Table 1. Comparison of Outcomes Between Estrogen Patches and Luteinizing Hormone-releasing Hormone Agonists During the First Stage of the Prostate Adenocarcinoma Trans Cutaneous Hormones Trial (n=254).
| Outcomes | LHRHa group (n=85) | Estrogen-patch group (n=169) |
|---|---|---|
| Cardiovascular events * | ||
|
| ||
| Number of events (fatal events) | 6 (1) | 18 (5) |
|
| ||
| Number of patients with events | 6 | 17 |
|
| ||
| Proportion (95 % CI) of patients with events | 7.1 % (2.7–14.9) | 10.1 % (6.0–15.6) |
|
| ||
| Type of events (fatal events) | ||
| Heart failure | 0 | 3 (1) |
| Acute coronary syndrome | 2 (1) | 6 (1) |
| Thromboembolic stroke | 1 (0) | 4 (1) |
| Other arterial embolic event | 0 | 1 (1) |
| Venous thromboembolism | 3 (0) | 4 (1) |
|
| ||
| Testosterone levels at 3 months $ | ||
|
| ||
| Proportion (95 % CI) of patients that achieved castrate testosterone concentrations | 93 % (85–98) | 92 % (85–96) |
|
| ||
| Metabolic changes at 12 months from baseline $ | ||
|
| ||
| Fasting glucose | ||
| Mean change (range, mmol/l) | +0.33 (−2.0 to 6.9) | −0.16 (−1.9 to 2.4) |
| Percentage change | 5.5 % | −2.4 % |
| Treatment effect p value=0.004 | ||
|
| ||
| Fasting cholesterol | ||
| Mean change (range, mmol/l) | +0.20 (−2.9 to 1.9) | −0.23 (−3.1 to 1.9) |
| Percentage change | 4.1 % | −3.3 % |
| Treatment effect p value <0.0001 | ||
CI = confidence interval.
*
The primary cardiovascular analysis was based on a modified intention-to-treat approach: patients were included in the estrogen patch group if they had been treated with patches at any point, and were included in the luteinizing hormone-releasing hormone agonist (LHRHa) group if they had received LHRH but not patches at any point. Median follow-up was 19 months (interquartile range 12–31). The analysis was not powered to compare treatment groups.
$
Based on patients with data available who are still on allocated treatment without additional therapy. Reproduced from Langley et al.58