New Cholesterol Drug Called a Game Changer

Find Out If You’re a Candidate For New Cholesterol-Lowering Medication

By Gina Roberts-Grey, Special to Lifescript
Published July 27, 2015

A new class of drug that battles high cholesterol levels has won approval from the Food and Drug Administration. Read on to learn how the new drug, called a game changer, works and whether it’s right for you…

Patients whose high cholesterol is resistant to most treatments now have a new weapon in their medication arsenal.

The injectable prescription medication alirocumab won Food and Drug Administration (FDA) approval July 24. It’s the first in a new class of drugs aimed at lowering high cholesterol. Although it’s not yet approved for use in all patients, the medicine is creating a great deal of excitement in the medical world.

Who should take it?
Only patients with heterozygous familial hypercholesterolemia – a genetic condition in which you have high cholesterol levels, or have had a prior heart attack or stroke – should take the drug, according to the FDA release.

Not a statin
Typically, high cholesterol is treated with statins such as atorvastatin or simvistatin.

“These medications are effective in most patients, but are not potent enough to lower LDL [bad] cholesterol to target levels in extreme situations, including patients with heterozygous familial hypercholesterolemia,” says Guy Mayeda, M.D., a cardiologist at Good Samaritan Hospital in Los Angeles.

That’s where alirocumab come in.
“This new medication … provides a new alternative for patients with the highest risk of cardiovascular events from inadequately controlled high cholesterol,” Dr. Mayeda says.

Five studies involving nearly 2,500 patients were conducted to test the safety and efficacy of the drug. Alirocumab was found to lower LDL levels between 36% and 59%.

However, that better control comes with big price tag.

Expensive medication
“[Alirocumab] is significantly more expensive than traditional statin medications,” Dr. Mayeda says.

Regeneron, the makers of alirocumab, will sell the drug wholesale for $1,120 for two doses, which lasts 28 days. The annual cost of the drug could cost patients up to $14,560, depending on their health insurance coverage and co-pays.

The drug is not without risks, either.

Side effects
The FDA says the most common side effects include “itching, swelling, pain, or bruising where the injection is given, nasopharyngitis [inflammation of the mucus membranes] and flu.”

Allergic reactions, including vasculitis (a skin rash that appears as purple-colored spots on the skin and is associated with inflammation of the small blood vessels) and hypersensitivity reactions requiring hospitalization have been reported with the use of the drug.

“As with all newly approved medications, patients and their physicians should be diligent in watching for potential side effects,” Dr. Mayeda cautions.

Not a magic bullet
While alirocumab may hold promise, experts caution it’s not a cure-all for high cholesterol.

“[Alirocumab] is a supplemental therapy to diet and statin therapy,” says Robert Greenfield, M.D., a cardiologist, lipidologist and chief of staff at Orange Coast Memorial Medical Center in Fountain Valley, CA.

”This is not meant to replace statins, as statins have decades of outcome data proving that they save lives by reducing heart attack and stroke rates.”

Although positive safety data were presented to the FDA, additional data that will come after many more patients use the medication may reveal “additional adverse side effects,” Dr. Greenfield says.

The next phase of trials will help doctors and their patients know if the drug is as promising as the initial results seem to indicate.
interview with Dr. Guy Mayeda

Why exercise is important— even if you don’t need to lose weight

exercise important for more than just losing weight


Fox News interview with Dr. Mayeda:

The promise of a smaller waistline may get you into the gym, but all of your sweating and panting is delivering far more than aesthetic changes. An active lifestyle isn’t all about weight loss. Regular exercise can help prevent some of the most common diseases of the day, including heart disease, diabetes and certain types of cancer.

One in four deaths in the United States are due to heart disease, according to the Centers for Disease Control and Prevention (CDC), and more than 9 percent of the population lives with diabetes. Both of these conditions are largely preventable through proper diet and exercise, and their risks are tied to obesity. But some research suggests weight loss shouldn’t be the primary goal of a disease prevention lifestyle.

Shifting the focus from weight loss

“Recent articles that say exercise is ‘not worthwhile’ in regards to weight loss promote a dangerous misconception,” says Dr. Guy Mayeda, a cardiologist at Good Samaritan Hospital in Los Angeles.

A June editorial in the British Journal of Sports Medicine “busted the myth” of exercise being a catalyst for dropping pounds, saying “physical activity does not promote weight loss.”

