CVS, Medco at vanguard of effort to match patients, drugs by genetic tests
 

 
Boston.com, January 26, 2010, by Carolyn Y. Johnson  —  For years, hype has built around personalized medicine – a tantalizing future in which insights gleaned from genetic tests will result in individualized treatment, guiding the drugs people take and at what doses.

Now, moves by two large companies that focus on controlling drug costs are leading the way for the field to become a routine part of medicine.

CVS Caremark, the Woonsocket, R.I., company that is the largest provider of prescriptions in the United States, said late last year it expects to begin offering genetic testing services to clients of its pharmacy benefit management program this year. It also invested in Generation Health, a company with offices in Waltham that is focused on helping companies manage costs and improve health by using genetic information.

A CVS competitor, Medco Health Solutions, offers genetic tests to guide the use of two drugs and plans to add four more tests this year. Medco has 270 clients, representing 7 million people, participating in its personalized medicine program.

The companies work with insurance plans or large employers and use their buying power to keep drug costs low. They want to use genetic tests to sift out patients who are unlikely to benefit from a drug they have been prescribed or who could experience dangerous or costly side effects.

When a doctor submits a prescription, for example, the company that manages a patient’s drug benefits may call the doctor and offer a genetic test. Ultimately, results might discourage the doctor from prescribing a drug that won’t work, help determined what dosage to use, or suggest an equally effective generic option. CVS said that testing would be integrated into the prescription-filling process.

“The hope is that as we learn more and more about the genome . . . we’ll be in the situation where a lot of different kinds of medications will have the choice of the medication or the dosing of the medication indicated by a genetic test,’’ said Dr. Troyen Brennan, chief medical officer of CVS.

The companies’ interest in using genetic information stems from a longstanding problem: Drugs may be more effective in some patients than others, and doctors often have no way of knowing before they prescribe them. Insight from genetics is beginning to explain some of those differences.

Patients with a particular genetic makeup do not effectively break down Plavix, an anticlotting drug. Variations in two genes affect how people re spond to the common blood thinner warfarin. Genetic testing provides a new way to understand which drugs will work for which patients, meaning people and insurers might have a new tool to avoid paying for drugs that may not work.

“We’re in a good place, theoretically, because we’re being hired to help people manage their prescriptions,’’ said Dr. Robert Epstein, chief medical officer of Medco.

Still, using genetic testing to better target drugs is controversial. Even as evidence has emerged that variations in a particular gene may change a person’s response to a drug, the evidence may not exist that changing the dose or drug leads to a better outcome or is more cost effective, given the cost of the test. The Food and Drug Administration has changed the labels of various drugs, sometimes mentioning a gene that may affect response to the drug but not always recommending or requiring a test.

“The FDA can label drugs to say that this medication is only indicated if you have this [genetic] finding,’’ as it does for the cancer drug, Herceptin, said Dr. Marc S. Williams, vice president of the American College of Medical Genetics. But in other cases it has not gone so far.

“Predicting the dose better does not translate automatically into better safety for patients,’’ Williams said.

The interest of pharmacy benefit management companies in personalized dosages is intriguing, he said, because they reach so many patients and can begin to collect data to better understand how drugs and genes interact. Medco has entered a partnership with the FDA to begin to answer some of those questions by collecting data and studying factors such as safety, physician participation, and the tests’ usefulness.

To advocates for personal medicine, the companies’ interest is a powerful vote of confidence.

“This is the most exciting thing in personalized medicine today, because Medco and CVS are big players with enormous impact in the field,’’ said Edward Abrahams, executive director of the Personalized Medicine Coalition, an education and advocacy organization, which is funded by diagnostic, pharmaceutical, and health insurance companies, and hospitals, among others. “The point of personalized medicine is to develop better efficacy, better outcomes, fewer adverse events, and lower systemic costs. The pharmacy benefits manager is interested in all of those things.’’

In Medco’s personalized medicine program, genetic testing is offered to patients prescribed the breast cancer drug tamoxifen or warfarin. Responses to both have been found to be affected by particular genes, although how and whether to test has been a subject of considerable debate within the medical community.

