Does testosterone increase heart rate

Testosterone Supplements Tied to Heart Attacks, Strokes, Early Death

By Chaitanya Madamanchi, M.D.:

Men who take testosterone supplements may be putting themselves at increased risk of death, heart attacks and strokes, according to a study published Tuesday in the Journal of the American Medical Association.

The new research looks at more than 8,000 male veterans with low testosterone. Researchers compared the rates of cardiovascular ills among those who’d received testosterone supplementation and those who had not, and found that men who used testosterone were 29 percent more likely to die, have a heart attack or a stroke after three years of use.

This difference could be seen even after the researchers took into account age, blood pressure, the presence of heart disease and various other factors.

More Middle-Age Men Turn to Testosterone for an ‘Edge’

Testosterone supplementation is a billion-dollar industry that has experienced a more than five-fold increase from 2000 to 2011, according to the study, with U.S. doctors writing 5.3 million prescriptions each year. Men take testosterone for a variety of reasons, from the hope that it will improve their sexual function to increasing their muscle mass and strength.

Dr. Michael Ho, a cardiologist at the University of Colorado and lead author of the study, said he was surprised when he found that the risks of testosterone supplementation appeared to be the same for men regardless of whether they had existing coronary artery disease.

“This study provides some information about potential adverse effects ,” Ho said. “This study should help inform the discussion between patient and providers about the risks and benefits before making an individualized decision.”

Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who was not involved in the study, said the finding underscores concerns that he and other cardiologists already had about testosterone supplementation.

“The widespread use of testosterone replacement in men is concerning, with no studies that show long-term safety,” he said, adding that the findings should serve as a “warning to slow down the rush to place large numbers of men on hormone replacement therapy.”

The problem, Nissen explained, is that direct-to-consumer advertising of low-testosterone treatments has led many men to ask their doctors about supplementation.

“It is now imperative that the FDA insist on large randomized controlled trials to find out if this therapy is safe or not,” he said.

Dr. Anne Cappola, an endocrinologist at the University of Pennsylvania and author of an accompanying editorial to the JAMA study, said she prescribed testosterone “to those for whom it is indicated and may derive benefit,” according to guidelines from the Endocrine Society.

But, she said, “a large number of men are taking testosterone, and it is not clear that all are doing so based on the right indications. … Men should make sure they are on testosterone for the right reasons, as there may be risks involved.”

Companies marketing prescription testosterone supplementation defended their products. AbbVie, the company behind the popular AndroGel testosterone product, pointed to past studies suggesting that testosterone supplementation, in men with low testosterone, protects against metabolic syndrome and early death.

“FDA-approved testosterone-replacement therapies have been used to treat men with low or no testosterone (hypogonadism), who have been diagnosed by a physician, for 20 years, with therapeutic risks well documented in the prescribing labels,” the company said in a statement to ABC News.

Meanwhile, Lilly, which markets Axiron testosterone gel, said it actively monitored all adverse events reported in men taking testosterone supplements.

“Axiron is a prescription medication, approved by the FDA, for men with certain conditions associated with a deficiency or absence of testosterone,” Lilly said in a statement to ABC News. “Lilly does not condone the use of our medicine for off-label purposes.”

Doctor’s Take

For some men who are truly experiencing health effects because of low testosterone, such decreased libido, decreased strength, and low energy levels, therapies that increase testosterone levels may indeed be beneficial and improve their quality of life.

However, it’s important for men to remember that these symptoms can occur even if their testosterone levels are not low. In light of this, it is important that men undergo appropriate testing to ensure that they actually have low levels of testosterone before they start treatment.

The best thing that men who are curious about testosterone supplementation can do is to talk to their doctors about all the risks and benefits rather than basing a decision on an advertising campaign.

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Testosterone and Your Heart

In 2015, the U.S. Food and Drug Administration (FDA) updated its recommendations for testosterone. The FDA now advises that testosterone should be approved only for people who have low testosterone because of certain medical conditions.

Conditions such as disorders of the testicles or a problem with the pituitary gland may cause low testosterone levels in men. Lowered testosterone also occurs as a normal result of aging and doesn’t always mean that something is wrong with you.

In the past, doctors frequently prescribed testosterone therapy for men without medical conditions who had low testosterone as a result of normal aging. But now, the FDA recommends that testosterone shouldn’t be used for low levels as a result of normal aging.

This FDA warning is based on older evidence that testosterone may increase the risk of heart attack and stroke, but newer research is challenging those thoughts. For example, a 2018 study found that having low testosterone levels may actually be linked to heart problems.

Another recent study published in the journal The Aging Male also found an association between low serum testosterone and heart problems. And although more long-term studies are needed, newer research on men who take testosterone has suggested that they do not have any increased risk of heart problems from the testosterone alone in the short term.

In fact, another study found that testosterone supplementation may help some men avoid heart attacks, but ultimately the results were inconclusive.