But that conclusion is only part of the story. Although weight loss and management motivate many Americans to find time for exercise, those walkers, yogis and cyclists reap many additional benefits regardless of weight.

Mayeda adds that “while exercise alone will not guarantee weight loss in the presence of unlimited calorie intake,” it remains important in reducing various health risks and providing an overall sense of well-being.

Building a stronger heart and lungs

Obesity is a known risk factor for cardiovascular disease, but it isn’t the only one, and your bathroom scale can’t read the others.

“Exercise is the best medicine for the heart, and (the risks of) a sedentary lifestyle are equivalent to smoking one pack of cigarettes per day,” explains Dr. Robert Greenfield, medical director of non-invasive cardiology and cardiac rehabilitation at MemorialCare Heart & Vascular Institute in Fountain Valley, Calif.

Regular exercise increases the efficiency and health of your heart and lungs. It can also decrease your waist circumference— a known risk factor for heart disease— and instantly reduce your blood pressure, independent of weight.

Cancer risk reduction

Increasing your activity levels can reduce your risk of colon cancer by 30 to 40 percent, according to the National Cancer Institute, and the more active you are, the greater your risk reduction, regardless of your weight. Exercise drives similar dramatic reductions in the risk of breast cancer, and researchers around the world have repeatedly linked physical activity to reduced risks of uterine, lung and prostate cancers.

Improved digestive health

Exercise also regulates digestion, stimulating the muscles throughout your stomach and intestines, preventing constipation. It’s believed this stimulation could be tied to the reduced risk of colon cancer in active people.

Diabetes prevention and management

Type 2 diabetes is most commonly thought of as an obesity-related disease, and there’s no doubt that being overweight or obese puts you at a greater risk of getting it. But exercise can help even when your weight remains static.

According to the American Journal of Clinical Nutrition, waist circumference is the best determinant for diabetes risk than BMI or weight, meaning a lifestyle that reduces your stomach size can reduce your diabetes risk no matter your weight. Also, exercise increases insulin sensitivity and reduces blood sugar levels, again, regardless of what the scale says.

A sharper, happier brain

The benefits of exercise aren’t merely physical. Research has repeatedly shown that exercise reduces stress, improves mood, decreases the risks of anxiety and depression, and even boosts memory and cognition.

“All studies have shown that people who exercise suffer from less stress, are better with anger management, have healthier interpersonal relationships on average, sleep better and even think more clearly,” says Dr. Brian Quebbemann, bariatric surgeon and president of The N.E.W. Program bariatric clinics in Newport Beach, Calif. “In fact, contrary to the popular myth of the ‘dumb jock’, scientific data has shown that athletes, on average, perform higher on IQ tests than people who are sedentary.”

In short: Stay active.

Whether you’re happy with your weight or need to drop a few pounds, exercise has beneficial effects that surpass the number on your scale. Research published in the journal The Physician and Sports Medicine even suggests that approaching lifestyle disease risks, like heart disease, from a “non-weight loss centered paradigm” could be more beneficial than merely focusing on dropping pounds, even in overweight and obese people.

What does this mean for you? In addition to a healthy diet, staying active is crucial for overall health, and your body weight is just one factor in the complex equation.

Health: 12 Subtle Symptoms To Never Ignore

Excerpt from Prevention magazine: Health: Weird Health Symptoms, 12 Subtle Symptoms to Never Ignore by Linda Melone, CSC

Chest pains, sudden trauma, or profuse bleeding are sure signs to seek medical attention STAT. But some symptoms are not as obvious. Thirst, breathlessness, and snoring may seem like business as usual, but they can actually be signs to see a doctor in certain cases. Experts tell how to know the difference between (likely) harmless symptoms and when it’s time to schedule a medical evaluation.

1. You’re losing weight without trying.
See a doctor if you lose 5% of your weight within 6 to 12 months without trying, especially if you’re an older adult.

2. Your stomach hurts.
See a doctor if pain lasts more than 3 days or is associated with trauma. Also, if the pain is accompanied by chest pressure or pain, causes severe pain, if you have nausea and vomiting, if your abdomen is severely tender or distended, or if you’re showing signs of jaundice, seek medical help immediately.

3. You can’t catch your breath.
See a doctor if it’s hard to breathe and you’re also experiencing chest pain, swelling in the feet or ankles, trouble breathing when lying flat, high fever, chills and cough, lips or fingertips turning blue, or if it’s a worsening of a pre-existing shortness of breath.