Warfarin, which can cause bleeding in high doses, is a common cause of emergency room visits for adverse drug reactions, according to the FDA. Variations in two genes have been shown to affect how people respond to the drug, indicating they may need a lower dose.

Having a variation of a gene involved in the metabolism of tamoxifen has been shown to increase the risk of a recurrent cancer, and knowing this could allow a physician to prescribe a different treatment.

In both cases, Medco does not require the physician to order a test in order to prescribe the drug, but it tells them a gene test is available.

An example of the potential benefit from the use of such information could come from one of the most-prescribed drugs, Plavix.

A 2008 study found that a variation in a gene that occurs in about a third of the population causes them to not respond as well to the drug because they do not metabolize it properly. The FDA changed the label to include the genetic risk last year. Last fall, Medco said it would compare Plavix with another drug, Effient, to see how a person’s genetic makeup affected his or her response to the drug. Because Plavix will lose its patent status in 2011, if it is found to be as effective as Effient for people with a particular genetic makeup, it could give patients who get a test a cheaper option.

“How can we help clients maintain the affordability of insurance and drugs and make the best outcome,’’ Epstein asked. “The problem is not with the science, it’s with the adoption.’’

Carolyn Y. Johnson can be reached at cjohnson@globe.com.  

The Wall Street Journal, January 26, 2010  —  The emergence of a new field of diagnostics is changing the way both patients and doctors view pre-treatment initiatives, according to Northland Securities Senior Analyst Stephen D. Simpson. This move to so-called “personalized medicine” may result in increasing opportunities for life sciences companies who research treatments for specialized diseases, and for those larger companies who will wish to acquire them.

“Personalized medicine is the idea that you can use genetic information about a patient to better diagnose and treat them. For example, there is a range in how people will respond to blood thinning drug like Coumadin, and you can predict that through genetic testing,” said Simpson, explaining that such genotype studies could lead to more appropriate prescriptions and dosing recommendations based on a patient’s susceptibility to certain medicines.

“The more we know about patients’ individual conditions, individual diseases, the better you can diagnose them and the better you can fine tune that therapy to get maximum effect and minimum side effects,” he said.

As smaller, more innovative companies in the life sciences space move toward genetic diagnostics and personalized medicine, Simpson predicts the bigger industry names, such as Abbott (ABT), Life Technologies (LIFE) and Millipore (MIL) will be on the prowl for attractive acquisition targets.

“If you have a test, a very good test that has good clinical use but for a relatively small application in terms of patient population, more likely than not you’re going to be acquired,” said Simpson, citing Genzyme (GENZ) and Alexion (ALXN) as two possible acquisition targets going forward.

“I just don’t see those companies staying independent for a particularly long period of time because Wall Street constantly demands growth, constantly demands the new things,” he said. “So many times it’s a path of least resistance to take a lucrative bio bid from a pharmaceutical company or a larger health care company that looks at acquisitions as a way of substituting their own slowing organic growth.”

Medco and other pharmacy benefit managers say future profits depend on matching drugs to patients based on their genes

BusinessWeek.com, January 25, 2010, by John Carey  —  The dirty little secret about drugs is that they only work in about half of the people who take them. So says an educational nonprofit called the Personalized Medicine Coalition, and many drug executives concede as much. Of the $292 billion spent in the U.S. on prescription drugs in 2008, as much as $145 billion went to medications that didn’t help individual patients, said Jerel Davis, project manager at McKinsey, at a recent conference. And billions more are being spent to treat adverse drug reactions and other complications. “When you look at the data, it’s shocking,” says Dr. Robert S. Epstein, chief medical officer at Medco Health Solutions (MHS), a $51 billion company that manages drug prescriptions for 60 million Americans.

Researchers know how to solve this problem. First, figure out the differences between those patients who respond to a drug and those who don’t, then treat only to those who will benefit. But this personalized medicine approach “has been slower to develop than we thought 10 years ago,” says Richard K. Schatzberg, CEO of Generation Health, a startup that offers targeted medicine services. Lack of enthusiasm in the drug industry is a big reason; companies would lose billions of dollars if only those who actually benefit were to use such blockbuster drugs as antidepressants, arthritis medicines, and cholesterol pills.

