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J Labenz

Publications and source records attributed to J Labenz.

At least 37 records · Page 2Linked to original sources
PubMed2003

A summary of Food and Drug Administration-reported adverse events and drug interactions occurring during therapy with omeprazole, lansoprazole and pantoprazole.

BACKGROUND: Pantoprazole is claimed to have a lower potential for drug interaction than other proton pump inhibitors. AIM: To estimate the frequency of adverse events and drug interactions reported to the Food and Drug Administration in patients receiving omeprazole, lansoprazole or pantoprazole. METHODS: The study involved a search of the Food and Drug Administration's database for adverse events and drug interactions with omeprazole, lansoprazole or pantoprazole as primary or secondary suspect drug. An estimate of the amount of drug dispensed during the adverse event collection period (from US drug launch) was obtained from the International Medical Statistics health database. RESULTS: Of the suspected drug interactions recorded, vitamin K antagonist interactions, although rare, were the most common. The frequency of vitamin K antagonist interactions was 0.09 per million packages for omeprazole and 0.11 per million packages for lansoprazole and pantoprazole. Interactions with benzodiazepines or phenytoin were even rarer, being reported in less than 10 patients on each proton pump inhibitor. CONCLUSION: The frequency of reported drug interactions was low for omeprazole, lansoprazole and pantoprazole and vitamin K antagonist interactions were by far the most common. These potentially important drug interactions, although rare, were no less frequent on pantoprazole than on omeprazole or lansoprazole, suggesting a class effect.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

Impact of reflux disease on general and disease-related quality of life - evidence from a recent comparative methodological study in Germany.

BACKGROUND: The clinical and socioeconomic burden of gastro-esophageal reflux disease (GERD) is considerable. The primary symptom of GERD is heartburn, but it may also be associated with extraesophageal manifestations, such as asthma, chest pain and otolaryngologic disorders. AIM: To describe the impact of heartburn on patients' Health-Related Quality of Life (HRQL) in Germany, using validated generic and disease-specific instruments to measure patient-reported outcomes. METHOD: Patients with symptoms of heartburn completed the German versions of the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), the Short Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn during the previous 7 days were also recorded. RESULTS: 142 consecutive patients completed the assessments (mean age of 47.5 years, SD = 14.6; 55.6 % female). 70 % of patients had moderate symptoms. Over half (68 %) had symptoms on more than 4 days in the previous week. Patients were most bothered by symptoms of reflux with a mean GSRS score, (ranges from 1 [not bothered] to 7 [very bothered]), of 3.9, indigestion of 3.3 and abdominal pain of 3.0, respectively. As a result of their symptoms, patients experienced problems with food and drink. The mean QOLRAD score (ranges from 1 to 7; the lower the value the more severe the impact on quality of life) of daily functioning was 4.4, impaired vitality 4.6, emotional distress 5.0 and sleep disturbance 5.1, respectively. This led to impaired overall HRQL across all domains (mean SF-36 score of this heartburn population compared to a general population in Germany). Using HAD, 25 % of patients were anxious and 8 % were depressed. CONCLUSION: There is consistent evidence that heartburn substantially impairs all aspects of health-related quality of life.

Adult↗
PubMed2002

[Proton pump inhibitors according to need. Always for heartburn].

Gastroesophageal reflux disease (GERD) is one of the most common medical problems. The large majority of patients so affected have no endoscopically evident disease, or only mild erosive reflux esophagitis. Since both forms of GERD are probably non-progressive, on-demand therapy aimed at adequately controlling symptoms is safe treatment. Proton pump inhibitors (PPI) are the drugs of choice for acute and long-term treatment. In 1999, the first study reporting on on-demand therapy with omeprazole was published. A clear superiority over placebo was found, as was also dependence of the effect on the dose. In the recent past, publications have reported on on-demand therapy with the s-isomer of omeprazole--esomeprazole. With success rates of around 90%, on-demand therapy has proven to be highly effective. On average, the patients take one 20 mg tablet of esomeprazole on every third to fourth day.

