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FDA Approves New Drug for Varicose Veins

Role of Diosmin in Chronic Venous Disease

Leg cramps, swelling, bulging veins or unsightly veins are issues commonly found in many middle aged women and often men as well.  These swollen blood vessels called Varicose Veins not only make your legs look unattractive, but they also indicate a serious circulatory problem leading to a disease called Chronic Venous Insufficiency or CVI.  At our clinic, Vein Clinic of Texas, our main focus is screening and early detection of varicose veins.  We have a full spectrum of treatment options for advanced disease as well.  More information can be found on our website at http://www.veinclinicoftexasc.com.

Although CVI is not a major life threatening issue, it can have a severe impact on both an individual’s life and the healthcare system.  It is estimated that more than 50 percent of women in America develop varicose veins by the age of 50.  Along with pain and disfiguration, CVI adds to the expense of the medical system.  The cost of treating CVI has been estimated to be $750 million to $1 billion per year. The average cost of treatment for a single patient can exceed $40000.  Estimates of 2 million work days are lost due to medical conditions and around $3 million are lost in health care costs.

The treatment methods currently available include compression stockings or bandages, sclerotherapy, laser or radiofrequency ablation and surgical intervention.  However, these methods are cumbersome and come with financial and biological issues.  Surgical remedies are expensive and comprehensive bandages are time consuming as well as difficult to apply.  We reserve surgical intervention for advanced disease.  The least invasive and least painful treatment is radiofrequency ablation, RFA, for varicose veins which is offered at our clinic and done within the office setting.  Please see http://www.veinclinicoftexasc.com for more details.

Phlebotonics are drugs or nutrients functioned to improve vein health.  Out of various phlebotonics, Diosmin has been labelled as especially useful in countering CVI.

Diosmin is a naturally occurring hesperidin bioflavonoid, first identified in 1925.  It is prescribed as a standard pharmaceutical intervention in Europe for CVI and hemorrhoids.  Many women in the US have been using this European drug available without prescription, as a food supplement.  Micronized Diosmin has been clinically proven to produce healthier looking legs by healing swollen ankles, spider and varicose veins and leg ulcers.

Before getting into detail about Diosmin, First we must know what chronic venous disease is and how it affects an individual’s life.

What is CVI?

CVI occurs when veins in the legs don’t allow blood to travel back to the heart due to incompetent venous valves.  This leads to venous hypertension and improper circulation of blood in the leg.  CVI is a common cause of leg pain and swelling, associated with varicose veins.

Normally, each pump in the heart pushes blood around the body.  This pump works well for outgoing blood coursing around the arteries.  By the time blood hits and returns through the veins, much of the propulsion generated by the heart is gone.  In addition to this challenge, returning blood travelling from the legs has to fight against gravity.

Our body has a complicated system set up to perform this operation.  This system includes venous muscle pump, a series of flap valve and perforating veins to allow communication of the superficial and deep venous system.  Dysfunction of any of the normal structures, specifically the venous valve may lead to venous hypertension and development of CVI.

Venous valves are a series of one-way valves that prevent blood from returning to the feet.  As these valves become incompetent they allow retrograded flow of blood towards the feet and build up pressure in lower veins.  This pressure in turn weakens the valve further down.  Engorged with blood, the vein walls weaken, turning them into varicose and spider veins.  This vicious cycle develops blood that seeps through weakened vein walls and pools in the calves of the legs.  The buildup of lymph fluid and blood causes swelling and discoloration which can get worse with the development of painful and stubborn ulcers.

Even though CVI is not life threatening, it can affect quality of life if left untreated.  CVI can lead to serious medical conditions including phlebitis and DVT.  Risk factors of CVI include work environments that involve standing or sitting for a long period, women over the age of 50, tall height, pregnancy, physical activity, smoking, obesity and family history of varicose veins.

What is Diosmin?

Diosmin is a naturally occurring hesperidin bioflavonoid extracted from the rind of sweet oranges.

The most clinically effective Diosmin is micronized, which means it has undergone a scientifically controlled process to reduce the size of standard particles in order to increase its bio-availability and rapid relief of symptoms that accelerate healing.