The research suggests that the low testosterone itself may be linked to heart problems and not just the testosterone therapy. So, men who were taking testosterone were more prone to have heart attacks and strokes in the first place.

However, the FDA is still investigating what risks testosterone might have on men’s heart health. Regulations require that all medication that contains testosterone is labeled with the possible increased risk of heart attack and stroke for men. They also encourage men to speak with their doctors about the benefits and risks before starting any testosterone therapy.

It’s recommended that if you’re a male taking testosterone, you should report any of the following conditions to your doctor and seek medical attention immediately, as they may be a sign of a heart attack:

  • chest pain
  • shortness of breath or trouble breathing
  • weakness in one part or one side of the body
  • slurred speech

Testosterone deficiency (TD) is a well-established and significant medical condition.1,2 It has been defined as a clinical and biochemical syndrome, associated with older age and comorbidities.3 It is characterised by a deficiency in serum androgen levels, with or without reduced genomic sensitivity to androgens.2 The latter relates to the functionality of androgen receptors. For example, if there is CAG repeat polymorphism on exon 1 of the androgen receptor gene, the response to any given serum testosterone (T) concentration is reduced as the number of CAG repeats increases.4–8

Biochemical TD must be associated with relevant signs and symptoms for a diagnosis to be made. The hormone has important physiological functions and deficiency can adversely affect the brain, peripheral nerves, muscle, fat, bone, the cardiovascular (CV) system and especially the male genital and reproductive systems. T is important for the regulation of carbohydrate metabolism, lipids and proteins, and positively affects glucose control, liver fat, cardiac biomarkers, muscle growth and adipogenesis.1,9–15

Epidemiology

Epidemiological studies vary regarding the prevalence of TD. Perhaps the most useful study is the European Male Ageing Study, which evaluated more than 3,000 men between the ages of 40 and 79 years, recording biochemistry results and symptoms. An overall prevalence of 2.5% was reported and rates varied from 0.1% in men aged 40–49 years to 5.1% in those aged 70–79. In this study, TD was defined as three or more sexual symptoms associated with a total T (TT) level <11 nmol/l and a free T (FT) level less than 0.22 nmol/l.16 Three-quarters of men maintained normal T levels into old age. Based on biochemical levels, the prevalence of secondary TD was 11.8%, primary TD 2.0% and compensated (subclinical) TD 9.5% (worthy of observation but not treatment).17

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Aetiology

Normal T levels depend on a healthy hypothalamic–pituitary–gonadotropin axis. Primary TD results from disruption at the level of the testes, secondary TD from disruption at the level of the hypothalamus and pituitary and combined TD from disruption at both these levels.3 Secondary TD is the most common form.17,18

Pituitary tumours can cause centrally mediated TD. Primary testicular failure may result from orchitis, Klinefelter’s syndrome, chemotherapy or radiation. Additional causes of TD include obesity, diabetes, metabolic syndrome, HIV infection, chronic renal failure, and chronic glucocorticoid and opioid use.19,20

Making the Diagnosis

The signs and symptoms of TD are shown in Table 1. Sexual symptoms are the most common, but there are many less specific symptoms such as fatigue, sleep disturbance, visceral obesity, loss of physical strength, decreased muscle mass, decreased energy and motivation, hot flushes, changes in cognition and memory, depression and decreases in bone mineral density.1–3,21–23

The patient should be asked if they are taking any medications – prescription or otherwise – that can lower T levels, e.g. corticosteroids or opiates, or drugs that can cause erectile dysfunction (ED), and if they have previously taken T therapy.1,21

Physical examination should include height, weight, BMI and waist circumference, together with an assessment of body hair, any significant breast enlargement and the appearance of the penis and testicles.1,21,22,24 A prostate examination is also recommended.1,21

The British Society for Sexual Medicine (BSSM) recommendations for case finding are to test for TD in adult men with persistent and multiple signs of TD and to screen for TD in all men presenting with ED, loss of spontaneous erections or low sexual desire, type 2 diabetes (T2D), BMI >30 kg/m2 or waist circumference >102 cm and those on long-term opiate, antipsychotic or anticonvulsant medications.1

T has a diurnal rhythm in younger men, which may become less marked with age but not invariably so.22 Thus, the recommendation is to measure T between 7 am and 11 am on at least two occasions, with a reliable method, preferably 4 weeks apart and, if possible, not during an acute illness.1 A fasting sample is generally advised because T levels are influenced by insulin and glucose, and this is particularly important for the second test.25 If the first result was close to the lower normal range (8–12 nmol/l), it is advised to include levels of sex hormone binding globulin (SHBG).1

The bioavailable forms of T are those not bound to SHBG, known as FT, and this may provide the most reliable clinical androgen status in some patients.16

FT may be calculated using the equation of Vermeulen et al.26 Online FT calculators are provided by the International Society for the Study of the Aging Male (ISSAM), available at: http://issam.ch/freetesto.htm and the Primary Care Testosterone Advisory Group (PCTAG), available at: http://www.pctag.uk/testosterone-calculator/. Reference ranges quoted by laboratories represent the normal population and these are often much lower than the advised action levels recommended by the various guideline groups.