Now, however, the promise of personalized drug treatments appears more realistic, thanks to new players on the sceneand a new business model. The recent entrants are pharmacy benefit managers (PBMs) such as Medco and CVS Caremark (CVS). Medco is testing patients for genetic variations that explain why they respond differently to drugs like warfarin, a widely used blood thinner, and tamoxifen for breast cancer. CVS Caremark has taken a majority stake in Generation Health and expects to launch a similar testing program in May. The move by the PBMs “is transformative,” says Edward Abrahams, executive director of the Personalized Medicine Coalition, whose members include scientists, health-care providers, payers, and patients’ groups. “We are talking about better care for millions of people and keeping costs down for employers, whose insurance costs are exploding. It could be the tipping point.”

PBMs plan to make money by selling personalized medicine services to employers, which are willing to pay them higher fees for improved health outcomes and lower prescription costs. Medco and other PBMs also hope to win market share from their slower-moving competitors. “It is a differentiator for us,” says Dr. Jane Barlow, vice-president for Medco’s personalized medicine business. Plus, they expect genetic testing will increase the percentage of patients using certain cheaper generic drugs, thus increasing profits. Medco has signed up 200 employers to its program, representing 7 million people. “This has been the fastest adoption of a new program in Medco history,” says Epstein. One early—and eager—adopter: IBM (IBM), which expects better health outcomes and cost savings, says Dr. Martin Sepulveda, an IBM vice-president for health matters.

SECOND OPINION

The idea took a long time to bear fruit at Medco, even though it was an obsession for Epstein, an epidemiologist by training. “Back in 2000, Rob Epstein explained to me this would change the face of medicine—and make all the pharmaceutical companies nervous,” recalls Schatzberg. “It took longer than he thought.” The company’s first foray into personalized treatments in 2002 foundered. Epstein wanted to do genetic testing on asthma patients to predict better which ones might end up in the hospital, “but I couldn’t see the return on investment,” he says.

The business case improved as scientists identified more genes linked to drug responses. For many medicines, enzymes produced in the liver are crucial. Some enzymes change drugs so that they are excreted from the body. Others convert drugs that have no effect when first administered into a medically active form. Because of variations in genes, these enzymes may work quickly or slowly or not at all. One example is tamoxifen, used to prevent breast cancer recurrence. In 20% of people, the enzyme that usually activates this drug is partially or completely ineffective, and the drug provides little or no benefit.

A turning point for Medco came in 2005, when a Food & Drug Administration advisory committee recommended that genetic information be considered in making treatment decisions with warfarin. The blood thinner is widely prescribed to prevent clots, but it’s notoriously difficult to get the dose right. “We know that we kill people with warfarin all the time,” says Dr. Issam Zineh, associate director for genomics at the FDA’s Center for Drug Evaluation Research. Too much warfarin raises chances of bleeding and strokes caused by bleeding; too little allows deadly clots to form. The cost of using the wrong doses is estimated to be in the billions of dollars per year. With a genetic test, doctors can determine if people will need more or less warfarin than the standard 5-milligram dose.

When Epstein looked at Medco’s medical records of its million patients on the drug, he discovered something alarming: As many as 25% of them ended up in the hospital within six months of starting on warfarin. “Avoiding one hospitalization could underwrite the cost of the test for 100 patients,” Epstein reasoned. Medco worked with the Mayo Clinic to measure the clinical benefits and cost savings from genetic tests for warfarin. The final data won’t be released for several months, but Medco found that employers were eager to sign on for the testing service anyway. Now, when Medco sees a prescription coming in for warfarin, it recommends genetic testing to the doctor and patient. In Medco’s experience, 67% of doctors and 82% of patients agree to testing.

“THE INCENTIVES ALIGN”

The next drug Medco personalized was tamoxifen. Identifying women who can’t metabolize the drug into its active form and putting them on a different drug reduces the cancer’s chances of recurrence—and the costs of future treatment. Coming soon is a test for another blood thinner, the blockbuster Plavix. Pinpointing those who benefit will enable Medco to keep more patients on the drug when it goes generic, instead of switching to a more expensive alternative that doesn’t require a test. A bonus is that the results from any given genetic test are usually applicable to many drugs. The same variation that determines the response to Plavix, for instance, can help determine how Valium, heartburn drugs like Nexium, and the antidepressant Celexa should be used.

