Median Percentage Of Time Research Articles

Racial/Ethnic Differences in Ischemic Stroke Rates and the Efficacy of Warfarin Among Patients With Atrial Fibrillation

Warfarin reduces stroke risk in studies of predominantly white patients with atrial fibrillation (AF). Whether nonwhites also have lower rates of stroke while treated with warfarin is unclear. A multiethnic stroke-free cohort hospitalized with nonrheumatic AF was identified in a large health maintenance organization. Stroke risk factors (advanced age, diabetes, hypertension, and heart failure), warfarin use, and anticoagulation intensity were assessed. Crude ischemic stroke rates were calculated by Poisson regression for each group while using and not using warfarin. Cox proportional hazard models were constructed to assess the independent effect of race/ethnicity on ischemic stroke. Between 1995 and 2000, we identified 18867 AF hospitalizations (78.5% white, 8% black, 9.5% Hispanic, and 3.9% Asian). Over the course of 63204 person-years follow-up (median, 3.3 years), 1226 ischemic strokes were identified. The percent-time on warfarin did not differ by race/ethnicity. The median percent-time on warfarin that international normalized ratio was 2 to 3 was 54.5% overall, but it was lower in blacks at 47.8%, whereas the other groups had a rate of approximately 54%. The rate ratios (95% CI) of ischemic stroke with warfarin compared to without warfarin for whites, blacks, Hispanics, and Asians were 0.79 (0.68 to 0.90), 0.92 (0.65 to 1.30), 0.71 (0.48 to 1.05), and 0.65 (0.34 to 1.23), respectively. In this cohort, we did not observe a statistically significant lower rate of stroke with warfarin therapy among nonwhites (in particular blacks) with previous AF hospitalizations. The relatively small numbers of nonwhites renders our estimates less than precise and should be interpreted with caution.

Wireless Esophageal pH Monitoring in Children

A wireless BRAVO (Medtronic, Shoreview, MN) capsule for pH measurement in the diagnosis of gastroesophageal reflux disease (GERD) is intended to be less uncomfortable, and facilitates activity during the measuring period, compared to the usual method with a naso-esophageal catheter. The aim of this study was to report on our experience with the wireless system in children. A secondary aim was to see if there was any cut-off level for esophageal acid exposure causing esophagitis as verified by pathologic examination. A total of 62 wireless 24-hour pH measurements with the BRAVO capsule were carried out over a period of 2 years in 58 children with symptoms of GERD. The median age of the children was 8 +/- 4 years (range, 1-15). They underwent upper endoscopies and the placement of the capsule under general anesthesia. Correlations between endoscope findings and pathologic diagnosis were done. In 10 children, the endoscopies showed esophagitis. The median percent time of pH <4 was 7.0 +/- 9.6% (range, 0-61). The DeMeester score was abnormally high in 33 children. Three children described dysphagia during the measuring time. In 3 patients, we experienced technical problems with the wireless system. Biopsies were taken in 49 children, of which 18 showed esophagitis, with no correlation to the 24-hour pH-measurement findings. Ambulatory pH monitoring, using the wireless pH system, is feasible and was well tolerated by the children. No cut-off level for the acid exposure in correlation to pathologic diagnosis of esophagitis could be found. We recommend the use of the wireless pH-measurement system in children.

48-Hour Wireless Oesophageal pH-Monitoring in Children: Are Two Days Better than One?