The BSSM and International Society for Sexual Medicine (ISSM) recommend the following action levels:1,27

  • TT less than 8.00 nmol/l, or FT less than 0.18 nmol/l (based on two separate levels taken between 8 am and 11 am) usually requires T therapy.
  • TT higher than 12.00 nmol/l, or FT higher than 0.225 nmol/l does not require T therapy.
  • TT levels between 8.00 nmol/l and 12.00 nmol/l may require a trial of T therapy, for a minimum of 6 months, according to symptoms.

The BSSM and ISSAM also recommend the following:1,22

  • Increased luteinising hormone (LH) levels and T levels below normal or in the lower quartile range indicates testicular failure, so T therapy should be considered.28
  • Men with increased LH levels, normal T levels but TD symptoms should be considered to have TD.

European Male Ageing Study data demonstrated that clinical symptoms were more closely related to calculated FT than TT.29

Testosterone Levels in Men

Araujo et al. performed a meta-analysis that included 18 studies and more than 22,000 subjects and concluded that both overall and CV mortality were related to T levels.31

Corona et al. comprehensively reviewed 1,178 articles and included 70 in their meta-analysis. They demonstrated a clear association between low T/high oestradiol levels and CV disease (CVD). They made the point that longitudinal studies demonstrated that overall mortality and CV mortality were highest in those with lowest T levels.32

Coronary Artery Disease and Testosterone Deficiency

Clinical studies show favourable effects of short- or long-term exposure to T therapy on coronary and peripheral vasomotion and peripheral arterial stiffness.33–35 Physiological concentrations of intracoronary T cause epicardial coronary artery dilatation and increases in volume blood flow in men with coronary artery disease (CAD).33

T therapy in hypogonadal men delays time to ischaemia, improves mood and is associated with potentially beneficial reductions in biomarkers, total cholesterol and serum tumour necrosis factor-alpha.13,36

Three early randomised, placebo-controlled trials demonstrated that administration of T improves myocardial ischaemia in men with CAD. All three trials found that in men with CAD, T prolongs the time to exercise-induced ST-segment depression as measured on treadmill stress testing.37–39

Numerous studies have demonstrated a negative correlation between endogenous T levels and intima-media thickness of the carotid arteries, abdominal aorta and thoracic aorta, which suggests that men with lower levels of endogenous T may be at a higher risk of developing more generalised atherosclerosis.40–47 Evidence also suggests that men with lower T levels are more likely to develop CAD during their lifetime and CAD severity has been shown to correlate with the degree of TD.48–55

Budoff et al. studied 170 T deficient men over the age of 65 years in a double-blinded, placebo-controlled trial setting in the US.56 Men with symptoms suggestive of hypogonadism were enrolled in the study between June 2010 and June 2014. Treatment was with T gel, with the dose adjusted to maintain the T level in the normal range for young men, or placebo gel for 12 months. Plaque volume was determined by coronary CT angiography. For the primary outcome, T therapy compared with placebo was associated with a significantly greater increase in non-calcified plaque volume from baseline to 12 months. There were no major adverse CV events in either group.

The authors point out that this trial had several strengths, including a placebo-controlled design, selection of men with unequivocally low T and a relatively high retention rate. However, they also point out that the study had some limitations. The assumptions about the composition of plaque components as detected by coronary CT angiography were not confirmed by direct radiological and pathological studies. Furthermore, the volume and radiological characteristics of coronary artery plaques are only surrogate outcomes and do not account for other factors that can influence the frequency and extent of plaque rupture and thrombosis. In fact, T therapy was associated with a significant increase in the volume of fibrous plaque, which may be more stable than other types of plaque. The major limitation is that the trial was not large enough or long enough to draw conclusions about the risk of T therapy on major adverse CV events. Larger studies are needed to understand the clinical implications of this finding.

All-cause Mortality, Cardiovascular Mortality and Testosterone Deficiency

Long-term studies, reviews and meta-analyses have supported the association between TD and increased all-cause and CV mortality.2,30,31,57–60

A meta-analysis by Araujo et al. included 12 studies involving more than 17,000 participants. Although there was considerable heterogeneity in these studies resulting from study and subject characteristics, low endogenous T levels were associated with both overall and CV mortality.31

Corona et al. included 70 papers in their meta-analysis and showed a clear association between low T/high oestradiol levels and increased risk of CVD and CV mortality.32

