Health Report:

Statin Drugs & Blood Clots (Thromboembolism)

“A critical weekly review of important new research findings for health-conscious readers…”

By, Robert A. Wascher, MD, FACS

Updated:  05/3/2009

The information in this column is intended for informational purposes only, and does not constitute medical advice or recommendations by the author.  Please consult with your physician before making any lifestyle or medication changes, or if you have any other concerns regarding your health.

STATIN DRUGS & BLOOD CLOTS (THROMBOEMBOLISM)

As I’ve mentioned in previous columns, the statin class of cholesterol-lowering drugs have revolutionized the management of elevated cholesterol levels, and have been shown, by multiple clinical studies, to significantly decrease the incidence of serious cardiovascular events, including fatal heart attacks (myocardial infarction) and strokes. 

The statins were originally developed for their ability to block a key enzyme required for the body’s synthesis of cholesterol.  Thus, the statins decrease total cholesterol levels in the blood and, most importantly, they specifically reduce LDL (the “bad cholesterol”) levels.   Numerous clinical research studies have shown that statin drugs reduce the risk of heart disease and heart attacks in patients with elevated cholesterol levels.  Additional research has also strongly suggested that statins can also reduce the risk of cardiovascular disease even in patients with normal cholesterol levels.  More recently, additional research into the biochemical function of these powerful drugs has also revealed other mechanisms of action in addition to their known direct effects on cholesterol synthesis and metabolism.  One of the most clinically important additional mechanisms of action of statins appears to be their ability to reduce inflammation throughout the body.  These anti-inflammatory effects have been linked not only to the statins’ ability to reduce cardiovascular disease, but also to their ability to potentially reduce the risk of stroke and, perhaps, even the risk of some cancers, as well.  However, the data supporting these additional potential benefits of statins has been less convincing than that for cardiovascular disease reduction.  I should also stress that not all claims currently being made for statins are likely to turn out to be true, and that, as with all medications, statins have been associated with potentially serious side effects (most notably, injury to the liver and to muscle tissue).  However, as I have observed before, it is difficult to think of any other recently developed class of medications that have accumulated a more impressive reputation for preventing life-threatening diseases than the statins (not surprisingly, the statin class of drugs remain the most commonly prescribed class of medications in the United States).

The good news regarding the potential beneficial health effects of statin drugs continues to roll in.  For example, in recent weeks, clinical research data has been presented suggesting that statins may reduce the risk of prostate cancer, and may also be able to slow the growth of tumors in men who already have prostate cancer (it should be noted, however, once again, that there have been conflicting research results published, thus far, regarding the ability of statin drugs to reduce cancer risks, and to shrink tumors in patients who already have cancer).  

This week, another important new clinical research study on statin drugs has just been published.  In this new study, which appears in the New England Journal of Medicine, the potential effects of statin drugs in preventing blood clots of the veins was assessed in a huge randomized, placebo-controlled, double-blind, prospective clinical research trial.  Nearly 18,000 clinically healthy men and women participated in this very important clinical research trial.  All participants in this study had normal LDL cholesterol levels, but they also all had elevated levels of C-Reactive Protein (CRP), a protein in the blood that is associated both with chronic inflammation and an elevated risk of cardiovascular disease.  These 17,802 patient volunteers were randomized to receive either a statin pill (rosuvastatin, 20 milligrams per day) or an identical placebo pill (sugar pill).  This huge group of patients were then followed, for as long as 5 years, and were observed for evidence of blood clot formation within the large veins of the body (deep venous thrombosis), as well as the presence of blood clots that had migrated to the veins of the lungs (pulmonary embolism).  The results of this study, as I will discuss shortly, were quite remarkable.

Venous thromboembolic (VTE) disorders are a major cause of disability and death throughout the world.  Deep venous thrombosis (DVT) results when blood clots form within the deep veins of the body (most commonly within the large veins of the legs and pelvis).  A variety of conditions and circumstances can lead to DVT formation.  These include decreased blood flow, or “stasis,” involving the body’s deep veins, injury or inflammation of the internal surfaces (endothelium) of these veins, and any underlying health condition that increases the blood’s tendency to form blood clots (hypercoagulable state).  Pulmonary embolism (PE) is a potentially life-threatening condition, and most commonly arises in patients who have already developed DVT (PE occurs when chunks of DVT-associated clots break away and travel to the lung).  When the lung’s circulation becomes clogged-up with these itinerant clots (emboli), patients may experience shortness of breath, chest pain, or in serious cases of PE, complete cardiovascular collapse and death. 

VTE remains an underappreciated cause of serious illness, disability, and death.  Patients with severe or repeated cases of DVT often develop chronic swelling, pain, and skin damage of the affected extremities, due to the progressive destruction of the one-way valves in the large veins of the lower body that help to prevent pooling of blood in these dependent areas of the body (post-thrombotic syndrome).  Patients who survive significant PEs may also go on to develop permanent damage to the venous circulation of the lungs, leaving them with decreased blood flow to the lungs (pulmonary hypertension) and, in severe cases, chronic shortness of breath, lung injury, and heart damage (PE also remains the most common cause of unexpected death in hospitalized patients).  An estimated 900,000 new cases of VTE occur in the United States every year, and as many as one-third of these cases of VTE are fatal, which makes VTE a more common cause of death than either heart attacks or strokes!  As these statistics suggest, VTE remains a very serious public health problem in the United States, and throughout much of the world, as well.

