NEW Investigational drug being studied in participants with high cholesterol

NEW Investigational drug being studied in participants with high cholesterol or other risk factors for heart disease

The SPIRE program is looking for people who are taking a cholesterol lowering medication but still have high cholesterol. If you qualify, you might be interested in participating in a research study.

This study evaluates the PCSK9 inhibitor, Bococizumab compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL or non-HDL-C >/= 100 mg /dl

The full study details and eligibility criteria are listed here. Please complete the online questionnaire to check if you’re eligible for the trial here.

If you’re not familiar with clinical trials, here are some FAQs: What are clinical trials? Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.

Why participate in a clinical trial?

You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Learn why I’m talking about Clinical Trials Here

Have severe Asthma? Here is a Clinical study that may help with new treatments

There is a clinical trial going on right now that assesses the safety and effectiveness of the investigational drug when administered in severe asthma patients whose symptoms are otherwise uncontrolled with current standard therapy.

Despite standard treatment, up to 50% of asthma patients have symptoms that are not well controlled, with a negative impact on quality of life.

Here is some basic information about Asthma Clinical study:

Asthma Clinical study participants must: be between 12 – 75 years old have asthma diagnosed by a doctor. have been treated with an inhaler in the past 3 months have had at least 1 exacerbation (worsening of your asthma that requires medical intervention or a change in medications) in the past year

Asthma Clinical study participants must not:

have severe lung disease other than asthma have HIV, Hepatitis B or C The full study details and eligibility criteria are listed here.

Please complete the online questionnaire here to check if you’re eligible for the trial. If you’re not familiar with clinical trials, here are some FAQs: What are clinical trials? Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people. Please complete the online questionnaire here to check if you’re eligible for the trial. Why participate in a clinical trial? You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future. Learn why I’m talking about Clinical Trials

Reduce your chances of heart disease by lowering your cholesterol.

Cholesterol, what's the risk? Total cholesterol is a measure of the total amount of cholesterol in your blood and is based on the HDL, LDL, and triglycerides numbers.

LDL cholesterol makes up the majority of the body’s cholesterol. LDL is known as “bad” cholesterol because having high levels can lead to plaque buildup in your arteries and result in heart disease and stroke.

The two important types of lipoproteins are low-density lipoprotein (LDL) and high-density lipoprotein (HDL). At the same time as LDL and HDL are being tested for, another type of fat called triglycerides is often included in the test. There is a NEW research study for people with high cholesterol that evaluates the PCSK9 inhibitor, Bococizumab, in reducing the occurrence of major cardiovascular events.

Take a health questionnaire to see if you qualify!

HDL cholesterol absorbs cholesterol and carries it back to the liver, which flushes it from the body. HDL is known as “good” cholesterol because having high levels can reduce the risk for heart disease and stroke. Triglycrides are a type of fat found in your blood that your body uses for energy. The combination of high levels of triglycerides with low HDL cholesterol or high LDL cholesterol can increase your risk for heart attack and stroke.

Cholesterol is a major player in increasing the risk of heart disease and quite a few people do not understand this. Not all cholesterol is bad, it is necessary component for new cells, it acts as an insulator for nerves and helps in the production of hormones. There are two sources of cholesterol, one source is the food you eat, such as meat, eggs and milk. And your liver produces cholesterol as well. Cholesterol is needed to a certain level in your body, but as the level goes past the safe mark it increases your risk for heart disease.

Take a health questionnaire to see if you qualify!

As you can see from this number 73.5 million adults (31.7%) in the United States have high low-density lipoprotein (LDL), or “bad,” cholesterol, high cholesterol is a fairly large problem. People with high total cholesterol have approximately twice the risk for heart disease as people with ideal levels.

As the cholesterol builds in your blood it begins to plant itself on the artery walls, untreated this can result in atherosclerosis, called hardening of the arteries. What actually takes place is that the arteries begin to narrow as more and more bad cholesterol is deposited onto them which results in the blood flow going to and coming from the heart muscle slowing down or worse ending up blocked altogether. Oxygen is carried in your blood and moves back and forth into the heart but as cholesterol builds up in your arteries the blood flow is reduced this will eventually result in an uncomfortable feeling in your chest, as the narrowing in your arteries progresses this will turn into pain if the cholesterol is allowed to build up to the point of actually blocking your arteries the result will be a heart attack.

Molecules called lipoproteins carry cholesterol in the blood. Two important kinds of lipoproteins are low-density lipoprotein (LDL) and high-density lipoprotein (HDL). When checking LDL and HDL, doctors often include another type of fat called triglycerides.

"Total cholesterol is a measure of the total amount of cholesterol in your blood and is based on the HDL, LDL, and triglycerides numbers. LDL cholesterol makes up the majority of the body’s cholesterol. LDL is known as “bad” cholesterol because having high levels can lead to plaque buildup in your arteries and result in heart disease and stroke. HDL cholesterol absorbs cholesterol and carries it back to the liver, which flushes it from the body. HDL is known as “good” cholesterol because having high levels can reduce the risk for heart disease and stroke. Triglycerides are a type of fat found in your blood that your body uses for energy. The combination of high levels of triglycerides with low HDL cholesterol or high LDL cholesterol can increase your risk for heart attack and stroke." http://www.cdc.gov/cholesterol/ldl_hdl.htm

There are no symptoms created by having high cholesterol levels, consequently it is necessary to check your cholesterol level. This is done by means of a blood test and will establish what your HDL and also LDL levels are. Monitoring your cholesterol levels is similar to monitoring your blood pressure only the levels are not checked as frequently. Adults beginning at the age of 20 need to have regular tests done to check cholesterol levels. It is recommended that a test be done every years if you have been diagnosed with heart disease, some people will need to have their cholesterol levels checked more frequently. Children and adolescents starting at 9 years and up to 11 years should have their cholesterol checked at least once and then again between the ages of 17 and 21 years.