How does it work?

Diosmin reduces the sensation of pain, swelling, tension and heaviness in the legs associated with chronic venous disease.  Micronized Diosmin prolongs the vasoconstrictor effect of noradrenaline on the vein wall and by doing so, increases venous tone, and thereby reduces pooling that can lead to swollen veins.  It has anti-inflammatory effects on vessel walls as well.

Clinical Data

In a study of 245 patients with varicose vein disease who underwent surgical removal of an affected vein, those given micronized Diosmin pre- and post-operative therapy (two weeks before and for 30 consecutive days after surgery) achieved a measurable reduction in postoperative hematoma, pain severity and limb heaviness, as well as ease of exercise and improved quality of life.

Diosmin’s clinical efficacy has been tested in more than 40 clinical trials comprising of more than 15,000 patients.  The largest published clinical trial for CVI was a two year trial which enrolled 5,052 patients in 23 countries.  After six months, there were significant reductions in edema and improved quality of life (QOL).  Objective endpoints like decrease in venous reflux, increase in venous flow and reduction in venous pressure was also statistically significant in the Diosmin treated group.

Studies showed that micronized Diosmin protects the one way venous valves from leukocyte induced inflammation and destruction.  Micronized Diosmin also increases venous tone and reduces venous stretching and blood pooling.  This increases blood flow towards the heart and reduces venous high blood pressure present in suffering from chronic venous disease.

Other Benefits

Venous Leg Ulcers. Unhealed leg ulcers are a major consequence of chronic venous disease and major health issues.

Studies show that micronized Diosmin helps heal leg ulcerations by inhibiting the synthesis of inflammatory prostaglandin and free radicals.  Micronized Diosmin also decreases microvascular leakage and inhibits white blood cell trapping and migration.  One study found that treatment with micronized Diosmin led to complete healing of infected leg ulcers.

A multicenter, randomized, controlled trial tested micronized Diosmin in addition to standard compression stocking therapy versus placebo for two months in patients with leg ulcers.  A complete healing of leg ulcers is seen in patients who use Diosmin and compression stockings.

Lymphedema. Lymphedema is an abnormal swelling due to blockage of the lymphatic system.

Micronized Diosmin has been shown to improve lyphatic drainage by promoting lymphatic contraction by increasing the number of functional lymphatic capillaries and by decreasing the diameter of lymphatic capillaries and the intralymphatic pressure.

One study analyzed micronized Diosmin as a treatment of upper limb lymphedema secondary to conventional therapy for breast cancer.  Results showed improvement of the lymphedema but no significant reduction of arm swelling and no effect on cancer.

Diosmin may also bring relief to people suffering from secondary restless leg syndrome.

Micronized Diosmin alleviates acute and chronic pain and swelling of hemorrhoids.

Summary

There are multiple ways to treat chronic venous insufficiency including compression bandages, sclerotherapy and surgery but nothing has come closer to the inexpensive and effective treatment with micronized Diosmin.

Micronized Diosmin is the only oral treatment shown to be effective with the earliest symptoms of chronic venous insufficiency up to the most severe stage.

Because of unique and clinically proven mode of action which deals with all the clinical aspects of venous disease it should be used as a first line treatment for edema and symptoms of CVI at any stage of the disease along with other conservative therapy.

Micronized Diosmin enjoys an outstanding safety record unrivaled by any other drug used to treat venous disorders.  The majority of published studies, including the ones involving pregnancy, show that Diosmin is generally nontoxic at recommended doses.  However, those who are pregnant or take any prescription medications should check with a physician before taking micronized Diosmin.

Now a prescription formulation is also available in the US known as Vasculera (Diosmiplex).  It consists of a proprietary blend of micronized and highly purified Diosmin glycotides in combination with alkaline granules, alka4 complex.  It is the only FDA approved formulation in the US.

For further information and to schedule a free vein screening please contact our office at 972-529-6939.  Our physicians, Dr. M. Akram Khan and Dr. Ambreen Ashfaque have many years of experience in varicose vein care and are both certified by the American Board of Venous and Lymphatic Medicine.  Visit our website for more information at http://www.veinclinicoftexasc.com.