In view of the seriousness of VTE as a public health problem, the findings of this newly published statin study are potentially very significant.  Among the 17,802 patients who participated in this prospective clinical trial, a total of 94 patients developed VTE, with 60 cases occurring in the placebo group and only 34 cases occurring in the statin group.  This represents a nearly 45 percent overall reduction in the risk of VTE associated with the daily use of the statin drug rosuvastatin.  When the researchers looked at potential risk factors for VTE among these 94 patients, additional important information was discovered, as well.  Among patients with known VTE risk factors (including cancer, recent major trauma, recent major surgery, or hospitalization for other reasons), the use of a statin drug reduced the risk of VTE by nearly 50 percent.  Among patients without any known risk factors for VTE, the daily use of rosuvastatin reduced the risk of VTE by about 40 percent.  When looking specifically of the risk of PE, the statin group of patients experienced a 23 percent risk reduction for PE, while the risk of DVT, specifically, was reduced by a whopping 55 percent in the statin group. 

The results of this study are quite remarkable, and they suggest that daily statin use may reduce the risk of VTE by nearly 50 percent, especially in people who are already at increased risk for VTE (whether or not all of the currently available statin drugs can provide VTE protection equivalent to rosuvastatin is unknown at this time, although all high-activity statins should, in theory, provide comparable protection).  This highly significant VTE prevention effect is, of course, a potential “health bonus” in addition to the cardiovascular disease reduction effect that statin drugs were originally designed for.  If you fall into a high-risk category for VTE, and you also have coexisting risk factors for cardiovascular disease, then you should certainly discuss statin drug therapy with your primary physician, based upon the findings of this pivotal clinical research trial.

Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity

Dr. Wascher is an oncologic surgeon, a professor of surgery, a widely published author, and a Surgical Oncologist at the Kaiser Permanente healthcare system in Orange County, California

Send your feedback to Dr. Wascher at:  rwascher@doctorwascher.net

Dr. Wascher’s Biography

Links to Other Health & Wellness Sites

http://doctorwascher.com

Copyright 2009

Robert A. Wascher, MD, FACS

All rights reserved

Dr. Wascher’s Archives:

4-26-2009:  Are We Really Losing the War on Cancer?

4-19-2009:   Exercise in Middle Age & Risk of Death

4-12-2009:  Can Chronic Stress Harm Your Heart?

4-5-2009:  Does PSA Testing for Prostate Cancer Save Lives?

3-22-2009:  CABG Surgery vs. PCI in Diabetics with Coronary Artery Disease; Sweetened Beverages and Coronary Artery Disease

3-15-2009:  Depression, Stress, Anger & Heart Disease

3-8-2009:  Coronary Artery Disease: CABG vs. Stents?; Swimming Lessons & Drowning Risk in Children

3-1-2009:  Aspirin & Colorectal Cancer Prevention; Fish Oil & Respiratory Infections in Children

2-22-2009:  Health Differences Between Americans & Europeans; Lycopene & Prostate Cancer

2-15-2009:  Statin Drugs & Death Rates; Physical Activity, Breast Cancer & Sex Hormones

2-8-2009:  Hormone Replacement Therapy (HRT) & Breast Cancer; Stool DNA Testing & Cancer of the Colon & Rectum

2-1-2009:   Obesity and the Complications of Diverticulosis (Diverticulitis & Bleeding); Obesity, Weight Loss & Urinary Incontinence

1-25-2009:  Prostate Cancer, Fatigue & Exercise; Does your Surgeon “Warm-up” Before Surgery?

1-18-2009:  Cancer and Vitamins; Teenagers, MySpace and Risky Behaviors

1-11-2009:  Exercise Reverses Some Effects of Fatty Meals; Vitamin C and Blood Pressure

1-4-2009:  Secondhand Smoke & Heart Attack Risk; Poor Physical Fitness During Childhood & Heart Disease Risk During Adulthood

12-28-2008:  Stress & Your Risk of Heart Attack; Vitamin D & the Prevention of Colon & Rectal Polyps

12-21-2008:  Breast Cancer Incidence & Hormone Replacement Therapy; Circumcision & the Risk of HPV & HIV Infection

12-14-2008:  Vitamin E, Vitamin C and Selenium Do Not Prevent Cancer;  Postscript: A Possible Cure for Down’s Syndrome

12-7-2008:  Generic vs. Brand-Name Drugs, Stress & Breast Cancer Survival

11-30-2008:    A Possible Cure for Down’s Syndrome?; Smoking & Cognitive Decline; Calcium & Vitamin D & Breast Cancer Risk

11-23-2008:  Breast Cancer & Fish Oil; Lymphedema after Breast Cancer Treatment; Vasectomy & Prostate Cancer Risk

11-16-2008:  Vitamin E & Vitamin C: No Impact on Cardiovascular Disease Risk; Does Lack of Sleep Increase Stroke & Heart Attack Risk in Hypertensive Patients?

11-9-2008:  Statins Cut Heart Attack Risk Even with Normal Cholesterol Levels; Statins & PSA Level

11-2-2008:  Radiation Treatment of Prostate Cancer & Second Cancers; Sexual Content on TV & Teen Pregnancy Risk

10-26-2008:  Smoking & Quality of Life

10-19-2008:  Agent Orange & Prostate Cancer

10-12-2008:  Pomegranate Juice & Prostate Cancer

10-5-2008:  Central Obesity & Dementia; Diet, Vitamin D, Calcium, & Colon Cancer

9-28-2008:  Publication & Citation Bias in Favor of Industry-Funded Research?

9-21-2008:  Does Tylenol® (Acetaminophen) Cause Asthma?

