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1.
J Crohns Colitis ; 9(9): 747-53, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26055976

ABSTRACT

BACKGROUND AND AIMS: The ECCO-EpiCom study investigates the differences in the incidence and therapeutic management of inflammatory bowel diseases [IBD] between Eastern and Western Europe. The aim of this study was to analyse the differences in the disease phenotype, medical therapy, surgery, and hospitalization rates in the ECCO-EpiCom 2011 inception cohort during the first year after diagnosis. METHODS: Nine Western, five Eastern European centres and one Australian centre with 258 Crohn's disease [CD], 380 ulcerative colitis [UC] and 71 IBD unclassified [IBDU] patients [female/male: 326/383; mean age at diagnosis: 40.9 years, SD: 17.3 years] participated. Patients' data were registered and entered in the web-based ECCO-EpiCom database [www.epicom-ecco.eu]. RESULTS: In CD, 36 [19%] Western Europe/Australian and 6 [9%] Eastern European patients received biological therapy [p = 0.04], but the immunosuppressive [IS] use was equal and high in these regions [Eastern Europe vs Western Europe/Australia: 53% vs 45%; p = 0.27]. Surgery was performed in 17 [24%] CD patients in Eastern Europe and 13 [7%] in Western Europe/Australia [p < 0.001, pLogRank = 0.001]. Of CD patients from Eastern Europe, 24 [34%] were hospitalized, and 39 [21%] from Western Europe/Australia, [p = 0.02, pLogRank = 0.01]. In UC, exposure to biologicals and colectomy rates were low and hospitalization rates did not differ between these regions during the 1-year follow-up period [16% vs 16%; p = 0.93]. CONCLUSIONS: During the first year after diagnosis, surgery and hospitalization rates were significantly higher in CD patients in Eastern Europe compared with Western Europe/Australia, whereas significantly more CD patients were treated with biologicals in the Western Europe/Australian centres.


Subject(s)
Colectomy/statistics & numerical data , Hospitalization/statistics & numerical data , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/therapy , Practice Patterns, Physicians'/statistics & numerical data , Adult , Aged , Australia/epidemiology , Combined Modality Therapy , Databases, Factual , Europe/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/epidemiology , Male , Middle Aged , Phenotype , Prospective Studies , Young Adult
2.
J Crohns Colitis ; 8(8): 811-8, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24439390

ABSTRACT

BACKGROUND AND AIMS: The EpiCom study and inception cohort was initiated in 2010 in 31 centers from 14 Western and 8 Eastern European countries, covering a 10.1million person background population. Our aim was to investigate whether there is a difference between Eastern and Western Europe in health care and education of patients with inflammatory bowel disease (IBD). METHODS: A quality of care (QoC) questionnaire was developed in the EpiCom group consisting of 16 questions covering 5 items: time interval between the onset of symptoms and diagnosis, information, education, empathy and access to health care providers. RESULTS: Of 1,515 patients, 947 (217 east/730 west) answered the QoC questionnaire. Only 23% of all patients had knowledge about IBD before diagnosis. In Eastern Europe, significantly more patients searched out information about IBD themselves (77% vs. 68%, p<0.05), the main source was the Internet (92% vs. 88% p=0.23). In Western Europe, significantly more patients were educated by nurses (19% vs. 1%, p<0.05), while in Eastern Europe, gastroenterologists were easier to contact (80% vs. 68%, p<0.05). CONCLUSION: Health care differed significantly between Eastern and Western Europe in all items, but satisfaction rates were high in both geographic regions. Because of the low awareness and the rising incidence of IBD, general information should be the focus of patient organizations and medical societies. In Western Europe IBD nurses play a very important role in reducing the burden of patient management.


Subject(s)
Inflammatory Bowel Diseases/therapy , Patient Education as Topic , Quality of Health Care/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Cohort Studies , Europe/epidemiology , Europe, Eastern/epidemiology , Female , Humans , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/psychology , Male , Middle Aged , Patient Education as Topic/statistics & numerical data , Patient Satisfaction/statistics & numerical data , Surveys and Questionnaires , Time Factors , Young Adult
3.
Gut ; 63(4): 588-97, 2014 Apr.
Article in English | MEDLINE | ID: mdl-23604131