Anti-Ulcer Agents↗
PubMed2002

[Prevalence of gastro-oesophageal reflux disease in general practice].

BACKGROUND AND OBJECTIVE: While there is an ever rising prevalence of gastro-oesophageal reflux disease among people in the western world, the actual number are usually underestimated, because many afflicted persons do not seek medical care. This study was undertaken to determine the frequency of unrecognized reflux disease among an unselected patient cohort in general practice. In addition, answers by these patients to a questionnaire were evaluated. PATIENTS AND METHODS: 162 consecutive patients of a general practice without known gastro-oesophageal reflux took part. After the questionnaire had been filled in a history was obtained with semi-quantitative grading of dyspeptic symptoms, and all underwent a physical examination. A gastroscopy was offered to all patients. Gastro-oesophageal reflux was diagnosed when endoscopy revealed typical oesophageal lesions and/or there were at least moderately severe reflux symptoms that had reduced the patient's quality of life. RESULTS: 82 patients (51%) had reflux disease. 121 patients underwent endoscopy. Structural changes (reflux oesophagitis, Barrett metaplasia) were seen in 28 of the 82 patients with reflux disease (34%), 17% of the entire cohort. Axial hiatus hernia, positive family history, advancing age, over-weight, female gender and treatment with NSAIDs or aspirin were significant risk factors in the development of reflux disease. Patients with reflux disease significantly more frequently suffered from hoarseness and/or cough. Positive or negative predictability of the questionnaire regarding the diagnosis of reflux disease was 94% each way. CONCLUSION: The prevalence of unrecognized gastro-oesophageal reflux disease in the population is extraordinarily high. One quarter to one third of those with reflux disease have cough or hoarseness. The disease can apparently be reliably diagnosed by a standardized questionnaire.

Adult↗
PubMed2002

High rate of post-therapeutic resistance after failure of macrolide-nitroimidazole triple therapy to cure Helicobacter pylori infection: impact of two second-line therapies in a randomized study.

BACKGROUND: The optimal second-line treatment after failed Helicobacter pylori therapy has not been established. AIMS: To ascertain whether quadruple therapy or triple therapy with omeprazole, clarithromycin and amoxicillin is the superior re-treatment after triple therapy containing a macrolide and a nitroimidazole, and to determine the impact of microbial in vitro resistance. METHODS: Patients after failed triple therapy were randomly allocated to one of two 1-week second-line treatments: omeprazole, 40 mg, clarithromycin, 500 mg, and amoxicillin, 1 g, all b.d.; or omeprazole, 20 mg b.d., bismuth subsalicylate, 600 mg q.d.s., metronidazole, 400 mg t.d.s., and tetracycline, 500 mg q.d.s. Post-therapeutic Helicobacter pylori status was assessed by 13C-urea breath test at least 4 weeks after treatment. RESULTS: The study was terminated after including 84 patients. H. pylori cure rates differed significantly: omeprazole-clarithromycin-amoxicillin: intention-to-treat, 43%; per protocol, 50%; omeprazole-bismuth subsalicylate-metronidazole-tetracycline: intention-to-treat, 68%; per protocol, 69%. The frequencies of resistance after first-line therapy were: metronidazole, 90%; clarithromycin, 71%; both combined, 68%. For clarithromycin resistance, H. pylori cure with omeprazole-clarithromycin-amoxicillin was 30% vs. 83% for clarithromycin susceptibility. CONCLUSIONS: Omeprazole-bismuth subsalicylate-metron- idazole-tetracycline was superior to omeprazole-clarithromycin-amoxicillin, but both therapies yielded unsatisfactory results. The high rate of post-therapeutic dual resistance has a negative impact on omepraz- ole-clarithromycin-amoxicillin, and probably also on omeprazole-bismuth subsalicylate-metronidazole-tetracycline, and limits the choice for second-line treatment.