Use of a catheter-free, radio telemetric, oesophageal pH-monitoring system in paediatric clinical practice allows patients to follow a more normal physiological pattern of activities and causes less discomfort. At our institution, placement of the capsule is done under general anaesthesia, which restricts the child's activity during the first day. The aim of this study was to determine whether oesophageal pH-measurements should be performed over 48 hours or whether 24-hour measurement provides sufficient and reliable results. The study included 24 consecutive children with symptomatic gastro-oesophageal reflux problems who had undergone upper gastrointestinal endoscopies under general anaesthesia. The radio-transmitting Bravo capsule was introduced transorally and placed above the diaphragm at a width of two vertebral bodies. Oesophageal acid exposure was monitored via a portable receiver for 48 hours. The children's symptoms during measurements were registered. Wilcoxon signed rank test for paired samples was used after power analysis. The capsule was successfully attached to the oesophageal mucosa in all cases with minor technical problems in only one patient. The 48-hour pH-monitoring was completed in 23 patients. The median percentage time with an oesophageal pH of less than 4 was 5.4 +/- 6.8 for the first 24 hours and 5.8 +/- 7.4 for the 48-hour measurement. The DeMeester score was 20.5 +/- 23.7 and 22.2 +/- 25.7, respectively. Ambulatory pH-monitoring using the wireless system is feasible and safe. It was well-tolerated by the children. There was no statistical difference between the pH-measurements or DeMeester scores during the first 24 hours compared with the 48-hour measurements. Individual variations were noted but had no clinical significance except in two patients. Our results support the use of pH-measurement for a period of 24 hours only.

Endoscopic Full-Thickness Plication with Two Serially Placed Implants Improves Esophagitis, GERD Symptoms and Reduces PPI Use and Esophageal Acid Exposure

Purpose: Recently, several endoluminal procedures for the treatment of GERD have been introduced. However, most of these techniques have been abandoned due to either lack of long-term efficacy or serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator™ (NDO Surgical, Inc.) proved effective at controlling reflux symptoms and reducing medication use and esophageal acid exposure. Methods: In all studies to date, a single Plicator implant was placed to form a full thickness plication of the anterior gastric cardia. However, in several cases the narrowing of the GE-junction remained incomplete with this technique. Therefore, we evaluated the safety and effectiveness of placing two Plicator implants within 1 cm of the anterior GE-junction for the treatment of GERD. Results: 37 patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months post-treatment, the proportion of patients achieving >50% improvement in GERD-HRQL score was 68%. Complete PPI cessation was achieved in 59% of patients. In pH studies conducted at 6-months (N = 29), median percent time pH < 4 decreased 36%, with 28% of patients experiencing pH normalization. Erosive Reflux Disease (ERD) was diagnosed in 21 patients before endoscopic full-thickness plication. 16 patients had NERD before endoscopic full-thickness plication. Six months after endoscopic full-thickness plication the number of subjects with ERD was 15 and the number of subjects without esophagitis was 22. There were no serious adverse events observed. Minor adverse events included abdominal pain (73%), sore throat (54%), and chest pain (57%). All adverse events resolved spontaneously without intervention. Conclusion: In this study, endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, GERD medication use, and esophageal acid exposure. When compared to previous studies using a Plicator single implant technique, the Plicator multiple-implant technique demonstrates a similar safety profile and superior efficacy.

Evidence that the Degree and Duration of Acid Suppression are Related to Helicobacter pylori Eradication by Triple Therapy

Eradication rates of Helicobacter pylori by a proton pump inhibitor-based triple therapy depend on CYP2C19 genotype status. We investigated whether gastric acid inhibition during an eradication therapy would influence the eradication rates attained by the triple therapy. Thirty-two patients with H. pylori infection underwent the first-line triple therapy with lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 400 mg b.i.d. for 1 week. In all 32 patients, the 24-hour intragastric pH monitoring was performed on day 6 during the treatment period. The intention-to-treat-based eradication rate by the first-line therapy was 75.0% (24/32, 95%CI: 56.60-88.54%). In patients with successful eradication, the median 24-hour pH was 6.4 (range; 5.0-7.6), which was significantly higher than that in patients without eradication [5.2 (2.2-6.2), p = .0131]. The median percentage time of pH < 4.0 during 24-hour postdose in patients with eradication [0.5% (0.0-31.6%)] was significantly shorter than that in patients without eradication [26.7% (6.0-72.2%), p = .0017]. These parameters for acid inhibition significantly differed among the different CYP2C19 genotype groups. When the percentage time of pH < 4.0 and 24-hour pH were attained < 10% and > 6.0, respectively, during the eradication treatment, the majority of patients could eradicate H. pylori infection, irrespective of the bacterial susceptibility to clarithromycin. The sustained intragastric pH > 4.0 for a longer postdose time appears to be required for a successful eradication of H. pylori with lansoprazole and acid-labile antibiotics.

