Breaking Diabetes News: New Drug Reduces CV Death

EMPA-REG OUTCOME is a new cardiovascular-safety trial for a Type 2 Diabetes medication which is on the market under the name Jardiance (empagliflozin).

Approximately half of all deaths in people with Type 2 Diabetes are caused by heart disease.  So focusing on heart health and Diabetes is at the center of Research and the results of this class of drug (SGLT-2 inhibitor) reveal very exciting news. Previously many trials with this medication have shown cardiovascular safety, but for the first time a Study has shown that this medication actually cuts cardiovascular deaths.

This particular Study focused on high risk cardiovascular patients with Type 2 Diabetes.  It was seen that not only CV deaths were reduced, but over all deaths were lower in the group being treated with empagliflozin than those who were on a placebo (an inactive substance used to measure the control group).

There are theories as to why this occurs, but the mechanism remains unknown.  It could possibly be that the medication is treating mild heart failure, or preventing it from developing which could be preventing these high cardiac risk patients from suddenly dying, according to Dr. Inzucchi, the senior author on the trial. More research will need to be conducted.

Dr Pfeffer is an expert in heart failure.  He was lead author on the ELIXA trial and he said he never tries to determine mechanisms from studies such as EMPA-REG but stressed that empagliflozin “is clearly showing benefit.”

The full article on this Study is certainly worth the read.  This is an exciting time for Diabetes Research! Visit Medscape Here to Read the Full Article.

 

If you would like to participate in Clinical Research visit www.sestron.com.  We have done many Studies with empagliflozin in the past and could potentially be conducting more for Type 1 and Type 2 Diabetes!

World COPD Day

Twitter is a buzz with #WorldCOPDDay and several medical and pharmaceutical companies are finding innovative ways to bring awareness to this crippling disease. One of my personal favorites is the  “Make Twitter #COUGH” campaign, put on by Boehringer Ingelheim.

Today, on World COPD Day 2015, Boehringer Ingelheim is making Twitter #COUGH to raise awareness of this chronic lung disease.

As the world #COUGHs to raise awareness of COPD (chronic obstructive pulmonary disease), the hashtag will produce a noisy spike in tweets, simulating the sound wave of a COPD sufferer’s chronic cough – a key symptom of the disease.

“Boehringer Ingelheim is calling on Twitter users to help raise awareness of COPD.” said Professor Klaus Dugi, Medical Director and Managing Director UK & Ireland, Boehringer Ingelheim “We want to highlight the importance of supporting people living with this life-changing condition while also addressing and tackling the problem of late diagnosis and misdiagnosis, which can impact life expectancy and dramatically affect the quality of life of people affected by COPD.”

Here at Sestron Clinical Research, we are participating in the global initiative to help bring new COPD medications to market.

COPD is the third leading cause of death in the United States. More than 11 million people have been diagnosed with COPD, but an estimated 24 million may have the disease without even knowing it. COPD causes serious long-term disability and early death. At this time there is no cure, and the number of people dying from COPD is growing.

Help us bring awareness about this smoking related illness and help America breathe better. Tweet #WorldCOPDDay November 18th, 2015.

Global Site Solutions Summit

This past weekend the Global Site Solutions Summit was held in Amelia Island, FL.

This event included attendees from Clinical Research Sites, Sponsors, CRO’s, IRB’s and even presence from the FDA.  The entire gamut of alphabet soup! The collaboration of partners was truly exciting to witness. Topics of break-out sessions ranged from “preparing for an FDA audit” to “reducing the number of screen fails”. There was a record number of people interested in the new “Common Rule”, which will affect all of us involved in conducting clinical trials.  The streamlining process has begun with Christie advocating for us, the Sites.

A big Thank You to all who attended the event and made it such a raving success. See you all next year!

#SCRS15

Visit The Society of Clinical Research Sites for all of the information. Don’t forget to check out @SestronResearch on Twitter and see the photos from the Conference and Gala.  Did I mention, the food was the best I’ve had yet? And there may even be some “selfies”!

Glucose Logs on your iPhone? It’s Here!

With a growing demand for streamlining technology and the record breaking use of cell phones being substituted for PC’s, this is a moment Diabetics have all been waiting for!

Are you sick and tired of juggling multiple devices such as lancets and glucometers?  Are you over lugging around multiple devices, just to monitor your blood glucose? Would you give anything not to have to stick your finger multiple times a day? Your wish may have come true.

