Essential Guide

Did you get your flu vaccination yet? How about today?

beach scene There you were sitting on the beach. Where does the time go? Summer is over now and the leaves are starting to fall. I got my flu shot yesterday. How about you?

Repatha (evolucomab)- First PCSK9 Inhibitor in the world is approved in Europe

 building at DawnFirst PCSK9 Inhibitor in the world is approved in Europe

 

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 building at DawnFirst PCSK9 Inhibitor in the world is approved in Europe

 

We've seen the dawn of a new family of medicines to treat cholesterol. The European Commission (agency analogous to the FDA in the US) approved evolocumab (Repatha) July 21, 2015 in Europe. This new class (family) of medicines offers great hope for treating abnormal cholesterol. Prescribers in Europe may soon be able to be use Repatha for:

 

1)      Treating adult patients who have a kind of cholesterol problem known as primary hypercholesterolemia (Heterozygous familial and non-familial HeFH or mixed dyslipidemia in addition to dietary steps. In these patients, Repatha can be used:

  1. Alone or in combination with other lipid-lowering treatments when they don’t tolerate an earlier approved family of medicines known as statins (HMG-CoA reductase inhibitors such as Lipitor [atorvastatin] or rosuvastatin [Crestor]. This is a novel approach for such statin-intolerant people. Repatha will also be able to be used in patients who should not be given a statin (those for whom a statin is contraindicated).
  2. In combination with a statin or statin combined with other lipid-lowering therapies in people who do not reach their LDL cholesterol goals with the maximum tolerated dose of a statin, OR

 

2)      Treating of adults or adolescents who are 12 years old or older who have homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.

 

While this discussion is somewhat complicated, several Repatha Essentials emerge in this exciting new topic:

  • In Europe, current therapies (statins and other approved lipid-lowering medicines) fail to adequately lower bad cholesterol (LDL-C) over 60% of the time in high risk patients.
  • In very high risk patients, previously available treatments failed more than 80% of the time to lower bad cholesterol enough.
  • Repatha is the first PCSK9 inhibitor to be approved anywhere in the world.
  • Problems from Repatha (adverse event or AE profile) was similar overall to the placebo (control) groups of patients. The most common Adverse Reactions (ARs) more than or equal to 2% were nausea, flu (influenza)joint or back pain, upper respiratory tract infection or nose or throat soreness (nasopharyngitis). Most new medicines are studied after approval have results based on approval studies and reports are submitted which show more about potential problems as time goes on. The FOURIER study below will undoubtedly tell more about additional benefits from Repatha treatment and while not expected, will reveal any problems not seen in the approval studies.
  • The cost of cardiovascular disease (CVD) in the European Union (EU) is immense and totals roughly 106 billion Euros each year.
  • While Repatha may be reasonably expected (based on the ability to lower LDL cholesterol and thinking toward parallel results from the statin family of medicines) to decrease problems from and death from heart disease (cardiovascular morbidity and mortality), this is still unknown. There is a large study (clinical trial) called FOURIER- Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) which should let us know that answer. This is a 22 500-patient trial comparing evolocumab to statin treatment to see how it compares in:

1)      Lowering

  • 1) cardiovascular death
  • 2) heart attack (MI)

 

2)      Lowering hospitalization for unstable angina, stroke, or coronary revascularization.

The full results from FOURIER won't be available until 2018 at the earliest.

 

Because evolocumab (Repatha) is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in the world, I will most likely create a profile for the new Essential Guide to Prescription Drugs, using Repatha as the representatve member of this impressive new family. Once the results of the FOURIER study are known, I may opt to include it in the True Breakthroughs in Medicines section.