 

 

 

 

We Are Looking for Participants! Clinical Trial for PAD – Peripheral Artery Disease

Our cardiologist, Dr. Akram Khan, in association with North Dallas Research Associates is looking for participants in a clinical trial for the treatment of Peripheral Artery Disease. Read more about the study below…to be part of the study or for more information contact Irfan Ullah, Director of Clinical Research, at 972-562-2345. To view the PDF click here: Clinical Trial in McKinney, TX peripheral artery disease.

Clinical Trial in McKinney TX for PAD peripheral artery disease

Compression Stockings & Varicose Veins

Varicose Veins (VV) or Chronic Venous Insufficiency (CVI) is a widespread and debilitating disease estimated to affect 10 to 15 million Americans, resulting in the loss of more than two million work-days annually.

 

There are two kind of management for Varicose Veins:

  • Medical or Conservative management.
  • Surgical or Interventional management.

 

Most of the time medical management is practiced until the condition, as it is a progressive disease, reaches the point where the intervention is required.

 

Medical management includes keeping the leg elevated while sitting or lying down to reduce edema, wearing compression stockings, and watching salt intake, as it should be 2 gram or less per day. Higher salt intake will lead to swelling and fluid retention.

 

Surgical management of varicose veins includes Laser or Radio Frequency Ablation to cause closure of incompetent valves and veins. Spider veins are usually treated with sclerosing agents, a spider vein treatment technique known as sclerotherapy.

 

What are Compression Stockings?

Compression stockings for varicose veins

 

Compression stockings are specialized long socks which are worn from the foot to the knee/thigh. These specially fitted hose are designed to reduce the pooling that occurs in spider and varicose veins. The stockings apply pressure in a gradient fashion- highest around the ankle with less pressure as they go up the leg. This helps milk the blood back up the leg towards the heart.

 

Compression stockings continue to be the mainstay in the management of varicose veins before and after intervention.

 

Uses of Compression Stockings

 

Compression stockings are recommended by a medical doctor to prevent new varicose veins from forming and keep existing venous disease under control.

 

Although wearing compression stockings won’t eliminate varicose veins, they can help alleviate symptoms caused by the diseased veins, such as aching, heaviness, and swelling as well as help prevent worsening of the incompetent veins leading to ulceration. Wearing compression stockings can also reduce the risk of developing blood clots from long plane or car rides and is recommended to avoid venous problems during pregnancy.

 

A compression stocking must not be worn in the case of circulation disorders in the leg arteries and in the case of heart complaints that are difficult to treat. Caution is also recommended in the case of sensory impairments due to diabetes and neuropathy.

 

Types of Compression Stockings

 

 They come in various strengths and sizes and should be prescribed by your physician. They can range in price from $50-$125. Your doctor will either supply you with compression stockings or give you prescription to be used in a medical supply store. Over-the-counter stockings offer less compression than the prescription variety and may not be adequate.

 

Remember that there are a few brands that are used by the physicians. Any of these major brands are effective for their purpose. Please note that, like many other items, you pay more for a certain name brand.

 

The compression stockings we provide are affordable and provide adequate support. They come as latex free and cotton free variety which include moisture regulating benefits known as Clima fresh. There are seven sizes and two leg lengths available to ensure a custom-like fit in a ready-to-wear stocking. Diverse products offer an option for every patient to aid in their compliance.

 

Stockings come in a variety of strengths, styles and colors. With the variety offered with us, you’re likely to find a stocking that you’re comfortable wearing. We offer 30 days fit guarantee and a 6 month compression guarantee on stockings.

 

Please note that compression stockings should be strong but not very tight. If you have week hands or arthritis, getting these stockings on may be difficult. There are devices to make putting them on easier.

 

You are advised to contact your doctor for any further question or concerns.

 

Thanks for reading our blog! At the Cardiac Center of Texas, we are committed to helping inform our community about heart and vein health through our blog and through social media. Join us on Facebook and help us share the knowledge!

 

Vascular Disease Statistics – Did You Know?