Adult↗
PubMed2002

Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial.

BACKGROUND: There is much controversy as to whether or not treatment of Helicobacter pylori reduces the occurrence of peptic ulcers during therapy with a non-steroidal anti-inflammatory drug (NSAID). AIM: To assess the efficacy of triple therapy or omeprazole on the occurrence of diclofenac associated ulcers in H pylori positive patients. METHODS: This was a randomised, double blind, placebo controlled, multicentre trial in H pylori positive patients requiring NSAID therapy who had no past or current peptic ulcer. They received diclofenac 50 mg twice daily for five weeks in combination with one of the four randomly assigned treatments: anti-H pylori treatment for one week (omeprazole 20 mg+clarithromycin 500 mg+amoxicillin 1 g, all twice daily) followed by placebo for four weeks (OAC-P); anti-H pylori treatment for one week followed by antisecretory treatment with omeprazole 20 mg once daily for four weeks (OAC-O); omeprazole 20 mg once daily for five weeks (O-O); or placebo for five weeks (P-P). Patients were endoscoped before and after treatment. RESULTS: Data from 660 patients were included in an intention to treat analysis. The occurrence of peptic ulcers in the four treatment groups during the study period was: 1.2% for OAC-P, 1.2% for OAC-O, 0% for O-O, and 5.8% for P-P (p<0.05 between placebo and all active treatment groups). Patients who received active treatment developed therapy requiring dyspeptic symptoms less frequently than those who received placebo (p<0.05 between placebo and all active treatment groups). CONCLUSIONS: In H pylori infected patients, all three active therapies reduced the occurrence of NSAID associated peptic ulcer and dyspeptic symptoms requiring therapy.

Adult↗
PubMed2001

[Insufficient validity of a rapid blood test for diagnosis of Helicobacter pylori infection].

BACKGROUND AND AIM: Rapid blood tests for diagnosis of Helicobacter (H.) pylori infection enable to detect antibodies against H. pylori instantly without laboratory equipment. Primary aim: to validate the Helisal Rapid Whole Blood Test (HRBT) with endoscopic bioptic methods as reference. Secondary aim: to compare the HRBT with ELISA IgG serology. PATIENTS AND METHODS: The HRBT was performed in 145 consecutive dyspeptic patients (median age 59 years) before undergoing esophagogastroduodenoscopy including biopsies from gastric antrum and corpus. A positive H. pylori status was defined by a positive culture or the combination of a positive rapid urease test and a positive histology. Serum for ELISA IgG testing was available from 92 patients. RESULTS: The H. pylori status was positive in 66% of the patients. The sensitivity of the HRBT resulted at 80%, the specificity at 82%. The sensitivity of the HRBT for a positive ELISA test amounted to 87%, the specificity to 96%. CONCLUSIONS: The diagnostic validity of the HRBT is insufficient for clinical application. False test results add up by the general discrepancy between serological and bioptic methods and by diminished sensitivity compared to ELISA serology.

Adult↗
PubMed2001

Current role of acid suppressants in Helicobacter pylori eradication therapy.

Helicobacter pylori induces chronic active gastritis that may progress to atrophy. Serious clinical consequences are peptic ulcer disease and gastric malignancies. Today, treatment of the infection is an appropriate option and is strongly recommended in various clinical situations. Although many antibiotics are effective against H. pylori in vitro, few substances are suitable for use in vivo. This is because H. pylori lives in a unique environment in which several factors may affect the pharmacokinetic and pharmacodynamic properties of the anti-microbial agents. One of the most important factors is gastric acidity. This article reviews the effects of acid suppression on H. pylori and the associated gastritis, the potential mechanisms by which anti-secretory drugs such as proton pump inhibitors might enhance the activity of anti-microbials in vivo, and the results of clinical trials supporting the current view that proton pump inhibitors are a mainstay in the treatment of this infection.

