Randomised clinical trial: the efficacy and safety of propionyl-L-carnitine therapy in patients with ulcerative colitis receiving stable oral treatment

Autor:	Mikhailova TL, Sishkova E, Poniewierka E, Zhidkov KP, Bakulin IG, Kupcinskas L, Lesniakowski K, Grinevich VB, Malecka Panas E, Ardizzone S, Valpiani D, Koch M, Denapiene G, Vago G, Fociani P, Zerbi P, Ceracchi M, Camerini R, Gasbarrini G., D'ARIENZO, AGESILAO
Přispěvatelé:	Mikhailova, Tl, Sishkova, E, Poniewierka, E, Zhidkov, Kp, Bakulin, Ig, Kupcinskas, L, Lesniakowski, K, Grinevich, Vb, Malecka Panas, E, Ardizzone, S, D'Arienzo, Agesilao, Valpiani, D, Koch, M, Denapiene, G, Vago, G, Fociani, P, Zerbi, P, Ceracchi, M, Camerini, R, Gasbarrini, G.
Rok vydání:	2011
Předmět:	Adult Male Dose-Response Relationship Drug Anti-Inflammatory Agents Non-Steroidal Administration Oral Middle Aged Severity of Illness Index ulcerative coliti randomised clinical trial Cohort Studies Young Adult propionyl-L-carnitine Treatment Outcome Double-Blind Method Carnitine Humans Colitis Ulcerative Female
Zdroj:	Alimentary pharmacologytherapeutics. 34(9)
ISSN:	1365-2036
Popis:	Ulcerative colitis (UC) is characterised by impaired fatty-acid oxidation; l-carnitine has a key role in fatty-acid metabolism and short-chain fatty acids such as butyrate and propionate are important energy source for intestinal epithelial cells.To evaluate efficacy and safety of colon-release propionyl-L-carnitine (PLC) in patients with mild-to-moderate UC receiving stable oral aminosalicylate or thiopurine therapy.In a multicentre, phase II, double-blind, parallel-group trial, patients were randomised to receive PLC 1 g/day, PLC 2 g/day or placebo. Main inclusion criteria were as follows: age 18-75; disease activity index (DAI) score 3-10 inclusive, be under oral stable treatment with aminosalicylate or thiopurine. The primary endpoint was clinical/endoscopic response, defined as a decrease in DAI score ≥ 3 points or remission, defined as a DAI score ≤ 2 with no individual sub-score1.Of 121 patients who were randomised, 57 of 79 (72%) patients receiving PLC (combined 1 g and 2 g cohort) had a clinical/endoscopic response vs. 20 of 40 (50%) receiving placebo (P = 0.02). Specifically, in PLC 1 g/day group, 30 of 40 (75%) patients had clinical/endoscopic response (P = 0.02 vs. placebo) and 27 of 39 (69%) in the PLC 2 g/day group (P = 0.08 vs. placebo). Rates of remission were 22/40 (55%), 19/39 (49%), 14/40 (35%) in the PLC 1 g, PLC 2 g, and placebo groups, respectively. PLC had a similar safety profile to placebo; the most common adverse events were gastrointestinal.Propionyl-L-carnitine 1 g/day should be investigated further as a co-treatment for mild-to-moderate ulcerative colitis (NCT-01026857).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::d34b4c949303122d847d132ebed3ea74 https://pubmed.ncbi.nlm.nih.gov/22248423 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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