9-14-208:   Arthroscopic Knee Surgery- No Better than Placebo?; A Healthy Lifestyle Prevents Stroke

8-23-2008:  Alcohol Abuse Before & After Military Deployment; Running & Age; Running & Your Testicles

8-12-2008:  Green Tea & Diabetes; Breastfeeding & Adult Cholesterol Levels; Fish Oil & Senile Macular Degeneration

8-3-2008:   Exercise & Weight Loss; Green Tea, Folic Acid & Breast Cancer Risk; Foreign Language Interpreters & ICU Patients

7-26-2008:  Viagra & Sexual Function in Women; Patient-Reported Adverse Hospital Events; Curcumin & Pancreatic Cancer

7-13-2008:  Erectile Dysfunction & Frequency of Sex; Muscle Strength & Mortality in Men; Cryoablation for Prostate Cancer

7-6-2008:  Sleep, Melatonin & Breast Cancer Risk; Mediterranean Diet & Cancer Risk; New Treatment for Varicose Veins

6-29-2008:  Bone Marrow Stem Cells & Liver Failure; Vitamin D & Colorectal Cancer Survival; Green Tea & Colorectal Cancer

6-22-2008:  Obesity, Lifestyle & Heart Disease; Effects of Lifestyle & Nutrition on Prostate Cancer; Ginkgo Biloba, Ulcerative Colitis & Colorectal Cancer

6-15-2008:  Preventable Deaths after Coronary Artery Bypass Graft (CABG) Surgery; Green Tea & Colorectal Cancer; Attention-Deficit/Hyperactivity Disorder (ADHD) & St. John’s Wort

6-8-2008:  Vitamin D & Prostate Cancer Risk; Radiofrequency Ablation (RFA) of Kidney (Renal) Cancer; Antisense Telomerase & Cancer

6-2-2008:  Acute Coronary Syndrome- Do You Know the Symptoms?; Green Tea & Lung Cancer; Episiotomy & Subsequent Deliveries- An Unkind Cut

5-25-2008:  Early Childhood Screening Predicts Later Behavioral Problems; Psychiatric Disorders Among Parents of Autistic Children; Social & Psychiatric Profiles of Young Adults Born Prematurely

5-18-2008:  Can Statins Reverse Coronary Artery Disease?; Does Breast Ultrasound Improve Breast Cancer Detection?; Preventive Care Services at Veterans Administration (VA) Medical Centers

5-11-2008:  Smoking Cessation & Risk of Death; Childhood Traumas & Adult Suicide Risk; “White Coat Hypertension” & Risk of Cardiovascular Disease

5-4-2008:  Super-Size Me: Fast Food’s Effects on Your Liver; Exercise, Weight & Coronary Artery Disease; Contamination of Surgical Instruments in the Operating Room

4-27-2008:  Stents vs. Bypass Surgery for Coronary Artery Disease; The “DASH” Hypertension Diet & Cardiovascular Disease Prevention; Testosterone Therapy for Women with Decreased Sexual Desire & Function

4-20-2008:  BRCA Breast Cancer Mutations & MRI Scans; Bladder Cancer Prevention with Broccoli?; Diabetes: Risk of Death Due to Heart Attack & Stroke

4-13-2008:  Breast Cancer Recurrence & Hormone Replacement Therapy (HRT); Carotid Artery Disease: Surgery vs. Stents?; Statin Drugs & Cancer Prevention

4-6-2008:  Human Papilloma Virus (HPV), Pap Smear Results & Cervical Cancer; Human Papilloma Virus (HPV) Infection & Oral Cancer; Hormone Replacement Therapy (HRT) & the Risk of Gastroesophageal Reflux Disorder (GERD)

3-30-2008:  Abdominal Obesity & the Risk of Death in Women; Folic Acid Pretreatment & Heart Attacks; Pancreatic Cancer Regression after Injections of Bacteria

3-23-2008:  Age of Transfused Blood & Risk of Complications after Surgery; Obesity, Blood Pressure & Heart Size in Children

3-16-2008:  Benefits of a Full Drug Coverage Plan for Medicare Patients?; Parent-Teen Conversations about Sex; Soy (Genistein) & Prostate Cancer

3-9-2008:  Flat Colorectal Adenomas & Cancer; Health Risks after Stopping Hormone Replacement Therapy (HRT); Television, Children & Obesity 

3-2-2008:  Medication & Risk of Death After Heart Attack; Hormone Replacement Therapy (HRT) & Mammogram Results; Selenium: Cancer, Heart Disease & Death

2-23-2008:  Universal Healthcare Insurance Study; Glucosamine & Arthritis

2-17-2008:  Exceptional Longevity in Men; Testosterone & Risk of Prostate Cancer; Smoking & Pre-malignant Colorectal Polyps

2-10-2008:  Thrombus Aspiration from Coronary Arteries; Intensive Management of Diabetes & Death; Possible Cure for  Down’s Syndrome?

2-3-2008:  Vitamin D & Cardiovascular Health; Vitamin D & Breast Cancer; Green Tea & Colorectal Cancer

1-27-2008:  Colorectal Cancer, Esophageal Cancer & Pancreatic Cancer: Update from the 2008 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium

1-20-2008:  Testosterone Levels & Risk of Fractures in Elderly Men; Air Pollution & DNA Damage in Sperm; Statins & Trauma Survival in the Elderly

1-12-2008:  Statins, Diabetes & Stroke and Obesity; GERD & Esophageal Cancer

1-7-2008:  Testosterone Supplements in Elderly Men; Colorectal Cancer– Reasons for Poor Compliance with Screening Recommendations

12-31-2007:  Minority Women, Hormone Replacement Therapy & Breast Cancer; Does Health Insurance Improve Health?