Anti-Ulcer Agents↗
PubMed2001

Diagnostic accuracy of (13)C-urea breath test in the diagnosis of Helicobacter pylori infection in patients with partial gastric resection due to peptic ulcer disease: a prospective multicenter study.

AIMS: We investigated the diagnostic properties of the (13)C-urea breath test ((13)C-UBT) prospectively. These are well validated in nonresected patients before and after treatment of Helicobacter pylori infection but not in patients with partial gastric resection due to peptic ulcer disease. METHODS: Hospitalized patients with previous gastric resection and indications for upper gastrointestinal endoscopy were recruited for the study. Biopsy specimens were obtained from the fundus mucosa and the gastric remnant adjacent to the gastroenteric anastomosis for histological examination and rapid urease test (HUT test). Histological slides were evaluated after hematoxylin and eosin and Warthin-Starry dye staining. 200 ml orange juice was given orally after two baseline breath samples had been taken, and 30 min after ingestion of 75 mg (13)C urea two more breath samples were obtained and analyzed by ratio mass spectrometry. The Warthin-Starry dye-stained sample was taken as reference. RESULTS: 68 patients (47 male, 21 female, mean age 62 years; 52 Billroth II resection, 17 Billroth I resection) were included in the study. The overall prevalence of histologically proven H. pylori infection was 36.7%. The sensitivity of the (13)C-UBT was 52%, the specificity 93%. The positive predictive value was 81.25%, the negative predictive value 76.9% and the accuracy was 77.9%. The sensitivity of the HUT test reached 60%, and the specificity 97%. CONCLUSION: The diagnostic accuracy of (13)C-UBT compared with the Warthin-Starry dye staining is low. The breath test, performed in the above-described manner, cannot be recommended as a noninvasive diagnostic tool for diagnosis of H. pylori infection in patients after partial gastrectomy as a result of peptic ulcer disease.

Administration, Oral↗
PubMed2001

Helicobacter pylori and gastric cancer:current status of the Austrain Czech German gastric cancer prevention trial (PRISMA Study).

AIM: To test the hypothesis that Helicobacter pylori eradication alone can reduce the incidence of gastric cancer in a subgroup of individuals with an increased risk for this fatal disease. METHODS: It is a prospective, randomized, double blind, placebo controlled multinational multicenter trial. Men between 55 and 65 years of age with a gastric cancer phenotype of Helicobacter pylori gastritis are randomized to receive a 7 day course of omeprazole 2 X 20mg, clarithromycin 2 X 500mg, and amoxicillin 2 X 1g for 7 days, or omeprazole 2 X 20mg plus placebo. Follow-up endoscopy is scheduled 3 months after therapy, and thereafter in one-year intervals. Predefined study endpoints are gastric cancer, precancerous lesions (dysplasia, adenoma), other cancers, and death. RESULTS: Since March 1998, 1524 target patients have been screened, 279 patients (18.3%) had a corpus dominant type of H. pylori gastritis, and 167 of those were randomized (58.8%). In the active treatment group (r = 86), H. pylori infection infection was cured in 88.9% of patients. Currently, the cumulative follow-up time is 3046 months (253.38 patient years, median follow up 16 months). So far, none of the patients developed gastric cancer or any precancerous lesion. Three (1.8%) patients reached study endpoints other than gastric cancer. CONCLUSION: Among men between 55 and 65 years of age, the gastric cancer phenotype of H. pylori gastritis appears to be more common than expected. Further follow up and continuing recruitment are necessary to fulfil the main aim of the study.

Amoxicillin↗
PubMed2000

One-week triple therapy with esomeprazole provides effective eradication of Helicobacter pylori in duodenal ulcer disease.

