Table 1

Characteristics of placebo-controlled randomized trials giving the effects of testosterone therapy on cardiovascular-related events among men
Author and publication year Study Participants Industry funding
Setting Duration Dose Cardiovascular-related events based on Age range Number Health status Initial T (nmol/L)
Copenhagen Study Group [49] 1986 Denmark About 16 monthsa 200 mg/8 h micronized T, PO Deaths 24 to 79 221 alcoholic cirrhosis about 20 None given
Marin [39] 1993 Denmark 9 months T gel 125 mg/day Withdrawals 40 to 65 21 Obese, low T 15.3 Funded by Besins Iscovesco
Hall [51] 1996 UK 9 months T enanthate 250 mg /month, IM Withdrawals 34 to 79 35 Rheumatoid arthritis 16.1 Funded by Schering Healthcare
Sih [52] 1997 US 12 weeks T cypionate IM every 14 to 17 days Withdrawals 51 to 79 32 T<60 ng/dl 9.2 None given
English [53] 2000 UK 12 weeks Transdermal T 5 mg/day Withdrawals and safety data Mean 62 50 Coronary artery disease 12.9 Patches given by Smith Kline Beecham
Snyder [19] 2001 US 36 months Transdermal T 6 mg/day Clinically apparent from hospital records 65+ 108 Men with T one SD <475 ng/dl 12.7 Patches given by ALZA Corporation
Amory [54] 2004 US 36 months T enanthate 200 mg/2 weeks, IM Serious adverse cardiovascular events 65 to 83 48 TT <350 ng/dl 10 None given
Kenny [55] 2004 US 12 weeks T enanthate 200 mg/3 weeks, IM General description 73 to 87 11 Cognitive decline, bioavailable T <128 ng/dl 14.1 None
Svartberg [56] 2004 Norway 26 weeks T enanthate 250 mg/month, IM General description Mean 66 29 COPD 21.1 None
Brockenbrough [57] 2006 US 6 months Transdermal T gel 10 g/day Side effects and adverse events Mean 56 40 Dialysis and TT <300 ng/dl 7.3 Supported by Auxilium Pharmaceuticals
Malkin [58] 2006 UK 12 months Transdermal T patch 5 mg/day Serious adverse events Mean 64 76 Heart failure 13.0 Medication given by Watson Pharmaceuticals
Merza [59] 2006 UK 6 months Transdermal T patch 5 mg/day Withdrawals 40+ 39 TT <10 nmol/L 8.0 Supported by Ferring Pharmaceuticals Ltd
Nair [60] 2006 US 24 months Transdermal T patch 5 mg/day Adverse events 60+ 62 DHEA<1.57 μg/ml, bioavailable T <103 ng/dl 13.7 Supported by The Endocrine Society
Emmelot-Vonk [61] 2008 Netherlands 6 months TU 160 mg/day, PO Adverse events 60 to 80 237 TT<13.7 nmol/L 10.7 Medication given by Organon NV
Svartberg [41] 2008 Norway 52 weeks TU 1000 mg, MI at 0, 6, 16, 28 and 40 weeks Deaths 60 to 80 38 TT≤11.0 nmol/L 8.3 Grant from Bayer Schering Pharma AG
Caminiti [62] 2009 Italy 12 weeks TU 1000 mg MI for 0, 6 and 12 weeks General description of events 66 to 76 70 Heart failure 7.0 None given
Chapman [48] 2009 Australia 1 year TU 80 mg orally twice a day Hospitalizations 65+ 23 Undernourished 18.8 Organon provided funding
Legros [46] 2009 Europe 1 year TU 80, 160 and 240 mg orally per day Safety assessments 50+ 316 Free T<0.26 nmol/L 12.8 Funded by Schering-Plough
Aversa [63] 2010 Italy 24 months TU 1,000 mg (every 12 weeks) Safety aspects 45 to 65 50 MS and/or T2DM TT<3.0 ng/ml 8.5 None given
Basaria [50] 2010 US About 6 monthsa Transdermal T gel 100 mg/day Cardiovascular-related events 65+ 209 Frial, TT 100 to 350 ng/dl 8.4 Medication given by Auxilium Pharmaceuticals
Srinivas-Shankar [64] 2010 US 6 months Transdermal T gel 50 mg/day Serious adverse events and withdrawals 65+ 274 TT≤12 nmol/L (345 ng/dl) 11.0 Supported by Bayer Schering Pharma
Jones [65] 2011 Europe 12 months T gel 60 mg/day Cardiovascular events 37 to 88 220 Hypogonadal with type 2 diabetes and/or MetS, 9.4 Supported by ProStrakan
Ho 2011 [66] Malaysia 1 year TU 1000 mg MI for 0, 6, 18, 30 and 42 weeks Withdrawals 40+ 120 T<12 nmol/L, 9.0 Supported by Bayer Schering Pharma
Kaufman [44] 2011 US 182 days 1.62% T gel 2.5 mg/day Safety aspects 45 to 64 274 Hypogonadal, T<300 ng/dl 9.8 Funded by Abbott.
Kalinchenko [67] 2010 Russia 30 weeks TU 1,000 mg MI for 0, 6, 18 and 30 weeks Withdrawal 35 to 70 184 T<350 ng/dl 7.0 Supported by Bayer Schering Pharma
Hoyos [68] 2012 Australia 18 weeks TU 1000 mg MI at 0, 6 and 12 weeks Adverse events 18+, mean 49 67 Obese men with obstructive sleep apnea 13.3 Supported by Bayer Schering Pharma
Spitzer [26] 2012 US 14 weeks 1% T gel 10 g/day Adverse events 40 to 70 140 Erectile dysfunction low T and a sexual partner 12.3 none

atrial stopped early so duration varies. IM= intramuscularly; P, placebo; PO, orally; T= testosterone; TT= total testosterone; TU= testosterone undecanoate.

Xu et al.

Xu et al. BMC Medicine 2013 11:108   doi:10.1186/1741-7015-11-108

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