ObjectiveTo compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS).
Patients and MethodsThis was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q max ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q max , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-totreat analysis was used for outcome measures.
ResultsOf the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q max were À1.69 (95% confidence interval [CI] À1.4 to À2.0), À0.70 (95% CI À0.60 to À0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group.
ConclusionThe combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q max compared to monotherapy with tamsulosin, without an increase in AEs.
End-stage renal disease (ESRD) is increasing worldwide. In India, diabetes mellitus and hypertension are the leading causes of chronic kidney disease and ESRD. Hemodialysis is the most prevalent renal replacement therapy (RRT) in India. The ideal RRT must mimic the complex structure of the human kidney while maintaining the patient's quality of life. The quest for finding the ideal RRT, the “artificial kidney”– that can be replicated in the clinical setting and scaled-up across barriers– continues to this date. This review aims to outline the developments, the current status of the artificial kidney and explore its future potential.
METHODS: 41 BPH patients received teverelix LA 60 mg via subcutaneous (sc) administration on Day 1 and Day 3 and 40 patients received placebo (5 per cent mannitol) sc Day 1 and Day 3. Subjects were treatment naive, 50 years or over, with bothersome LUTS (I-PSS 13 or more), and peak urinary flow rate (Qmax) < 13 mL/sec with a minimum voided volume of 150 mL. All subjects underwent a 4 weeks placebo run-in phase. Subjects attended follow-up visits for 16 weeks. The primary endpoint was a reduction in I-PSS. The secondary endpoints included uroflow, prostate volume, residual volume, pharmacodynamics and safety. Responder rate data was also reviewed.RESULTS: See Table 1 for mean baseline data. A clinically relevant reduction in I-PSS is considered to be a score reduction of 3 or more points. In this study, there was a statistically significant improvement in absolute change in I-PSS compared with baseline (Day 1) for patients in the teverelix LA group compared with patients in the placebo group at all timepoints for the both the intent to treat and per protocol dataset. A clinically relevant reduction in I-PSS was seen in 44 per cent (18/41) of teverelix LA subjects as soon as Week 2 and 76 per cent (31/ 41) per cent of treated subjects by Week 4 (Figure 1). At Week 12, 83 per cent of treated subjects had a clinically relevant reduction in I-PSS and this was persisting at the end of the monitoring period of the study at Week 16.CONCLUSIONS: Teverelix LA may offer superior treatment for BPH to existing therapies in terms of rapid effects on symptoms alongside disease progression with a higher proportion of patients responding to teverelix LA compared to current treatments.
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