Acid-Suppressive Effects of Various Regimens of Omeprazole in Helicobacter pylori-Negative CYP2C19 Homozygous Extensive Metabolizers: Which Regimen Has the Strongest Effect?

To achieve more potent and long-lasting acid suppression, omeprazole was administered for 7 days in 5 regimens: 10, 20, and 40 mg once daily (od), and 10 and 20 mg twice daily (bid), in 7 healthy Helicobacter pylori-negative CYP2C19 homozygous extensive metabolizers, and intragastric pH was continuously measured. The median intragastric pH and percent time pH > 4.0 for 24 hours increased dose dependently with 10, 20, and 40 mg od. Ten and 20 mg bid wre comparable to 20 and 40 mg od, respectively. Concerning percent time pH > 4.0 in the nighttime (20:00-8:00 hours), 20 mg bid was significantly superior to 40 mg od (P < .05). In 4 of the 5 regimens, all 7 subjects had nocturnal acid breakthrough, whereas with 20 mg bid it occurred in only 3. We concluded that, considering nighttime acid suppression, omeprazole 20 mg bid had the strongest effect.

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.

Acid-suppressive effects of rabeprazole: Comparing 10 mg and 20 mg twice daily in Japanese Helicobacter pylori-negative and -positive CYP2C19 extensive metabolisers

Background Rabeprazole 10 mg b.i.d. is often administered as therapy for eradication of Helicobacter pylori (H. pylori) and is also proposed as therapy for refractory gastro-oesophageal reflux disease. However, there has not been a comprehensive assessment of its acid-suppressive effects. Aims To compare the acid-suppressive effects of rabeprazole 10 mg b.i.d. with 20 mg b.i.d. considering H. pylori status. Subjects Thirteen H. pylori-negative and eleven H. pylori-positive Japanese CYP2C19 extensive metabolisers (<35 years). Methods Intragastric pH was measured for 24 h three times in a randomised manner; on day 7 of the repeated administration of rabeprazole 10 mg b.i.d. or 20 mg b.i.d., or a placebo. Results In median intragastric pH value and percent time of pH > 3.0, >4.0, >5.0, >6.0, and >7.0 for 24 h, no significant differences were observed between the two doses in either H. pylori-negative or H. pylori-positive subjects. At either dose, these parameters were significantly higher in H. pylori-positive subjects than in H. pylori-negative subjects. Nocturnal acid breakthrough occurred in seven and two of the thirteen H. pylori-negative subjects and one and two of the eleven H. pylori-positive subjects at each dose, respectively. Conclusions The effects of rabeprazole 10 mg b.i.d. were equal to those of 20 mg b.i.d. in H. pylori-positive subjects; whereas in H. pylori-negative subjects, 20 mg b.i.d. was superior for prevention of nocturnal acid breakthrough.

Acid Reflux Immediately Above the Squamocolumnar Junction and in the Distal Esophagus: Simultaneous pH Monitoring Using the Wireless Capsule pH System

The pattern of reflux in the most distal esophagus of asymptomatic individuals is largely unknown. Using a wireless technique we compared the degree and the pattern of acid reflux just above the squamocolumnar junction (SCJ) with that measured at the conventional level for pH monitoring. Fifty-three asymptomatic volunteers underwent endoscopy with transoral placement of two pH recording capsules, one immediately above and one 6 cm above the SCJ. Ambulatory pH monitoring was performed during 48 h. Three subjects were excluded as the distal capsule was inadvertently placed with the pH electrode below the SCJ. The median percent time with pH < 4 and the median number of reflux episodes were significantly higher immediately above the SCJ compared with that found more proximally (1.6%vs 0.9% and 67 vs 26, p < 0.0001). Of all acid reflux events, 69% were isolated episodes immediately above the SCJ. Only 26% of reflux episodes detected at the SCJ extended to the more proximal pH electrode. Reflux events occurring just above the SCJ were more acidic. The number of reflux events with a minimum pH below 2 or 3 was significantly higher at the SCJ compared with that recorded by the upper capsule (16% and 44%vs 6% and 34%, p < 0.0001). Conventional pH monitoring substantially underestimates the degree of acid exposure in the most distal esophagus. In healthy subjects, acid exposure immediately above the SCJ was considerably higher and was characterized by shorter reflux episodes that had a lower minimum pH compared with that measured at the traditional level for pH monitoring.

