Cetrorelix shows promise for benign prostatic hyperplasia
http://www.medwire-news.md/50/75490/Urology/Cetror [2008-7-21]
Tag : gluconic acid
MedWire News : Weekly or biweekly injections of the luteinizinghormone-releasing hormone antagonist cetrorelix (CET) may beeffective for symptomatic benign prostatic hyperplasia (BPH), aphase II study suggests.
Frans Debruyne (Hospital Nijmegen, The Netherlands) and colleaguesstudied the effect of CET in 140 patients with moderately severe orsevere symptomatic BPH, defined as an international prostatesymptom score (IPSS) of 13 or more and peak urinary flow rate of 5to 13 ml/s.
After a 4-week placebo run-in, participants were randomly assignedto receive 4 weeks of CET in gluconic acid at doses of 5 mg perweek, 10 mg every 2 weeks, or 10 mg per week, and were thenfollowed-up for a further 16 weeks.
Overall, 139 patients were evaluable for efficacy and 131 for theprimary endpoint at week 12.
The primary endpoint of mean IPSS from baseline to week 12decreased from 19.3 to 14.5 with the 5-mg injections, from 18.7 to13.7 with the two 10-mg injections, and from 18.8 to 13.0 with thefour 10-mg injections.
In contrast, mean IPSS with placebo changed from 19.0 to just 17.2.
Maximum uroflow also increased significantly compared with baselinein all CET groups but remained unchanged with placebo.
Prostate volumes decreased slightly in all groups, with only apersistent reduction up to week 20 in the groups using the 10-mgdoses. There was a dose-dependent decrease in testosterone levelsin all CET groups to levels above castration values.
Writing in the journal European Urology , the researchers note that CET improvements lasted well beyond thedosing period.
"This should allow for the development of intermittent dosageregimens of CET with two or three treatment courses per year, thusrelieving the concern about treatment compliance with drugsrequiring daily dosing," they say.
Free abstract
MedWire News : Weekly or biweekly injections of the luteinizinghormone-releasing hormone antagonist cetrorelix (CET) may beeffective for symptomatic benign prostatic hyperplasia (BPH), aphase II study suggests.
Frans Debruyne (Hospital Nijmegen, The Netherlands) and colleaguesstudied the effect of CET in 140 patients with moderately severe orsevere symptomatic BPH, defined as an international prostatesymptom score (IPSS) of 13 or more and peak urinary flow rate of 5to 13 ml/s.
After a 4-week placebo run-in, participants were randomly assignedto receive 4 weeks of CET in gluconic acid at doses of 5 mg perweek, 10 mg every 2 weeks, or 10 mg per week, and were thenfollowed-up for a further 16 weeks.
Overall, 139 patients were evaluable for efficacy and 131 for theprimary endpoint at week 12.
The primary endpoint of mean IPSS from baseline to week 12decreased from 19.3 to 14.5 with the 5-mg injections, from 18.7 to13.7 with the two 10-mg injections, and from 18.8 to 13.0 with thefour 10-mg injections.
In contrast, mean IPSS with placebo changed from 19.0 to just 17.2.
Maximum uroflow also increased significantly compared with baselinein all CET groups but remained unchanged with placebo.
Prostate volumes decreased slightly in all groups, with only apersistent reduction up to week 20 in the groups using the 10-mgdoses. There was a dose-dependent decrease in testosterone levelsin all CET groups to levels above castration values.
Writing in the journal European Urology , the researchers note that CET improvements lasted well beyond thedosing period.
"This should allow for the development of intermittent dosageregimens of CET with two or three treatment courses per year, thusrelieving the concern about treatment compliance with drugsrequiring daily dosing," they say.
Free abstract
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