Diabetics rejoice! There is a new CGM (continuous glucose monitor), the Dexcom G5 mobile CGM, which has just been approved by the FDA on August 25th.  It has Bluetooth capabilities built right into it and transmits data to an app on iOS enabled smart phones.  It has been FDA approved for people as young as 2 years of age! This app can be synced with as many as 5 devices. That means parents and caregivers can stay up to date with their loved ones blood glucose levels in a convenient and streamlined way.

All of your glucose logs kept conveniently on you phone. Incredible!

If you don’t have an iPhone, don’t worry! Android is expecting to release their app at the beginning of the year.

To read the article on Medscape Click Here

High Cholesterol: Who’s at risk?

Sestron Clinical Research is beginning a Study on a new medication to lower cholesterol.  In light of this news, I wanted to share with you some risk factors, and how to determine your risk factors.

High Cholesterol in the United States

  1. 73.5 million adults (31.7%) in the United States have high low-density lipoprotein (LDL) also known as bad cholesterol.
  2. Fewer than 1 out of every 3 adults (29.5%) with high LDL cholesterol has the condition under control.2
  3. Less than half (48.1%) of adults with high LDL cholesterol are getting treatment to lower their levels.1
  4. People with high total cholesterol have approximately twice the risk for heart disease as people with ideal levels.
  5. Nearly 31 million adult Americans have a total cholesterol level greater than 240 mg/dL

(http://www.cdc.gov/heartdisease/index.htm)

What is cholesterol? Cholesterol helps you digest foods and build cell membranes. Your liver actually makes all the cholesterol that your body needs. Too much of it can put you at risk for heart disease and clog your arteries.

Are you at risk? One in 6 adult American’s have high cholesterol. Even children can have it.  Age, sex, and heredity are not factors that you can change, but there are risk factors that you can control.  Living a physically inactive lifestyle, being overweight, smoking, and eating unhealthy food- these are things you can change!

But I don’t have any Symptoms: Most people with high cholesterol do not have any symptoms.

How can I calculate my risk?

Step1: In order to analyze your risk, you will need to schedule an appointment with your Dr. for a simple blood test. They will look at you LDL (bad cholesterol), HDL (good cholesterol), Triglycerides, and Total cholesterol.

LDL should be under 100, HDL 40-59, and Total Cholesterol less than 200.

If this is you: Go celebrate your health!

If not, it’s okay.  You can get there!

Step 2: Identify the presence of factors that increase the risk of Coronary Heart Disease (CHD): Clinically diagnosed CHD, Symptomatic coronary arterial disease, Peripheral arterial disease, Abdominal aortic aneurysm

Step 3: Determine the presence of major risk factors: smoking, high blood pressure (greater than 140/90), Low HDL (less that 40), Family history of CHD, women over 55 and men over 45 yrs of age.

Step 4: If you have 2 or more risk factors, you may be in need of more than just lifestyle changes and require a medication to lower your risk.  It would be a good idea to see your Doctor.

Step 5: determine your goal!

Would you like to lower your risk? The Therapeutic Lifestyle Changes (TLC) feature:

  • Diet: Saturated fat <7% of calories, cholesterol <200mg/day
  • Increasing fiber (10-25) g/day) and plant stanols/sterols (Click Here for diet suggestions)
  • weight management – (Click here)
  • Physical Activity- we suggest starting by walking out your front door and picking a direction (right or left) and walking 10 min out and 10 min back, at least 3 times a week.  Then you can build up to the CDC’s recommendations for 2 hours and 30 min each week. (Click Here for the CDC recommendations)

It’s so simple! It takes 28 days to develop a habit. I challenge you – Try it for 28 days – then let me know about your successful new habit!

COPD… What is it and could you have it?

24 million Americans have COPD, but 12 million do not know that they have it. Are you one of the missing millions?

Sestron Clinical Research is currently conducting a trial for people with moderate to severe COPD.  I thought this would be the perfect opportunity to bring some awareness to this subject.

COPD– stands for Chronic Obstructive Pulmonary Disease. It is a disease that progressively gets worse over time, making it difficult to breathe. It can cause coughing that produces mucus, wheezing, shortness of breath, chest tightness, and other symptoms.

Smoking cigarettes is the leading cause of COPD. Other irritants such as air pollution, chemical fumes, or dust may also contribute to COPD.