12-23-2007:  Is Coffee Safe After a Heart Attack?; Impact of Divorce on the Environment; Hypertension & the Risk of Dementia; Emotional Vitality & the Risk of Heart Disease

12-16-2007:   Honey vs. Dextromethorphan vs. No Treatment for Kids with Night-Time Cough, Acupuncture & Hot Flashes in Women with Breast Cancer, Physical Activity & the Risk of Death, Mediterranean Diet & Mortality 

12-11-2007:  Bias in Medical Research; Carbon Nanotubes & Radiofrequency: A New Weapon Against Cancer?; Childhood Obesity & Risk of Adult Heart Disease

12-2-2007:  Obesity & Risk of Cancer; Testosterone Level & Risk of Death; Drug Company Funding of Research & Results; Smoking & the Risk of Colon & Rectal Cancer 

Dr. Wascher’s Home Page

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Health Report:

 

Statin Drugs & Death Rates

 

Physical Activity, Breast Cancer & Sex Hormones

 

“A critical weekly review of important new research findings for health-conscious readers…”

By, Robert A. Wascher, MD, FACS

 

Last Updated:  02/15/2009

The information in this column is intended for informational purposes only, and does not constitute medical advice or recommendations by the author.  Please consult with your physician before making any lifestyle or medication changes, or if you have any other concerns regarding your health.

 

STATIN DRUGS AND DEATH RATES

 

As I’ve mentioned in previous columns, the statin class of cholesterol-lowering drugs have revolutionized the treatment of elevated cholesterol levels, and have been shown, by multiple clinical studies, to decrease the incidence of cardiovascular events, including fatal heart attacks (myocardial infarction), in susceptible patients.  While their value in reducing non-cardiovascular disease events (such as cancer, for example) continues to be debated, there is no question but that statin drugs can significantly drive down the risk of coronary artery disease in patients with elevated cholesterol levels, as well as in patients with high-normal levels of  LDL (the “bad cholesterol”). 

 

A new clinical study assessing statin drugs and death rates has just been published in the Archives of Internal Medicine.  Nearly 230,000 adult patients (average age was about 58 years) enrolled in an HMO were retrospectively assessed in this huge public health study, which was performed in Israel; and all of these patients were started on statin medications between 1998 and 2006.  Two general groups of patients were included in this study.  The first group included patients who were prescribed statin drugs to prevent coronary artery disease, and who had no clinical evidence of coronary artery disease at the time they started receiving statins.  The second group consisted of patients who were prescribed statin drugs because they already had been diagnosed with coronary artery disease.  In this study, the researchers were able to determine the level of compliance of each patient with their statin medications, based upon the HMO’s pharmacy refill data.

 

After an average follow-up of about 5 years, the death rates among the compliant and noncompliant patients were then compared.  The patients who were at least 90 percent compliant with their statin prescriptions experienced a whopping 45 percent reduction in their risk of death, from any cause, when compared to the patients who were less than 10 percent compliant with their statin medications!  Furthermore, this dramatic difference in survival was observed in both the prevention group and in the coronary artery disease group. 

 

 

The research data also revealed that the greatest reduction in the risk of death was observed in patients with very high baseline LDL levels, and in patients treated with more potent statin drugs.  These latter two observations are especially important, because the retrospective nature of this study increases the risk that undetected biases might have influenced the researchers’ conclusions.  (For example, patients who were noncompliant with their statin drugs may have also engaged in other risky health behaviors that, independent of not taking their statin drugs, might also have increased their risk of death.)       

 

The 45 percent reduction in all-cause mortality that was associated, in this study, with a greater than 90 percent patient compliance rate with statin prescriptions is significantly greater than has been observed in most prospective randomized clinical research studies, to date.  Given the retrospective nature of this study, it is not clear if the much greater mortality benefit of statin drug compliance observed in this study is entirely valid or not, but the enormous population of HMO patients included in this study, and the moderately long duration of their follow-up (albeit retrospective in nature), suggests that this study’s conclusions are probably reasonable. 

 

If you have significant risk factors for coronary artery disease, or if you already have coronary artery disease, and your doctor has prescribed a statin drug for you, then the results of this study suggest that you can markedly reduce your risk of death by taking your medications as prescribed.

 

 

PHYSICAL ACTIVITY, BREAST CANCER & SEX HORMONES

 

 

There is considerable research evidence showing that regular exercise decreases the risk of several different types of cancer, including breast cancer.  In the case of breast cancer, given that 85 to 90 percent of breast cancer cases appear to be linked in some way to exposure to estrogen and progesterone (the “female sex hormones”), most experts have assumed that increased levels of regular physical activity must somehow affect circulating sex hormone levels in the blood, but the research data in this area has been unclear.  However, a new clinical research study, published in the journal Cancer Epidemiology Biomarkers & Prevention, now appears to provide evidence of a direct link between exercise and circulating sex hormone levels in the blood.

 

In this study, more than 800 postmenopausal women who participated in a large European public health study, the EPIC study, were evaluated.  Physical activity data for these women was obtained by the use of patient questionnaires, and blood was drawn from all study participants and tested for levels of both female and male sex hormones.

 

The investigators soon discovered that increasing levels of physical activity resulted in decreasing levels of estrogen in the blood, as well as increased levels of a protein in the blood that binds up circulating sex hormones (sex hormone binding globulin).  Furthermore, high levels of physical activity, as occurs with vigorous exercise, also increased blood levels of the male sex hormone dehydroepiandrosterone (DHEA) in these postmenopausal women. 

