Dr. Ron’s Research Review – March 18, 2015

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This week’s research review examines the results of Vigen on testosterone therapy and adverse events.

Of the 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes.  Of the 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. (Vigen et al., 2013)

 

No testosterone

Testosterone

RR  

Mortality

681÷7446 =
9.145%

67÷1223 =
 5.478%

0.5990,
P < 0.0001

MI

420÷7446 =
5.64%

23÷1223 =
1.88%

0.3337, 
P < 0.0001

Stroke

486÷7446 =
6.52%

33÷1223 =
2.698%

0.4141, 
P < 0.0001

                                                     
In Cox proportional hazards models adjusting for the presence of coronary artery disease, testosterone therapy use as a time-varying covariate was associated with increased risk of adverse outcomes (hazard ratio, 1.29; 95% CI, 1.04 to 1.58).
Table 1 compares the two groups and shows that the two groups differ greatly in comorbid cardiovascular conditions, resulting in significant adjustments. Given the large difference in sample sizes (7486 vs 1223), pair matching would be advantageous.                             

Dr. Ron


Articles

 

Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels
         (Vigen et al., 2013) Download
IMPORTANCE: Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown. A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety. OBJECTIVES: To assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease. DESIGN, SETTING, AND PATIENTS: A retrospective national cohort study of men with low testosterone levels (<300 ng/dL) who underwent coronary angiography in the Veterans Affairs (VA) system between 2005 and 2011. MAIN OUTCOMES AND MEASURES: Primary outcome was a composite of all-cause mortality, MI, and ischemic stroke. RESULTS: Of the 8709 men with a total testosterone level lower than 300 ng/dL, 1223 patients started testosterone therapy after a median of 531 days following coronary angiography. Of the 1710 outcome events, 748 men died, 443 had MIs, and 519 had strokes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. The absolute rate of events were 19.9% in the no testosterone therapy group vs 25.7% in the testosterone therapy group, with an absolute risk difference of 5.8% (95% CI, -1.4% to 13.1%) at 3 years after coronary angiography. In Cox proportional hazards models adjusting for the presence of coronary artery disease, testosterone therapy use as a time-varying covariate was associated with increased risk of adverse outcomes (hazard ratio, 1.29; 95% CI, 1.04 to 1.58). There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease (test for interaction, P = .41). CONCLUSIONS AND RELEVANCE: Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy.

 

References

Vigen, R., et al. (2013), ‘Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels’, JAMA, 310 (17), 1829-36. PubMedID: 24193080