| As I've mentioned in previous columns, the statin class | | | | A variety of conditions and circumstances can lead to |
| of cholesterol-lowering drugs have revolutionized the | | | | DVT formation. These include decreased blood flow, |
| management of elevated cholesterol levels, and have | | | | or "stasis," involving the body's deep veins, injury or |
| been shown, by multiple clinical studies, to significantly | | | | inflammation of the internal surfaces (endothelium) of |
| decrease the incidence of serious cardiovascular | | | | these veins, and any underlying health condition that |
| events, including fatal heart attacks (myocardial | | | | increases the blood's tendency to form blood clots |
| infarction) and strokes. | | | | (hypercoagulable state). Pulmonary embolism (PE) is a |
| The statins were originally developed for their ability to | | | | potentially life-threatening condition, and most |
| block a key enzyme required for the body's synthesis | | | | commonly arises in patients who have already |
| of cholesterol. Thus, the statins decrease total | | | | developed DVT (PE occurs when chunks of |
| cholesterol levels in the blood and, most importantly, | | | | DVT-associated clots break away and travel to the |
| they specifically reduce LDL (the "bad cholesterol") | | | | lung). When the lung's circulation becomes clogged-up |
| levels. Numerous clinical research studies have shown | | | | with these itinerant clots (emboli), patients may |
| that statin drugs reduce the risk of heart disease and | | | | experience shortness of breath, chest pain, or in |
| heart attacks in patients with elevated cholesterol | | | | serious cases of PE, complete cardiovascular collapse |
| levels. Additional research has also strongly suggested | | | | and death. |
| that statins can also reduce the risk of cardiovascular | | | | VTE remains an underappreciated cause of serious |
| disease even in patients with normal cholesterol levels. | | | | illness, disability, and death. Patients with severe or |
| More recently, additional research into the biochemical | | | | repeated cases of DVT often develop chronic |
| function of these powerful drugs has also revealed | | | | swelling, pain, and skin damage of the affected |
| other mechanisms of action in addition to their known | | | | extremities, due to the progressive destruction of the |
| direct effects on cholesterol synthesis and metabolism. | | | | one-way valves in the large veins of the lower body |
| One of the most clinically important additional | | | | that help to prevent pooling of blood in these |
| mechanisms of action of statins appears to be their | | | | dependent areas of the body (post-thrombotic |
| ability to reduce inflammation throughout the body. | | | | syndrome). Patients who survive significant PEs may |
| These anti-inflammatory effects have been linked not | | | | also go on to develop permanent damage to the |
| only to the statins' ability to reduce cardiovascular | | | | venous circulation of the lungs, leaving them with |
| disease, but also to their ability to potentially reduce the | | | | decreased blood flow to the lungs (pulmonary |
| risk of stroke and, perhaps, even the risk of some | | | | hypertension) and, in severe cases, chronic shortness |
| cancers, as well. However, the data supporting these | | | | of breath, lung injury, and heart damage (PE also |
| additional potential benefits of statins has been less | | | | remains the most common cause of unexpected |
| convincing than that for cardiovascular disease | | | | death in hospitalized patients). An estimated 900,000 |
| reduction. I should also stress that not all claims | | | | new cases of VTE occur in the United States every |
| currently being made for statins are likely to turn out to | | | | year, and as many as one-third of these cases of |
| be true, and that, as with all medications, statins have | | | | VTE are fatal, which makes VTE a more common |
| been associated with potentially serious side effects | | | | cause of death than either heart attacks or strokes! |
| (most notably, injury to the liver and to muscle tissue). | | | | As these statistics suggest, VTE remains a very |
| However, as I have observed before, it is difficult to | | | | serious public health problem in the United States, and |
| think of any other recently developed class of | | | | throughout much of the world, as well. |
| medications that have accumulated a more impressive | | | | In view of the seriousness of VTE as a public health |
| reputation for preventing life-threatening diseases than | | | | problem, the findings of this newly published statin |
| the statins (not surprisingly, the statin class of drugs | | | | study are potentially very significant. Among the 17,802 |