 

The results of this study offer at least one potential explanation for the inverse relationship between levels of physical activity and breast cancer risk that has been identified in previous clinical studies.  Irrespective of the precise mechanism(s) involved, there is ample evidence that 4 to 5 thirty-minute periods of moderate-to-vigorous exercise each week can significantly reduce a woman’s risk of developing breast cancer, and that this exercise-related risk reduction is present irrespective of whether a woman is overweight or not.  Also, as we all know, exercise is good for both the heart and mind, as well!

Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity

Dr. Wascher is an oncologic surgeon, a professor of surgery, a widely published author, and a Surgical Oncologist at the Kaiser Permanente healthcare system in Orange County, California

Send your feedback to Dr. Wascher at:

 

rwascher@doctorwascher.net

Dr. Wascher’s Biography

 

Links to Other Health & Wellness Sites

http://doctorwascher.com

 

Copyright 2009

  

Robert A. Wascher, MD, FACS

  

All rights reserved

 

Dr. Wascher’s Archives:

 

2-8-2009:  Hormone Replacement Therapy (HRT) & Breast Cancer; Stool DNA Testing & Cancer of the Colon & Rectum

2-1-2009:   Obesity and the Complications of Diverticulosis (Diverticulitis & Bleeding); Obesity, Weight Loss & Urinary Incontinence

1-25-2009:  Prostate Cancer, Fatigue & Exercise; Does your Surgeon “Warm-up” Before Surgery?

1-18-2009:  Cancer and Vitamins; Teenagers, MySpace and Risky Behaviors

1-11-2009:  Exercise Reverses Some Effects of Fatty Meals; Vitamin C and Blood Pressure

1-4-2009:  Secondhand Smoke & Heart Attack Risk; Poor Physical Fitness During Childhood & Heart Disease Risk During Adulthood

12-28-2008:  Stress & Your Risk of Heart Attack; Vitamin D & the Prevention of Colon & Rectal Polyps

12-21-2008:  Breast Cancer Incidence & Hormone Replacement Therapy; Circumcision & the Risk of HPV & HIV Infection

12-14-2008:  Vitamin E, Vitamin C and Selenium Do Not Prevent Cancer;  Postscript: A Possible Cure for Down’s Syndrome

12-7-2008:  Generic vs. Brand-Name Drugs, Stress & Breast Cancer Survival

11-30-2008:    A Possible Cure for Down’s Syndrome?; Smoking & Cognitive Decline; Calcium & Vitamin D & Breast Cancer Risk

11-23-2008:  Breast Cancer & Fish Oil; Lymphedema after Breast Cancer Treatment; Vasectomy & Prostate Cancer Risk

11-16-2008:  Vitamin E & Vitamin C: No Impact on Cardiovascular Disease Risk; Does Lack of Sleep Increase Stroke & Heart Attack Risk in Hypertensive Patients?

11-9-2008:  Statins Cut Heart Attack Risk Even with Normal Cholesterol Levels; Statins & PSA Level

11-2-2008:  Radiation Treatment of Prostate Cancer & Second Cancers; Sexual Content on TV & Teen Pregnancy Risk

10-26-2008:  Smoking & Quality of Life

10-19-2008:  Agent Orange & Prostate Cancer

10-12-2008:  Pomegranate Juice & Prostate Cancer

10-5-2008:  Central Obesity & Dementia; Diet, Vitamin D, Calcium, & Colon Cancer

9-28-2008:  Publication & Citation Bias in Favor of Industry-Funded Research?

9-21-2008:  Does Tylenol® (Acetaminophen) Cause Asthma?

9-14-208:   Arthroscopic Knee Surgery- No Better than Placebo?; A Healthy Lifestyle Prevents Stroke

8-23-2008:  Alcohol Abuse Before & After Military Deployment; Running & Age; Running & Your Testicles

8-12-2008:  Green Tea & Diabetes; Breastfeeding & Adult Cholesterol Levels; Fish Oil & Senile Macular Degeneration

8-3-2008:   Exercise & Weight Loss; Green Tea, Folic Acid & Breast Cancer Risk; Foreign Language Interpreters & ICU Patients

7-26-2008:  Viagra & Sexual Function in Women; Patient-Reported Adverse Hospital Events; Curcumin & Pancreatic Cancer

7-13-2008:  Erectile Dysfunction & Frequency of Sex; Muscle Strength & Mortality in Men; Cryoablation for Prostate Cancer

7-6-2008:  Sleep, Melatonin & Breast Cancer Risk; Mediterranean Diet & Cancer Risk; New Treatment for Varicose Veins

6-29-2008:  Bone Marrow Stem Cells & Liver Failure; Vitamin D & Colorectal Cancer Survival; Green Tea & Colorectal Cancer

6-22-2008:  Obesity, Lifestyle & Heart Disease; Effects of Lifestyle & Nutrition on Prostate Cancer; Ginkgo Biloba, Ulcerative Colitis & Colorectal Cancer

6-15-2008:  Preventable Deaths after Coronary Artery Bypass Graft (CABG) Surgery; Green Tea & Colorectal Cancer; Attention-Deficit/Hyperactivity Disorder (ADHD) & St. John’s Wort

6-8-2008:  Vitamin D & Prostate Cancer Risk; Radiofrequency Ablation (RFA) of Kidney (Renal) Cancer; Antisense Telomerase & Cancer