The PBMs’ foray into individualized treatments “is where the business rubber meets the road,” says Michael Stocum, managing director of consultant Personalized Medicine Partners. “The incentives align. Patients want to get the right drug, and payers are willing to pay if they get a benefit.”

Targeting drugs to those who benefit will obviously cut revenues for some drugmakers. But the pharmaceutical industry itself has started to back away from trying to sell the same medicines to everyone, says former Pfizer drug researcher Dr. Bruce H. Littman, now president of consultant Translational Medicine Associates. “The blockbuster mentality is still in place, but drugmakers are coming around,” he says.

If they don’t, the FDA may not be pleased. In the future, the agency may balk at approving drugs that can’t be directed to the right patients—and payers may decline to reimburse. Amgen, for one, strongly backs the use of a test for a gene called KRAS for its $8,400-per-month colon cancer drug, Vectibix. About 40% of people have a variation of KRAS that prevents the drug from working. Drugmakers “see a future business model where they just want all of the smaller market of appropriate patients,” says Generation Health’s Schatzberg.

Given these trends, the once overhyped idea of personalized medicine “is really starting to get legs,” says Dr. Eric Topol, chief academic officer at Scripps Health. “The old way of giving therapeutics will be obsolete.”

1)  A Breakfast Staple That Blocks Heart Failure

January 25, 2010, by Mehmet C. Oz, MD, and Michael F. Roizen, MD |

Fruit, veggies, exercise — they all make the heart-healthy list. And now, according to a new study, so does this breakfast staple: cereal.

But we’re not talking about Cocoa Puffs. We’re talking about whole-grain cereals — like steel-cut oats, shredded wheat, or muesli. Men in a study who noshed at least once a week on whole-grain cereals were significantly less likely to experience heart failure.

Longer Life in Every Bowl?
Several studies suggest that it’s the fiber in whole-grain cereals that may quell risk factors for heart failure, including high blood pressure, high blood sugar, and obesity. The other heart-protective habits addressed in the study: maintaining a healthy body weight, exercising regularly, eating lots of fruits and vegetables, drinking alcohol only in moderation, and not smoking.

A Combo Protects Best
Men who practiced at least four of the six lifestyle habits on the study’s heart-healthy list cut their risk for heart failure in half. So start stacking the odds in your heart’s favor with these heart-helping strategies:

  • Sneak more fruits and veggies into your day.
  • Even a minimal amount of exercise may help protect your heart.
  • Alcohol – one drink of wine, beer, or liquor per day for most women, and two drinks per day for most men. This also is the general recommendation given by the U.S. Department of Agriculture and the U.S. Department of Health and Human Services.

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Benefit

Keeping your blood pressure at 115/76 mm Hg can make your Real-Age as much as 12 years younger.

References 

Relation between modifiable lifestyle factors and lifetime risk of heart failure. Djousse L. et al., JAMA 2009 Jul 22;302(4):394-400.

2)  Burn More Fat with This Wonder Breakfast
January 25, 2010, by Mehmet C. Oz, MD, and Michael F. Roizen, MD |

Your workouts might melt even more body fat if you eat this at breakfast: whole-grain cereal.

Why? A small study suggests that eating healthy carbs in the morning may turbocharge your fat-burning furnaces when you exercise later on in the day.

Good Carbs, Bad Carbs
The key here is the whole grain — because the study showed that low-glycemic-index carbs (the high-fiber kind) were what moved the dial on fat burning. When sedentary women ate these kinds of carbs as part of a healthy breakfast, they burned far more body fat during an hour walk later in the day, compared with women who ate a wimpy-carb breakfast. The winning breakfast? Muesli, fresh fruit, skim milk, and low-fat yogurt..