4. Your head aches.
A stress headache after a meeting with your boss is nothing to be concerned about. But see a doctor if you have a sudden, new, severe headache, a headache associated with neurological symptoms or a headache associated with a fever, shortness of breath, stiff neck, or rash, severe nausea and vomiting, or one that awakens you at night or takes place after a head injury. More than 3 headaches a week or ones not easily relieved with OTC meds are also signs to see a physician.

5. You’re feverish.
Fevers typically happen when your body’s fighting off an infection. Most people’s baseline temperature is 98.6°F. Sunburn, heat exhaustion, and medications can also trigger a fever. See a doctor if your temperature is 103°F or higher, or you’ve had a fever for more than 3 days. Also seek help if you experience hallucinations, mental confusion, listlessness or irritability, convulsions, dehydration, severe headaches, skin rash, stiff neck, or pain when bending your neck forward.

6. You snore.
Snoring can be simply annoying to your partner but can sometimes be a sign of something amiss. See a doctor if you snore every night and your snoring is broken up by gasps and snorts, says Peter Fotinakes, MD, medical director of the Sleep Disorders Center. These symptoms plus daytime sleepiness may be signs of sleep apnea, which can lead to high blood pressure and heart problems.

7. You notice dark stools.
Stool color can range from light yellow to nearly black. Changes in the color of stool isn’t always cause for alarm. For example, eating beets, cranberries, or other red vegetables may change the color of stool to red. “However, these are short-lived events and can be directly associated with a dietary event,” says Jack Jacoub, MD, internist and medical oncologist. See a doctor if you notice red or maroon stools not associated with diet, especially if accompanied by other symptoms such as abdominal pain, nausea, cramping, vomiting, weight loss, etc., says Jacoub.

8. You have odd-looking freckle.
Many bumps, spots, and various colored freckles such as bright red small red spots cause no serious harm. Soft flesh-colored growths on your neck called skin tags are also non-cancerous. See a doctor if you have a new or irregular brown spot. Consult your dermatologist if moles exhibit signs of melanoma: asymmetry, a scalloped or jagged border, multiple colors, is 6 mm or larger and/or begins to change shape, color, size, or becomes itchy or painful. Also seek a doctor if you notice any shiny pink growth or pink scaly rough patches.

9. You can’t quench your thirst.
See a doctor if your thirst is accompanied by swelling in the legs and rapid weight gain. Unquenchable thirst along with nausea, dizziness, blurred vision, and fatigue should be checked immediately.

10. You pop Rolaids like candy.
An occasional bout of indigestion or GERD can be expected, especially after eating Mexican food or after overdoing alcohol. But when the burning sensation in your chest becomes more frequent, indigestion could be a warning sign of something more serious, says Guy Mayeda, MD, cardiologist at Good Samaritan Hospital in Los Angeles, CA. “Pay attention to your normal baseline.” If you usually get heartburn once a month and now it’s nearly every night, a problem could be brewing.

See a doctor if symptoms occur during activity or when walking, which could be classic signs of angina or heart disease, says Mayeda. “Symptoms should go away after walking around and taking antacids. If it gets worse when you start walking, it’s probably not GERD.”


11. Your muscles ache.
You expect sore muscles after a tough workout. But soreness beyond the norm could indicate something more serious. Muscle soreness is a normal response to working out when it occurs four to six hours after exercise,” says Mayeda. Also called DOMS, for “delayed onset muscle soreness,” discomfort typically peaks around 48 hours post-workout. “Statins may also cause muscle soreness, although it’s very rare unless they’re taken with another drug called fibrates,” says Mayeda.

See a doctor if you experience total body achiness, the soreness gets worse as time goes on and you feel weaker, and you notice dark urine (a late stage symptom). These could be signs of rhabdomyolysis, a serious syndrome that results from a breakdown of muscle tissue that releases potentially toxic cellular contents into the blood and could lead to kidney failure if untreated.

12. You’re not as “regular” as usual.
Feeling “stopped up” and constipated on occasion isn’t uncommon, but sometimes constipation can be a sign of serious illness.  See a doctor if you experience a new onset of constipation lasting more than 2 weeks, you notice blood with the bowel movement, have unexpected weight loss without being on a diet, your stool size change becomes “pencil thin,” or severe abdominal pain accompanies a bowel movement.

Read entire article here.