Early detection is the key with this type of disease, since quitting smoking can greatly help reduce the problems associated with COPD.  Stress is another trigger that has been found to worsen the symptoms of COPDStress management skills are a great tool to help both your mind and body relax .

Below I am providing a personal story of a woman with COPD

When I quit smoking back on Jan. 16, 2005, I was using oxygen 24/7. I needed to take breathing treatments every four hours and was watching the clock for the next treatment. I was on 20 different medications, and up until five years prior, I had smoked two packs of cigarettes a day for 40 years. I coughed constantly and had a magnificent wheeze going most of the time. I was only 57 years old.

Before I quit, my smoker’s cough was diagnosed as stage III COPD (there are four stages). COPD covers conditions such as emphysema and chronic bronchitis. It is a progressive condition and will never go away once you have it.

I couldn’t walk to the mailbox. When I went to the market or Target or Walmart, I had to use one of those motorized carts. I couldn’t even unload all the groceries when I got home, only the perishables.

And then I quit smoking and immediately expected all these wonderful improvements. But it didn’t happen. I became frustrated, but I still kept at it.

Three months after I quit, I became ill with a lung infection that was resistant to several antibiotics. It took more than five months and three hospitalizations to get rid of it.

To be honest, if I had been smoking, I doubt that I would have survived the infection. During one of those hospital visits, I was also diagnosed with the beginning of congestive heart failure (CHF) and told that it was caused by my lung disease. Apparently, they go hand in hand. (Since that time, I have seen a cardiologist and I no longer have CHF).

Truthfully, I thought I was going to die soon and I had my lawyer draw up my living trust and will. I even wrote out what songs I wanted played at my memorial service. I had some heart-to-heart talks with my wonderful family, too. They were so afraid that they were going to lose me. I wasn’t depressed or morbid. I’m just one of those people who function better if I’ve got things arranged and organized. It gave me peace of mind.

And then, I decided to control this condition instead of having it control me!

I found a new personal doctor and a new lung doctor. I asked the doctor to cut out some of my medications and he cut them down to only nine — from 20.

And I didn’t smoke!

I researched heart disease on the Internet and signed up for the American Heart Association newsletter. I also subscribe to the American Lung Association newsletter. I began eating a heart-healthy diet and started a pulmonary rehabilitation class at my local hospital.

And I don’t smoke!

My lung volume (FEV1) has increased from 38 percent to 43 percent of the normal predicted value. At pulmonary rehab, I was able to exercise at a steady pace for 12 continuous minutes without a drop in my oxygen and I needed no supplementaloxygen. I no longer need any supplemental oxygen.

And I can walk to the mailbox again and shop without the motorized carts!

I can sing again! And I love to whistle! I can sing again! And I love to whistle!

And I don’t smoke!

I may not be able to ever get rid of this disease — but trust me, I’ve sure slowed it down. I plan to live every day of my life now!

I just hope that those of you who are struggling or playing around with quitting will finally realize that smoking is doing nothing but killing you, cell by cell. I hope you quit before you get sick with cancer or heart disease or lung disease.

All you have is now. It will determine tomorrow.

By “GrammaCC” | Medically reviewed by Kevin O. Hwang, MD, MPH

Read the article on: EveryDayHealth

You can see why early detection is so important!

Please take this 5 question risk screener — it takes less than a minute to find out if you are at risk for COPD. – at: http://www.copdfoundation.org/Screener.aspx#sthash.8ORTCX8I.dpuf

Millions have Diabetes and don’t even know it!

Everyone has to eat, right?  But did you know that most of the food you eat is turned into glucose?  Glucose is basically sugar, and that is what our body uses for energy.  The pancreas is an organ, located near your stomach, which makes a hormone called insulin.  Insulin helps the glucose enter into our cells- where it can be used by the body.  Diabetes is a disease in which blood glucose levels are above normal. When you have diabetes you have one of two issues:

1. Your body doesn’t produce enough insulin.

2. Your body can’t use the insulin it does produce the way it should.

When this happens the sugar builds up in your blood.

Diabetes can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations.  Diabetes is the seventh leading cause of death in the United States.

Diagnosed and undiagnosed diabetes in the United States. Total: 29.1 million people or 9.3% of the population have diabetes. Undiagnosed: 8.1 million people (27.8% of people with diabetes are undiagnosed)

It is very important to know what your A1c is and to live a healthy lifestyle! Your Dr. can check your A1c with a simple blood test.  If you  live in GA, Sestron Clinical Research can help.

Visit the CDC website for more information!