More to the Fat-Burning Story
Seems when you eat high-fiber carbs, you store fewer carbs as a fuel source, forcing your body to use fat for energy instead. Thus, the extra fat-burning boost during exercise. Two additional benefits experienced by the healthy carbs group: extra fat-burning during a post-breakfast rest period and greater feelings of fullness. Burn extra fat and not feel hungry? Sold! Now, make your workouts feel easy with this important balance of energy-boosting nutrients.

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Benefit
Maintaining a constant desirable weight can make your RealAge 6 years younger.

References
Fat oxidation during exercise and satiety during recovery are increased following a low-glycemic index breakfast in sedentary women. Stevenson, E. J. et al., Journal of Nutrition 2009 May;139(5):890-897.

3)  The Strange Side Effect of Healthy Food

January 25, 2010, by Mehmet C. Oz, MD, and Michael F. Roizen, MD |

We’re big fans of nuts. Meaning, the ones from trees, not necessarily the ones that make the nightly news kicker because of counterfeiting a $1 bill (not making this up) or trying to rob a bank with a note on the back of a subpoena issued to the robber. Tree nuts (and peanuts, which are legumes) add healthy fats to your diet and reduce your risk of heart disease and diabetes.

But one type of nut in particular does a funny thing sometimes: It leaves a bitter taste in your mouth for weeks. We got a note from a woman whose son experienced this after eating an entree liberally sprinkled with pine nuts. The bitter taste got worse whenever he ate anything, especially sweets (a stay-away-from-sweets strategy we don’t recommend). Other pine nut eaters have experienced the same thing, and a journal report linked the lingering bitter taste to nuts that were imported from China in 2008.

Scientists aren’t sure what could cause your taste buds to get tripped up like this, but suggest that if pine nuts aren’t stored in a cool, dry place, oxidation could occur and quickly turn them rancid and bitter. Why the bitterness sticks around, nobody knows. But it does usually get better in 1 to 3 weeks. If this hassle has visited your mouth, try flavonoid-rich foods (vegetables and fruits) as well as Altoids (recommended by past victims). And if the pine nuts you’re about to put on your salad are from 2008 and China, don’t try them; buy fresher ones.

4)  How Are Your Arteries? Take This Free Test

January 25, 2010, by Mehmet C. Oz, MD, and Michael F. Roizen, MD |

Would you know if your arteries were stiffer than a double martini? New research suggests there’s a way to know that doesn’t involve doctors, insurance, or machinery.

An easy sit-and-reach test that indicates how flexible your body is may also tell you how flexible your arteries are. In study participants over age 40, a stiffer body corresponded to stiffer arteries (and higher heart disease risk).

The test: Warm up for 10 minutes (easy walking is fine). Then, sit on the floor with your legs straight out in front of you, feet about 12 inches apart. Place a yardstick between your feet, with the 0 mark pointing toward your body, and the 15-inch mark even with your heels. Tape it in place. Place one hand on top of the other, lightly touching the yardstick. Now, reach forward slowly by dropping your head toward or between your arms, maintaining contact with the yardstick. Have someone check where your fingertips land. Average flexibility for someone age 40 to 45 means hitting the 15-inch mark if you’re male, 17 if you’re female. The range shortens by about 2 inches per decade for men beyond age 45 (until age 66+, in which case average guys still hit the 10 or 11); it shortens by about 1 inch per decade for women beyond 45.

True, people and their arteries are more flexible when they do more cardiovascular exercise. But this study looked at flexibility independent of that and still found a link. So, will stretching, yoga, and Pilates soften up your arteries? There’s no answer yet, but don’t wait to dive in — they’re smart components of any exercise and stress-reduction routine.

January 25, 2010, by Gabe Mirkin MD  —  You don’t have to play tennis to develop tennis elbow. It can be due to any movement that puts excessive force on the wrist muscles. Tennis elbow refers to elbow pain as the result of an injury to the elbow tendons that bend and straighten the wrist. Hold your hand down with your thumb on the outside (lateral to your hand) and your elbow straight. Pain on the lateral (outside) part of your elbow is called backhand tennis elbow. Pain on the medial (inside) part is called forehand tennis elbow.