Design and implementation of GRIP: a computerized glucose control system at a surgical intensive care unit

BackgroundTight glucose control by intensive insulin therapy has become a key part of critical care and is an important field of study in acute coronary care. A balance has to be found between frequency of measurements and the risk of hypoglycemia. Current nurse-driven protocols are paper-based and, therefore, rely on simple rules. For safety and efficiency a computer decision support system that employs complex logic may be superior to paper protocols.MethodsWe designed and implemented GRIP, a stand-alone Java computer program. Our implementation of GRIP will be released as free software. Blood glucose values measured by a point-of-care analyzer were automatically retrieved from the central laboratory database. Additional clinical information was asked from the nurse and the program subsequently advised a new insulin pump rate and glucose sampling interval.ResultsImplementation of the computer program was uneventful and successful. GRIP treated 179 patients for a total of 957 patient-days. Severe hypoglycemia (< 2.2 mmol/L) only occurred once due to human error. With a median (IQR) of 4.9 (4.2 – 6.2) glucose measurements per day the median percentage of time in which glucose fell in the target range was 78%. Nurses rated the program as easy to work with and as an improvement over the preceding paper protocol. They reported no increase in time spent on glucose control.ConclusionA computer driven protocol is a safe and effective means of glucose control at a surgical ICU. Future improvements in the recommendation algorithm may further improve safety and efficiency.

Role of Gastric Acid in Stomal Ulcer after Gastric Bypass

The pathogenetic mechanisms of stomal ulcer after Roux-en-Y gastric bypass (RYGBP) are unclear. In order to study the role of gastric acid, we measured acidity in the proximal pouch using a pH-sensitive probe. 6 patients (5 females, mean age 45 years old at time of operation) with endoscopically confirmed stomal ulcer, were studied 2 to 6 years after RYGBP. All complained of epigastric pain that improved during proton pump inhibitor (PPI) therapy. Control subjects were 6 females (50 years old) who had had RYGBP at least 5 years earlier and denied symptoms of epigastric pain or heartburn. The pH-sensitive probe (Digitrapper-pH, Medtronic) was passed through the nose to the proximal pouch, guided by the calculated distance and pH response. The probe was left in place for 4 hours. The percentage of time with pH <4 was calculated. The probe could be accurately positioned in the proximal pouch both in symptomatic patients and in controls as evidenced by the acid pH reaction. The proximal pouches of patients with stomal ulcer were significantly more exposed to acid compared to controls. The median percentage of time with pH <4 was 69% and 20% in the stomal ulcer and the control group, respectively (P<0.01). Barium follow-through excluded gastro-gastric fistula in stomal ulcer patients. RYGBP patients with stomal ulcer have increased acid production in their proximal pouch in comparison with asymptomatic RYGBP patients. Gastric acid appears to have an important role in the pathogenesis of stomal ulcer.

Lack of predictors of normalization of oesophageal acid exposure in Barrett's oesophagus

