Testosterone Therapy in Low T Syndrome in Veteran’s tied To Higher Cardiovascular Risk.

Cardiovascular RiskMedPage Today is reporting a Veteran’s Affair study which indicates that men with and without coronary artery disease who received testosterone supplements had a higher risk of death, heart attack and stroke.  The current study looked at 8709 veterans who underwent coronary angiography between 2005 and 2011 and had a testosterone level less than 300 ng/dL.  These findings surprised researchers who had looked at a previous VA study that suggested that testosterone therapy reduced cardiovascular risk.

Steven Nissen, MD of the Cleveland Clinic, a world respected cardiologist felt the study was a “red flag” that “demands attention from not just physicians but also from regulators.”  He is concerned about the “increasingly commonly prescribed (testosterone replacement therapy) “practice which is largely “fueled by direct to consumer advertising that’s urging men to get tested for low testosterone and then to seek replacement.” Nissen pointed out that in both men and women a drop in hormone levels is a normal part of aging and it is not necessarily a disease. “Making it into a disease may end up causing more harm than good.”

Anne R. Coppola, MD of the University of Pennsylvania in an editorial noted that “what is missing from the literature are data from randomized trials that include a sufficient numbers of men for an adequate amount of time to assess the long term benefits and risks of testosterone therapy.”   She cited a small study called the Testosterone Trial in Older Men which had to be stopped early because of a higher rate of cardiovascular events “in the group taking testosterone.

In our market you cannot turn on a sports talk radio show or ride down an Interstate highway without seeing ads for “Low- T Syndrome.”  It is a highly profitable cash business being fueled by testimonials and word of mouth rather than well planned medical studies. Legitimate research is ongoing at Harvard Medical School but it is difficult for others to obtain funding when the producers of the product can make so much money based on here say and nothing else. The number of prescriptions for testosterone products has increased since 2000 from 5.3 million to 1.6 billion.  The American College of Endocrinology has clear and strict guidelines on when supplementation in young men is appropriate. There is a large anti-aging medical community who feel that even if you are older and have normal levels you will feel better and benefit from supplementation. This research questions that feeling and begs for regulators to step in and stop an unproven possibly dangerous practice until we have more data.


New Weight Loss Drug on the Market

OverweightFor the last 13 years there have been no new medications designed specifically for weight reduction that have received FDA (Food and Drug Administration) approval. The long drought came on the heels of the reported adverse effects of the successful weight reduction combination of phentaramine and fenfluramine. While patients lost weight successfully on this combination of medications plus diet they additionally risked developing disease of the heart valves and its consequences. In July the FDA approved Belviq or lorcasrin HCl for weight reduction. Pharmaceutical manufacturer Vivus received approval for its weight reduction product Qsymia recently which is a combination of phentermine and topiramate. Topiramate has been on the market as a medicine to treat vascular and migraine type headaches and to treat seizures.

Vivus submitted data to the FDA involving 756 obese subjects, which showed that over seven months of treatment obese patients lost 10% or more of their body weight 38% of the time among those taking Qsymmia 7.5 /46 mg and 43% of the time when they used the higher dose of 15/92 mg. Patients taking placebo plus diet lost 10% of their body weight only 6.8%. The dose of topiramate in this combination drug is significantly lower than the starting dose for that drug when treating neurological issues. When the researchers looked at statistical significance the lower dose combination was actually more successful than the higher dose combination.

Adverse effects were more common in the higher dose group and included parasthesia (23%), dry mouth in 18.5%, headache and constipation. The drug was released to a limited number of pharmacies in April but has been slow to catch on. Its use is cautioned in individuals with existing heart, liver and kidney disease.

Obesity is epidemic in this country. Increased activity and dietary intervention are always our first line of therapy. Dietary counseling, organized diet programs with meal replacement therapy and bariatric surgery are available to help. Adding new medications to a difficult treatment problem is always a welcome step but will require that we closely watch their risk and side effect profile as the drugs become more popular and are used more frequently.

