Real-world experience with the all-oral, interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry.

Real-world studies are relevant to complement clinical trials on novel antiviral therapies against chronic hepatitis C; however, clinical practice data are currently limited. This study investigated effectiveness and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±ribavirin (RBV) for treatment of HCV genotype (GT) 1 and GT4 infection in a large real-world cohort. The German Hepatitis C Registry is an observational cohort study prospectively collecting clinical practice data on direct-acting antiviral therapies. Patients with GT1/4 infection treated with OBV/PTV/r±DSV±RBV were analysed. Effectiveness was assessed by sustained virologic response in 558 patients who reached post-treatment week 12 (SVR12). Safety is reported in 1017 patients who initiated treatment. Of the patients, 892 (88%) had GT1 and 125 (12%) had GT4 infection. Prior treatment experience and cirrhosis were reported in 598 (59%) and 228 (22%) patients, respectively. Overall, SVR12 (mITT) was 96% (486/505) in GT1- and 100% (53/53) in GT4 patients. SVR12 rates were high across subgroups including patients with cirrhosis (95%, 123/129), patients with moderate to severe renal impairment (100%, 34/34), and subgroups excluded from registrational trials like patients ≥70 years (96%, 64/67) and failures to prior protease inhibitor treatment (96%, 46/48). Adverse events (AEs) and serious AEs were reported in 52% (525/1017) and 2% (21/1017) of patients, respectively, and led to treatment discontinuation in 1.5% (15/1017) of patients. OBV/PTV/r±DSV±RBV was effective and generally well tolerated for treatment of HCV infection in clinical practice.

Real-world use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection.

BACKGROUND: Treatment of chronic hepatitis C genotype 3 (GT3) is more challenging compared with other genotypes. Since 2014, several new treatment regimens have been approved but sometimes based on limited data. AIM: To validate the use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection under real-word conditions. METHODS: The German Hepatitis C-Registry is a large national non-interventional real-world study for patients with chronic hepatitis C. A total of 1322 GT3 patients were enrolled (211 untreated and 1111 treated patients). RESULTS: Between February 2014 and September 2015, five different treatment strategies have been used (PegIFN+RBV, PegIFN+RBV+SOF, SOF+RBV, DCV+SOF±RBV, LDV/SOF±RBV). Treatment uptake and use of treatment concepts changed markedly and rapidly during the study influenced by new approvals, guideline recommendations, and label updates. PegIFN-based therapies constantly declined while DCV-based therapies increased with one interruption after the approval of LDV/SOF, which was frequently used until new guidelines recommended not using this combination for GT3. Per-protocol SVR ranged from 80.9% in the PegIFN+RBV group to 96.1% in PegIFN+RBV+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90-95% for DCV+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens. CONCLUSIONS: Real-world data can validate the effectiveness and safety for treatment regimens that had previously been approved with limited data, in particular for specific subgroups of patients. The present study demonstrates how rapid new scientific data, new treatment guidelines, new drug approvals and label changes are implemented into routine clinical practice today.

Chronic hepatitis C patients prior to broad access to interferon-free treatments in Germany.

