Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
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{"title"=>"TESTOSTERONE PRODUCTS AND CARDIOVASCULAR SAFETY NATIONAL PBM BULLETIN DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION (VHA) PHARMACY BENEFITS MANAGEMENT SERVICES (PBM), MEDICAL ADVISORY PANEL (MAP), AND CENTER FOR MEDICATION SAFETY (VA MEDSA", "type"=>"journal", "authors"=>[{"last_name"=>"(VHA)"}, {"first_name"=>"DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH", "last_name"=>"ADMINISTRATION"}, {"first_name"=>"PHARMACY BENEFITS MANAGEMENT SERVICES", "last_name"=>"(PBM)"}, {"first_name"=>"AND CENTER FOR MEDICATION SAFETY (VA MEDSAFE)", "last_name"=>"MEDICAL ADVISORY PANEL (MAP)"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"1932-6203", "pmid"=>"24489673", "doi"=>"10.1371/journal.pone.0085805"}, "id"=>"f8b4ab75-92e7-3626-b58d-bce673c804ed", "abstract"=>"I. ISSUE Two recent studies identify a possible risk of increased cardiovascular events in men receiving testosterone therapy. FDA continues to evaluate this association between testosterone treatment and increased risk of stroke, heart attack, or death, but has not yet reached a firm conclusion. 1 II. BACKGROUND Testosterone use is indicated for men with testosterone deficiency associated with a medical condition, such as genetic problems, chemotherapy, or other biochemical disorders affecting the production of testosterone by the testicles. Low testosterone levels in the absence of a medical condition are not an approved indication for testosterone products. FDA-approved testosterone formulations consist of a topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. III. DISCUSSION Two publications have prompted FDA to reassess the cardiovascular safety of testosterone therapy. One observational study looking at elderly men in the U.S. Veteran Affairs health system who underwent coronary angiography to assess for coronary artery disease and had a low serum testosterone suggested a 30 percent increase in risk for stroke, heart attack, and death in the group that received testosterone therapy compared to the group that did not receive any testosterone therapy. Many of these patients had underlying cardiovascular disease. 2 Another observational study reported an increased risk of heart attack in older men (two-fold increase in the risk of heart attack among men aged 65 years and older within 90 days after initial prescription), as well as in younger men with pre-existing heart disease (a two-to three-fold increase in the risk of heart attack within 90 days after initial prescription). Younger men with no history of heart disease who received a prescription for testosterone did not demonstrate an increased risk of heart attack.", "link"=>"http://www.mendeley.com/research/testosterone-products-cardiovascular-safety-national-pbm-bulletin-department-veterans-affairs-vetera", "reader_count"=>3, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>1, "Student > Postgraduate"=>1, "Student > Bachelor"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>1, "Student > Postgraduate"=>1, "Student > Bachelor"=>1}, "reader_count_by_subject_area"=>{"Medicine and Dentistry"=>2, "Chemical Engineering"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>2}, "Chemical Engineering"=>{"Chemical Engineering"=>1}}, "group_count"=>0}

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  • {"files"=>["https://ndownloader.figshare.com/files/1366182"], "description"=>"*<p>Adjusted for age and pre-existing medical conditions and medication use associated with MI or its risk factors.</p>†<p>Effective sample size of PDE5 inhibitor cohort after weighting.</p><p>Under 65 with heart disease history: 9,003.</p><p>Under 65 without a history of heart disease: 112,588.</p><p>65 and older with heart disease history: 4,190.</p><p>65 and older without a history of heart disease: 15,718.</p>‡<p>RRR = RR TT cohort/RR PDE5I cohort.</p>", "links"=>[], "tags"=>["cardiovascular", "Myocardial infarction", "Clinical research design", "Cohort studies", "epidemiology", "Drugs and devices", "Pharmacoepidemiology", "Endocrinology", "Endocrine physiology", "hormones", "Cardiovascular disease epidemiology", "oncology", "Cancer treatment", "Hormonal therapy", "myocardial", "infarction", "men", "65", "older", "pre-", "post-prescription", "intervals", "tt", "pde5", "ratios", "limits"], "article_id"=>917850, "categories"=>["Medicine"], "users"=>["William D. Finkle", "Sander Greenland", "Gregory K. Ridgeway", "John L. Adams", "Melissa A. Frasco", "Michael B. Cook", "Joseph F. Fraumeni Jr", "Robert N. Hoover"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0085805.t004", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Rates_of_myocardial_infarction_in_men_under_and_65_and_those_65_and_older_per_1_000_PY_in_pre_and_post_prescription_intervals_for_an_initial_prescription_for_TT_or_PDE5_inhibitors_with_adjusted_rate_ratios_RR_ratio_of_rate_ratios_RRR_and_95_confidence_li/917850", "title"=>"Rates of myocardial infarction in men under and 65 and those 65 and older per 1,000(PY) in pre- and post-prescription intervals for an initial prescription for TT or PDE5 inhibitors, with adjusted<sup>*</sup> rate ratios (RR), ratio of rate ratios (RRR) and 95% confidence limits (CL) by history of heart disease.