Barrett's oesophagus patients may continue to have abnormal oesophageal acid exposure on proton pump inhibitor therapy. The effect of factors such as Barrett's oesophagus length, hiatal hernia size and Helicobacter pylori infection on intra-oesophageal pH in Barrett's oesophagus patients has not been adequately studied. To evaluate oesophageal acid exposure in a large Barrett's oesophagus population on b.d. proton pump inhibitor therapy and determine clinical factors predicting normalization of intra-oesophageal pH on therapy. Barrett's oesophagus patients were studied using 24 h pH monitoring to evaluate intra-oesophageal acid suppression on b.d. dosing of rabeprazole. Forty-six Barrett's oesophagus patients completed the study. Median total percentage time pH < 4 was 1.05% (range: 0-29.9%) in the entire group and respective values for upright and supine percentage time pH < 4 were 1.15% and 0%. However, 34 of the Barrett's oesophagus patients (73.9%) had a normal pH study (median total percentage time pH < 4: 0.2%) and 12 patients (26.1%) had an abnormal result (median total percentage time pH < 4: 9.3%). There were no significant differences between patients with a normal and abnormal 24 h pH result with respect to age, Barrett's oesophagus length, hiatal hernia size and presence of H. pylori infection. Approximately 25% of Barrett's oesophagus patients continue to have abnormal total intra-oesophageal pH profiles despite b.d. proton pump inhibitor therapy. Factors such as age, Barrett's oesophagus length and hiatal hernia size cannot be used to predict persistent abnormal intra-oesophageal pH on proton pump inhibitor.

Pharmacodynamic effects of 3-day intravenous treatment with pantoprazole or ranitidine after 10 days of oral ranitidine

Tachyphylaxis (drug tolerance) is an undesirable condition in drug therapy with histamine-2-receptor antagonists (H2RAs). The concept of overcoming tachyphylaxsis via intravenous (i.v.) administration of proton-pump inhibitors (PPIs) or H2RAs is of significant interest to physicians. In the present study, 32 healthy Helicobacter pylori negative male volunteers were evaluated for the ability of i.v. pantoprazole or i.v. ranitidine to overcome oral ranitidine tachyphylaxis. After 10 days of oral treatment with enteric-coated 300-mg ranitidine tablets once daily in the evening, two groups of 16 volunteers each were randomized to receive either i.v. pantoprazole or i.v. ranitidine for up to 72 h. The primary variable was defined as the increase in 24-h gastric pH median after 1 day of i.v. treatment; the secondary variable was median percentage of time that 24-h gastric pH was <4, as calculated by Hodges-Lehman shift estimators. After 10 days of oral ranitidine treatment, tachyphylaxis was present in all volunteers. Within 1 day of continuous i.v. pantoprazole or i.v. ranitidine administration, 24-h median gastric pH increased from pH 1.45 to pH 3.50 (241%) and from pH 1.50 to pH 2.35 (157%), respectively. I.v. pantoprazole was found to be significantly more effective (p<0.05) than i.v. ranitidine in increasing the 24-h gastric pH after oral ranitidine tachyphylaxis.

Wireless oesophageal pH monitoring: Feasibility, safety and normal values in healthy subjects

ObjectiveA new wireless technique for oesophageal pH monitoring has recently been introduced (Bravo®). To implement this technique in clinical practice, values of normal oesophageal acid exposure need to be defined in a large age- and gender-matched healthy population. The aims of this study were to investigate the feasibility and safety of the wireless technique and to establish normal values for oesophageal acid exposure.Material and methodsFifty-seven asymptomatic subjects underwent upper gastrointestinal endoscopy with transoral placement of a radio-transmitting capsule 6 cm above the squamocolumnar junction. Oesophageal acid exposure was monitored via a portable receiver during 48 h.ResultsSeven men were excluded from the study: capsule dysfunction in 1 and oesophagitis in 6. Fifty subjects (25 M, 25 F, median age 42 years) were included in the study. The radio-transmitting capsule was successfully attached to the oesophageal mucosa in all cases and there were no complications. During pH monitoring 2 capsules were prematurely detached after 32 and 36 h, respectively. The median percentage time with oesophageal pH of less than 4 was 0.7% on day 1 and 1.0% on day 2 (p=0.033) and the 95th percentile for the 48-h recordings was 4.4%.ConclusionsAmbulatory pH monitoring using the Bravo® system is feasible and appears to be safe. This is the first study to establish normal values for oesophageal acid exposure in a large age- and gender-matched healthy population and offers a basis for the use of the wireless technique in clinical practice.