In 2014, the first interferon-free treatment options for chronic Hepatitis C (CHC) became available in Europe introducing a new era of highly effective and well tolerated oral treatment options for CHC. The data from the cross-sectional study CURRENT-C highlights the epidemiological characteristics of patients with CHC in Germany. During the period that the study was conducted, the approval of the combination drugs for the treatment of CHC was imminent.Between June and November 2014, 1471 CHC-patients not receiving anti-HCV treatment were included nationwide in 40 German centers specializing in viral hepatitis. The mean age was 52.4 years with 41.2 % of the patients being female. Presumed route of infection in male patients was most frequently drug use (46.2 %) and blood products in females (22.8 %). The route of infection was unknown in 28.2 % of male and 43.1 % of female patients. Compared to male patients, female patients were older (55.6 vs. 50.1 years) and longer diagnosed with HCV (18 vs. 15 years). First language of the patients was most frequently German (72.2 %), followed by Russian (14.2 %), and Polish (2.9 %). HCV genotype (GT) 1 was found in 73.8 % (1a 29.0 %, 1b 38.4 %), GT2 in 3.5 %, GT3 in 18.3 %, GT4 in 4.2 %, GT5 in 0.2 %, and GT6 in 0.3 %. Liver cirrhosis was diagnosed in 15.7 % of the patients (17.1 % male, 13.7 % female). 43.2 % of the patients had already received HCV treatment, most frequently dual therapy with pegIFN + RBV (75.8 %) or triple therapy with telaprevir or boceprevir (20.3 %). Compared to treatment-naïve patients, pretreated HCV patients were older (55.1 vs. 50.3 years) and more frequently had liver cirrhosis as clinical diagnosis (22.2 % vs. 10.8 %). Patients scheduled for HCV treatment within the next 3 months had higher rates of pre-treatment (49.4 % vs. 37.0 %), and liver cirrhosis (21.4 % vs. 10.0 %).Compared to epidemiological data of Hüppe et al. 1 from 2003 to 2006, Klass et al. 2 stated in 2012 in a comparable setting that the German CHC population were older and had more advanced liver disease. The current data seem to support this ongoing trend towards more difficult to treat patients with an urgent need for new treatment options.

Costs and outcomes of treating chronic hepatitis C patients in routine care - results from a nationwide multicenter trial.

Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly.

Real-life experience with first generation HCV protease inhibitor therapy in Germany: The prospective, non-interventional PAN cohort.

BACKGROUND AND AIMS: The efficacy and safety of peginterferon alfa-2a (PEG-IFN) plus ribavirin (RBV) and either boceprevir (BOC) or telaprevir (TVR), and physician adherence to treatment algorithms were evaluated in patients included in an ongoing non-interventional study (PAN) enrolling adults with chronic hepatitis C virus (HCV) infection managed in German office-based practices. METHODS: The analysis included HCV genotype 1-infected, treatment-naïve and treatment-experienced patients treated with BOC or TVR. Demographic, treatment history, virological response, safety, and patient management data were collected. RESULTS: Of a total 1087 patients, 58.1 % achieved sustained virological responses (SVR). Response rates were higher in treatment-naïve (BOC 55 %; TVR 63.4 %) and prior relapse patients (BOC 63.2 %; TVR 74.5 %) versus previous null-responders (BOC 14.3 %; TVR 25 %). The most commonly reported adverse event overall was fatigue (60.6 %); 45.8 % patients experienced hemoglobin < 10 g/dL. Patients with cirrhosis had lower rates of SVR versus those without (42.9 % vs. 60.7 %, respectively), and had a higher incidence of serious adverse events (SAEs) (16.7 % vs. 8.6 %, respectively) and treatment discontinuation (44.6 % vs. 25.2 %, respectively). According to recommended response-guided treatment algorithms, about 70 % of patients were managed appropriately, 11/10 % (BOC/TVR) received unnecessarily extended therapy, and 19/7 % (BOC/TVR) received inappropriately shortened therapy. CONCLUSIONS: The efficacy and safety of BOC- and TVR-based triple therapy in this large, "real-world" cohort were largely comparable to that reported in pivotal clinical trials, although SVR rates were lower overall. Recommended futility or treatment extension rules were violated in a substantial proportion of patients with potential implications for response, adverse events and costs.

Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry.

