The efficacy and safety of solifenacin in patients with overactive bladder syndrome [Učinkovitost i sigurnost solifenacina u liječenju bolesnica s prekomjerno aktivnim mokraćnim mjehurom]

Orešković, Slavko and But, Igor and Banović, Maja and Šprem Goldštajn, Marina (2012) The efficacy and safety of solifenacin in patients with overactive bladder syndrome [Učinkovitost i sigurnost solifenacina u liječenju bolesnica s prekomjerno aktivnim mokraćnim mjehurom]. Collegium Antropologicum, 36 (1). pp. 243-248. ISSN 0350-6134

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Abstract

The aim of the randomised, double blind, placebo controlled study was to evaluate the efficacy, tolerability and safety of solifenacin, a once-daily M3 selective receptor antagonist, in patients with overactive bladder syndrome. Following a single blind 2-week placebo run in period, patients who complained from symptoms of OAB for at least 6 months, were randomized to 4 weeks of solifenacin in 5 mg once daily doses or placebo. 171 patients were enrolled in the study and 157 patients completed the study. Patients with solifenacin had significantly improved micturitions per 24 hours after first week of treatment (1.75 +/- 0.63 vs. 2.64 +/- 0.48, p < 0.001), and after four weeks (1.56 +/- 0.58 vs. 2.71 +/- 0.45, p < 0.001) compared to placebo group. The mean number of urgency episodes per 24 hours had significantly decreased in patients with solifenacin compared to placebo after first week (5.75 +/- 1.43 vs. 6.65 +/- 0.65, p < 0.001), and after four weeks of treatment (5.77 +/- 1.33 vs. 6.54 +/- 0.50, p < 0.001). Solifenacin was also significantly more effective than placebo in reducing the mean number of episodes of severe urgency from baseline to end point (5.83 +/- 1.16 vs. 6.48 +/- 0.50, p < 0.001). Compared with changes obtained with placebo, episodes of urinary frequency were significanlty reduced after first week (0.3 vs. -0.5, p < 0.001) and four weeks check up periods in patients treated with solifenacin (0.19 vs. -0.15, p < 0.001). Episodes of nocturia was significantly reduced in patients treated with solifenacin after first week (0.3 vs. -0.5, p < 0.001), and after four weeks treatment period (0.45 vs. -0.50, p < 0.001). The number of incontinence episodes was also significantly decreased in solifenacin group compared to placebo group after first week (1.06 +/- 0.57 vs. 2.74 +/- 0.47, p < 0.001) and four weeks check up (0.96 +/- 0.57 vs. 2.75 +/- 0.43, p < 0.001). The most common adverse effects with solifenacin were dry mouth and constipation. Adverse effects were mild or moderate severity. The discontinuation rate owing to adverse effects was 4.5%-6.7% with solifenacin and 3.8%-6.1% with placebo, respectively. According to subjective estimation, significant improvement was achieved in 71 (92.21%) of patients treated with solifenacin and in 68 (85%) patients treated with placebo there was no change in OAB symptoms compared to baseline values. UDI score was significantly improved after solifenacin (22.26 +/- 5.91 vs. 29.61 +/- 8.45, p < 0.001) compared to placebo. IIQ score was significantly decreased in patients with solifenacin (36.25 +/- 10.34 vs. 46.86 +/- 6.81, p < 0.001) compared to placebo. In conclusion, solifenacin is a safe and effective treatment alternative for patients with overactive bladder symptoms.

Abstract in Croatian

Cilj randomizirane, dvostruko slijepe placebo kontrolirane studije je procjeniti učinkovitost, podnošljivost i sigurnost solifenacina, selektivnog M3 antagonista u bolesnica s prekomjerno aktivnim mokraćnim mjehurom. Nakon jednostruko slijepog dvotjednog »run in« perioda, bolesnice sa smetnjama prekomjerno aktivnog mokraćnog mjehura u trajanju od najmanje šest mjeseci randomizirane su na primjenu 5 mg solifenacina ili placeba u trajanju od četiri tjedna. Od 171 pacijentica uključenih u studiju, njih 157 je završilo istraživanje. Bolesnice liječene solifenacinom imaju značajno bolje mikcijske parametre u usporedbi sa pacijenticama tretiranim placebom. Bolesnice liječene solifenacinom imaju značajno smanjen broj epizoda mikcije na 24 sata nakon prvog tjedna studije (1,75±0,63 vs. 2,64±0,48, p<0,001), te nakon četiri tjedna studije (1,56±0,58 vs. 2,71±0,45, p<0,001) u usporedbi s placebom. Prosječan broj epizoda urgencije u 24 sata značajno je manji u žena korisnica solifenacina nakon prvog tjedna ispitivanja (5,75±1,43 vs. 6,65±0,65, p<0,001) i nakon četiri tjedna (5,77±1,33 vs. 6,54±0,50, p<0,001) u usporedbi s placebom. Solifenacin je značajno učinkovitiji u smanjenju epizoda teške urgencije u usporedbi s placebom (5,83±1,16 vs. 6,48±0,50, p<0,001). U usporedbi s placebom, značajno je manji broj epizoda urinarne frekvencije u žena korisnica solifenacina nakon prvog tjedna (0,3 vs. –0,5, p<0,001) i nakon četvrtog tjedna liječenja (0,19 vs. –0,15, p<0,001). Broj epizoda nikturije značajno je manji u žena koje su liječene solifenacinom nakon prvog tjedna liječenja (0,3 vs. –0,5, p<0,001) i nakon četvrtog tjedna liječenja (0,45 vs. –0,50, p<0,001). Broj epizoda inkontinencije značajno je smanjen u žena korisnica solifenacina u usporedbi s placebom nakon prvog tjedna liječenja 1,06±0,57 vs. 2,74±0,47, p<0,001) i nakon četvrtog tjedna liječenja (0,96±0,57 vs. 2,75±0,43, p<0,001). Najčešće nuspojave u žena koje su liječene solifenacinom su bile suha usta i opstipacija. Stopa prekida liječenja zbog nuspojava iznosila je 4,5%–6,7% za solifenacin i 3,8%–6.1% za placebo. Na temelju subjektivne procjene, značajno poboljšanje je postignuto u 71 (92,21%) pacijentica korisnica solifenacina, a u 68 (85%) pacijentica liječenih placebom nisu uočene promjene u simptomima prekomjerno aktivnog mokraćnog mjehura u odnosu na početne vrijednosti. UDI skor je značajno poboljšan u žena liječenih solifenacinom (22,26±5,91 vs. 29,61±8,45, p<0,001) u usporedbi s placebom. U usporedbi s placebom, IIQ skor je značajno manji u bolesnica koje su primjenjivale solifenacin 36,25±10,34 vs. 46,86±6,81, p<0,001). U zaključku, solifenacin predstavlja sigurnu i učinkovitu terapijsku alternativu u liječenju bolesnica s prekomjerno aktivnim mokraćnim mjehurom.

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