Mark L. Fuerst

Cheng C, Daskalakis C. Association of ambulatory heart rate and atherosclerosis risk factors with blood pressure in young non-hypertensive adults. 

 Shimada YJ, Tsugawa Y, Brown DF, Hasegawa K. Bariatric surgery and emergency department visits and hospitalizations for heart failure exacerbation. 

 Valensise H, Lo Presti D, Gagliardi G, et al. Persistent maternal cardiac dysfunction after preeclampsia identifies patients at risk for recurrent preeclampsia. 

 Walsh KB, Adeoye O, Sekar P, et al. Importance of untreated hypertension for intracerebral hemorrhage. American Stroke Association’s International Stroke Conference. Los Angeles, Feb 17-19, 2016. Abstract 126.

http://openheart.bmj.com/content/3/1/e000332.abstract

http://content.onlinejacc.org/article.aspx?articleID=2492944

http://hyper.ahajournals.org/content/early/2016/02/22/HYPERTENSIONAHA.115.06674.abstract?sid=670729ab-7fc4-4739-ac3b-e0b1172676ca

http://stroke.ahajournals.org/content/47/Suppl_1/A126.abstract?sid=d40f905a-3c55-4b9f-9d12-ca42f03a67c5

Articles

Highlights of four recent studies in hypertension, heart failure, preeclampsia expose vulnerable populations.

CardioScience Update, 4 New Studies

	Men with documented testosterone deficiency should be allowed to take testosterone replacement therapy if they have cardiovascular disease (CVD) or localized prostate cancer, according to 

 issued by the Canadian Men’s Health Foundation. In addition, testosterone therapy was said to be appropriate for testosterone deficiency associated with alterations in body composition and metabolic issues, as well as in other chronic illnesses, for example, HIV infection and depression.

	Studies of testosterone replacement therapy and the CV effects in men have shown mixed results. Earlier this year, the FDA required manufacturers of all approved testosterone products to add information on the labels about possible increased risks of heart attacks and strokes in patients taking testosterone.

	The use of testosterone therapy has increased significantly, according to the FDA, with more than 2 million patients having received a prescription for testosterone replacement in 2013.

No Added Prostate Cancer Risk With Long-term Testosterone Tx

Testosterone Tx Gives Weak Signal for Cardiovascular Risk

Testosterone Replacement OKd for Men with Heart Disease

Social Environment Plays Key Role in Men’s Health

Testosterone Not Just for Fun Anymore: 3 Questions About Risk

Prostate Cancer Treatments Abundant, Not Perfect

	The new Canadian guidelines recommend that testosterone replacement therapy in men with CVD be restricted to those who have stable disease, only after a discussion of the potential risks and benefits.

	The Foundation assembled a multidisciplinary Task Force to develop a clinical practice guideline for the 

management of testosterone deficiency syndrome. The Task Force, a range of specialists-clinical biochemists, endocrinologists, epidemiologists, family physicians, and urologists-who conducted a literature search and systematic review through April 2015, used an evidence-based approach to generate its recommendations.

	The main recommendations, and the quality of evidence, include the following:

	• Men with documented testosterone deficiency syndrome and no contraindications should receive treatment with testosterone (strong recommendation; high-quality evidence).

	• Men with testosterone deficiency syndrome and stable CVD are candidates for testosterone treatment (weak recommendation; low-quality evidence).

	• Men with testosterone deficiency syndrome and localized prostate cancer and no evidence of active disease should receive testosterone therapy (weak recommendation; low-quality evidence).

	• Testosterone treatment for men with testosterone deficiency syndrome and mild-to-moderate symptoms resulting from benign prostatic hypertrophy (weak recommendation; very-low-quality evidence).

	• Testosterone replacement therapy in men with metastatic prostate cancer (strong recommendation; moderate- to high-quality evidence).

	• Men with a history of breast cancer are not candidates for testosterone replacement therapy (weak recommendation; moderate level of evidence).

	• A recommendation against testosterone replacement therapy in men more interested in maintaining fertility over symptomatic improvement (strong recommendation; high-quality evidence).

	• Treatment with a phosphodiesterase type 5 inhibitor in men with testosterone deficiency syndrome and persistent erectile dysfunction that is adequately treated with testosterone (strong recommendation; high-quality evidence).

	• Men with a clinical picture strongly suggestive of testosterone deficiency syndrome but testosterone levels in the low-normal range should have a therapeutic trial with testosterone (weak recommendation; very-low-quality evidence).

	The Task Force noted in conclusion that the management of testosterone deficiency syndrome is contentious. “The current evidence conclusively shows the importance of an adequate diagnostic approach followed by testosterone supplementation when the diagnosis is reached,” they stated. “The evidence also points to the importance of regular follow-up, frequently within the first year after the start of treatment and less stringent thereafter but uninterrupted for the duration of treatment.”

Men with documented testosterone deficiency should be allowed to take testosterone replacement therapy if they have cardiovascular disease (CVD) or localized prostate cancer, according to new guidelines issued by the Canadian Men’s Health Foundation.

	There is no compelling evidence that testosterone therapy increases or decreases cardiovascular risk, according to a new 

 from the American Academy of Clinical Endocrinologists (AACE).

	The statement was issued in response to recent publications that have raised concern that testosterone replacement therapy (TRT) increases cardiovascular risks in men and media reports about the dangers of testosterone therapy.