BACKGROUND: The aim of this cross-sectional study was to establish an online inflammatory bowel disease (IBD) registry for a first picture of the situation of IBD outpatients' treatment in Germany. METHODS: Between March 2006 and July 2007 IBD outpatients from 24 gastroenterological specialist practices and two hospitals in Germany were enrolled in an Internet-based registry to evaluate the outpatients' clinical status, psychological impairments, provided health care, as well as medical treatment and medication costs. RESULTS: 1032 IBD patients (ulcerative colitis/UC: 519; Crohn's disease/CD: 511; indeterminate colitis: 2) were enrolled in the study (age: 43 ± 14 years/M ± SD). Disease duration of all patients averaged 10 ± 8.5 years. In 519 UC-patients (49% male; 33% pancolitis), 66% were in remission as were 55% of CD patients (37 % male; 41 % active smokers). Associated with higher rates of disease activity (CDAI ≥ 150; CAI>4) were corticosteroids (CD, UC), topical medication (UC), relevant reported depressive symptoms (15%; 6-31%) and impairments in sexuality (21%; 9-42%). Relevant medication groups prescribed were oral aminosalicylates (UC: 70%; CD: 47%); immunosuppressive therapy - mostly azathioprine/6 MP (CD: 47%; UC: 26%), and Infliximab (CD: 8%; UC: 3%). Strongly associated with their clinical disease activity in UC as well as CD patients, 15% (6-31%) reported relevant depressive symptoms and 21% (9-42%) relevant impairments in sexuality. CONCLUSIONS: The registry constitutes a large complemental database for the patient population in Germany. About one third of the IBD patients were not in clinical remission (CDAI ≥150/CAI >4) (CD: 45%; UC: 27%), although high rates of immunosuppressive drugs (CD: 47%; UC 26%) were administered. This study shows a large burden of active disease associated with an unexpectedly high (co)morbidity and high psychosocial impairments, indicating a reduced health state in IBD patients.

[Rational and efficient diagnosis in different stages of Crohn's disease]. / Rationale und rationelle Diagnostik in unterschiedlichen Krankheitsphasen des Morbus Crohn.

The treatment of patients with inflammatory bowel disease has become more complex in recent years through the introduction of various immunosuppressive agents as well as the approval of monoclonal antibodies. Patients receiving such treatment must be carefully monitored. National and international guidelines define a diagnostic and therapeutic context for the practitioner, but can only partially respond to specific questions on the procedure for individual patients. Within the framework of a project initiated by Abbott entitled "IBD ahead" 34 German IBD experts have elaborated concrete proposals for the utility of clinical symptom assessment, endoscopy and the use of laboratory parameters including foecal markers of inflammation. Furthermore, we discuss the significance of conventional X-rays, computed tomography, ultrasound and magnetic resonance tomography. These recommendations are illustrated by case studies from everyday practice in the participating centres.

Treatment results of chronic hepatitis C genotype 5 and 6 infections in Germany.

Chronic hepatitis C due to HCV genotype 5 and 6 infection is infrequently reported and patients are usually not included in trials. As boceprevir and telaprevir are not approved for these genotypes, pegylated interferon plus ribavirin will remain the treatment of choice for the coming years. Patients infected with HCV genotype 5 or 6 were identified by data base search from an ongoing observational cohort study in Germany. Of the total 23 893 patients, 39 patients (0.2 %) carried a HCV genotype 5 and 39 patients a HCV genotype 6 (0.2 %). Compared to other genotypes patients with genotype 5 were older and more often had a history of blood transfusion. Patients with genotype 6 were more often Asian and showed higher baseline alanine transaminase. Therapy with pegylated interferon alfa-2a and ribavirin was initiated in 24 patients with HCV genotype 5 and 27 patients with HCV genotype 6. After completion of 48 weeks of therapy an end of treatment response was achieved in 79 % and 81 % of treated patients, respectively. Sustained virological response was achieved in 58 % of patients with genotype 5 and in 59 % genotype 6 patients. HCV genotype 5 and 6 infections are rare in Germany. Our findings suggest that most HCV genotype 6 infections are seen in migrants from Asia, whereas HCV genotype 5 infections seem more due to spontaneous local infections. Sustained virological response seems to be better than for patients with genotype 1 or 4 with similar treatment duration.

[Epidemiology and clinical characteristics of patients with chronic hepatitis B (CHB) in Germany - results of a nationwide cross-sectional study]. / Epidemiologie und Klinik von Patienten mit chronischer Hepatitis B (CHB) in Deutschland - Ergebnisse einer bundesweiten Querschnittstudie.