The muscles and tendons are damaged when the force on them is greater than their inherent strength. If the ball hits your racquet with a force that is greater than the strength of your wrist muscles, your wrist tendons tear. In the same way, carrying a suit case, twisting a screwdriver, turning a stuck faucet, or trying to open a jammed door can tear your wrist muscles and cause tennis elbow.

More than 50 percent of professional tennis players suffer from tennis elbow. Conventional treatments, such as acupuncture, corticosteroids pills and injections, and surgery are usually ineffective.

Physical therapists at the Nicholas Institute of Sports Medicine and Athletic Trauma at Lenox Hill Hospital in New York City report that eccentric exercises offer simple and effective cure for tennis elbow (July 2009 annual meeting of the American Orthopedic Society for Sports Medicine).

(Eccentric contractions occur during a biceps curl when you lower the weight and your biceps lengthens. Concentric contractions occur when you raise the weight and your biceps muscle shortens.)

The researchers prescribed either standard physical therapy for tennis elbow to 10 control patients and physical therapy plus special eccentric exercises to 11 others. After less than two months, the program was terminated because the control group had not improved, while the eccentric group reported an 81 percent improvement in pain and a 72 percent improvement in strength.

Exercise For Tennis Elbow

The exercise is done with an inexpensive piece of equipment called the Thera-Band Flexbar, available at www.Amazon.com. Hold the bar upright with your hand of the affected side. With your hand of the healthy side, grasp the bar near the top and twist it in front of the body. Then use the sore elbow-side hand to slowly untwist the bar by flexing the wrist.

Exercise For Golfers Elbow

Women tend to be more affected than men, with approximately 30% of women developing varicose veins in their lifetime, compared to 15% of men, and they can cause particular embarrassment to women due their often unsightly appearance.

January 25, 2010, by Gabe Mirkin MD  —  Several studies have shown that exercise is beneficial for people with varicose veins; a regular exercise program may be the most effective treatment.

Veins are supposed to contain valves that keep blood from backing up. When the valves cannot close properly, veins become varicose, blood backs up, causing the veins to widen and look like blue snakes underneath the skin. Since varicose veins swell because blood pools in them, the best treatment is to empty blood from the veins. When you exercise, your leg muscles alternately contract and relax squeezing blood back toward the heart, so running, walking, cycling, skiing, skating and dancing are ideal treatments, while standing or sitting increase blood pooling and widen the veins.

Varicose veins are caused by a genetic weakness in the valves or an obstruction of blood flow, such as by obesity, pregnancy, tumors, clots and heart disease. Superficial varicose veins that you can see can cause a feeling of heaviness or aching, but they are rarely painful. Most varicose veins are best left alone. Special injections and laser burning remove only small veins. If you don’t like the way that large veins look, you can have a surgeon make a cut through the skin above and below the veins, attach a wire and pull the vein out from underneath your skin. People with varicose veins should not stand around for a long time/ and should wear support hose when they stand or walk slowly, but don’t need them when they exercise. Leg ulcers associated with varicose veins are best treated with a bacterial culture and injections of massive doses of the appropriate antibiotic. Surgery is rarely curative.

If you have varicose veins and develop severe pain, usually in the veins in your calf muscles, you have to worry about a clot. Clots in veins are dangerous usually only if they break lose and travel to your lungs to obstruct the flow of blood. So, doctors order tests for obstruction of venous blood flow in people who develop sudden severe pain deep in muscles. If a clot is present, doctors look for clotting disorders such as caused by tumors and antiphospholipid antibody.

By Gabe Mirkin, M.D., for CBS Radio News

Read More………………

Varicose Veins

Varicose veins are swollen and twisted veins that are visible just under the surface of the skin. They appear most commonly in the legs, but also can develop in other parts of the body.

Varicose veins usually don’t cause medical problems. On occasion, they require treatment for pain, skin problems, blood clots, or other complications. People may choose to have cosmetic treatment to improve the appearance of varicose veins.

Related Vein Problems

A number of other types of vein problems are related to varicose veins.

Spider Veins

Spider veins are a smaller version of varicose veins. They occur in the capillaries, which are the smallest blood vessels in the body. Spider veins are commonly found on the legs and face, and they usually resemble a spider web or tree branch in shape. They can be red or blue. Spider veins are usually not a medical concern.

