Table 2.
Risk of CV events in placebo-controlled randomized clinical trials published through May 2014
| Author, Year | TRT Mode | TRT Events/Subjects | Placebo Events/Subjects | Relative Risk |
|---|---|---|---|---|
| Basaria, 2010 (10) | Gel | 25/106 | 5/103 | 4.86 |
| Brockenbrough, 2006 (61) | Gel | 9/19 | 9/21 | 1.11 |
| Glintborg, 2013 (32) | Gel | 0/20 | 0/18 | 0.90 |
| Kaufman, 2011 (44) | Gel | 11/234 | 0/40 | 4.01 |
| Kenny, 2010 (47) | Gel | 14/69 | 19/62 | 0.66 |
| Marin, 1993 (53) | Gel | 1/11 | 0/10 | 2.75 |
| Spitzer, 2012 (73) | Gel | 4/70 | 2/70 | 2.00 |
| Srinivas-Shankar, 2010 (74) | Gel | 5/138 | 2/136 | 2.46 |
| Hildreth, 2013 (37) | Gel | 3/96 | 10/47 | 0.15 |
| Jones, 2011 (41) | Gel | 1/108 | 2/212 | 0.52 |
| All gel studies | 1.22 | |||
| English, 2000 (27) | Patch | 2/25 | 025 | 5.00 |
| Malkin, 2006 (52) | Patch | 4/37 | 4/39 | 1.05 |
| Merza, 2006 (56) | Patch | 0/20 | 1/19 | 0.32 |
| Snyder, 2001 (72) | Patch | 9/54 | 5/54 | 1.8 |
| Nair, 2006 (58) | Patch | 7/27 | 6/31 | 1.34 |
| All patch studies | 1.46 | |||
| Amory, 2004 (7) | Injection | 1/24 | 0/24 | 3.00 |
| Aversa, 2010 (8) | Injection | 0/40 | 1/10 | 0.09 |
| Caminiti, 2009 (22) | Injection | 2/35 | 1/35 | 2.00 |
| Hackett, 2014 (33) | Injection | 1/97 | 0/102 | 3.15 |
| Hall, 1996 (35) | Injection | 0/17 | 2/18 | 0.21 |
| Ho, 2012 (38) | Injection | 1/60 | 1/60 | 1.00 |
| Hoyos, 2012 (39) | Injection | 1/33 | 0/34 | 3.09 |
| Kalinchenko, 2010 (42) | Injection | 0/113 | 2/71 | 0.13 |
| Kenny, 2004 (46) | Injection | 0/6 | 1/5 | 0.29 |
| Sih, 1997 (67) | Injection | 1/17 | 1/15 | 0.88 |
| Svartberg, 2008 (78) | Injection | 1/19 | 0/19 | 3.00 |
| Svartberg, 2004 (77) | Injection | 0/15 | 1/14 | 0.31 |
| Borst, 2014 (19) | Injection | 0/31 | 1/29 | 0.31 |
| Tan, 2013 (80) | Injection | 2/56 | 2/58 | 1.04 |
| Sheffield-Moore, 2011 (64) | Injection | 0/8 | 0/8 | 1.00 |
| Ferrando, 2002 (30) | Injection | 0/7 | 0/5 | 0.75 |
| All injection studies | 0.66 | |||
| Chapman, 2009 (23) | Oral | 1/11 | 1/12 | 1.09 |
| Emmelot-Vonk, 2008 (26) | Oral | 8/120 | 3/117 | 2.60 |
| Legros, 2009 (50) | Oral | 1/237 | 0/79 | 1.01 |
| Copenhagen, 1986 (6) | Oral | 16/134 | 5/87 | 2.08 |
| All oral studies | 2.20 |
Cardiovascular (CV) risk varies by route of Tadministration. Oral T replacement therapy (TRT) produces significant risk, and gel and patch TRT produce possible risk,whereas im-injected TRT produces possible benefit (18).