BACKGROUND AND AIMS: Knowledge about the epidemiology, demography and social status of patients with replicative chronic hepatitis B (CHB) in Germany is still scarce. This cross-sectional study evaluated in patients with chronic hepatitis B infection, with a serum HBV-DNA concentration of at least 10,000 copies/mL (> 2000 IU/mL) at documentation visit, the epidemiology, socio-demographics, time of diagnosis, history of disease, prior therapies as well the therapeutic decision. METHODS: 74 German centres with predominately hepatologic focus, recorded in an online-survey the pseudonymised data of patients with chronic HBV-infection with a serum HBV-DNA-concentration of at least 10,000 copies/mL (n = 35). RESULTS: 65 % of the patients were male. The mean age was 40 ± 14 years. 63 % were immigrants (i. e., country of birth not being Germany). 37 % were HBeAg-positive. Mean ALT value 114 ± 183 IU/mL in males and 77 ± 176 IU/mL in females. ALT was above the upper limit of normal (ULN) in 59 % and 9 % of the patients were cirrhotic. The large immigrant groups, Turks (22 %), people from the former USSR (11 %) or from Southeast Asia (10 %) differed in terms of age, sex, HBeAg-status and clinical parameters clearly from each other as well as from German patients. 55 % of the patients from SE-Asia were female and overall considerably younger than German patients. 69 % of the patients with HBV-DNA > 10,000 copies/mL combined with ALT-levels above ULN, and 87 % with advanced fibrosis recieved antiviral treatment. CONCLUSIONS: This database currently contains the largest collection of epidemiological data of CHB patients in Germany. It therefore allows a representative overview on the disease in Germany. In Germany CHB epidemiology is triggered by migration from countries with higher CHB prevalence. However, the high proportion of patients coming from states of the former USSR is likely to be a historical peculiarity of Germany. The sometimes weak German language skills as well as the cultural specifics in the different immigrant groups are still a challenge for health-care providers. The high proportion of viraemic patients, already being treated, could indicate a suboptimal efficacy of the available therapeutic options at the time documentation.

[IBD ahead 2010--Answering important questions in Crohn's disease treatment]. / IBD ahead 2010--Antworten auf zehn zentrale Fragen in der aktuellen Therapie des Morbus Crohn.

The treatment of patients with inflammatory bowel disease has become more complex in recent years through the introduction of various immunosuppressive agents as well as the approval of monoclonal antibodies against TNF-α and patients receiving such treatment must be carefully monitored. National and international guidelines define a diagnostic and therapeutic context for the practitioner, but can only partially respond to specific questions on the procedure for individual patients. Within the framework of a project initiated by Abbott entitled "IBD ahead" 38 German IBD experts have elaborated concrete proposals for dealing with corticosteroids, immunosuppressants and TNF-α antibodies on the basis of the published literature and their own personal experience in order to close the gap between these guidelines and daily clinical practice. Statements were developed on the choice of correct timing of initiation, dose and duration of the individual substances and on how to proceed with patients exhibiting treatment failure. Moreover, recommendations are also made on drug combination strategies, safety monitoring and the risks regarding the development of infectious complications and malignancies. These recommendations are illustrated by case studies from everyday practice in participating centres.

Bowel Preparation for Colonoscopy with Sodium Phosphate Solution versus Polyethylene Glycol-Based Lavage: A Multicenter Trial.

BACKGROUND: Adequate bowel preparation is essential for accurate colonoscopy. Both oral sodium phosphate (NaP) and polyethylene glycol-based lavage (PEG-ELS) are used predominantly as bowel cleansing modalities. NaP has gained popularity due to low drinking volume and lower costs. The purpose of this randomized multicenter observer blinded study was to compare three groups of cleansing (NaP, NaP + sennosides, PEG-ELS + sennosides) in reference to tolerability, acceptance, and cleanliness. PATIENT AND METHODS: 355 outpatients between 18 and 75 years were randomized into three groups (A, B, C) receiving NaP = A, NaP, and sennosides = B or PEG-ELS and sennosides = C. Gastroenterologists performing colonoscopies were blinded to the type of preparation. All patients documented tolerance and adverse events. Vital signs, premedication, completeness, discomfort, and complications were recorded. A quality score (0-4) of cleanliness was generated. RESULTS: The three groups were similar with regard to age, sex, BMI, indication for colonoscopy, and comorbidity. Drinking volumes (L) (A = 4.33 + 1.2, B = 4.56 + 1.18, C = 4.93 + 1.71) were in favor of NaP (P = .005). Discomfort from ingested fluid was recorded in A = 39.8% (versus C: P = .015), B = 46.6% (versus C: P = .147), and C = 54.6%. Differences in tolerability and acceptance between the three groups were statistically not significant. No differences in adverse events and the cleanliness effects occurred in the three groups (P = .113). The cleanliness quality scores 0-2 were calculated in A: 77.7%, B: 86.7%, and C: 85.2%. CONCLUSIONS: These data fail to demonstrate significant differences in tolerability, acceptance, and preparation quality between the three types of bowel preparation for colonoscopy. Cleansing with NaP was not superior to PEG-ELS.