Vascular Diseases like abdominal aortic aneurysm (AAA), peripheral artery disease (PAD), stroke, venous insufficiency, and blood clots affect millions of Americans. Yet many people have never heard of them. Raising awareness of these conditions will help save lives. Below are some important statistics to know from the Vascular Disease Foundation:

Peripheral Artery Disease (PAD)

  •  One in 3 people age 70 or older has PAD.
  • PAD affects at least 8 to 12 million Americans. The disease prevalence increases with age and 12-20% of Americans age 65 and older (4.5 to 7.6 million) have PAD. As the population ages, the prevalence could reach 9.6 to 16 million in those age 65.


AAA – Abdominal Aortic Anuerysm

 Each year, physicians diagnose approximately 200,000 people in the United States with Abdominal Aortic Aneurysm (AAA). Of those 200,000, nearly 15,000 may have an AAA threatening enough to cause death from its rupture if not treated.

STROKE 

Stroke is the number four cause of death and the leading cause of adult disability in the United States.

VENOUS DISEASE (Venous Insufficiency)

  •  Ten times more people suffer from venous insufficiency than PAD in the United States. It affects all age groups.
  • More than 24 million Americans have varicose veins and 6 million have skin changes associated with Chronic Venous Insufficiency.
  • Dangerous blood clots form in the leg veins of over 2.5 million Americans each year.
  • 10-35% of adults have leg veins that do not work properly.
  • Half a million Americans have ulcers on their legs caused by diseased veins.
  • Deep Vein Thromobis (DVT) occurs in approximately 1 person in 20 over his or her lifetime.
  • Over 600,000 people are hospitalized for DVT each year.
  • DVT with its risk of pulmonary embolism (PE) may be the most preventable cause of death among people hospitalized today in the United States.
  • Chronic Venous insufficiency (CVI) can cause varicose veins, leg edema, leg pain, chronic skin changes and non-healing ulcers. These problems may make it difficult to sit or stand for long periods, and make it difficult to work at home or on the job.
  • Post-thrombotic syndrome (PTS) may develop following DVT in up to two thirds of those affected. Pain and leg swelling often limit normal activities.

 

 

Olympic Gold Medalist Talks Varicose Veins in “Rethink Varicose Veins” Awareness Campaign

Varicose Veins Awareness and Summer SandersSummer Sanders is best known for her work as a sports commentator and reporter, TV show host, and retired Olympic gold medalist in swimming. Now Sanders is leading a campaign to raise awareness about varicose veins and other serious forms of vein disease. The American College of Phleblogy (ACP), Society for Vascular Surgery and the American Venous Forum partnered with Sanders in the “Rethink Varicose Veins” campaign promoting awareness of varicose vein health risks.

 

The focus of the campaign is to encourage people suffering from varicose veins to understand and learn more about their condition. Varicose veins left untreated can progress to a more serious form of vein disease called CVI or chronic venous insufficiency.  Some studies show that only 1.9 million of the more than 30 million Americans suffering from venous (vein) disease seek treatment annually, the vast majority of sufferers remain undiagnosed and untreated. *

 

To help raise community awareness, Sanders is sharing her personal experience with venous insufficiency, which is the underlying cause of varicose veins. She also shares how she improved following treatment for varicose veins.

 

Sanders had many of the classic complaints of varicose veins, achy heavy legs that she attributed to being on her feet and getting older.  When she finally spoke with a vein specialist, she learned that the symptoms were due to venous insufficiency. Sanders was informed that if she didn’t seek treatment for varicose veins and her condition progressed to chronic venous insufficiency (CVI) that she could have ended up with more serious symptoms like skin texture and color changes, leg ulcers and severe pain.

 

With varicose veins and CVI , the valves in  the veins of the leg that direct blood from the legs back up toward the heart no longer function correctly, causing blood to pool in the legs. Although this can occur at any age, increased age is considered a risk factor. Varicose veins and CVI also tend to be more prevalent in women who have been pregnant, and in people who have a family history of CVI. Those whose jobs require them to spend a great deal of time standing are also at an increased risk for CVI and varicose veins.