ABSTRACT

OBJECTIVE: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe. The reasons for these changes remain unknown. The aim of this study was to investigate whether an East-West gradient in the incidence of IBD in Europe exists. DESIGN: A prospective, uniformly diagnosed, population based inception cohort of IBD patients in 31 centres from 14 Western and eight Eastern European countries covering a total background population of approximately 10.1 million people was created. One-third of the centres had previous experience with inception cohorts. Patients were entered into a low cost, web based epidemiological database, making participation possible regardless of socioeconomic status and prior experience. RESULTS: 1515 patients aged 15 years or older were included, of whom 535 (35%) were diagnosed with Crohn's disease (CD), 813 (54%) with ulcerative colitis (UC) and 167 (11%) with IBD unclassified (IBDU). The overall incidence rate ratios in all Western European centres were 1.9 (95% CI 1.5 to 2.4) for CD and 2.1 (95% CI 1.8 to 2.6) for UC compared with Eastern European centres. The median crude annual incidence rates per 100,000 in 2010 for CD were 6.5 (range 0-10.7) in Western European centres and 3.1 (range 0.4-11.5) in Eastern European centres, for UC 10.8 (range 2.9-31.5) and 4.1 (range 2.4-10.3), respectively, and for IBDU 1.9 (range 0-39.4) and 0 (range 0-1.2), respectively. In Western Europe, 92% of CD, 78% of UC and 74% of IBDU patients had a colonoscopy performed as the diagnostic procedure compared with 90%, 100% and 96%, respectively, in Eastern Europe. 8% of CD and 1% of UC patients in both regions underwent surgery within the first 3 months of the onset of disease. 7% of CD patients and 3% of UC patients from Western Europe received biological treatment as rescue therapy. Of all European CD patients, 20% received only 5-aminosalicylates as induction therapy. CONCLUSIONS: An East-West gradient in IBD incidence exists in Europe. Among this inception cohort--including indolent and aggressive cases--international guidelines for diagnosis and initial treatment are not being followed uniformly by physicians.


Subject(s)
Inflammatory Bowel Diseases/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/epidemiology , Colitis, Ulcerative/therapy , Colonoscopy , Crohn Disease/diagnosis , Crohn Disease/epidemiology , Crohn Disease/therapy , Europe/epidemiology , Europe, Eastern/epidemiology , Female , Humans , Incidence , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/therapy , Male , Middle Aged , Prospective Studies , Young Adult
4.
J Crohns Colitis ; 8(7): 607-16, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24315795

ABSTRACT

BACKGROUND AND AIMS: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe possibly due to changes in environmental factors towards a more "westernised" standard of living. The aim of this study was to investigate differences in exposure to environmental factors prior to diagnosis in Eastern and Western European IBD patients. METHODS: The EpiCom cohort is a population-based, prospective inception cohort of 1560 unselected IBD patients from 31 European countries covering a background population of 10.1 million. At the time of diagnosis patients were asked to complete an 87-item questionnaire concerning environmental factors. RESULTS: A total of 1182 patients (76%) answered the questionnaire, 444 (38%) had Crohn's disease (CD), 627 (53%) ulcerative colitis (UC), and 111 (9%) IBD unclassified. No geographic differences regarding smoking status, caffeine intake, use of oral contraceptives, or number of first-degree relatives with IBD were found. Sugar intake was higher in CD and UC patients from Eastern Europe than in Western Europe while fibre intake was lower (p<0.01). Daily consumption of fast food as well as appendectomy before the age of 20 was more frequent in Eastern European than in Western European UC patients (p<0.01). Eastern European CD and UC patients had received more vaccinations and experienced fewer childhood infections than Western European patients (p<0.01). CONCLUSIONS: In this European population-based inception cohort of unselected IBD patients, Eastern and Western European patients differed in environmental factors prior to diagnosis. Eastern European patients exhibited higher occurrences of suspected risk factors for IBD included in the Western lifestyle.


Subject(s)
Colitis, Ulcerative/epidemiology , Crohn Disease/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Appendectomy/statistics & numerical data , Colitis, Ulcerative/pathology , Colitis, Ulcerative/therapy , Crohn Disease/pathology , Crohn Disease/therapy , Dietary Fiber/statistics & numerical data , Dietary Sucrose , Europe/epidemiology , Fast Foods/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Male , Measles/epidemiology , Middle Aged , Mumps/epidemiology , Prospective Studies , Risk Factors , Severity of Illness Index , Surveys and Questionnaires , Vaccination/statistics & numerical data , Whooping Cough/epidemiology , Young Adult
5.
Gut ; 58(2): 233-40, 2009 Feb.
Article in English | MEDLINE | ID: mdl-18832520