[Effectiveness of screening colonoscopy in a community-based study]. / Die Vorsorgekoloskopie rettet Leben--Ergebnisse der Herner Vorsorgedatei.

In 2002 screening colonoscopy was introduced in Germany for the prevention of colorectal cancer (CRC) and CRC mortality. Individuals took part in a prospective study from October 2002 until September 2005 performed at a single centre for gastroenterology. Histopathological data, surgical-pathological stages and further follow-up events were recorded until 31st of December 2006. For screened individuals without symptoms, the data obtained were compared to those from age-matched patients who presented with clinical symptoms/signs and who underwent colonoscopy during the same period in time. A total of 5066 individuals underwent screening colonoscopy. In this group, colorectal cancer was detected in 46 individuals (0.9%). Endoscopic treatment was considered adequate for 21 cancers. In this group of 46 patients, 94.5% were classified into UICC stages I-II by pathological staging. In 504 screened individuals, colorectal polyps were detected (12.2%) and removed by polypectomy. Of these polyps, 16 were classified as cancer, 496 as adenomas and 1 as a carcinoid tumour. High grade dysplasia was noted in 41 polyps (8.3% of adenomas). In comparison, 4099 symptomatic patients underwent colonoscopy. In this group 100 cancers (2.4%) were detected. Advanced malignant tumours were noted in 39% of these; endoscopic treatment was feasible in 16% of the cancers. As of December 2006, cancer-related deaths were observed in 20% of symptomatic patients with CRC. Screening colonoscopy detects colorectal cancers in the early stages. Given the favourable prognosis in these stages, screening can reduce CRC-related mortality.

[Epidemiology of chronic hepatitis C in Germany--an analysis of 10,326 patients in hepatitis centres and outpatient units]. / Epidemiologie der chronischen Hepatitis C in Deutschland--Eine Analyse von 10,326 Hepatitis-C-Virus-Infizierten aus Schwerpunktpraxen und -ambulanzen.

Little is known about the epidemiology of chronic hepatitis C (CHC) in Germany and especially about the importance of transmission, duration of infection, genotypes, symptoms and quality of life of the patients. The current study prospectively evaluates epidemiological and clinical data of patients infected with the hepatitis C virus (HCV). Using online data entry, various characteristics of 10,326 untreated patients with CHC were documented from March 2003 until May 2006 in 352 centres all over Germany. Mean age of patients was 43.4 years. Patients infected by i.v. drug abuse were considerably younger (36.5 years) than the remaining patients (49.2 years). As indicated by their native language, 64.4% of the patients came from Germany and 19.2% from Russia. 61.7% were infected with genotype 1 and 34.9% with genotype 2 or 3. 45.5% of the patients had been infected by i.v. drug abuse. In at least 5.4% of the patients liver cirrhosis had been proved by biopsy. 63.5% of the patients felt an impairment of quality of life caused by CHC. In many patients infected with hepatitis C socio-economic issues are existent. This is reflected, i.e., in very high rates of unemployment in special subpopulations. Coinfections with hepatitis B and HIV occurred in 1.5% and 4.7%, respectively. Nearly 80% of patients were managed near their homes. The data of the 10 326 patients represent about 2% of all German patients with CHC. This database is up to now the largest of its kind and gives a representative insight into the epidemiological situation of CHC in Germany.

Safety, tolerability and efficacy of peginterferon alpha-2a and ribavirin in chronic hepatitis C in clinical practice: The German Open Safety Trial.

