Meta-analysis of the efficacy and safety of combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia

Abstract

BackgroundWe performed a meta-analysis to confirm the efficacy and safety of the combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia (BPH) during a treatment cycle of at least 1 year.MethodsRandomized controlled trials were searched by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was evaluated and statistically analyzed by using RevMan version 5.3.0.ResultsFive studies including 4348 patients were studied. The analysis found that the combination group was significantly greater effect in international prostate symptom score (mean difference [MD], − 1.43; 95% confidence interval [CI], − 2.20 to − 0.66; P = 0.0003), prostate volume (MD, − 10.13; 95% CI, − 12.38 to − 7.88; P < 0.00001), transitional zone volume (MD, − 3.18; 95% CI, − 3.57 to − 2.79; P<0.0001), maximum urine flow rate (MD, 1.05; 95% CI, 0.82 to 1.29; P < 0.00001), prostate specific antigen (MD, − 0.54; 95% CI, − 0.80 to − 0.29; P < 0.0001) and post-void residual volume (MD, − 3.85; 95% CI, − 4.95 to − 2.76; P < 0.00001) compared with the tamsulosin group. In terms of safety, including adverse events (odds ratio [OR], 2.06; 95% CI, 1.34 to 3.17; P = 0.001), erectile dysfunction (OR, 2.24; 95% CI, 1.73 to 2.92; P < 0.00001), ejaculation disorder (OR, 3.37; 95% CI, 1.97 to 5.79; P < 0.0001), retrograde ejaculation (OR, 2.30; 95% CI, 1.08 to 4.93; P = 0.03), decreased libido (OR, 2.25; 95% CI, 1.53 to 3.31; P < 0.0001) and loss of libido (OR, 3.38; 95% CI, 1.94 to 5.88; P<0.0001), the combination group showed poor tolerance than the tamsulosin group with the exception of dizziness (OR, 1.16; 95% CI, 0.75 to 1.80; P = 0.50). The combination group significantly reduced the risk of clinical progression than the tamsulosin group especially in incidence of BPH-related symptom progression (OR, 0.56; 95% CI, 0.46 to 0.67; P < 0.00001) and acute urinary retention (OR, 0.61; 95% CI, 0.38 to 0.98; P = 0.04).ConclusionThe combination of tamsulosin plus dutasteride provides a preferable therapeutic effect for BPH with a higher incidence of sexual side effects, but combination-therapy can markedly reduce risk of BPH-related symptom progression and acute urinary retention relative to tamsulosin monotherapy.

Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia

“…Creatinine (mg/dL) 1.0 (0.8;1.2) 1.0 (0.9;1. Two large randomized trials 33,34 and a recent meta-analysis 35 demonstrated that, when compared to placebo, the use of these drugs, alone and even more in combination, is able to reduce clinical BPH progression. The exponential efficacy of combined treatment depends on the different mechanism of action of these drugs.…”

The Urological Society of India guidelines on management of benign prostatic hyperplasia/benign prostatic obstruction (Executive summary)

“… Offer combination therapy (alpha-blocker +5 ARI) to all men with moderate-to-severe symptoms and large prostates (>30 g or >40 g) and poor flow rates, i.e., men with a high risk of disease progression[ 18 ] (GR strong) Inform patients about the ability of this treatment to reduce the disease progression and risk of sexual side effects (GR strong) Offer combination therapy to men with a high risk of progression where follow-up is likely to be poor (GR conditional/selective) Consider discontinuation of alpha-blocker after combination therapy of 6 months or more[ 19 ] (GR: conditional/selective). …”

“…Offer combination therapy (alpha-blocker +5 ARI) to all men with moderate-to-severe symptoms and large prostates (>30 g or >40 g) and poor flow rates, i.e., men with a high risk of disease progression[ 18 ] (GR strong)…”

Phloretin Ameliorates Testosterone-Induced Benign Prostatic Hyperplasia in Rats by Regulating the Inflammatory Response, Oxidative Stress and Apoptosis

“…According to the literature [ 1 ], most urologists and patients start treatment with medicines of alpha-blockers or 5-α reductase (5α-R) inhibitors, with the most frequently prescribed drug being alpha-blockers [ 1 ]. Although alpha-blockers are more efficient in improving the maximal flow rate than in combination with a 5α-R inhibitor, it is insufficient in controlling the International Prostate Symptom Score, prostatic volume, and transitional zone volume [ 2 ]. However, a combination of an alpha-blocker and 5α-R inhibitor would result in more significant adverse effects such as problems in ejaculation, erection, and libido [ 2 ].…”

“…Although alpha-blockers are more efficient in improving the maximal flow rate than in combination with a 5α-R inhibitor, it is insufficient in controlling the International Prostate Symptom Score, prostatic volume, and transitional zone volume [ 2 ]. However, a combination of an alpha-blocker and 5α-R inhibitor would result in more significant adverse effects such as problems in ejaculation, erection, and libido [ 2 ]. These adverse effects would compromise men’s quality of life and decrease adherence to therapies.…”