ABSTRACT

OBJECTIVES: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis. DESIGN: A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III non-inferiority study. SETTING: 54 centres in 13 countries. PATIENTS: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI)>4 and endoscopic index > or =4 at baseline) were randomised and treated. INTERVENTIONS: 8-week treatment with either 3 g OD or 1 g TID mesalazine granules. MAIN OUTCOME MEASURES: Clinical remission (CAI< or =4) at study end. RESULTS: 380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p<0.0001 for non-inferiority). Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group (86%; n = 97) versus the TID group (73%; n = 100; p = 0.0298). About 70% of patients in both treatment groups achieved endoscopic remission, and 35% in the OD group and 41% in the TID group achieved histological remission. About 80% of all patients preferred OD dosing. Similar numbers of adverse events occurred in 55 patients (28.8%) in the OD group and in 61 patients (32.3%) in the TID group, indicating that the two dosing regimens were equally safe and well tolerated. CONCLUSIONS: OD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule. With respect to the best possible adherence of patients to the treatment, OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Colitis, Ulcerative/drug therapy , Mesalamine/administration & dosage , Adult , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Chi-Square Distribution , Colitis, Ulcerative/pathology , Colonoscopy , Double-Blind Method , Drug Administration Schedule , Female , Humans , Kaplan-Meier Estimate , Male , Mesalamine/therapeutic use , Middle Aged , Patient Compliance , Sample Size , Treatment Outcome
6.
Aliment Pharmacol Ther ; 23(2): 303-12, 2006 Jan 15.
Article in English | MEDLINE | ID: mdl-16393311

ABSTRACT

BACKGROUND: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis. AIM: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema. METHODS: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol). RESULTS: A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%). CONCLUSION: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , Budesonide/administration & dosage , Proctitis/drug therapy , Administration, Rectal , Adolescent , Adult , Aged , Anti-Inflammatory Agents/adverse effects , Budesonide/adverse effects , Colitis, Ulcerative/drug therapy , Double-Blind Method , Enema/methods , Female , Humans , Male , Middle Aged , Patient Satisfaction , Proctocolitis/drug therapy , Treatment Outcome
7.
Dis Esophagus ; 17(3): 223-7, 2004.
Article in English | MEDLINE | ID: mdl-15361095

ABSTRACT

It is still not known whether there are differences between erosive and nonerosive GERD. The aim of the present study is to evaluate the prevalence of Helicobacter pylori (HP) infection, and other differences between erosive and nonerosive gastroesophageal reflux disease (NERD) patients. One-hundred and four consecutive GERD patients (mean age: 41.6 +/- 12.3 years) were interviewed, endoscoped and tested for HP. Erosive GERD was defined according to the Los Angeles classification. Patients who had no erosions in the esophagus but complained of heartburn or/and acid regurgitation at least twice a week and for whom these symptoms had a negative impact on daily activities were considered to be NERD patients. Erosive GERD was identified in 53 (51%) patients (mean age: 41.0 +/- 12.7 years) and NERD in 51 (49.0%) patients (mean age: 42.2 +/- 11.9 years). HP infection was found in 32 (60.4%) erosive GERD patients, and 41 (80.4%) NERD patients, P < 0.05. Multivariate analysis revealed that there were two statistically significant prediction factors for NERD: female sex with odds ratio (OR) of 6.34 (95% CI: 2.41-16.64; P = 0.0002) and HP infection with odds ratio (OR) of 3.28 (95% CI: 1.26-8.58; P = 0.015). The presence of HP and female sex are found to be statistically significant predictors of NERD.


Subject(s)
Esophagitis/microbiology , Gastroesophageal Reflux/microbiology , Helicobacter Infections/epidemiology , Helicobacter pylori , Adult , Atrophy , Body Mass Index , Endoscopy, Gastrointestinal , Esophagitis/classification , Esophagitis/epidemiology , Esophagus/microbiology , Esophagus/pathology , Female , Gastroesophageal Reflux/epidemiology , Gastroesophageal Reflux/pathology , Heartburn/epidemiology , Helicobacter Infections/diagnosis , Helicobacter pylori/isolation & purification , Hernia, Hiatal/epidemiology , Humans , Lithuania/epidemiology , Logistic Models , Male , Middle Aged , Multivariate Analysis , Prevalence , Pyloric Antrum/pathology , Sex Factors , Smoking/epidemiology
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