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Long-term study to assess the efficacy of tamsulosin in the control of symptoms and complications developed in patients with symptomatic benign prostatic hyperplasia (OMNICONTROL study): first-year follow-up report.
Arch Esp Urol. 2004 May; 57(4):451-60.AE

Abstract

OBJECTIVE

To evaluate: i. long-term efficacy of tamsulosin in the control of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) using the I-PSS questionnaire, ii. the frequency of complications related to the disease, and iii. short and long-term tolerability of tamsulosin.

METHODS

A total of 2.921 patients with LUTS suggestive of BPO for more than 6 months and total IPSS > 7 treated with tamsulosin (Omnic) in real life practice conditions in Spain entered an observational prospective multicentre clinical study. Efficacy was primarily assessed by changes from baseline to endpoint in I-PSS symptoms score (total, irritative and obstructive), and secondarily by the appearance of disease complications, and urinary flow measurements. Safety was assessed recording every suspected adverse reaction, blood pressure changes and laboratory data on months 6 and 12. Evolution in time of free flow and sonographical evaluation of the prostate were also obtained in 663 (22.7%) and 1346 (46.1%) cases, respectively, and the use of previous and concomitant medication was also analysed.

RESULTS

After 6 and 12 months total I-PSS, irritative, and obstructive symptoms were significantly reduced with the use of tamsulosin 0,4 mg once daily. At 1 year follow-up total I-PSS score, irritative symptoms, and obstructive symptoms were reduced in 8.2, 3.5 and 4.8 points 146%, 45% and 48% improvement), respectively (p < 0.0001). The proportion of patients seriously symptomatic (total I-PSS score 20-35) was reduced from 34.8% at the start of the study to 8% at 6 months and 2.9% at 12 months. Mean QoL also significantly improved after 6 and 12 months of treatment. Average score QoL index was reduced from 4.1 to 1.86 after 12 months (2.24 points, 55% improvement) (p < 0.0001). Qmax also significantly improved after 6 and 12 months of treatment (p < 0.0001). The good tolerability profile of tamsulosin has been confirmed after 6 and 12 months of treatment.

CONCLUSIONS

Therapeutic intervention with tamsulosin 0,4 mg once daily is effective in all parameters analysed (I-PSS questionnaire and flow study), very well tolerated and safe in the short-term (6 and 12 months) in patients with LUTS suggestive of BPO. Long-term data specifically regarding the decrease in prostate volume and the evolution of the BPH condition will be welcome.

Authors+Show Affiliations

Servicio de Urología, H. Virgen de la Torre, Madrid, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

15270291

Citation

Palacio, A, et al. "Long-term Study to Assess the Efficacy of Tamsulosin in the Control of Symptoms and Complications Developed in Patients With Symptomatic Benign Prostatic Hyperplasia (OMNICONTROL Study): First-year Follow-up Report." Archivos Espanoles De Urologia, vol. 57, no. 4, 2004, pp. 451-60.
Palacio A, Hernández C, Marqués A, et al. Long-term study to assess the efficacy of tamsulosin in the control of symptoms and complications developed in patients with symptomatic benign prostatic hyperplasia (OMNICONTROL study): first-year follow-up report. Arch Esp Urol. 2004;57(4):451-60.
Palacio, A., Hernández, C., Marqués, A., Prats, J., & Espinosa, F. J. (2004). Long-term study to assess the efficacy of tamsulosin in the control of symptoms and complications developed in patients with symptomatic benign prostatic hyperplasia (OMNICONTROL study): first-year follow-up report. Archivos Espanoles De Urologia, 57(4), 451-60.
Palacio A, et al. Long-term Study to Assess the Efficacy of Tamsulosin in the Control of Symptoms and Complications Developed in Patients With Symptomatic Benign Prostatic Hyperplasia (OMNICONTROL Study): First-year Follow-up Report. Arch Esp Urol. 2004;57(4):451-60. PubMed PMID: 15270291.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term study to assess the efficacy of tamsulosin in the control of symptoms and complications developed in patients with symptomatic benign prostatic hyperplasia (OMNICONTROL study): first-year follow-up report. AU - Palacio,A, AU - Hernández,C, AU - Marqués,A, AU - Prats,J, AU - Espinosa,F J, PY - 2004/7/24/pubmed PY - 2004/9/28/medline PY - 2004/7/24/entrez SP - 451 EP - 60 JF - Archivos espanoles de urologia JO - Arch Esp Urol VL - 57 IS - 4 N2 - OBJECTIVE: To evaluate: i. long-term efficacy of tamsulosin in the control of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) using the I-PSS questionnaire, ii. the frequency of complications related to the disease, and iii. short and long-term tolerability of tamsulosin. METHODS: A total of 2.921 patients with LUTS suggestive of BPO for more than 6 months and total IPSS > 7 treated with tamsulosin (Omnic) in real life practice conditions in Spain entered an observational prospective multicentre clinical study. Efficacy was primarily assessed by changes from baseline to endpoint in I-PSS symptoms score (total, irritative and obstructive), and secondarily by the appearance of disease complications, and urinary flow measurements. Safety was assessed recording every suspected adverse reaction, blood pressure changes and laboratory data on months 6 and 12. Evolution in time of free flow and sonographical evaluation of the prostate were also obtained in 663 (22.7%) and 1346 (46.1%) cases, respectively, and the use of previous and concomitant medication was also analysed. RESULTS: After 6 and 12 months total I-PSS, irritative, and obstructive symptoms were significantly reduced with the use of tamsulosin 0,4 mg once daily. At 1 year follow-up total I-PSS score, irritative symptoms, and obstructive symptoms were reduced in 8.2, 3.5 and 4.8 points 146%, 45% and 48% improvement), respectively (p < 0.0001). The proportion of patients seriously symptomatic (total I-PSS score 20-35) was reduced from 34.8% at the start of the study to 8% at 6 months and 2.9% at 12 months. Mean QoL also significantly improved after 6 and 12 months of treatment. Average score QoL index was reduced from 4.1 to 1.86 after 12 months (2.24 points, 55% improvement) (p < 0.0001). Qmax also significantly improved after 6 and 12 months of treatment (p < 0.0001). The good tolerability profile of tamsulosin has been confirmed after 6 and 12 months of treatment. CONCLUSIONS: Therapeutic intervention with tamsulosin 0,4 mg once daily is effective in all parameters analysed (I-PSS questionnaire and flow study), very well tolerated and safe in the short-term (6 and 12 months) in patients with LUTS suggestive of BPO. Long-term data specifically regarding the decrease in prostate volume and the evolution of the BPH condition will be welcome. SN - 0004-0614 UR - https://www.unboundmedicine.com/medline/citation/15270291/Long_term_study_to_assess_the_efficacy_of_tamsulosin_in_the_control_of_symptoms_and_complications_developed_in_patients_with_symptomatic_benign_prostatic_hyperplasia__OMNICONTROL_study_:_first_year_follow_up_report_ L2 - http://www.aeurologia.com/articulo_prod.php?id_art=3865983192224 DB - PRIME DP - Unbound Medicine ER -