Muraleedharan et al. studied 581 men with T2D who were followed up for a mean of 5.8 years. Low T was defined as less than 10.4 nmol/l. A total of 51 men received T therapy for at least 2.0 years. Mortality rates were 20.0% in the low T group versus 9.1% in the normal T group, independent of comorbidities and other therapies, and T therapy reduced mortality similar to the controls.58

Daka et al. demonstrated that low concentrations of T predicted acute MI in men with T2D.60

Yeap et al. studied 3,690 older men over 10 years, TT and FT levels in the normal range were associated with reduced all-cause and CV mortality. Interestingly, both low and high levels of T were associated with all-cause mortality, and higher levels of dihydrotestosterone reduced ischaemic heart disease mortality.59

A review by Muraldeedharan et al. raised the issue that these studies do not prove a pathogenic link, but low T may simply be a marker of illness.61

Testosterone Therapy and Cardiovascular Risk

T therapy has been controversial, with worries that treatment will increase CV risk. An extensive review of the literature published between 1940 and 2014 found only four studies that reported increased CV risk.62 The authors concluded that two of these were retrospective analyses with serious methodological limitations; one was a prospective trial with only four major adverse CV events and the other a meta-analysis that was criticised for using few studies and CV endpoints of questionable clinical importance, e.g. non-specific ECG findings and palpitations.63–66

The study by Vigen et al. was indeed retrospective, involving 8,709 men with a baseline TT level no higher than 10.4 nmol/l.63 These men were undergoing angiography and were followed up for a mean of 840 days. Results showed 681 of the 7,486 patients who did not receive T therapy died, 420 had a MI and 486 had a stroke. Of the remaining 1,233 patients receiving T therapy, only 67 died, 23 had a MI and 33 had a stroke. The authors then performed a complex statistical analysis using more than 50 covariates and concluded that there was a greater risk in the T therapy group. Some 1,132 patients were excluded because they were prescribed T therapy after the event when they should have been included in the untreated group, which falsely increased the events by 70%. When challenged, the investigators revised the number to 132 but admitted that 104 women had been mistakenly included in the results. Worryingly, there were no data confirming the correct diagnosis of TD syndrome or T therapy and duration of therapy.62

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The Finkle et al. study provided prescribing data in men treated with T, but there were no records of T blood results or the patients’ symptoms.64 The researchers defined non-fatal coronary events as the major endpoint assessed in the 12 months before and 3 months after therapy. This is clearly a major weakness because the benefits of T therapy would take longer than this to appear and many other studies have excluded the first 3 months of treatment from analysis because of the likelihood of events relating to the pre-existing condition. In addition to this, data on fatal CV events and all-cause mortality were not collected and 12-month post-treatment data were collected but not presented. The lack of mortality data fails to recognise that any treatment that decreases mortality is, of course, likely to increase non-fatal events. The design was not prospective and although used as evidence against T therapy, it has been discredited by several design flaws and statistical analyses.62

Following these publications, in January 2014 the US Food and Drug Administration (FDA) convened an advisory committee meeting to review CV risks of T therapy. Subsequently, the FDA expanded the stated purpose of this committee to include a review of the suitable populations for T therapy. On 17 September 2014, the advisory committee voted to restrict therapeutic indications for T therapy and requested that the pharmaceutical industry perform a CV safety study. In March 2015, all US commercial T products underwent a mandatory label change that restricted the indicated population and warned against the possible risk of MI and stroke.67

The EU and Health Canada also issued warnings regarding T therapy and potential CV risk. A review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information warning about the potential increased CV risk in hypogonadal men using T therapy, but did not confirm an increase in heart problems with T medicines.68 These label changes have led to significant media coverage, which is ongoing.

Testosterone Therapy and Decreased Cardiovascular Risk

There are more than 100 studies showing CV benefits of higher endogenous T levels or improved CV risk factors with T therapy.69 This may not be surprising because long-term T therapy reduces fat mass, increases lean mass, improves glycaemic control, reduces insulin resistance and waist circumference and improves the ability to exercise.

In a retrospective observational study involving 1,031 hypogonadal men aged over 40 years, 398 of whom took T therapy, the cumulative mortality was 21% in the untreated group versus 10% in the treated group (p<0.0001). The mortality rates were 3.4 deaths per 100 person-years for T-treated men and 5.7 deaths per 100 person-years in men not treated with T. The greatest effect was observed in younger men and those with T2D.70

In a prospective study, 581 men with T2D and low T (defined as TT <10.4 nmol/l) were followed up for a mean of 5.8 years. Fifty-one men were treated for at least 2.0 years. Mortality rates were 20.0% in the low T group versus 9.1% in the normal T group, independent of comorbidities and therapies, and 9.4% in those with TD in the treated group.58

Both studies demonstrated that mortality was reduced by approximately half in those who received T therapy compared with those who did not.