	The detailed document noted that “randomized controlled trials have not been powered to evaluate the effect of testosterone replacement in men on cardiovascular events or mortality.” 

 have raised concern that testosterone therapy increases cardiovascular risk, but those studies have major flaws. A more recent retrospective 

 that used enrollment and claims data or Medicare beneficiaries showed no effect of TRT on myocardial infarctions.

	The AACE statement challenges several aspects of a recent FDA 

 that suggests “health-care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy.” The FDA released a new warning and updated labeling on TRT to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.

	The committee that wrote the AACE report, led by Neil Goodman, MD, of the University of Miami Miller School of Medicine, “concurs in the FDA conclusion that the signal for cardiovascular risk is weak and that we need definitive studies.”

	The FDA also recommended that TRT be used only for men who have disorders of the testicles, pituitary gland, or brain that cause hypogonadism and not to relieve the symptoms of low testosterone that result from aging.

	However, the committee thinks this is not a clear recommendation. “It is our opinion that any patient being considered for TRT must undergo a thorough diagnostic work-up,” they stated. “The decision to replace testosterone should be guided by the signs/symptoms and testosterone concentrations rather than the underlying cause.”

	The committee agrees with the FDA that the risk/benefit ratio of TRT is not well established in aging-associated hypogonadism.

	Other key points in the position statement: 

			Epidemiological studies strongly support the association of low testosterone concentrations and hypogonadism with cardiovascular events and all-cause mortality, especially in older men. However, low testosterone could be a marker of illness and not a causal factor.

			TRT favorably changes many cardiovascular risk factors. It decreases fat mass, increases muscle mass, decreases insulin resistance, and can reverse metabolic syndrome in some men.

	In addition, the committee recommends that symptomatic men who have unequivocally low total and/or free testosterone levels that are assayed on at least 2 samples drawn before 10 a.m. should be considered for TRT.

	The committee also advises practicing clinicians to use extra caution in symptomatic older patients with demonstrably low testosterone levels before embarking on replacement therapy and “to avoid treatment of the frail elderly until better outcome data are available.”

	“Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed,” according to the statement.

There is no compelling evidence that testosterone therapy increases or decreases cardiovascular risk, according to a new position statement from the American Academy of Clinical Endocrinologists (AACE).The statement was issued in response to recent publications that have raised concern that testosterone replacement therapy (TRT) increases cardiovascular risks in men and media reports about the dangers of testosterone therapy.

	At the American College of Physicians Internal Medicine Meeting 2015 in Boston, Peter Zimetbaum, MD, Associate Professor of Medicine, Harvard Medical School, presented an “Update In Cardiology.” Here are the highlights of his presentation and the implications for clinical practice. 

	Definite uses for aspirin in primary prevention of CVD include: multiple risk factors for vascular disease (older age, hypertension, smoking, hyperlipidemia). Questionable indications for aspirin: moderate risk over 10 years. No indication: low-risk patients.

	Preliminary evidence suggests a benefit on cardiovascular mortality with PCSK9 inhibitors. They induce about 60% reduction in LDL cholesterol that is durable for at least 52 weeks. Adverse events with PCSK9 inhibitors include injection site reactions and neurocognitive effects.

	Use adjuncts to statin therapy in patients who cannot get to target lipid levels on statins alone and in statin-intolerant patients. Change in target LDL to lower values.

	Aspirin is no longer recommended for thromboembolic prophylaxis. New oral anticoagulants are recommended equally with warfarin for thromboembolic prophylaxis. The Watchman™ Left Atrial Appendage Closure Device is an alternative for thromboembolic prophylaxis in patients with contraindication to oral anticoagulants.

	Two FDA-approved valves are now available for patients at high risk for complications from aortic valve surgery. Choice of the valves is based mostly on technical/anatomic considerations. The valves are capable of being placed within failing aortic valve prosthesis.

	Newer generations of devices have smaller delivery systems and are technically easier to place and reposition. Major complications include vascular trauma, stroke, paravalvular aortic regurgitation, and heart block. The long-term durability of these valves is still unknown.

	Dual antiplatelet therapy (DAPT) provides some benefit up to 30 months. Weigh against an increased bleeding risk in patients with a drug-eluting stent (DES). If the risk of bleeding is minimal, there is likely an advantage to continued DAPT. Discontinue or interrupt DAPT after 6 months (perhaps even 3 months) if bleeding risk necessitates.

			Transcatheter aortic valve replacement is an option for patients with severe aortic stenosis and high risk for surgical complication.

			Aspirin is not indicated for CVD prevention in low-risk patients.

			Dual antiplatelet therapy should be continued for a total of 30 months if the bleeding risk is not significant.

			PCKS9 inhibitors are effective at lowering LDL and may reduce cardiovascular mortality.

			Aspirin is no longer recommended for thromboembolic prophylaxis

	At the American College of Physicians Internal Medicine Meeting 2015 in Boston, Peter Zimetbaum, MD, Associate Professor of Medicine at Harvard Medical School, presented an “Update In Cardiology.”

	Here are the highlights of his presentation-and the implications for primary care clinical practice.

At the American College of Physicians Internal Medicine Meeting 2015 in Boston, Peter Zimetbaum, MD, Associate Professor of Medicine, Harvard Medical School, presented an “Update In Cardiology.” Here are the highlights of his presentation and the implications for clinical practice.

Author | Mark L. Fuerst

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