6-2-2008:  Acute Coronary Syndrome- Do You Know the Symptoms?; Green Tea & Lung Cancer; Episiotomy & Subsequent Deliveries- An Unkind Cut

5-25-2008:  Early Childhood Screening Predicts Later Behavioral Problems; Psychiatric Disorders Among Parents of Autistic Children; Social & Psychiatric Profiles of Young Adults Born Prematurely

5-18-2008:  Can Statins Reverse Coronary Artery Disease?; Does Breast Ultrasound Improve Breast Cancer Detection?; Preventive Care Services at Veterans Administration (VA) Medical Centers

5-11-2008:  Smoking Cessation & Risk of Death; Childhood Traumas & Adult Suicide Risk; “White Coat Hypertension” & Risk of Cardiovascular Disease

5-4-2008:  Super-Size Me: Fast Food’s Effects on Your Liver; Exercise, Weight & Coronary Artery Disease; Contamination of Surgical Instruments in the Operating Room

4-27-2008:  Stents vs. Bypass Surgery for Coronary Artery Disease; The “DASH” Hypertension Diet & Cardiovascular Disease Prevention; Testosterone Therapy for Women with Decreased Sexual Desire & Function

4-20-2008:  BRCA Breast Cancer Mutations & MRI Scans; Bladder Cancer Prevention with Broccoli?; Diabetes: Risk of Death Due to Heart Attack & Stroke

4-13-2008:  Breast Cancer Recurrence & Hormone Replacement Therapy (HRT); Carotid Artery Disease: Surgery vs. Stents?; Statin Drugs & Cancer Prevention

4-6-2008:  Human Papilloma Virus (HPV), Pap Smear Results & Cervical Cancer; Human Papilloma Virus (HPV) Infection & Oral Cancer; Hormone Replacement Therapy (HRT) & the Risk of Gastroesophageal Reflux Disorder (GERD)

3-30-2008:  Abdominal Obesity & the Risk of Death in Women; Folic Acid Pretreatment & Heart Attacks; Pancreatic Cancer Regression after Injections of Bacteria

3-23-2008:  Age of Transfused Blood & Risk of Complications after Surgery; Obesity, Blood Pressure & Heart Size in Children

3-16-2008:  Benefits of a Full Drug Coverage Plan for Medicare Patients?; Parent-Teen Conversations about Sex; Soy (Genistein) & Prostate Cancer

3-9-2008:  Flat Colorectal Adenomas & Cancer; Health Risks after Stopping Hormone Replacement Therapy (HRT); Television, Children & Obesity 

3-2-2008:  Medication & Risk of Death After Heart Attack; Hormone Replacement Therapy (HRT) & Mammogram Results; Selenium: Cancer, Heart Disease & Death

2-23-2008:  Universal Healthcare Insurance Study; Glucosamine & Arthritis

2-17-2008:  Exceptional Longevity in Men; Testosterone & Risk of Prostate Cancer; Smoking & Pre-malignant Colorectal Polyps

2-10-2008:  Thrombus Aspiration from Coronary Arteries; Intensive Management of Diabetes & Death; Possible Cure for  Down’s Syndrome?

2-3-2008:  Vitamin D & Cardiovascular Health; Vitamin D & Breast Cancer; Green Tea & Colorectal Cancer

1-27-2008:  Colorectal Cancer, Esophageal Cancer & Pancreatic Cancer: Update from the 2008 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium

1-20-2008:  Testosterone Levels & Risk of Fractures in Elderly Men; Air Pollution & DNA Damage in Sperm; Statins & Trauma Survival in the Elderly

1-12-2008:  Statins, Diabetes & Stroke and Obesity; GERD & Esophageal Cancer

1-7-2008:  Testosterone Supplements in Elderly Men; Colorectal Cancer– Reasons for Poor Compliance with Screening Recommendations

12-31-2007:  Minority Women, Hormone Replacement Therapy & Breast Cancer; Does Health Insurance Improve Health?

12-23-2007:  Is Coffee Safe After a Heart Attack?; Impact of Divorce on the Environment; Hypertension & the Risk of Dementia; Emotional Vitality & the Risk of Heart Disease

12-16-2007:   Honey vs. Dextromethorphan vs. No Treatment for Kids with Night-Time Cough, Acupuncture & Hot Flashes in Women with Breast Cancer, Physical Activity & the Risk of Death, Mediterranean Diet & Mortality 

12-11-2007:  Bias in Medical Research; Carbon Nanotubes & Radiofrequency: A New Weapon Against Cancer?; Childhood Obesity & Risk of Adult Heart Disease

12-2-2007:  Obesity & Risk of Cancer; Testosterone Level & Risk of Death; Drug Company Funding of Research & Results; Smoking & the Risk of Colon & Rectal Cancer 

 

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BREAST CANCER RECURRENCE & HORMONE REPLACEMENT THERAPY (HRT)

 

Regular readers of this column are already well informed about the known risks associated with taking hormone replacement therapy (HRT) to relieve the symptoms of menopause.  With the results of the landmark Women’s Health Initiative Study (WHIS), and similar studies, clearly implicating combination HRT with an increased risk of breast cancer, heart disease, stroke, dementia, and other serious illnesses, physicians and their patients are, increasingly, taking a more conservative approach to dealing with the unpleasant symptoms that often accompany the onset of menopause. 

 

Among women who have previously been diagnosed with breast cancer, the risk of developing a recurrence of their cancer, and new breast cancers as well, is known to be higher than for women of otherwise average breast cancer risk, and with no prior history of breast cancer. 