A retrospective study followed up 857 men with T2D for 4 years after baseline T measurements. Patients were randomised to long-acting T undecanoate or placebo. Low baseline TT and FT levels were associated with increased all-cause mortality. T therapy and phosphodiesterase type 5 (PDE5) inhibitor use were independently associated with lower all-cause mortality (Figures 1–4).71 Interestingly, the greatest benefits from the two treatments were seen in older men (Figure 5).72

This finding regarding PDE5 inhibitor treatment was supported by two database studies demonstrating CV and mortality benefits.73,74

Registry data provide useful evidence where parenteral T undecanoate was used for up to 10 years in 656 men with a mean age of 60.7 years. Long-term treatment was well tolerated, with excellent adherence. Importantly, mortality related to CVD was significantly decreased in the group taking T versus the untreated group.75

A large retrospective study examined 83,010 male veterans with low TT levels who were categorised into three groups:76

  • group 1: T therapy resulting in normalisation of T levels;
  • group 2: T therapy without normalisation of T levels; and
  • group 3: did not receive T therapy.

A further large study compared acute MI rates in 6,355 men aged 66 years and older who received at least one T injection, compared with a matched placebo group over an 8 year period. It found no overall increase in events, those at greatest risk experienced a significant reduction in events and mortality and there was no increased risk from thromboembolism.77

A virtual controlled study examined electronic medical records from 1996 to 2011 to identify 5,695 men who had a low initial TT level, a subsequent T level and up to 3 years of follow-up. It demonstrated a positive impact of T therapy – particularly on mortality – and there was no suggestion of increased risk with sustained higher serum levels.78 In a more recent study, the same group reported a significant reduction in CV events in a cohort of hypogonadal men with angiographically confirmed CAD.79

Wallis et al. compared 10,311 T-treated men with 28,029 controls. They found a reduction in all-cause and CV mortality with T therapy. They also found an increase in mortality in the first 6 months compared with normal, which was attributed to the impact of underlying undertreated TD. Reassuringly, this study also reported a 40% reduction in new diagnoses of prostate cancer in the treated group versus the control group.80

Lastly, a study comparing 8,808 T-treated men with 35,527 untreated men with low T reported a 33% reduction in cardiac events associated with T therapy.81

These results corroborate those of registry studies, which have published data collected over 6 years of follow-up, with no suggestion of increased mortality.82

Heart Failure

TD is common during the course of chronic heart failure (CHF). Reduction in circulating T level predicts a deterioration of functional capacity and suggests a role for managing TD in CHF. T is a determinant of exercise capacity, muscle mass and strength. TD is involved in the pathophysiology of CHF, contributing to some features of this syndrome such as reduced muscle mass, abnormal energy handling, fatigue, dyspnoea and, ultimately, cachexia.83–85

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Approximately 25% of patients affected by CHF have T levels below normal ranges and this is related to disease progression. In addition, reduction of circulating T levels may contribute to some specific features of CHF, such as abnormal energy handling, weakness, dyspnoea and cachexia in particular. T therapy may improve muscle strength and functional pulmonary capacity in (CHF) in men with TD.86

Jankowska et al. studied 208 men with CHF and 366 healthy male controls.87 Low T levels were found in all New York Heart Association (NYHA) classes of heart failure. It has also been shown that reduced T levels in men with CHF indicates a poor prognosis and is associated with increased hospital admissions and mortality.88,89

A meta-analysis of a small number of randomised controlled trials studied the effect of T therapy on exercise capacity in HF patients.90 The four studies (n=198; men, 84%; mean age 67 years) tested either transdermal or intramuscular T, given between 12 weeks and 12 months. The endpoints were 6-minute walk test (6MWT), incremental shuttle walk test, or peak VO2 by cardiopulmonary exercise test. The 6MWT increased by 54.0 metres, incremental shuttle walk test increased by 46.7 metres, and peak VO2 increased by 2.7 ml/kg/min in the T-treated patients versus placebo. The increase in peak VO2 and distance walked in the T-treated group correlated with the increase in FT.

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This degree of improvement in the 6MWT is similar to that seen with other therapies in patients with HF. The NYHA functional class improved by ≥1 grade in 9.8% of patients in the placebo group versus 35.0% of patients in the T therapy group. There were no significant differences in major adverse cardiac events between the T therapy and placebo groups.90

Concern About Prostate Cancer

There is no compelling evidence that T therapy is associated with an increased risk of prostate cancer. This statement is supported by guidelines from the European Association of Urology, the BSSM, the International Consultation on Sexual Medicine (ICSM) and the ISSM.1,3,21,23 The ISSAM states that there is no evidence that T therapy converts subclinical prostatic lesions into clinically detectable prostate cancer, and the ICSM states that there is no compelling evidence that T therapy is associated with prostate cancer progression.3,22

T therapy may make occult prostate cancer cases detectable within an early phase of treatment and present a beneficial effect in relation to early detection. Future longitudinal studies are needed to confirm these findings.91

Testosterone Therapy

The choice of therapy lies between the transdermal route and long-acting T undecanoate injection, depending on patient choice. Adverse events related to T therapy are relatively rare, but follow-up is important because T therapy – especially shorter-acting injections – can increase the haematocrit.92

In patients with TD, ischaemia should be addressed wherever possible and underlying risk factors corrected. Mathur et al. tested the effect of T therapy on ischaemia during 12 months of treatment.93 Long-term treatment with T increased time to develop ischaemia on a treadmill (129 seconds in T patients versus 12 seconds in placebo patients, p=0.020).

