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Abstract

COMPARISON OF EFFICACY AND SAFETY PROFILE BETWEEN TAMSULOSIN CONTINUS® CONTROLLED RELEASE PREPARATION AND TAMSULOSIN SUSTAINED RELEASE PREPARATION IN PATIENTS OF BENIGN PROSTATIC HYPERPLASIA SUFFERING FROM LOWER URINARY TRACT SYMPTOMS

*Amit Jain1, Jatinder Singh2, Surinder Gupta3, Vikas Gupta4

1Department of Pharmacology, Government Medical College, Amritsar
2Department of Pharmacology, GGS Medical College, Faridkot
3Department of Surgery, Government Medical College, Amritsar
4University Centre of Excellence in Research, BFUHS, Faridkot. India.

ABSTRACT

Purpose: To compare efficacy and safety profile between tamsulosin continus« controlled release preparation and tamsulosin sustained release preparation in patients of benign prostatic hyperplasia (BPH) suffering from lower urinary tract symptoms (LUTS). Materials and Methods: This open labeled, prospective, randomized, parallel group, intention to treat study was conducted at Government Medical College, Amritsar. Sixty patients selected from the OPD of Department of Surgery, Guru Nanak Dev Hospital, Amritsar attached to Government Medical College, Amritsar were randomly divided into two groups. They were subjected to Tab tamsulosin continus controlled release preparation 0.4 mg once daily in group I and Tab tamsulosin sustained release preparation 0.4 mg once daily in group II. The effect of the preparations of tamsulosin on IPSS score, QOL score, prostate size and residual urine volume was evaluated. Incidence of adverse events was also noted. Results: At the end of the study, there was a significant decrease from 18.333 ▒ 4.205 to 10.700 ▒ 3.993 at week 12 in IPSS as compared to the baseline (p<0.05). The percentage decrease was 41.16%. Quality of Life (QOL) score at the end of the study, there was a statistically significant decrease of 1.667 at 12 weeks from the baseline (p<0.05). The percentage decrease was 40.33%. Residual urine volume showed a significant decrease from 98.633 ▒ 27.802 ml at week 0 to 71.567 ▒ 23.008 ml at week 12 as compared to the baseline (p<0.05). The percentage decrease came out to be 27.44%. Most common adverse effect seen with in the treatment groups was dizziness, one patient had an attack of rhinitis, incidence of 3.33% of total. The analysis clearly shows a non significant difference between the two groups. Conclusion: The analysis clearly shows improvement in IPSS, quality of life score and residual urine volume without any improvement in prostate size in both the treatment groups, with a non significant difference between them.

Keywords: Tamsulosin continus® controlled release, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, IPSS score, residual urine volume, prostate size.


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