| remain the most commonly prescribed class of | | | | patients who participated in this prospective clinical trial, |
| medications in the United States). | | | | a total of 94 patients developed VTE, with 60 cases |
| The good news regarding the potential beneficial health | | | | occurring in the placebo group and only 34 cases |
| effects of statin drugs continues to roll in. For example, | | | | occurring in the statin group. This represents a nearly |
| in recent weeks, clinical research data has been | | | | 45 percent overall reduction in the risk of VTE |
| presented suggesting that statins may reduce the risk | | | | associated with the daily use of the statin drug |
| of prostate cancer, and may also be able to slow the | | | | rosuvastatin. When the researchers looked at potential |
| growth of tumors in men who already have prostate | | | | risk factors for VTE among these 94 patients, |
| cancer (it should be noted, however, once again, that | | | | additional important information was discovered, as |
| there have been conflicting research results published, | | | | well. Among patients with known VTE risk factors |
| thus far, regarding the ability of statin drugs to reduce | | | | (including cancer, recent major trauma, recent major |
| cancer risks, and to shrink tumors in patients who | | | | surgery, or hospitalization for other reasons), the use of |
| already have cancer). | | | | a statin drug reduced the risk of VTE by nearly 50 |
| This week, another important new clinical research | | | | percent. Among patients without any known risk |
| study on statin drugs has just been published. In this | | | | factors for VTE, the daily use of rosuvastatin reduced |
| new study, which appears in the New England Journal | | | | the risk of VTE by about 40 percent. When looking |
| of Medicine, the potential effects of statin drugs in | | | | specifically of the risk of PE, the statin group of |
| preventing blood clots of the veins was assessed in a | | | | patients experienced a 23 percent risk reduction for |
| huge randomized, placebo-controlled, double-blind, | | | | PE, while the risk of DVT, specifically, was reduced by |
| prospective clinical research trial. Nearly 18,000 clinically | | | | a whopping 55 percent in the statin group. |
| healthy men and women participated in this very | | | | The results of this study are quite remarkable, and |
| important clinical research trial. All participants in this | | | | they suggest that daily statin use may reduce the risk |
| study had normal LDL cholesterol levels, but they also | | | | of VTE by nearly 50 percent, especially in people who |
| all had elevated levels of C-Reactive Protein (CRP), a | | | | are already at increased risk for VTE (whether or not |
| protein in the blood that is associated both with chronic | | | | all of the currently available statin drugs can provide |
| inflammation and an elevated risk of cardiovascular | | | | VTE protection equivalent to rosuvastatin is unknown |
| disease. These 17,802 patient volunteers were | | | | at this time, although all high-activity statins should, in |
| randomized to receive either a statin pill (rosuvastatin, | | | | theory, provide comparable protection). This highly |
| 20 milligrams per day) or an identical placebo pill (sugar | | | | significant VTE prevention effect is, of course, a |
| pill). This huge group of patients were then followed, for | | | | potential "health bonus" in addition to the cardiovascular |
| as long as 5 years, and were observed for evidence | | | | disease reduction effect that statin drugs were |
| of blood clot formation within the large veins of the | | | | originally designed for. If you fall into a high-risk |
| body (deep venous thrombosis), as well as the | | | | category for VTE, and you also have coexisting risk |
| presence of blood clots that had migrated to the veins | | | | factors for cardiovascular disease, then you should |
| of the lungs (pulmonary embolism). The results of this | | | | certainly discuss statin drug therapy with your primary |
| study, as I will discuss shortly, were quite remarkable. | | | | physician, based upon the findings of this pivotal clinical |
| Venous thromboembolic (VTE) disorders are a major | | | | research trial. |
| cause of disability and death throughout the world. | | | | Disclaimer: As always, my advice to readers is to |
| Deep venous thrombosis (DVT) results when blood | | | | seek the advice of your physician before making any |
| clots form within the deep veins of the body (most | | | | significant changes in medications, diet, or level of |
| commonly within the large veins of the legs and pelvis). | | | | physical activity. |