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-29 03:39:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/1366183"], "description"=>"<p>The TT prescription patients were unweighted and the PDE5I patients were weighted to match the TT prescription cohort based on odds of TT prescription.</p><p>These descriptive tabulations are restricted to exposures that occur in at least 2% or more of individuals. Please see the <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085805#pone.0085805.s001\" target=\"_blank\">Tables S1</a> and <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085805#pone.0085805.s002\" target=\"_blank\">S2</a> for a full list.</p>", "links"=>[], "tags"=>["cardiovascular", "Myocardial infarction", "Clinical research design", "Cohort studies", "epidemiology", "Drugs and devices", "Pharmacoepidemiology", "Endocrinology", "Endocrine physiology", "hormones", "Cardiovascular disease epidemiology", "oncology", "Cancer treatment", "Hormonal therapy", "baseline", "covariates", "medicare", "enrollees", "tt", "pde5i", "cohorts"], "article_id"=>917851, "categories"=>["Medicine"], "users"=>["William D. Finkle", "Sander Greenland", "Gregory K. Ridgeway", "John L. Adams", "Melissa A. Frasco", "Michael B. Cook", "Joseph F. Fraumeni Jr", "Robert N. Hoover"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0085805.t002", "stats"=>{"downloads"=>9, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Distribution_of_baseline_covariates_for_all_Medicare_and_commercial_insurance_enrollees_in_the_TT_prescription_and_PDE5I_cohorts_before_and_after_weighting_/917851", "title"=>"Distribution of baseline covariates for all Medicare and commercial insurance enrollees in the TT prescription and PDE5I cohorts before and after weighting.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-29 03:39:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/1366184"], "description"=>"*<p>Adjusted for age and pre-existing medical conditions and medication use associated with MI or its risk factors (<a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085805#pone-0085805-t001\" target=\"_blank\">Table 1</a> and Supplemental Tables).</p>†<p>Effective sample sizes of PDE5I cohorts after weighting:</p><p>All Ages: 141,671.</p><p>Age <65: Years 121,696.</p><p>Age ≥65: Years 19,505.</p>", "links"=>[], "tags"=>["cardiovascular", "Myocardial infarction", "Clinical research design", "Cohort studies", "epidemiology", "Drugs and devices", "Pharmacoepidemiology", "Endocrinology", "Endocrine physiology", "hormones", "Cardiovascular disease epidemiology", "oncology", "Cancer treatment", "Hormonal therapy", "myocardial", "infarction", "persons", "men", "65", "years", "pre-", "post-prescription", "intervals", "pde5i", "ratios"], "article_id"=>917852, "categories"=>["Medicine"], "users"=>["William D. Finkle", "Sander Greenland", "Gregory K. Ridgeway", "John L. Adams", "Melissa A. Frasco", "Michael B. Cook", "Joseph F. Fraumeni Jr", "Robert N. Hoover"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0085805.t003", "stats"=>{"downloads"=>2, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Rates_of_myocardial_infarction_per_1_000_persons_per_year_PY_in_men_under_age_65_years_and_those_age_65_years_and_older_in_pre_and_post_prescription_intervals_for_an_initial_prescription_for_PDE5I_with_adjusted_rate_ratios_RR_and_95_confidence_intervals_/917852", "title"=>"Rates of myocardial infarction per 1,000 persons per year (PY) in men under age 65 years and those age 65 years and older, in pre- and post-prescription intervals for an initial prescription for PDE5I with adjusted<sup>*</sup> rate ratios (RR), and 95% confidence intervals (CI).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-29 03:39:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/1366185"], "description"=>"_", "links"=>[], "tags"=>["cardiovascular", "Myocardial infarction", "Clinical research design", "Cohort studies", "epidemiology", "Drugs and devices", "Pharmacoepidemiology", "Endocrinology", "Endocrine physiology", "hormones", "Cardiovascular disease epidemiology", "oncology", "Cancer treatment", "Hormonal therapy", "myocardial", "infarction", "persons", "men", "65", "years", "pre-", "post-prescription", "intervals", "testosterone", "ratios"], "article_id"=>917853, "categories"=>["Medicine"], "users"=>["William D. Finkle", "Sander Greenland", "Gregory K. Ridgeway", "John L. Adams", "Melissa A. Frasco", "Michael B. Cook", "Joseph F. Fraumeni Jr", "Robert N. Hoover"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0085805.t001", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Rates_of_myocardial_infarction_per_1_000_persons_per_year_PY_in_men_under_age_65_years_and_those_age_65_years_and_older_in_pre_and_post_prescription_intervals_for_an_initial_prescription_for_testosterone_therapy_rate_ratios_RR_and_95_confidence_intervals/917853", "title"=>"Rates of myocardial infarction per 1,000 persons per year (PY) in men under age 65 years and those age 65 years and older, in pre- and post-prescription intervals for an initial prescription for testosterone therapy rate ratios (RR) and 95% confidence intervals (CI).