Knee Replacement Postponed By Knee Injections

4.1.1The American College of Rheumatology meeting in San Diego, California is the site of scientific presentations on arthritis affecting us all. Roy D. Altman, MD of the University of California Los Angeles, presented data saying that injections of hyaluronic acid into the knee provided sufficient pain relief to allow patients to postpone knee replacements by 2.6 years. The delay is extremely important because the knee prostheses only last about ten years before they need to be surgically revised. ““Knee replacement isn’t a cure all,” said Altman and “it’s important to delay total knee replacement as long as possible.”

Twenty-seven million Americans have osteoarthritis of the knee according to Altman. Those with severe pain and impairment use these hyaluronic acid injections to help restore intra-articular synovial fluid function and improve outcomes. No data was available until now to see its effect on knee replacement. Altman and associates looked at patient insurance company data bases of more than 7 million people. They identified 26,627 who were diagnosed with knee osteoarthritis and had undergone surgical knee replacement. 7000 had received at least one injection of hyaluronic acid and several had up to four injections. They then looked the length of time from diagnosis to surgery and compared it to individuals who did not have injections of hyaluronic acid.

Hyaluronic acid injections are used by local physicians to relieve the pain of osteoarthritis frequently. We now know it is both reducing pain and postponing significant surgery.

Gum Health Associated With Carotids

GumsOver the years I have attended lectures led by Bradley Bale, MD and Amy Doneen, RN who promote the theory that inflammation is one of the major causes of acute heart attack and stroke.  They measure inflammation in men and women with normal lipid levels, normal blood pressure who are non-smokers and exercise but still have cardiovascular events such as heart attacks and strokes.  They talk about the formation of soft lipid plaque or foam cells forming in the walls of the blood vessels and then erupting into the lumen of the blood vessel under the influence of inflammation setting off a clotting cascade that leads to heart attacks and strokes acutely. They measure the degree of inflammation using a series of blood tests patented by the Cleveland Clinic and look for atherosclerosis by doing carotid ultrasounds in a special way to measure carotid artery intimae thickness which they believe correlates with the presence of atherosclerosis, soft plaque and the risk of an acute event.  When all traditional major  risk factors such as smoking, blood pressure, blood glucose level, high blood pressure , activity level and family history have been taken into account and treated there are individuals who still have inflammation and acute events.  They believe oral periodontal disease is the culprit and suggest treating it.

They receive confirmation of their theory in an online article in the Journal of the American Heart Association written by Moise Desvarieux, MD, PhD of Columbia University’s Mailman School of Public Health in NYC with his colleagues.  They demonstrated that by reducing periodontal disease over a three year period there was less progression of carotid artery intima media thickening.  As the gums improved and the oral microbes that are associated with periodontal disease decreased the progression of intimal thickness slowed.

It is clear that more research is needed but while it is ongoing simply seeing your dentist regularly and caring for your teeth and gums can go a long way to reducing your risk of a heart attack or stroke. The long hypothesized relationship between mouth disease and vascular disease has much stronger evidence after this study and it makes it necessary for those of us discussing prevention and risk factor reduction to ask you at your visits “are you up to date on your dental visits and dental hygiene?” It additionally adds clout to the argument that health insurance includes dental coverage as well!

Malaria Cases on the Rise in the U.S.

MalariaThe Center for Disease Control and Prevention (CDC) has reported the number of malaria cases in the U.S. hit a new high in the last reportable year – 2011. There were 1925 cases, including five deaths, which is an increase of 14%.  Not only were there more cases but there were more cases reported as “severe” than in previous years.  Most of the imported cases came from Africa although India had the largest number of cases at 223. Nigeria was next at 213.

The CDC reviewed the use of medications in 929 civilian cases and found that only 57 of the 929 had followed the CDC medication recommendation regimen.  Malaria is a serious disease and causes significant illness and mortality. As our population becomes more mobile, patients need to seek the advice of physicians knowledgeable in travel medicine and follow their recommendations.  

My web site has a link to the CDC website which provides travel information and I maintain a professional relationship with local travel services which keep in stock some of the more uncommon vaccines you need when traveling to exotic locations. Feel free to discuss travel plans in advance by calling the office for an appointment.

