Abstract


Samaneh Dowlatshahi*1, Alexandra Clark2, Erika Hoffman2, Laura Potoski2, Peter L Perreiah2 and R Harsha Rao2

1University of Pittsburgh Medical Center, Pittsburgh, PA, 2VA Pittsburgh Healthcare System, Pittsburgh, PA

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Samaneh Dowlatshahi*1, Alexandra Clark2, Erika Hoffman2, Laura Potoski2, Peter L Perreiah2 and R Harsha Rao2

1University of Pittsburgh Medical Center, Pittsburgh, PA, 2VA Pittsburgh Healthcare System, Pittsburgh, PA

Introduction: Studies report conflicting results across the risk spectrum for outcomes with TRT, extending, from a survival benefit, through no impact, to increased mortality1. Such stark contradictions might be explained if outcomes are driven by variable pre-existing risk for Major Adverse Cardiovascular Events (MACE) in different studies. A framework for defining such pre-existing risk exists in the Endocrine Society (ES) guidelines for TRT2, but it is not known if their use can forestall or mitigate MACE. The VAPHS Endocrine Division has followed a policy since 2008 that predates, but mirrors, ES guidelines for appropriate diagnosis and monitoring, and restricts TRT to a low risk population, defined by

  • Comorbid Contraindications:

    Absolute: MACE in prior year (MI, active coronary artery
    disease, stroke, thromboembolic/peripheral vascular event),
    untreated obstructive sleep apnea, liver disease, prostate
    cancer, breast cancer

    Relative: age>65, MACE >1y, PSA>4, hematocrit
    >50%

  • Diagnostic validation by ≥2 T levels at 8am by LC/MS/MS, with
    Total T (TT) <200ng/dl or calculated bioavailable T (cBAT)
    <100 ng/dl

  • Goal T 400-600 ng/dl
  • Monitoring: T, Hct, PSA 3-6m after initiation

Since most TRT is prescribed without any constraints by primary care physicians (PCPs) at VAPHS, it provides a unique opportunity to compare outcomes with unrestricted TRT use versus TRT use constrained by ES guidelines.

Objective: To compare the incidence of MACE with TRT prescribed according to a restrictive policy based on risk (ENDO cohort) versus unrestricted use (PCP cohort).
Design Retrospective cohort study of veterans prescribed TRT at VAPHS, 2008-2014, (PCP n=582 [first-time n=431, renewal from elsewhere n=151]; ENDO n=125 [first-time n=101, renewal n=24]).

Results: PCPs were significantly less likely (all p<0.001) to diagnose hypogonadism with ≥2 T levels (PCP 217/431 [50.3%], ENDO 87/101 [86.1%]), by LC/MS/MS assay (PCP 149/431 [34.6%],ENDO 80/101 [79.2%]), at 7-9am (PCP 100/431 [23.2%],ENDO 53/101 [52.5%], using strict criteria (Total T ≤200, cBAT <100: PCP 257/431 [60%] vs ENDO 79/101 [78%]).
PCPs more often prescribed TRT (all p<0.001) at age ≥65 (PCP 206/582 [35.4%], ENDO 20/125 [16%]), despite contraindications, both relative and absolute (PCP 388/582 [66.7%], ENDO 55/125 [44%]), and without proper monitoring within 6 mo (No TT: PCP 210/430 [48.8%], ENDO 14/104 [13.5%]; No Hct: PCP 213/430 [49.5%], ENDO 25/104 [24%]; No PSA: PCP 265/407 [65.1%], ENDO 32/83 [38.6%]).
Despite longer TRT duration (PCP 23.4±0.9mos; ENDO 28.7±2.1, p=0.015), the ENDO cohort experienced a ~70% relative risk (RR) reduction in MACE (PCP 105/582 [18%]; ENDO 9/125 [7.2%], RR 0.31 [95% CI 0.15, 0.65], P=0.002).

Conclusion: A restrictive policy adhering to ES guidelines for TRT to exclude high risk patients and enforce strict diagnostic criteria with appropriate monitoring is associated with a lower risk of MACE.

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