treatment to various targets. Evaluate all the literature and come to an informed decision about really what the blood pressure level should be for that individual.

 

SARAH:

Ann-Marie Navar-Boggan again. And I turned to Harlan Krumholz who wrote an editorial on the study. What did he make of these data?

 

KRUMHOLZ:

For patients, they need to decide whether its worth it to them to take these medications and we need to find ways to express to them the size of the potential benefit, the potential harms and costs that are associated with the different strategies, and try to sit down together and make a choice. Its not like “if you’ve got this, then you need this, bye see you next week.” And I think we may be past an era where we are just telling patients what to do, and I think these guidelines, and the controversy around them, is bringing this issue to the forefront.

 

SARAH:

Dr Harlan Krumholz, from Yale University School of Medicine, New Haven, Connecticut.

 


SEGMENT 3: Resistant hypertension: no significant reduction in systolic BP after renal-artery denervation 

 

PETER:

The intriguing possibility of treating resistant hypertension without drugs could now be dead in the water following findings published in the New England Journal of Medicine from Boston, USA.  The investigators conducted a controlled trial of denervation for refractory hypertension, in which an invasive sham procedure was compared with catheter-based renal artery denervation.  There were no significant differences in office or ambulatory systolic pressures between the groups – in contrast to findings from earlier uncontrolled studies, which the authors of this new study suggest could have been positive only because of strong placebo effect.

  

SEGMENT 4: Bariatric surgery: new treatment for overweight and mildly obese patients with type 2 diabetes

 

PETER:

You might think of bariatric surgery as the domain of ultimate therapies for the morbidly obese, but think again. Apparently it could become mainstream treatment for type 2 diabetes!

 

SARAH:

Yes. A group in the States has boldly gone with the logical step that if being overweight helps cause type 2 diabetes why not use all of the armoury at your disposal for fighting it?  And lead investigator of the New England Journal paper on bariatric surgery for diabetes, Philip Schauer, seemed to be telling me they’d hit the jackpot:

 

SCHAUER:

We found that not only did the patients having surgery have better blood sugar control but they were able to reduce their medications. In fact more than 90 per cent of the surgical patients were completely weaned off insulin and we also measured the quality of life, which was profoundly better in the surgical group.

 

SARAH:

And the surgery benefit was on top of medical therapy among the 150 obese patients with diabetes randomised to receive it in addition to the standard optimum regimen. But if you want to use bariatric surgery to treat your patient with diabetes, you might have some battles to fight first with the funding bodies, Dr Schauer told me: 

 

SCHAUER:

Most patients with type 2 diabetes have a body mass index between 25 and 35, and most insurance coverage throughout the world today will not cover these procedures with a BMI of less than 35. So our data suggest that these folks may equally benefit from these procedures, which were initially developed for weight loss, but we are finding now are very powerful anti-diabetic procedures as well.

 

SARAH:

Dr Philip Schauer, from the bariatric and metabolic institute, at the Cleveland Clinic, in Ohio.

 

SEGMENT 5: Improved survival after colon cancer diagnosis with aspirin

 

PETER:

There have been plenty of signals over the past few years that aspirin has some kind of anti-cancer effect in the bowel.  Well now there’s been a publication in JAMA documenting a therapeutic benefit of taking low dose aspirin if you have colorectal cancer.  Sarah:

 

SARAH:

The JAMA Internal Medicine paper reports on a thousand patients having surgery for their colon cancer, who had their prescription records checked to see if they’d taken a minimum of two weeks of aspirin since their diagnoses.  Nearly half of patients who had not taken aspirin died, while just less than 40 per cent of aspirin users died.  Gerrit Jan Liefers told me their findings add to a body of evidence supporting the addition of aspirin to adjuvant regimens for treating colorectal cancer: 

 

JAN LIEFERS: 

Our publication is one in many now that again hints at aspirin as a valid anti cancer treatment.  We think that by looking at the molecular up-make of tumours that benefit most, we have the hypothesis of why that is the case. But we think that in our paper in JAMA, we hypothesize the working mechanism of that.  But the take-home message today is that we need to do a bit more work in the randomised trial area before it can be recommended definitely.

 

SARAH:

Dr Gerrit Jan Liefers, from the Department of Surgery at Leiden University Medical Centre, in the Netherlands, is cautious, but Dr Alfred Neugut, who wrote a commentary in JAMA, took a pragmatic view:   

 

NEUGUT: 

The clinical take home message is that I think that we have a new treatment for stage III colon cancer, and I think going forward it should become … personally, I think that this should become the new standard of care.  It requires more testing but, at least for the moment, it should be the standard treatment for colon cancer patients with stage III cancer until evidence proves otherwise.

 

SARAH:

Dr Alfred Neugut, from Columbia University, in New York.

IN BRIEF 1: Cirrhosis: significant benefit from HCC surveillance

 

PETER:

Finally, in brief: a study in PLoS Medicine concludes that the large amount of data consistently demonstrating benefits of screening for hepatocellular carcinoma, in patients who have cirrhosis, should be regarded as providing enough of an evidence-base to justify surveillance to detect liver cancer, even in the absence of a randomized controlled trial. This advice comes from the authors of a systematic review and meta-analysis of 47 studies with 15,000 patients.

 

IN BRIEF 2: Rodents pose Y pestis risk to human populations

 

PETER:

If you want to avoid the Black Death, keep away from rats: a Lancet study has concluded that the Yersina pestis bacterium, that caused the first pandemic in the Dark Ages and the Black Death in London and elsewhere 800 years later, emerged independently from rodents and passed into human beings. The researchers sequenced and analyzed genomes of the bacterium taken from two unfortunates who succumbed in the first Y Pestis pandemic –the Plague of Justinian.  And they deduced that rodents worldwide represent important reservoirs for the repeated emergence of diverse lineages of Y pestis into human populations. You have been warned…!

 

PETER:

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then, from me Peter Goodwin, goodbye!

 

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