The combination treatment of peginterferon alpha-2a (PEG-IFN alpha-2a; Pegasys) plus ribavirin (RBV) is recommended as a standard care for HCV infections. Side effects and aspects of efficacy and safety have to be balanced. This study evaluates clinical practice data on safety and efficacy of HCV treatment with PEG-IFN in combination with RBV over 24 and 48 weeks. This study was a phase III, multi-centre, open-label study with two treatment groups: PEG-IFN in combination with RBV for 24 or 48 weeks. The allocation to the treatment groups was at the discretion of the investigator; 309 patients entered active treatment: 90 patients received PEG-IFN plus RBV for 24 weeks and 219 patients PEG-IFN plus RBV for 48 weeks. A sustained virological response (SVR) was achieved in 48.9% of all patients. Genotype 1 patients with a 48-week combination treatment achieved an SVR of 39.9%. In the 48-week group a low baseline viral load was associated with a higher SVR rate (47.0% vs. 32.4%). For genotype 2 or 3 patients, the SVR was 67.9%. For these patients there was no relevant difference between patients with low and high viral loads; 97.7% of the patients experienced at least one adverse event. The incidence of serious adverse events was distinctly lower in the 24-week group (4.4% vs. 10.5%). This investigation confirms the well-known risk-benefit ratio found in controlled studies in a clinical practice setting. The safety profile is similar and shows the highest incidence of adverse events in the first 12 weeks of treatment.

[Evaluation of outpatient management in HNPCC]. / Evaluation der ambulanten gastroenterologischen Betreuung von HNPCC-Patienten und deren Familien.

The differential diagnostic assignment of patients with hereditary non-polyposis colorectal cancer among patients with non-familial colorectal carcinoma is difficult but essential to provide early sufficient cancer screening. In order to analyze the actual situation of outpatients, 36 gastroenterologists in private practice have been interviewed with respect to their experience concerning outpatients. The interview data revealed that care for patients with colorectal cancer is a fundamental component of their work. A third of the gastroenterologists deal with patients suffering from colorectal cancer before 45 years of age. Yet these gastroenterologists did not report a single HNPCC patient. Especially gastroenterologists with long lasting experience in private practice did not mention HNPCC patients at all. These results may indicate that identifying the cases at risk for HNPCC is difficult in daily routine work. The possibility of genetic diagnostics (and counselling) should be taken into consideration in individual cases. In consequence comprehensive screening programs can be initiated for patients and their families.

[Effectiveness and patient tolerance of screening colonoscopy -- first results]. / Diagnostische Bedeutung und Akzeptanz der Vorsorgekoloskopie -- erste Ergebnisse.

BACKGROUND: In Germany screening colonoscopy was introduced into the national program on colorectal cancer prevention in October 2002 for asymptomatic subjects older than 55 years. It is the aim of this program to reduce the rate of mortality of colorectal cancer (CRC) during the next decade. Up to now no data are available concerning the outcome and patient tolerance of screening colonoscopy. METHODS: Patients were enrolled in the prospective study between October 2002 and June 2003. The diagnoses from colonoscopy and complications were recorded. A short interview provided information on individual family risks of CRC. During June 2003 all subjects were handed a questionnaire to evaluate their satisfaction and tolerance concerning screening colonoscopy. All subjects were offered sedation (Disoprivan: Propofol). RESULTS: A total of 1117 subjects (776 [69.5 %] female, 341 [30.5 %] male) underwent screening colonoscopy; age: 64.3 +/- 6.9 years. 1104 (98.8 %) requested sedation. In 1090 cases (97.6 %) colonoscopy was completed to the cecum (photographic documentation of cecal landmarks). A total of 11 patients had invasive cancer (1 %), 4 of these had adenomas containing invasive carcinoma. The stage was T1/N0 or T2/N0. A total of 138 (12.4 %) patients had 168 polypoid lesions, which were treated by complete polypectomy. 402 small polypoid lesions (< 0.5 cm) were only detected by biopsy. In this group 233 adenomas (20.9 %) were found. Complications were: 1 perforation and 4 haemorrhages after polypectomy. Patient tolerance was very high. 99.4 % of all subjects agreed to a control colonoscopy or recommended screening colonoscopy to their relatives and friends. CONCLUSION: Screening colonoscopy is an effective and well-accepted method in our unit for gastroenterology. The high prevalence of adenoma and invasive carcinoma suggests that screening colonoscopy should be provided for all persons at the age of 55, especially for men.