As you all know by now, the American Heart Association and the American College of Cardiology published new guidelines on the prevention & treatment of heart disease earlier this week, focusing on cholesterol, lifestyle and obesity. However, I must admit to some disappointment as I read over the obesity guideline.
For instance, we're directed to measure & weight at each visit, at least annually. Really? Then the definition of overweight & obesity (class I, II & III) are reviewed. We are then advised to assess the need to lose weight. But wait! No pun intended, this is a guideline on obesity. Of course we're talking about people who are obese and need to lose weight! To add fuel to the fire, we are then told to advise our patients to avoid weight gain. No sh-t, Sherlock, pardon my French. Here I was hoping for new guidance on what diet to recommend. Or perhaps what medication to recommend. Or even a mention of body composition vs body mass index and what to do with those who are skinny fat.
Ironically, a systematic review was published yesterday early online in JAMA in which the authors concluded that weight loss medication used in conjunction w/lifestyle modifications did lead to greater weight loss than placebo. Orlistat & lorcaserin were noted to be least beneficial while the highest dose of phentermine plus topiramate had 3 times the relative weight loss.
So here it is w/2014 fast approaching and we still don't have a magic bullet to ward off obesity. As far as this guideline is concerned, it still comes down to eating less & moving more. That and maybe pop a pill.
What I found intriguing is that the recommendations to lower blood pressure are very similar to those to lower cholesterol. In other words, the authors found strong evidence to support consuming mostly vegetables, fruits & whole grains while limiting sweets, sugar-sweetened beverages, and red meat. Low-fat dairy products, poultry, fish, legumes & non-tropical vegetable oils & nuts help serve as an alternative.
While strong, the evidence regarding physical activity was not nearly as impressive as that of diet, whether attempting to improve cholesterol or blood pressure. Still the authors concluded that adults should be encouraged to reduce LDL cholesterol & blood pressure via 3-4 40 minute sessions a week of moderate-to-high intensity physical activity.
So there you have it. But before arranging for more meds, see if you can improve your risk factors via lifestyle modification.
1) those w/clinical heart disease
2) those w/LDL >190mg/dL
3) those diabetics 40-75yo w/LDL 70-189mg/dL w/o clinical heart disease
4) those w/o clinical heart disease or diabetes but w/LDL 70-189mg/dL plus estimated heart disease risk >7.5%
Of course I type heart disease but the study refers to atherosclerotic cardiovascular disease or ASCVD which clinically includes those w/acute coronary syndromes, history of heart attack, (un)stable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease. Those in groups 1 or 2 don't need to calculate their 10 year risk using the new Pooled Cohort Equations, while those in groups 3 & 4 will use said results to guide the intensity of therapy.
Speaking of intensity of therapy, we no longer have LDL targets. In other words, I don't have to discuss "good enough" results vs optimal goals. Instead, we are to offer either moderate intensity or high intensity LDL lowering therapy. The former is used in appropriate age diabetics w/10yr risk <7.5% or in those who cannot tolerate high intensity therapy. Just about everyone else in the above 4 groups gets high intensity therapy. The former aims to lower LDL by 30-50% while the latter aims to lower LDL by >50%.
Obviously I'm not about to summarize an 85 page guideline in a few simple paragraphs but it's interesting to note that non-statin options were not pushed to assist in achieving LDL goals as there was no outcome benefit from non-statin drugs. So if you thought you'd heard enough about statins, you ain't heard nothing yet!
For instance, while equal percentages of participants had obstructive sleep apnea (Table 1), there's no mention of any attempt to screen for those previously undiagnosed or untreated. Furthermore, the Endocrine Society's Clinical Practice Guidelines note that testosterone therapy may worsen untreated obstructive sleep apnea.
With regard to monitoring, the Endocrine Society recommends evaluating the patient 3-6mo after treatment initiation followed by annual evaluation. However, I find that to be a long time between contact & objective measurement. After all, how easily do you fall off the nutrition & physical activity bandwagon. Better to be reminded more often to stay on target as opposed to finding out too late.
And while there doesn't appear to be any difference in blood pressures in either group, there's no mention of hemoglobin or hematocrit, much less HDL cholesterol, all of which, when abnormal, can increase one's risk for prothrombotic events such as heart attack or stroke. This is mentioned several times in the Clinical Practice Guidelines.
Bottom line, get frequent follow up so that you can enjoy the benefits of testosterone for years to come.
So let's be clear. There is no such thing as a free lunch. All medications (and dietary supplements) have risks, whether known or unknown. Even natural, pure, organic herbs have side effects. The question then is whether the desired potential benefit exceeds the risk of side effects. I'm going to assume you've seen all the commercials, whether on TV or print, or heard them on radio asking "Do you have low T?" But as w/all advertisements for medical therapies, there is a hastily read disclaimer or one that is flashed onscreen for just a few brief moments in font size too small for easy research, which supposedly describes all known side effects to you.
With that said, part of me is not surprised by the findings of this study. Why? Because I counsel each of my patients who are considering testosterone therapy as to these exact outcomes, among others. Excess testosterone can increase blood pressure (not an issue in this study), lower HDL (good) cholesterol (not measured, at least, not reported, in this study), and increase red blood cell mass thereby increasing viscosity and one's risk for developing clots. As you know, clots in the heart are referred to as heart attack while those that occur in the brain are called strokes. So yes, I counsel all my patients repeatedly, before & during their time on T, about a possibly greater risk for heart attack, stroke & death.
But how I can I be so blase about all this? Because I monitor my patients' lab results at least every 6 months and check their blood pressure regularly. Excess blood is siphoned off to be donated to hungry vampire families. T regimen is adjusted to minimize highs & lows, of which the former is responsible for the increase in blood pressure & red blood cell mass. In fact, large monthly injections of T are notorious for these metabolic side effects while smaller doses of more frequent injections are not. Daily applications of creams, gels, patches, etc are least likely to cause this issue.
And to be as complete as possible, I also warn my patients about being rendered infertile as well as developing noticeable testicular atrophy. That's in addition to the risk for 'roid rage (akin to road rage), agitation, aggravation, impatience, intolerance, etc. Then let's not forget hair loss, oily skin (even acne), prostate enlargement (no new onset of cancer tho), male breast enlargement (gynecomastia). But even these risks can be mitigated by close monitoring & regimen adjustment. So at most, these study really demonstrates a link between testosterone therapy and bad outcomes when said therapy is not monitored closely: average number of lab measurements over the 3yrs was just 3.3, not nearly enough to mitigate risk.
In case you missed it, USA Today published an article yesterday about a study published today in JAMA in which the authors linked testosterone use to an increase risk of heart attack, stroke & death. Now before you peel off your patch, scrub off your gel, or throw away your vial & syringes, read the editorial. Then ask yourself why you're taking it in the first place. If it's for antiaging purposes, I would suggest you reconsider. But if you're taking it because you have clinical hypogonadism, then dig further into this study and its editorial along with the USA Today article which might make it a little easier to understand.
Let's first talk about what a statistical anomaly I found: the confidence interval crossed 0. The authors pointed out that the risk of adverse outcomes was higher at year 1, 2 & 3 for those who elected to take testosterone. Yet, when they compared the absolute risk difference, the confidence intervals always crossed 0 for each year. In other words, the purported risks are not statistically significant! Check out page 1832 for yourself. If you agree, then there's no need to tear this study apart any further.
But in case you don't agree, I'll analyze the study in more depth over the next day. Hint: several issues that I always address w/my patients considering testosterone therapy were not mentioned in the study.