 

At the Vein Clinic of Texas, we find that many of our patients, both men and women, think varicose veins are just a cosmetic issue, or a natural part of aging and are not aware that chronic venous insufficiency (CVI) is a progressive disease that requires proper diagnosis and medical treatment. They are often pleased to discover that there are effective minimally invasive treatment options and in many cases insurance may cover the cost of varicose vein treatment.

 

To read more about Sanders’ experience with vein disease and treatment, visit the website www.RethinkVaricoseVeins.com  There you can learn more about varicose veins, CVI , and  vein treatment options. Visitors to the website can also assess their own risk with an online tool or share an e-card with friends or family to encourage them to learn more about varicose veins and CVI.

Do Sex Hormones Give Men Varicose Veins?

Study Examines Role of Testosterone and Estradiol in Varicose Veins inMen and Varicose Veins Men

Believe it or not, it is estimated that over 50% of men will suffer from varicose veins at some point in their lives.  Gravity and heredity are known to contribute to varicose veins, but scientists are now exploring potential links between sex hormones like testosterone and estradiol and varicose veins.

 

In 2009, a study published in Angiology by Dermatologists at the Universitaetsklinikum Leipzig examined the link between testosterone and estradiol levels and varicose veins in a small study of 21 men with the complaint.

 

They wanted to research the relationship between sex hormones and varicose veins because varicose veins are common in women who have raised estradiol levels in their blood. Men with Klinefelter syndrome, who also have higher levels of estradiol than other men, are also more likely to suffer from varicose veins.

 

The German doctors compared the hormone levels of the 21 men with varicose veins with the levels of 13 men without varicose veins.What they discovered is that while there does not appear to be a link between testosterone levels and varicose veins, but there does appear to be a link between estradiol levels and varicose veins.

 

Researchers aren’t sure why this is the case, but if the results of the study are correct, then supplements that inhibit the conversion of testosterone into estradiol may help in preventing varicose veins. Examples include: mangosteen, kelp, Ginkgo biloba, Damiana, vitamin K, fish oil, green tea, grapeseed-extract and GLA.

 

Perhaps scientists will uncover a way to prevent varicose veins with supplements, but until then science has at least advanced enough to remove varicose veins once they appear.

 

What do you think? Did you know that sex hormones played a role in varicose veins?

 

*Photo Credit Tinou Baou

Source:
Angiology. 2009 Jun-Jul;60(3):283-9.

 

 

 

Varicose Vein Facts You Need to Know

Varicose veins affect nearly 10% to 20% of all adults. They are easily recognizable on legs -blue veins that appear swollen and twisted close to the surface of the skin. Because the valves in the veins are damaged, they hold more blood at a higher pressure than normal. The pressure in the veins forces fluid into the surroundingVaricose Veins tissue, which can make the affected leg swell and feel heavy.  In addition to being unappealing and uncomfortable, varicose veins can also cause swelling in the ankles and feet and itching of the skin. Varicose veins may occur in almost any part of the leg but are most commonly seen on the inside of the leg between the groin and the ankle or in the back of the calf.  If varicose veins are left untreated, patient symptoms are likely to worsen with some possibly leading to venous ulceration (leg ulcers).

 What causes varicose veins?

The normal function of the leg veins, including both the deep veins in the leg and the superficial veins – is to transport blood back to the heart. For example, during walking, the calf muscle acts as a pump, contracting veins and pushing blood back to the heart. To prevent blood from flowing in the wrong direction, veins have many valves inside. If the vein valves fail (a cause of venous reflux), blood flows back into superficial veins and back down the leg. This backflow of blood results in veins expanding and becoming varicose. The process is similar to blowing air into a balloon without letting the air flow out again- the balloon swells.

In order for varicose vein treatment to be successful, the treatment must stop this reverse flow of blood at the highest site or sites of valve failure. In the legs, veins closer to the surface of the skin drain into bigger veins, such as the saphenous vein, which run up to the groin. Damaged valves in the saphenous vein are often the cause of reversed blood flow back down into the surface veins.

Why do varicose veins occur more in the legs?

Gravity is the main culprit of varicose veins in the legs. The distance from the feet to the heart is the longest distance blood has to travel in the body. Consequently, those vessels undergo a tremendous amount of pressure. If vein valves can’t handle the pressure, the backflow of blood can cause the surface veins to become swollen and disfigured.