Telangiectasias

Telangiectasias are small clusters of blood vessels that look similar to spider veins. They are red in color and are commonly found on the upper body, including the face. They can develop during pregnancy and in people who have certain genetic disorders, viral infections, and other medical conditions (such as liver disease). Newly developed telangiectasias are often a reason to see a doctor.

Venous Lakes

Venous lakes are another type of varicose veins in which blood collects in the veins of the face and neck.

Reticular Veins

Reticular veins are flat blue veins commonly seen behind the knees.

Hemorrhoids

Hemorrhoids are varicose veins in blood vessels in and around the anus.

Varicoceles

Varicoceles are varicose veins in the scrotum (the skin over the testicles). Varicoceles may be linked to male infertility and should be checked by a doctor.

Symptoms

Common signs and symptoms of varicose veins include:

  • Enlarged veins that are visible on your skin
  • Mild swelling of your ankles and feet
  • Painful, achy, or “heavy” legs
  • Throbbing or cramping in your legs
  • Itchy legs, especially in the lower leg and ankle (sometimes incorrectly diagnosed as dry skin)
  • Discoloration of your skin surrounding the varicose veins

Complications

Only a small percentage of people have complications from varicose veins. Complications may include dermatitis and thrombophlebitis.

Dermatitis

Dermatitis is an itchy rash that can occur on the lower leg or ankle of a person with varicose veins in the legs. It can sometimes cause bleeding or a skin ulcer to develop if scratched or irritated.

Thrombophlebitis

This is a blood clot (thrombus) that occurs in a vein. There are two types of thrombophlebitis:

  • Superficial thrombophlebitis is a blood clot that occurs in a superficial vein and usually causes only minor problems that are limited to the area of the affected vein. Clots in varicose veins are usually of this type. Infections, chemical irritation, or other conditions that cause irritation and inflammation of the veins also can lead to superficial thrombophlebitis.
  • Deep vein thrombosis is a blood clot that develops in veins deeper in the body. It can be life threatening if the clot breaks off and travels to the lungs, which is called pulmonary embolism. This type of thrombophlebitis does not occur in varicose veins.

Diagnosis

Varicose veins are often diagnosed based simply on the appearance of the veins. For varicose veins in the legs, your doctor will examine your legs while you are standing or seated with your legs dangling. Your doctor may also ask you to describe pain or any other symptoms. Some diagnostic tests may be done to rule out other disorders or conditions.

Your doctor may order a Doppler ultrasound to evaluate the flow of blood in your veins and to look for blood clots. During a Doppler ultrasound, a handheld device is placed on your body and passed back and forth over the affected area. A computer converts sound waves into a picture of the blood flow in the arteries and veins.

Rarely, your doctor may order an angiogram to look at blood flow through your blood vessels. The procedure involves injecting a dye into your veins that can be seen using x ray. An angiogram can help to rule out other diagnoses besides varicose veins.

Causes

Veins, especially those in the legs, have to pump the blood “up hill” to the heart, against gravity. Inside the veins are one-way valves that help with pumping action and prevent blood from flowing backward. These valves allow blood to flow in only one direction, toward the heart. Varicose veins develop when the valves become weakened, damaged, or don’t work well.

Weakness in the valves may be due to weakness in the walls of the veins. This weakness tends to be associated with certain factors, including increasing age, a family history of varicose veins, or high pressure inside veins due to overweight or pregnancy.

When the walls of the veins are weak, they lose their normal elasticity, like an overstretched rubber band. This makes them longer and wider and causes the flaps of the valves to separate. Blood is then able to flow backward through the valves, filling the vein and stretching it even more. The vein becomes enlarged, swollen, and often twisted trying to squeeze into its normal space.

The illustration shows the location of leg veins, which can become varicose veins. Figure A shows a normal vein with working valves and normal blood flow. Figure B shows a varicose vein with deformed valves, abnormal blood flow, and thin, dilated (stretched) walls.

Reference:

National Heart, Lung, and Blood Institute, USA.