Key result
Testosterone patch cuts insulin resistance ~17% vs placebo in elderly women with chronic HF.
Why the study?
No study had evaluated the effects of testosterone supplementation on functional capacity and insulin resistance in female patients with chronic heart failure.
RCT (n=36)
2:1 ratio
Absolute Event Rate: -16.5% vs 5%
p-value: p=<0.05
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“This therapy improves important clinical measures – exercise capacity, muscle strength and insulin sensitivity – which all play a role in determining the prognosis and survival of female patients with chronic heart failure. While more research is needed, testosterone supplementation could be considered for female patients whose testosterone levels are at or below the normal range, provided that no contraindications to testosterone administration do exist.”
“Replacing testosterone that is lacking could be a novel approach, but larger clinical trials involving both men and women are needed to find the right dose and route of administration, as well as to assess not only symptomatic relief, but harder endpoints such as death and hospitalization for severe heart failure.”
Randomized trial demonstrates that testosterone therapy improves functional capacity and insulin sensitivity in women with chronic heart failure, suggesting a safe therapeutic option.
OBJECTIVES: The primary objective of this study was to assess the effect of a 6-month testosterone supplementation therapy on functional capacity and insulin resistance in female patients with chronic heart failure (CHF). BACKGROUND: Patients with CHF show decreased exercise capacity and insulin sensitivity. Testosterone supplementation improves these variables in men with CHF. No study has evaluated the effects of testosterone supplementation on female patients with CHF. METHODS: Thirty-six elderly female patients with stable CHF, (ejection fraction 32.9 ± 6) were randomly assigned (2:1 ratio) to receive testosterone transdermal patch (T group, n = 24) or placebo (P group, n = 12), both on top of optimal medical therapy. At baseline and after 6 months, patients underwent 6-min walking test (6MWT), cardiopulmonary exercise test, echocardiogram, quadriceps maximal isometric voluntary contraction, dynamic quadriceps isokinetic strength (peak torque), and insulin resistance assessment by homeostasis model. RESULTS: Distance walked at 6MWT as well as peak oxygen consumption significantly improved in the T group, whereas they were unchanged in the P group (p < 0.05 for all comparisons). The homeostasis model was significantly reduced in the T group in comparison with the P group (-16.5% vs. +5%, respectively; p < 0.05). Maximal voluntary contraction and peak torque increased significantly in the T group but did not change in the P group. Increase in distance walked at 6MWT was related to the increase in free testosterone levels (r = 0.593, p = 0.01). No significant changes in echocardiographic parameters were observed in either group. No side effects requiring discontinuation of T were detected. CONCLUSIONS: Testosterone supplementation improves functional capacity, insulin resistance, and muscle strength in women with advanced CHF. Testosterone seems to be an effective and safe therapy for elderly women with CHF.
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Iellamo et al. (2010) conducted an RCT in chronic heart failure (n=36). Testosterone transdermal patch vs. Placebo was evaluated on Change in insulin resistance assessment by homeostasis model (p=<0.05). A 6-month testosterone transdermal patch improved functional capacity and reduced insulin resistance (-16.5% vs +5%; p<0.05) compared to placebo in elderly women with stable chronic heart failure.
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