Biphosphonates Raise the Risk of Atrial Fibrillation

Atrial FibBiphosphonate drugs such as Fosamax, Boniva and Actonel are used commonly to treat osteoporosis and to prevent the progression of bone disease from low mineralization or osteopenia to osteoporosis. The most common side effect we normally see is gastrointestinal upset with inflammation of the esophagus and stomach especially when the pill is not swallowed with sufficient liquids.  Patients receiving biphosphonates are cautioned to take the pill with sufficient liquid, while remaining upright for 45 minutes to an hour.  Biphosphonates have revolutionized the prevention of and treatment of osteoporotic bone disease.

In October’s issue of Chest Medical Journal Dr. Abhishek Sarma, MD, of Maimonides Medical Center in Brooklyn, N.Y. shows that biphosphonate use is associated with an increased risk of developing the arrhythmia atrial fibrillation.  Atrial fibrillation is a disorderly rhythm of the upper chambers of the heart leading to ineffective blood flow and increased risks of clots forming in the heart chambers and disseminating causing strokes. Older adults, the same patient population that is at risk for osteoporosis, is the patient group who when they develop atrial fibrillation require the use of blood thinners such as warfarin or xarelto or elliquis to prevent clot formation and strokes. Dr. Sharma performed a review of existing randomized controlled and observational studies.  He concluded there was a 27% increased risk of developing atrial fibrillation if you were taking biphosphonates. They looked at six observational studies with almost 150,000 participants and six randomized controlled trials with 41,000 patients. The increased risk occurred in patients taking the biphosphonates by mouth or by intravenous infusion. They postulated that biphosphonate use triggers an inflammatory protein that effects intracellular calcium and leads to arrhythmias.

The study clearly requires follow-up. If you stop the biphosphonates will the patient return to a normal rhythm on their own or if chemically or electrically shocked back into a normal rhythm?  It is clear that we need to prevent and treat osteoporosis but it is now important for us to determine what this new finding means to a person’s long term health. If you are taking biphosphonates speak to your physician about this new finding and how or if it relates to you.

Do Probiotics Prevent Diarrhea and Antibiotic Related Colitis in Seniors?

ProbioticsProbiotics are medication containing bacteria that normally reside within a healthy intestinal tract and aid in digestion and the production of a solid stool.   Physicians and scientists have known for years that when a patient is given an antibiotic to treat a bacterial infection, that antibiotic works against the invading pathological bacteria as well as the bacteria that normally reside within us and keep us healthy. The theory for years is that by destroying the healthy normal flora of the intestine we are paving the way for virulent pathological and opportunistic bacteria such as clostridium difficile to invade the gut and produce antibiotic related colitis. The hope has been that by giving the intestine back the normal bacteria in the form of a pill containing normal gut flora, we can prevent diarrhea and even the more severe antibiotic related colitis when prescribing antibiotics appropriately to fight a bacterial infection.

Initial small Meta-analysis studies supported the notion. Based on these small studies private firms have produced over the counter probiotics such as Align and a series of prescription only probiotics for human consumption. Hospital and health systems have invested money in purchasing and prescribing probiotics to senior citizens given antibiotics to stave off diarrhea or antibiotic related colitis.  A new large study performed in South Wales and England looked at almost 3,000 patients aged 65 or older who were being treated with antibiotics while hospitalized.   Patients were treated with either a placebo pill or a probiotic pill containing two strains of Lactobacillus acidophilus, Bifidobaceterium bifidum and bifidobacterium lactis, for 21 days and between antibiotic doses.

Despite the probiotic administration, diarrhea occurred in 10.8% of the patients given probiotics and 10.4% of those given placebo. The researchers then went on to analyze the stool of half the diarrhea patients and found that Clostridia difficile was an uncommon finding in both groups. The probiotics did not produce any measurable adverse effects in the patients taking them.

The PLACIDE study was by far the largest study of the effectiveness of probiotics done to date. Its result speaks against the routine use of these agents to prevent antibiotic related diarrhea or colitis. There will be additional studies in the future.

The science of the composition of our intestinal flora is in its infancy. Studies have shown that genetically alike individuals have similar bacterial gut patterns. Studies have also shown that if you develop antibiotic related colitis and receive an enema containing stool from a genetically identical individual, your chances of recovering from previously resistant antibiotic related colitis are much better.   It could be that there will be different compositions of bacteria in future probiotics for genetically different individuals.  More research is needed.