BACKGROUND: Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of acid-related diseases. METHODS: Four hundred and forty eight duodenal ulcer patients with Helicobacter pylori infection, confirmed by 13C-urea breath test (UBT), and no current ulcer, were randomised to double-blind treatment with esomeprazole 20 mg twice daily (b.d.) (n=224) or omeprazole 20 mg b.d. (n=224), in combination with amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week (EAC and OAC, respectively). A negative UBT at both 4 and 8 weeks after completing therapy indicated successful H. pylori eradication. RESULTS: Intention-to-treat (ITT) analysis comprised 400 patients (EAC, n=204; OAC, n=196) and per protocol (PP) analysis 377 patients (EAC, n=192; OAC, n=185). Eradication rates (95% confidence intervals) for ITT and PP populations were: EAC, 90% (85-94%) and 91% (86-94%); OAC, 88% (82-92%) and 91% (86-95%). Between-group differences in eradication rates were not statistically significant. Both regimens were well tolerated, with an adverse event profile and frequency typical of proton pump inhibitor plus antibiotic combination therapy. CONCLUSIONS: Esomeprazole-based triple therapy for 1 week is highly effective in eradicating H. pylori infection in duodenal ulcer disease, offers comparable efficacy to omeprazole-based therapy, and is well tolerated.

Adult↗
PubMed2000

Consequences of Helicobacter pylori cure in ulcer patients.

In the complex pathogenesis of genuine ulcer disease Helicobacter pylori (H. pylori) is an essential, although not on its own sufficient, causal factor. Eradication of the infection heals the active ulcer and, in the long term, leads to a drastic reduction in ulcer recurrence and attendant complications. Some patients remain symptomatic even without ulcer recurrence, and in these, pre-existing, exacerbated or induced gastro-oesophageal reflux disease is probably of some significance. Possible causes of ulcer relapse are reinfection, the use of ulcerogenic drugs and persistent gastric hypersecretion. In adults, and probably also in children from the age of six years, H. pylori reinfection is rare, provided that a sensitive and specific test for H. pylori is carried out at the earliest 4 weeks after concluding anti-bacterial treatment. The most common cause of the reappearance of H. pylori is recrudescence - true reinfection hardly ever occurs. The healing of H. pylori-associated ulcer disease improves the patient's quality of life and possibly also life expectancy. Computer-aided calculations, together with a randomized controlled study, have shown not only that individual patients benefit, but that also the health system profits financially. The hypothetical negative effects of H. pylori eradication treatment are still being controversially discussed.

Adult↗
PubMed1999

[Helicobacter pylori screening in a general practice].

BACKGROUND AND OBJECTIVE: The significance of Helicobacter pylori (Hp) infection in asymptomatic persons is largely unknown. This prospective study was undertaken to evaluate the diagnostic and, if appropriate, therapeutic relevance of a noninvasive screening for Hp. In addition, the practicality and validity of a simple serological test on whole blood was elucidated. PATIENTS AND METHODS: 100 consecutive patients (29 males, 71 females, median age 46 [18-79] years) of a general medical practice, seen in November of 1997, were included. Three patients had to be subsequently excluded, because they had been treated for Hp infection. All patients were given a standard interview after which a serological whole-blood test (BM-Test Helicobacter pylori; Boehringer Mannheim) and a 13C-urea breath test were performed as noninvasive reference. Endoscopy of the upper gastrointestinal tract was offered if the serology and/or the breath test were gative. RESULTS: The Hp prevalence was 40%, rising significantly with age. The rapid serology test, when related to the breath test, had a negative and positive predictive value of < 80%. 44 of the 47 patients with a positive serological or breath test agreed to endoscopy. Eleven of them had a clinically significant abnormality macroscopically or histologically: four of them were found to have an Hp infection. CONCLUSIONS: Asymptomatic Hp-positive persons frequently have clinically abnormal findings in the upper gastrointestinal tract. These data point to the need for a large multi-centre study with cost-effect analysis to evaluate a noninvasive Hp screening test in nonsymptomatic persons as a public health measure. The 13C-urea breath test would be suitable as such a screening method.

Adult↗