Preliminary Analysis Results of BPH Combined Management with Doxazosin and Indigal Open Multicentre Trail («Odysseus»)

Sivkov A.V., Grigor'ev M.E., Krupin V.N., Pavlov V.N., Bazhenov I.V., Blyumberg B.I., Kul'chavenya E.V., Komyakov B.K., Kiselev V.I., Druh V.M.

Article is dedicated to analysis of results of open multicentre research of using doxazosin in combination with Indigal in patients with BPH. Research is held in 8 clinical centre, with 100 patients participating. The subjects for study were efficiency and safety of oral taking of doxazosin in combination with Indigal during a period of six months, long-term follow up was 6 months. Patients took two capsules of Indigal twice a day and doxazosin 2–8 mg, starting with 2 mg with following dose titration. Four visits to doctor were planned. During this period tendency to IPSS score decrease was mentioned, 1st visit mean IPSS score was 15.39, 2nd visit – 11.41, 3rd visit 10.79 and 4th visit mean IPSS score was 10.33.

Quality of life index was also improving in a period from 4.05 on a 1st visit to 2.75 on a last one. Also an influence of this combination on basic urodynamic characteristic values was assessed: residual volume decrease (from 27.48 ml on a first visit to 15.0 ml on 4th visit) and peak flow rate increase (from 10.64 ml per second on a first visit to 18.9 ml per second on 4th). Thus we can say that combination of doxazosin and Indigal allows maintaining of improvement of IPSS score and quality of life index on a period for six months from cancellation of medications prescription. Also statistically insignificant prostate volume and serum PSA increase were mentioned in 29.6±68,4% after six months and 8.4±52,2% after one year. One side effect was noticed (nausea, epigastric burning) so conclusion about safety of Indigal oral taking was made.

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