Nevertheless, it would seem sensible to be cautious in patients with CVD in an unstable state and approach replacement therapy in the same way as the correction of hypothyroidism, by slowly titrating the dose up to normal over 3 months.

Contraindications to Testosterone Therapy

The main contraindications to T therapy are a haematocrit >54%, male breast cancer, locally advanced or metastatic prostate cancer, an active desire to have children (T therapy reduces spermatogenesis) and severe CHF (NYHA class IV).1,21

Additional contraindications include an unevaluated prostate nodule or induration, prostate specific antigen >4 ng/ml (or >3 ng/ml in those at high risk of prostate cancer), severe untreated sleep apnoea and severe lower urinary tract symptoms associated with benign prostatic hyperplasia.1,3,22,24

Discussion

Both ED and TD are now regarded as independent CV risk factors.94–96 ED is common in cardiac patients and virtually all international guidelines recommend testing for TD in men with ED.97

PDE5 inhibitors are first-line therapy for men with ED.98 Patients unresponsive to PDE5 inhibitors may be rescued with T therapy, especially if their T level is less than 8 nmol/l.99

The Birmingham, Lichfield, Atherstone, Sutton and Tamworth (BLAST) study found that in patients with T2D, T therapy, PDE5 inhibitors and statin therapy appeared to be synergistic and independent in preventing morbidity and mortality.T therapy and PDE5 inhibitors were independently associated with reduced all-cause mortality, with the greatest benefit from both treatments being seen in older men.71,72

Evidence also suggests that PDE5 inhibitors improve insulin sensitivity.100,101 These findings of reduced mortality in men taking PED5 inhibitors are in close agreement with Anderson et al., who followed up 5,956 UK men with T2D over 6.9 years. A 31.0% reduction in all-cause mortality and a 26.0% reduction in MI were reported with a low rate of PDE5 inhibitor prescribing at 22.8%.73

PDE5 inhibitors protect against endothelial reperfusion injury, improve endothelial function and reduce systemic and pulmonary blood pressure.101 Andersson et al. followed up 43,415 Swedish men after first MI for 5 years and found a significant reduction in all-cause and CV mortality and a 30% reduction in new diagnoses of heart failure and related admissions in men prescribed PDE5 inhibitors.74 T levels were not recorded and the benefits of PDE5 inhibitors appeared dose related and were not seen with other treatments for ED.

An assessment of CV risk is inadequate and inaccurate if a question regarding ED is not included in the risk calculation, as in QRISK®3.95

Conclusion

The balance of evidence is that T therapy does not increase CV risk. Many studies have demonstrated that a low serum T concentration is associated with increased CV risk and mortality and that T therapy may have clinically relevant CV benefits.

Evidence demonstrates reduced CV risk with a higher endogenous T concentration, evidence of improvement of known CV risk factors with T therapy and reduced mortality in T deficient men who received T therapy versus untreated men, evidence of improvement of myocardial ischaemia in men with CAD, improved exercise capacity in men with CHF and improvement in serum glucose levels, HbA1c and insulin resistance in men with diabetes and prediabetes.

Bearing these facts in mind, when dealing with cardiac patients clinicians need to be alert to the possibility of undisclosed sexual problems and underlying TD, which are amenable to treatment.

The following statements are the conclusions of the BSSM:1

  • Other benefits of replacing T in deficient men are that beyond 6 months there is evidence of benefit of T therapy in terms of body composition, features of the metabolic syndrome and bone mineralisation.
  • T therapy also improves sexual desire, erectile function and sexual satisfaction. Reductions in BMI and waist circumference, and improvements in glycaemic control and lipid profiles, are observed in hypogonadal men receiving T therapy.
  • Trials of T therapy should extend beyond 6 months and maximal benefit is often seen after 12 months.
  • Patients should be informed about the benefits and side-effects of therapy to allow a joint decision regarding the appropriateness of treatment.
  • The adverse effects of T therapy should be fully discussed and, where appropriate its potential effect on future fertility for each patient and his partner.
  • When T therapy is prescribed, it should be accompanied by weight loss and lifestyle advice as standard management.
  • For patients who are severely symptomatic, with T levels <8 nmol/l, dietary and lifestyle advice alone is unlikely to produce meaningful improvement within a relevant clinical period.