 

Up until now, there has not been a great deal of research data looking specifically at the added risk, if any, of taking HRT after a prior diagnosis of breast cancer, although most experts believe that HRT is almost certainly a risk factor for breast cancer recurrence (i.e., in addition to the development of new cancers in the breast).  Now, a new study, from multiple university medical centers in Europe, looks at the impact of HRT in breast cancer recurrence among women with a prior history of this form of cancer.  This new research study, just published in the Journal of the National Cancer Institute, is part of a prospective study, called the HABIT Study, which consisted of 442 Scandinavian breast cancer survivors.  A total of 221 women were randomized to receive HRT, while the remaining 221 women were randomized to no HRT at all.

 

The results of this study were quite striking.  Among the 221 women taking HRT, just over 22% of these women were estimated to develop recurrent breast cancer after an average of 5 years of follow-up.  Among the 221 women who did not take HRT, only 8% went on to develop a recurrence of their previous breast cancer at 5 years.  This represents a nearly two-and-a-half fold increase in the risk of breast cancer associated with the use of HRT and, with respect to the natural history of breast cancer recurrence, within a rather short period of time as well.  In fact, because the risk of recurrent breast cancer appeared to be so high in the group of women taking HRT, this research study was prematurely halted in 2004 (just as the WHIS was prematurely terminated in 2002) , and the women taking HRT were warned about the apparent increased risk of breast cancer recurrence associated with taking HRT. 

 

As multiple other previous studies have shown, and as I and other breast cancer experts have warned for years, the use of HRT (and combination HRT in particular) appears to have significantly contributed to the decades-old gradual rise in the annual number of breast cancer cases diagnosed in the United States since the mid-1960s, when HRT became especially popular in the U.S. and in other western countries around the world.  The striking and unprecedented recent decline in the annual incidence of breast cancer in the United States, and in other western countries, following the publication of the preliminary results of the WHIS in 2002, has paralleled the declining number of prescriptions written for HRT since this landmark study was published in the Journal of the American Medical Association.  Ironically, I wrote a book on this very topic (including the shameful history of misrepresentation, and the covert financial and marketing support provided to pro-HRT physicians, by the dominant pharmaceutical manufacturer of HRT drugs in the mid-1960s, and thereafter) in 2004.  However, the majority of senior publishing house editors who reviewed the manuscript (most of whom were women, it must be said) dismissively accused me of being “biased” against HRT; and several opined that, as a man, I simply could not understand the ravages of menopause and, hence, the quality-of-life improvement brought about by HRT medications (notwithstanding decades of clinical research showing that only 2-5% of women experience profoundly disabling symptoms associated with menopause, and in the majority of all women passing through menopause, these symptoms significantly and spontaneously abate within 3-5 years).

 

The results of this new study are completely consistent with what we now know about the molecular biology of estrogen and progesterone (the primary female sex hormones), and their stimulatory effects on the proliferation of breast cancer cells (the overwhelming majority of breast cancers, especially in women aged 50 and older, have chemical receptors for these sex hormones, which stimulate these cancer cells to grow and divide).  My advice to all women, and especially to women with a prior history of breast cancer, is to avoid HRT drugs, period.  This has been my consistent recommendation for the past 20 years, based upon clinical research and observations dating back to the 1930s.  With the enormous amount of confirmatory data that has been subsequently published since 2004, I don’t appear to be the one with significant biases in this area….

 

 

CAROTID ARTERY DISEASE:  SURGERY VS. STENTS?

 

A relatively common manifestation of peripheral arterial atherosclerotic disease (“hardening of the arteries”) is carotid artery stenosis.  The carotid arteries supply most of the blood to the brain, and when they become clogged with atherosclerotic plaque and blood clots, bits of these materials can break off (or embolize) and lodge in the smaller arteries that feed the brain, causing temporary or permanent damage to the brain.  These embolic complications of carotid artery disease are referred to as, respectively, transient ischemic attacks and strokes (the same vascular disease process occurs in the coronary arteries, and leads to heart attacks, or myocardial infarctions). 

 

Nearly 150,000 operations for carotid artery stenosis are currently performed each year in the United States, as there is abundant research evidence supporting surgical over medical treatment in patients with significant narrowing of their carotid arteries (the primary risk of untreated carotid artery stenosis is stroke).  In this operation, the clogged-up, narrowed artery is surgically opened, and the surgeon then carefully peels the thickened, diseased lining away from the wall of the artery, leaving a clean surface behind.  The artery is then sewn shut (often, a synthetic patch is also used to reconstruct the artery, to prevent narrowing of the artery).  This operation, referred to as carotid endarterectomy, is not without risk (as with any operation), however, and is associated with a 0.5-2% risk of postoperative stroke, as well as a small risk of bleeding, infection and death. 

 

A relatively recent innovation in the management of arterial atherosclerotic disease has involved the use of shunts, most of which can be placed through small, superficial incisions in the groin or arm, much as cardiologists and interventional radiologists have been doing for decades in order to perform x-rays studies of the arterial system (“angiography”), and more recently, to treat diseased coronary arteries with balloon catheters and stents.  This minimally-invasive approach to atherosclerotic vascular disease has revolutionized the management of not only coronary artery disease, but also for aneurysms (abnormal dilation of atherosclerotic arteries) of the aorta (the largest artery in the body), and the large branch arteries that arise from the aorta to supply the lower extremities (the iliac and femoral arteries).  However, given the potentially catastrophic complications (including death) associated with strokes, the use of balloon catheters and stents to treat narrowed areas of the carotid arteries has not advanced as rapidly as it has for other diseased arteries in the body. 