Longitudinal course of bipolar I disorder

The course of bipolar I disorder is characterized by frequently fluctuating levels of manic and depressive symptoms. In the current study, we sought to characterize the month-by- month course of this disorder in 61 patients who were originally enrolled in a clinical trial and were followed for a mean of 23.7 months (SD = 6.1). All patients in the trial received medication management; some received family psychosocial interventions as well. On a monthly basis, we assessed symptom severity using the Modified Hamilton Rating Scale for Depression (MHRSD) and the Bech-Rafaelson Mania Scale (BRMS). Each month, we categorized each participant as fully symptomatic, partially symptomatic, or asymptomatic in terms of both depressed and manic symptoms. We found that the median percent time fully symptomatic was 8%, the median percent time partially symptomatic was 22%, and the median percent time asymptomatic was 59%. Using DSM-IV-TR criteria for defining an acute mood episode, we found that the median length of episode was 1 month, and participants experienced, on average, one episode every 8 months. Estimates concerning percent time fully symptomatic and asymptomatic converge with those reported in other datasets.

Survival after enrollment in an Australian palliative care program

Palliative care services aim to achieve the best quality of life for patients by controlling pain and other physical symptoms and attending to their psychospiritual needs. There have been many studies across different countries looking at timing of referral to palliative care services. Almost universally, timing of referral to palliative care is ‘late’ in the course of the patients' illness. This study looked at survival of patients after enrollment in an Australian integrated palliative care service that consists of inpatient beds (hospice), community care and consultation services. We analyzed the survival of 1138 patients enrolled over a 30-month period. The mean age was 70.1 years and 55% of the patients were male. The most common cancers were lung (19.1%), colorectal (13.4%) and prostate (5.8%), with nonmalignant disease accounting for 5.6% of all patients. The median length of survival was 54 days, with 9.3% of the patients dying within 7 days and 16.96% of patients living longer than six months. Perhaps more importantly than median survival is the time spent on a palliative care program in the overall context of diagnosis till death. The median percentage of time since diagnosis spent on the program was 17%. Timing of referral should be dependent on the need for intervention for physical or psychological symptoms. This can be meaningful whether the number of days till death is small or large.

Intragastric pH during continuous infusion with pantoprazole in patients with bleeding peptic ulcer.

In managing patients with bleeding peptic ulcers, prevention of rebleeding is a particular challenge to hemostasis and fibrinolysis, both of which involve reactions that are impaired in acidic gastric environment. Therefore, such patients are expected to benefit from profound acid suppression. The present investigation aimed to establish a safe and, with regard to pH elevation, effective treatment that, based on in vitro evidence, should provide clinical benefit in this patient population. Patients with acute bleeding peptic ulcers (Forrest Ia, Ib, IIa) after successful endoscopic hemostasis were enrolled in two pilot studies (N = 20 each). They were given an intravenous bolus injection of 80 mg of pantoprazole immediately followed by continuous infusion of either 6 mg/h or 8 mg/h pantoprazole for 72 h. Intragastric pH was measured continuously over 24 h and, if possible, for up to 48 h. Intragastric pH increased rapidly to values of about 6 with both treatments. For the 0-24 h period, the median pH values were 6.1 (68% range 4.5-7.4) and 6.1 (68% range 5.2-6.7) in patients receiving 6 mg/h and 8 mg/h continuous infusion, respectively; the values for the 0-48 h period were 5.9 (4.9-6.7) and 6.3 (5.5-7.0), respectively. The median percentage time that pH was > or =6 during the 0-48 h interval was 47% (68% range 28-89) for the 6 mg/h treatment group and 64% (68% range 41-84) for the 8 mg/h treatment group. Both treatment regimens with pantoprazole were well tolerated based on electrocardiographic measurements, vital signs, clinical laboratory values, and adverse events. Compared with the infusion with 6 mg/h pantoprazole, the continuous infusion of 8 mg/h pantoprazole showed a lower interindividual variability of the intragastric pH and a greater percentage of time that pH was >/ or =6. Thus, with regard to safety and efficacy, an initial 80-mg bolus injection, followed by 8 mg/h continuous infusion, seems to be the adequate treatment in patients with a high risk of rebleeding.