Popular Testosterone Therapy May Raise Risk Of Heart Attack

In addition to the new study and the one in 2010, a Veterans Affairs study last November found a higher rate of heart attacks, strokes and deaths among 1,223 men taking testosterone therapy, compared with 7,486 who didn’t get the hormone treatment.

Finkle, who’s with a California firm called Consolidated Research, tells Shots that “the risk of heart attack should be added to the discussion between patients and physicians” before anyone starts testosterone treatment.

He also says the Food and Drug Administration should require a warning on the labels of testosterone drugs such as Androgel and Axiron. “We have a 2010 study that was canceled because of unexpected cardiovascular risk,” he tells Shots. “I think that was sufficient to justify a warning. Why withhold that from the patient?”

Dr. Sidney Wolfe, of the Health Research Group, tells Shots that his consumer advocacy organization plans to petition the FDA, asking for a strong warning on the instructions for testosterone drugs. The group also intends to ask the FDA to hold off on a long-acting, injectable form of testosterone called Aveed. The agency is expected to make a decision on the drug in February.

But at least one advocate of testosterone therapy says the evidence of risks is overblown and poorly founded. “It feels almost like it’s open season on testosterone,” Boston urologist Abraham Morgentaler tells Shots. “None of the studies is very impressive.”

Morgentaler, author of Testosterone for Life, published by Harvard Health Books, says authors of the latest study “have made the classic mistake of confusing treatment for a condition with the condition. There’s a rich literature spanning more than 20 years that shows low testosterone itself is a risk factor for cardiovascular events.”

He also criticizes the new study for not following patients long enough, and notes that the rate of heart attacks among testosterone users was low.

It’s “high time” for a study of testosterone therapy involving a large number of men who are followed for years, Morgentaler says, similar to the Women’s Health Initiative study on postmenopausal estrogen supplements.

“There is potential for testosterone to be important for general health and longevity,” Morgentaler says. “There’s strong evidence it increases muscle strength and decreases fat — things we would associate with improved health.”

But large, lengthy studies cost hundreds of millions of dollars. And in the case of estrogen replacement, that sort of research ultimately discredited the long-held belief that taking hormone supplements lowers the risk of heart attacks.

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Heart Palpitations During Menopause
First and foremost, it must be said that heart disease must be taken very seriously, and each women should have any questions about her heart health answered by her a qualified healthcare professional. Heart disease is the leading cause of death in women, and heart disease is often under-diagnosed (or missed) during medical evaluation.
If you think you have heart disease, see a cardiologist and ask for a proper cardiac evaluation. You may also need to have your thyroid hormones tested, because hyperthyroid (excessive thyroid hormones) can occur, such as Grave’s disease. Do not minimize your symptoms, or let anyone tell you it is “only stress”, or you only need anti-anxiety medicine. Do no let your concerns about heart health be marginalized. We have come a long way in addressing heart health in women, but still have a long way to go.
That being said, it’s important to realize that heart palpitations are one of the most common symptoms associates with vasomotor instability in menopause. Other symptoms associate with vasomotor instability in menopause include hot flashes, night sweats, cold extremities, mood changes, etc. These symptoms all occur when shifts in hormone levels affect the circulation in such a way that it no longer has the smooth and gentle tone that is required for optimal circulation.
Decreased estrogen, testosterone, and/or progesterone may be associated with palpitations. When testosterone levels are low there may be increased angina, which of course requires medical attention. Since low estrogens is the most common cause of vasomotor symptoms in women of menopause age, consider EstroMend™ if there are other symptoms low estrogen.
It is notable that low testosterone can actually cause vasomotor symptoms in both women and men. So, if there are other symptoms of low testosterone, in addition to the heart palpitations, then TestoGain™ may be a good choice.
Progesterone is anti-inflammatory, as well as calming, soothing and relaxing (it maintains healthy function of GABA). So if there are other symptoms of low progesterone, then ProgestoMend™ may be a good choice. Heart palpitations can be also caused by anxiety and stress, so the calming anti-anxiety actions of the herbs in ProgestoMend™ may be beneficial.
Since it is possible to have more than one hormone imbalance, more than one of the Hormone Specific™ Formulations may be appropriate. Look at the symptoms associated with each major hormone imbalance to help you determine the most likely cause of these symptoms.
Consider EstroMend™ if you have other symptoms associated with low estrogen, which may include hot flashes; night sweats; feeling more depressed; more withdrawn or isolated; feel periods of hopelessness; feel apathetic; feel a loss of energy; feel more fatigued; feel less receptive to sex; feel less sensual; feel that your sex drive is diminished; increased vaginal pain, dryness or itching; insomnia, difficulty falling to sleep or difficulty staying asleep; trouble with your memory; having trouble remembering names; more forgetful; mood is low, less upbeat, less positive or less outgoing; less “good moods’ and times of joy; caring less about things that used to matter to you; trouble controlling your urine; have to urinate more often; spill urine when you cough or sneeze; your perception is weakening, it takes you longer to notice things; trouble thinking of the right word when speaking or writing; your mental skills are diminishing.
Consider ProgestoMend™ if you have other symptoms of low progesterone, which may include more aches and pain; starting to get arthritis; non-menstrual spotting or break-through bleeding; Dysfunctional Uterine Bleeding; more inflammations and swellings; new allergies or asthma; allergies or asthma getting w; twitches and spasms; mental fogginess; trouble thinking clearly; more mood swings; more fatigued; tired in the morning; more irritable; more nervous tension; more anxiety; feel more anxious.
Consider TestoGain™ if you have other symptoms of low testosterone, which may include decreased libido; less sexual fantasies or less sexual desire; less likely to become sexually aroused; less pleased with sex; feeling more irritable; feeling less composed and in control; feeling less motivated in general; less assertive; less energetic; becoming anemic, or think you are anemic; low blood pressure; less muscle strength; you feel weaker; having more trouble with mental skills requiring logic and problem solving; having trouble focusing and maintaining your attention; memory weakening; trouble remembering things and events; feel more depressed; mood is low; less confident; feeling frightened or afraid.
Other Considerations
Even though heart palpitations with menopause may simply be due to changes in hormones that can be addressed with one or more of the Hormone Specific™ Formulations, it is important to discuss these symptoms with a healthcare professional to make sure that there is not a more serious medical condition that needs to be addressed.
If there are other symptoms that may be due to menopause changes, consider using the Menopause Type® Questionnaire to do a more comprehensive analysis of which hormone problems may be involved.
Also consider using Endocrine Complete™ as a Hormone Specific™ multi-nutrient, formulated to maintain the health of your endocrine system with herbs that support the function of your adrenal glands, thyroid, gonadal, and pancreas, and help them make your hormones the way they were designed to be made.
Again, if you think you have heart disease, see a cardiologist and ask for a proper cardiac evaluation.

