Long-Term Effect of Loxoprofen Sodium on Nocturia in Patients with Benign Prostatic Hyperplasia

Shin, Hong Il; Kim, Byung Hoon; Chang, Hyuk Soo; Park, Choal Hee; Kim, Chun Il

Abstract

PURPOSE
We evaluated the long-term effects of loxoprofen on nocturia in patients with benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS
Between January 2006 and December 2008, 40 BPH patients with 2 or more episodes of nocturia received an alpha-blocker, 5-alpha reductase inhibitor, and a single dose of 60 mg of loxoprofen at night before sleep for 12 months (Group I). During the same period, 38 BPH patients selected as the control group received an alpha-blocker and 5-alpha reductase inhibitor (Group II). Patients were reevaluated after 3, 6, and 12 months of treatment by the number of nocturia episodes and side effects.
RESULTS
After 3 months of treatment, the number of nocturia episodes decreased significantly compared with baseline in both group I and group II (1.9+/-0.7, 2.1+/-0.7, respectively, p<0.05). The degree of decrease in nocturia was significantly different between the groups (-1.5+/-0.9, -1.1+/-0.9, respectively, p=0.034). After 6 and 12 months, the number of nocturia episodes decreased significantly compared with baseline in both group I and group II (p<0.05), but the degree of decrease was not significantly different between the groups (p>0.05). After 6 and 12 months of treatment in group I, treatment-emergent adverse events, including 5 cases of gastric discomfort (12.5%), 3 cases of leg edema (7.5%), and 1 case of decreased urine volume (2.5%), occurred in 9 of the 40 (22.5%) patients.
CONCLUSIONS
Loxoprofen can be an effective treatment for patients with nocturia secondary to BPH in the short term. Long-term use of loxoprofen is not recommended because of the side effects.