Intragastric pH during continuous infusion with pantoprazole in patients with bleeding peptic ulcer

Objectives In managing patients with bleeding peptic ulcers, prevention of rebleeding is a particular challenge to hemostasis and fibrinolysis, both of which involve reactions that are impaired in acidic gastric environment. Therefore, such patients are expected to benefit from profound acid suppression. The present investigation aimed to establish a safe and, with regard to pH elevation, effective treatment that, based on in vitro evidence, should provide clinical benefit in this patient population. Methods Patients with acute bleeding peptic ulcers (Forrest Ia, Ib, IIa) after successful endoscopic hemostasis were enrolled in two pilot studies (N = 20 each). They were given an intravenous bolus injection of 80 mg of pantoprazole immediately followed by continuous infusion of either 6 mg/h or 8 mg/h pantoprazole for 72 h. Intragastric pH was measured continuously over 24 h and, if possible, for up to 48 h. Results Intragastric pH increased rapidly to values of about 6 with both treatments. For the 0–24 h period, the median pH values were 6.1 (68% range 4.5–7.4) and 6.1 (68% range 5.2–6.7) in patients receiving 6 mg/h and 8 mg/h continuous infusion, respectively; the values for the 0–48 h period were 5.9 (4.9–6.7) and 6.3 (5.5–7.0), respectively. The median percentage time that pH was ≥6 during the 0–48 h interval was 47% (68% range 28–89) for the 6 mg/h treatment group and 64% (68% range 41–84) for the 8 mg/h treatment group. Both treatment regimens with pantoprazole were well tolerated based on electrocardiographic measurements, vital signs, clinical laboratory values, and adverse events. Conclusions Compared with the infusion with 6 mg/h pantoprazole, the continuous infusion of 8 mg/h pantoprazole showed a lower interindividual variability of the intragastric pH and a greater percentage of time that pH was ≥6. Thus, with regard to safety and efficacy, an initial 80-mg bolus injection, followed by 8 mg/h continuous infusion, seems to be the adequate treatment in patients with a high risk of rebleeding.

Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial

Objectives This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD). Methods In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2–4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by ≥50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events. Results At 12 months, 80.3% (95% CI = 69.9%–88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by ≥50%. Treatment response was more likely in patients with residual implant volume of ≥5 mL ( p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline ( p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication. Conclusions Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.

Efficacy and Safety of Oral Pantoprazole 20 mg Given Once Daily for Reflux Esophagitis in Children

To investigate the efficacy and safety of oral pantoprazole, 20 mg (0.5 to 1.0 mg/kg/day) once daily for 28 days, in pediatric patients with reflux esophagitis. Patients in this study (n = 15; 6 to 13 years old, 9 boys) had reflux esophagitis grade Ic or II (Vandenplas classification). The efficacy of pantoprazole to reduce esophageal acid exposure time (pH < 4), reduce the number and duration of reflux episodes, and to increase the percentage of time with gastric pH > 3 was assessed by continuous 24-hour pH monitoring. The intensity of 5 common symptoms of esophagitis was scored before and after treatment on a 4-point scale. Esophagitis was assessed at baseline and after treatment by visual inspection and by the histology of biopsies from the distal third of the esophagus. Before treatment, the median percentage of time with intra-esophageal pH <4 was 9.3%. After 28 days of therapy with pantoprazole, this value decreased to 2.7% (P = 0.0006). The median percentage of time with intragastric pH > 3 increased from 21% at baseline to 39% on day 28 of therapy (P = 0.005). After 28 days of treatment, all patients experienced at least partial relief from reflux symptoms. Endoscopically confirmed healing of esophagitis was seen in 47% of children (Savary-Miller classification). Histologic evidence of healing was not observed. Median serum gastrin levels were slightly elevated over baseline levels (from 74 pg/ml to 93 pg/ml). In one patient there was a transient elevation of serum GOT and GPT during treatment. Oral pantoprazole 20 mg daily provided gastric acid control in 15 pediatric patients with reflux esophagitis with partial clinical improvement of symptoms after 28 days of treatment. Pantoprazole was safe and well tolerated.