 

The original European press release is available at :http://www.prnewswire.com/news-releases/european-commission-approves-amgens-new-cholesterol-lowering-medication-repatha-evolocumab-the-first-pcsk9-inhibitor-to-be-approved-in-the-world-for-treatment-of-high-cholesterol-300116162.html 

Palcohol powdered alcohol approved and now not approved

 

young women drinking Palcohol. Powdered alcohol. Convenient for hikers, kayakers, anywhere where weight is an issue, but could the very convenience it brings increase risk of alcohol poisoning and under age drinking?

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young women drinking Palcohol. Powdered alcohol. Convenient for hikers, kayakers, anywhere where weight is an issue, but could the very convenience it brings increase risk of alcohol poisoning and under age drinking?

These appear to be the challenges that Lipsmark, the company that makes Palcohol and Mark Phillips, the company president are now facing.

In a recent interview, the president noted that he came up with the idea for use in hiking and wanting to enjoy an alcoholic beverage when the day is done. One of the Rum, Vodka, Cosmopolitan or Powderita packets apparently has as much alcohol as a typical drink. The prevalent video shows Mr. Phillips reconstituting a packet, then pouring a drink.

 

Concerns arose in the media and from legislators almost immediately. Colorado and several other states banned the product. Approval for the product apparently has been reversed.

This editor immediately had the caution reaction, noting that the recently released Essential Guide to Prescription Drugs, Update on Alcohol helps people understand how to drink safely and avoid interactions, but that the book didn't contain Palcohol data (except in the sense of a standard drink and being careful of intake).

 

The saga of Palcohol is not over, but is apprently being reviewed. There are several cases of prescription drugs where medguides (and perhaps the Essential Guide) could be used to teach people about the product and help avoid problems. Perhaps a limitation on sales (5 packets at a time to any single person) could help.

 

More to follow as always once new information becomes available.

Weight loss drug decreases heart attacks? Contrave and early data

 

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fireworks A study of 4,500 patients using a new weight loss drug called Contrave (bupriprion and naltrexone) had the expected effect of a weight loss benefit, and the drug was FDA approved. A study of 8,910 people in a follow up study had the weight loss benefit, however; the patients taking Contrave had fewer heart attacks than the people who didn't take it.

There is controversy over this trial and apparent early leaks of data, but the information that patients taking the drug had fewer heart attacks is stunning. Importantly, the researchers doing the study thought the benefit on heart attacks may be a direct effect of the drug combination!

More to follow as always.

New Essential Guide to Prescription Drugs, Upddate on Alcohol delves into alcohol poisoning and avoiding it

    two women drinking Roughly 130 million people in the US drink alcoholic beverages and many of us take alcohol for granted. Recent data compiled from the CDC reveal that roughly 6 people die a day from aclohol poisoning.

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    two women drinking Roughly 130 million people in the US drink alcoholic beverages and many of us take alcohol for granted. Recent data compiled from the CDC reveal that roughly 6 people die a day from aclohol poisoning. This sad and largely preventable death toll is related to the blood level of alcohol and also to potential drug interactions.

Surprisingly, alcohol is actually used for antifreeze poisoning, but is far more commonly used as an antianxiety/relaxation agent. So many of us know that after work cocktail or two and the effects of a drink and how it works--or do we? James Rybacki, the author of a new book on alcohol, entitles, The Essential Guide to Prescription Drugs, Update on alcohol (available from Amazon exclusively at present) was shocked to learn of the large daily number of deaths from such a common beverage. More importantly, when the new became available, he decided to update his prior publication (previously only available as a PDF) and launched a large awareness campaign to help people and thier children become more aware of risky drinking, binge drinking and important facts to help keep people safe.

While the eBook, The Essential Guide to Prescription Drugs, Update on Alcohol is currently only available from Amazon for Kindle, it will soom be available in the iBookstore and other outlets. Rybacki is quotes as saying, "the best colleague any clinician can have is a more fully informed patient and family." Very true words when it comes to alcohol.Find the book at Amazon and listed in Dr. Rybacki's vast publication list as the latest one at https://www.amazon.com/author/jamesrybacki.

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.