OBJECTIVES: Prucalopride is effective at alleviating symptoms of chronic constipation in women. The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation. METHODS: This was a multicenter, stratified, randomized, parallel-group, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov identifier: NCT01147926). The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week across the treatment period. Efficacy end points were assessed using daily electronic diaries, global assessment of the severity of constipation and efficacy of treatment, and Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires. RESULTS: In total, 374 patients were enrolled in the study. Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group (37.9%) than in the placebo group (17.7%, P<0.0001). The proportion of patients rating their constipation treatment as "quite a bit" to "extremely" effective at the final on-treatment visit was 46.7 and 30.4% in the prucalopride and placebo groups, respectively. The difference between treatment groups was statistically significant (P<0.0001). The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8% in the prucalopride and placebo groups, respectively (P=0.0035). Prucalopride had a good safety profile and was well tolerated. CONCLUSIONS: Prucalopride is effective, has a good safety profile, and is well tolerated for the treatment of men with chronic constipation.

• MeSH
• Serotonin 5-HT4 Receptor Agonists adverse effects   therapeutic use   MeSH
• Benzofurans adverse effects   therapeutic use   MeSH
• Abdominal Pain chemically induced   MeSH
• Headache chemically induced   MeSH
• Medical Records MeSH
• Chronic Disease MeSH
• Defecation MeSH
• Adult MeSH
• Double-Blind Method MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Nausea chemically induced   MeSH
• Diarrhea chemically induced   MeSH
• Surveys and Questionnaires MeSH
• Aged MeSH
• Severity of Illness Index MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase III MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

Prucaloprid je selektivní agonista serotoninových 5-HT4- -receptorů, jehož účinnost je v posledních letech testována v léčbě dráždivého tračníku či zácpy. V nedávno uveřejněné multicentrické randomizované studii III. fáze klinického zkoušení (n = 620) byla jeho účinnost hodnocena v dávkách 2 či 4 mg/den po dobu 12 týdnů v porovnání s placebem. Výsledky studie ukázaly, že podávání prucalopridu je výrazně účinnější, a to v obou sledovaných dávkách (p < 0,001). Téměř u poloviny pacientů v obou aktivně léčených skupinách (47,3 %, respektive 46,6 %) došlo během tříměsíčního sledování k výraznému zvýšení počtu spontánních stolic, zatímco u nemocných užívajících pouhé placebo tomu bylo pouze u 25,8 % (p < 0,001). Nejčastějším nežádoucím účinkem doprovázejícím léčbu byla bolest hlavy či břicha. Během léčby nebyl pozorován žádný kardiovaskulární nežádoucí účinek.

• Keywords
• prucaloprid,
• MeSH
• Serotonin 5-HT4 Receptor Agonists MeSH
• Benzofurans pharmacology   MeSH
• Clinical Trials, Phase III as Topic MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Receptors, Serotonin, 5-HT4 MeSH
• Irritable Bowel Syndrome drug therapy   MeSH
• Constipation drug therapy   MeSH
• Check Tag
• Humans MeSH