Who is at risk for varicose veins?

Several conditions contribute to varicose veins including genetics, obesity, pregnancy, hormonal changes at menopause, work or activities requiring extended standing, and past vein diseases such as thrombophlebitis(i.e. inflammation of a vein as a blood clot forms.) In addition, women are more likely to suffer from varicose veins and the incidence of varicose veins increases to 50% for people over the age of 50.

 

PAD What?

PAD Peripheral Arterial DiseaseI know what you’re saying—not another acronym! Now what does this one mean, do, say, you know, WHAT NOW!

 

Well, here goes—PAD stands for Peripheral Arterial Disease. You may hear it called PVD or peripheral vascular disease. Whatever you want to call it, PAD is a narrowing of the arteries that carry blood to your brain, organs, legs, arms, and other areas outside of your heart. The narrowing is caused by the same process that causes coronary artery disease.

 

Ten million people in the United States have PAD, which can lead to mortality rates similar to breast cancer and colon cancer. Risk factors include diabetes, high cholesterol, smoking, family history of heart disease, obesity, high blood pressure, and age over 50.

 

Symptoms to watch for include discomfort or aching in the calves, thighs, hips, or buttocks; rest pain in the toes and feet (especially at night) that is usually relieved by standing; changes in skin color or temperature; impotence; painful foot sores that don’t heal; ulcers; gangrene. Quite often, people who have this disease cannot walk more than a block or two and their calves or hips begin to hurt. After they rest for a few minutes, the pain disappears.

 

Now don’t run to make a doctor’s appointment right this second. Remember, ambiguous symptoms include arthritis, back problems, poor physical conditioning, or electrolyte imbalances, to name a few. If necessary, diagnosing the problem can be done with a simple, noninvasive test called an ABI (oops, another acronym). ABI stands for ankle /brachial index. Simply, does your blood flow get all the way from your heart down to your toes without anything stopping it? Other noninvasive tests include pressures and ultrasound Doppler. Invasive testing would be a peripheral arteriogram.

 

The good news… PAD can be fixed! The earlier that PAD is found, the easier the treatment and the better the outcome. Treatment options include lifestyle changes, medication, angioplasty, laser angioplasty, peripheral stenting, and, if necessary, bypass surgery.

 

With this is mind, we would like to introduce you to JoAnn Arden, a 49-year-old, white female. She is a mother of three who lives with her husband Steve in Denton, Texas. On Valentine’s Day 2001, instead of going to a romantic dinner, she found herself admitted to the hospital with a blackened right toe and heel in excruciating pain.

 

A known diabetic (non-insulin dependent, diagnosed at age 40) and prior smoker, her problem had begun six months earlier with numbness in her right foot. She was told that this was due to diabetes. In January, the problem escalated. She developed significant pain in her right foot. At this point, she was told that she had an infection in her toe and was given antibiotics.

 

Subsequently, her situation deteriorated to the point of the emergency visit to the hospital, where she was diagnosed with gangrene and faced the possibility of amputation. Multiple doctor visits and numerous diagnoses, but all along, the problem was PAD. She changed physicians, and an angiogram was then done, confirming that she had severe peripheral arterial disease (PAD) causing loss of blood flow to her foot.

 

A laser angioplasty was done on February 19, 2001. The procedure was a success and blood flow had returned to JoAnn’s foot and toes. JoAnn remains under the supervision of her cardiac specialist, who has performed subsequent procedures. He has also placed peripheral stents in the affected arteries. At her last checkup, JoAnn had recently walked the entire Grapevine Mills Mall. As a result of her ordeal, Jo Ann advises: “If you smoke, quit. If you have diabetes, control it. Diabetics, please take care of your feet. Get another opinion. Do not have an amputation.”

 

Hopefully, no one reading this finds him/herself where JoAnn did. With early diagnosis and proper treatment, people with PAD can look forward to increased activity and improved health. It all depends on early diagnosis. If you are at risk, ask about a screening test today.

 

Written by PeggySue Carroll, R.C.S., R.V.S., and Kathy Fleischmann, R.D.C.S., R.V.T.