Take a health questionnaire to see if you qualify!

The blood analysis that is used to determine cholesterol levels is known as a lipoprotein profile. Four measurements will be taken on a cholesterol test and these include the total cholesterol level, the LDL "bad" cholesterol, the HDL "good" cholesterol and the triglycerides.

A person whose total cholesterol is less than 200 is at a desirable rate; total cholesterol that is 200 to 239 is borderline high and 240 and over is high. LDL cholesterol that is less than 100 is optimal, while 100 to 129 is near optimal or above optimal and with HDL, the higher the number, the better it is. HDL cholesterol that measures 60 or more is at a desirable rate while less than 400 constitutes a major risk factor. Triglycerides that are less than 150 are at a normal or desirable rate while 150 to 199 is borderline high and 200 or more is high and may necessitate the need for medication in some individuals.

Sources for article http://www.cdc.gov/cholesterol/facts.htm http://www.cdc.gov/cholesterol/ldl_hdl.htm Learn why I’m talking about Clinical Trials

What Clinical Research Means to You.

Clinical Research Volunteers are Medical Heroes.

Part 1: What is Clinical Research?

What do we learn from studies? How well does a new drug work or not work? Is there a better way to treat a disease like cystic fibrosis?

How do genes affect illness?

Do peoples environments affect their health? •Where they live? •What they eat? •How much they exercise?

What is a clinical trial?

Scientific study that answers a medical question. “ Is a treatment safe? “ Does it improve a certain medical condition? “ Does it have side effects? “ How should people take it? “ Is it any better than medicines that are already on the market? " A clinical trial is NOT the same as standard of care. " Standard of Care. “ Routine care. “ Has been tested and approved. “ Works for most people.

Clinical Trial

“ Looks for answers to a question. “ Still learning how it works. People are different. We need all types of volunteers.

Clinical trials: a 4 step process.

Phase 1: Is it safe?

And what should be the dose in patients?

Phase 2: More safety and dosing data. Early data on whether it works (efficacy).

Phase 3: Does it improve patients health or make them feel better?

May be new treatment or comparison to an existing therapy. Tested in large and diverse group of patients.

Phase 4: Real world experience Clinical trials.

Clinical Trial Sponsors: “ Government. “ Academic Medical Centers. “ Pharmaceutical Companies. “ Biotechnology Companies. “ Medical Device Companies.

Part 2: The Research Team and Informed Consent. All members of the team are important. Principal Investigator. (PI) Like the head coach. “ Organizes the study. “ Records and studies the data. “ Directs the study staff. “ Follows a protocol (play book).

Clinical Research Coordinator (CRC).

Like the assistant coach. “ Handles day-to-day activities. “ Works with principal investigator (PI). “ Main contact for volunteers.

Volunteer Protections.

Like the referees. “ Review the study before it starts. “ Make sure the team follows the rules. “ Keep you safe and informed.

Volunteer Protections.

Institutional Review Boards (IRB).

“ Make sure a trial is ethical and fair. “ Make sure a trial is not too risky for volunteers. “ Receive continuous updates on trial status. " Serious side effects from study drugs. " Change in study plan. “ Can end a trial if it feels volunteers are not safe.

Volunteer Protections.

Food and Drug Administration. “ Reviews studies. “ Inspects research centers. “ Monitors research groups. “ Has the final say as to whether or not a treatment is approved.

Volunteers.

Like the players. “ The MOST important team member. “ Wide range of studies available (clinicaltrials.gov). “ Healthy volunteers needed too!

Friends, family and your supporters.

Like the fans. “ People to talk to about the study. “ Help you ask questions about the study. “ Support you during the study.

Eligibility Criteria.

Who is the right player for the game?

Informed Consent.

A process to make sure you understand and agree to be in the study. “ A conversation between you and the study staff. “ A form to sign. “ Answers all your questions.

You have rights and responsibilities.

“ To understand the. “ To ask questions and get answers. “ To quit at any time.

Part 3: Should I or Shouldnt I?

Whats right for me? " Understanding the study design. " Study Methods. “ Randomized: coin flip. “ Blinded : you do not know what treatment you are receiving. “ Placebo: sugar pill.

Possible benefits. “ Access to new therapies. “ Advance science and help others in the future. “ The research staff will observe your health closely. Possible risks.

“ Physical. “ Emotional. “ Financial. “ Privacy and confidentiality.

Things to consider.

“ Requires your time and commitment. “ The clinical trial could end at any time. “ You may not feel better. “ All your doctors need to know you are in a clinical trial.

Education before participation.

“ Do your homework. “ Take your time. “ Ask questions.

Your decision at every step.

Where should you go to learn more?

“ Your doctor. “ Advocacy groups. “ Pharmaceutical and biotechnology companies. “ The Internet. “ www.clinicaltrials.gov “ www.centerwatch.com “ www.researchmatch.org “ www.ciscrp.org

Thank you,to the millions of people who give the gift of participation in clinical trials each year and to the rest of us who admire them for doing so.

Article courtesy of www.ciscrp.org CISCRP

and

ClinicalTrials.gov.