 

A new study from Harvard University, and several other collaborating U.S. medical centers, and just published in this week’s New England Journal of Medicine, provides important clinical data to suggest that minimally invasive carotid artery stenting may finally have become at least the equal of carotid endarterectomy, at least in highly selected patients.  In this prospective randomized clinical study, a total of 334 patients with narrowed carotid arteries were randomized to either standard surgical treatment (i.e., carotid endarterectomy) vs. carotid artery stenting.  The average follow-up of these patients was 3 years.

 

Altogether, almost 80% of the patients participating in this clinical trial were available for follow-up evaluation after 3 years.  The bottom line: patients in both treatment groups experienced a statistically equivalent incidence of stroke, myocardial infarction and death (the average incidence of any of these three complications in both groups of patients, at 3 years, was 27%). 

 

This study will likely be considered a landmark research trial regarding the optimal management of severe carotid artery stenosis, especially in patients who are considered to be at very high risk of complications following traditional surgical intervention.  The use, in this study, of a special device designed to catch errant bits of clot and plaque that might be dislodged during placement of the stent very likely helped to achieve the excellent results reported in this high-quality research trial, and sets this study apart from some earlier studies that did not use such “anti-embolization” devices (and which often reported prohibitive stroke rates associated with carotid artery ballooning and stenting).

 

As a reminder to my readers, the risk factors most commonly associated with carotid artery atherosclerosis (and, indeed, with atherosclerosis throughout the body) include smoking, elevated cholesterol and fat levels in the blood, obesity, a sedentary lifestyle and high blood pressure.  Given that an ounce of prevention is worth far more than a pound of cure when it comes to your health, if you currently have any of these risk factors, then please see your physician soon, and modify your lifestyle to eliminate (or control) these risk factors.

 

 

STATIN DRUGS & CANCER PREVENTION

 

There continues to be a great deal of debate regarding the class of cholesterol-lowering drugs referred to as statins, and their effects (if any) on lowering the risk of developing certain cancers.  In addition to their potent ability to reduce the levels of so-called “bad cholesterol” (LDL) in the blood, and to increase the levels of “good cholesterol” (HDL), most statins appear to have at least mild anti-inflammatory effects as well.  (Chronic inflammation in the body has been linked both to the development of atherosclerotic narrowing of the arteries in our bodies as well as to the development of many cancers.)  Multiple prior laboratory and clinical research trials have generated conflicting data regarding the effects of statin drugs on cancer risk, with some studies showing a reduction in the risk of at least certain types of cancer with prolonged statin use, and other studies showing no apparent cancer-prevention benefit at all.

 

A newly published study, in The American Journal of Medicine, provides results that suggest, as other recent studies have, that there may actually be a small, but significant, cancer-prevention effect associated with at least some of the statin drugs.  This study, from Quebec, Canada, was based upon a large public health clinical data registry, and looked at patients aged 45 years and greater, between 1998 and 2004, who had survived a heart attack, and had been prescribed a statin drug as a results of their heart attack. Four statin drugs within the so-called “lipophilic class” (atorvastatin, simvastatin, lovastatin and fluvastatin) were specifically included in this retrospective research study.  More than 30,000 patient histories were evaluated in this large public health study, including more than 18,000 patients who were never prescribed a statin drug, 6,015 patients who received high-dose statin medications, and 5,323 patients who were prescribed low-dose statin medications.

 

After an average of 7 years of follow-up, this study determined that the high-dose statin users, when compared to patients not taking any statin drugs, experienced a 25% reduction in the likelihood of admission to a hospital with a new diagnosis of cancer.  The low-dose statin users also appeared to experience a reduction in hospital admissions related to the diagnosis of cancer, with a more modest 11% reduction in the incidence of admissions for cancer.  Unlike similar recent clinical studies that have shown that only prolonged statin use may be associated with a reduction in the risk of developing cancer, this particular study found that even relatively short durations of statin usage appeared to be associated with a reduced risk of being admitted to a hospital with a new diagnosis of cancer, especially among patients receiving higher doses of these medications.

 

This study offers some further encouragement to those who believe that at least some statin drugs may be associated with the incidental benefit of reducing the risk of cancer.  However, I think that the jury is still out on this one, for now anyway.  As with most retrospective studies based upon public health databases, there are many potential sources of bias in retrospective epidemiological studies such as this one.  Unlike randomized, prospective controlled studies, which seek to control as many potentially confounding variables as possible up front, retrospective studies are far more prone to bias, which can lead to erroneous conclusions. 

 

At this time, I would not recommend that anyone take a statin drug primarily to reduce their risk of cancer.  However, if you are already taking a lipophilic statin for elevated cholesterol levels, then there is at least the possibility that you may be receiving an additional health benefit from your statin drug.  Obviously, a prospective, randomized, placebo-controlled study of statins would have to be done to definitively answer the question regarding statins and cancer risk.  Until such a study is performed, we cannot be completely certain that statins really do reduce the risk of cancer.

 

 

Dr. Wascher is an oncologic surgeon, professor of surgery, a widely published author, and the Director of the Division of Surgical Oncology at Newark Beth Israel Medical Center:

http://www.sbhcs.com/hospitals/newark_beth_israel/mservices/oncology/surgical.html

Send your feedback to Dr. Wascher at:  rwascher@doctorwascher.net
 

http://www.doctorwascher.com

Copyright 2008.  Robert A. Wascher, MD, FACS.  

All rights reserved.

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