Summit Medical Group Web Site

Heart Palpitations: Common in Perimenopause and Menopause

Last updated: Feb 12, 2013
Reviewed by Andrew D. Beamer, MD, FACC

Are you a woman age 35 years or older who sometimes experiences skipped heart beats or a racing heart even when you’re not exerting yourself? Do you sometimes awaken with a racing heart? If you answered yes to either of these questions, you are likely experiencing common symptoms of perimenopause or menopause.

What are heart palpitations?
Palpitations are irregular heart beats that can include skipped beats, extra beats (as many as 8 to 16 beats a minute), and a racing heart (as many as 200 extra beats a minute). Many people suggest that having palpitations makes them “aware of their heart beating.”

Women and men can have heart palpitations. In healthy people, they are most common in perimenopausal and menopausal women as a result of fluctuating hormones such as estrogen and progesterone. Some perimenopausal and menopausal women suggest their palpitations occur during or after a hot flash.

“Palpitations usually last only a few seconds to a minute or two,” says Summit Medical Group cardiologist Andrew D. Beamer, MD, FACC. “If you have palpitations that are frequent and last for long periods, you should see your cardiologist immediately. Even if your palpitations are associated with perimenopause or menopause,” says Dr. Beamer, “there are treatments such as beta blockers that can help reduce their frequency and intensity.”

Common causes of heart palpitations include:

  • Alcohol
  • Caffeine
  • Pseudoephedrine, a stimulant in decongestants
  • Dehydration, causing an electrolyte embalance
  • Phentermine, ephedrine, and caffeine in diet pills
  • Emotional stress, which releases adrenaline
  • Hormonal changes
    Hormone replacement therapy (HRT), especially when first beginning treatment
  • Monosodium glutamate in Chinese food, processed foods, canned vegetables, canned soups, and processed meats
  • Nicotine

In most cases, palpitations associated with menopause are not an indication of heart problems. Palpitations often go away after several months, but even they can recur from time to time.

Medical conditions that can cause palpitations and require medical intervention, include:

  • Anemia
  • Heart disease
  • Heart valve Problems
  • Low blood sugar (hypoglycemia)
  • Thyroid conditions

If you have heart palpitations, you can reduce their frequency and intensity by avoiding:

  • Caffeine in soda, coffee, and tea as well as chocolate
  • Smoking and nicotine
  • Diet pills
  • Stress

Although heart palpitations can be disconcerting, remember that most often they are a normal part of aging. Try to remain calm when you have them and focus on your breathing. If you have heart palpitations when you are active, stop what you are doing and sit down or lie down and breathe deeply and slowly through your nose and out your mouth. Your normal heart rate should return within a few minutes.

If your heart rate is very fast,
if you are feeling dizzy or faint, or if you feel tightness or pain in the chest or neck,
you should get immediate emergency treatment.

For more information
or to schedule an appointment
with Dr. Beamer or another member of our cardiology team,
please call 908-273-4300 today.

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