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-29 03:39:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/1366186", "https://ndownloader.figshare.com/files/1366187"], "description"=>"<div><p>Background</p><p>An association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly.</p><p>Methods</p><p>We conducted a cohort study of the risk of acute non-fatal myocardial infarction (MI) following an initial TT prescription (N = 55,593) in a large health-care database. We compared the incidence rate of MI in the 90 days following the initial prescription (post-prescription interval) with the rate in the one year prior to the initial prescription (pre-prescription interval) (post/pre). We also compared post/pre rates in a cohort of men prescribed phosphodiesterase type 5 inhibitors (PDE5I; sildenafil or tadalafil, N = 167,279), and compared TT prescription post/pre rates with the PDE5I post/pre rates, adjusting for potential confounders using doubly robust estimation.</p><p>Results</p><p>In all subjects, the post/pre-prescription rate ratio (RR) for TT prescription was 1.36 (1.03, 1.81). In men aged 65 years and older, the RR was 2.19 (1.27, 3.77) for TT prescription and 1.15 (0.83, 1.59) for PDE5I, and the ratio of the rate ratios (RRR) for TT prescription relative to PDE5I was 1.90 (1.04, 3.49). The RR for TT prescription increased with age from 0.95 (0.54, 1.67) for men under age 55 years to 3.43 (1.54, 7.56) for those aged ≥75 years (p<sub>trend</sub> = 0.03), while no trend was seen for PDE5I (p<sub>trend</sub> = 0.18). In men under age 65 years, excess risk was confined to those with a prior history of heart disease, with RRs of 2.90 (1.49, 5.62) for TT prescription and 1.40 (0.91, 2.14) for PDE5I, and a RRR of 2.07 (1.05, 4.11).</p><p>Discussion</p><p>In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.</p></div>", "links"=>[], "tags"=>["cardiovascular", "Myocardial infarction", "Clinical research design", "Cohort studies", "epidemiology", "Drugs and devices", "Pharmacoepidemiology", "Endocrinology", "Endocrine physiology", "hormones", "Cardiovascular disease epidemiology", "oncology", "Cancer treatment", "Hormonal therapy", "non-fatal", "myocardial", "infarction", "testosterone"], "article_id"=>917854, "categories"=>["Medicine"], "users"=>["William D. Finkle", "Sander Greenland", "Gregory K. Ridgeway", "John L. Adams", "Melissa A. Frasco", "Michael B. Cook", "Joseph F. Fraumeni Jr", "Robert N. Hoover"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0085805.s001", "https://dx.doi.org/10.1371/journal.pone.0085805.s002"], "stats"=>{"downloads"=>18, "page_views"=>26, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Increased_Risk_of_Non_Fatal_Myocardial_Infarction_Following_Testosterone_Therapy_Prescription_in_Men_/917854", "title"=>"Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-01-29 03:39:49"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"37", "full-text"=>"48", "pdf"=>"14", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"3"}
  • {"unique-ip"=>"32", "full-text"=>"42", "pdf"=>"16", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2017", "month"=>"4"}
  • {"unique-ip"=>"49", "full-text"=>"61", "pdf"=>"13", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"5"}
  • {"unique-ip"=>"28", "full-text"=>"45", "pdf"=>"8", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"6"}
  • {"unique-ip"=>"37", "full-text"=>"52", "pdf"=>"13", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"7"}
  • {"unique-ip"=>"36", "full-text"=>"46", "pdf"=>"6", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2017", "month"=>"8"}
  • {"unique-ip"=>"34", "full-text"=>"52", "pdf"=>"10", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2017", "month"=>"9"}
  • {"unique-ip"=>"53", "full-text"=>"60", "pdf"=>"17", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"10"}
  • {"unique-ip"=>"63", "full-text"=>"73", "pdf"=>"32", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2017", "month"=>"11"}
  • {"unique-ip"=>"28", "full-text"=>"32", "pdf"=>"15", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2017", "month"=>"12"}
  • {"unique-ip"=>"49", "full-text"=>"60", "pdf"=>"14", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"1"}
  • {"unique-ip"=>"2", "full-text"=>"1", "pdf"=>"0", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2018", "month"=>"2"}
  • {"unique-ip"=>"60", "full-text"=>"85", "pdf"=>"12", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"3", "year"=>"2018", "month"=>"3"}
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  • {"unique-ip"=>"38", "full-text"=>"53", "pdf"=>"8", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"8"}
  • {"unique-ip"=>"44", "full-text"=>"54", "pdf"=>"15", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"10"}
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Relative Metric

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