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Biomedical subjects

Nimish Vakil

Publications and source records attributed to Nimish Vakil.

At least 37 records · Page 2Linked to original sources
PubMed2005

Increasing compliance with long-term therapy: avoiding complications and adverse events.

Compliance with long-term therapy is an important consideration in any chronic disease. Patients with gastroesophageal reflux disease (GERD) frequently stop and start treatment based on their symptoms. This form of therapy ("on-demand treatment") has been shown to be effective in patients with non-erosive reflux disease and may reduce the costs associated with long-term therapy. However, continuous medical therapy for erosive esophagitis is associated with fewer relapses and better outcomes. Similarly, long-term therapy administered continuously reduces complications such as stricture and may decrease the development of dysplasia in Barrett's esophagus.

Barrett Esophagus↗
PubMed2004

Inter- and intra-observer variability in the measurement of length at endoscopy: Implications for the measurement of Barrett's esophagus.

BACKGROUND: Endoscopic measurements are frequently used to determine the length of Barrett's epithelium. Decreases in measured length also are used to assess response to pharmacotherapy. The aim of this study was to determine the accuracy of the endoscopic measurement of length under standardized conditions. METHODS: A life-size model of the esophagus was built by using an opaque polyvinyl tube. Transparent plastic inserts designed to resemble Barrett's epithelium were created. Ten different insert lengths were randomly studied. Trained endoscopists and fellows in training blinded to the lengths of the inserts performed measurements twice in random order. RESULTS: A total of 240 measurements were made by 12 endoscopists. The mean difference (1 standard deviation) between the measured and correct length was 1.10 (1.7) cm. Overestimation of the length occurred in 47% and underestimation in 37%. The kappa statistic for the first and second measurement (within 0.5 cm) performed by the same individual (intra-observer) was 0.40, suggesting only fair agreement. There was considerable variability between endoscopists. CONCLUSIONS: Accurate measurement of length at endoscopy is difficult even under ideal conditions. Intra-observer agreement is fair, but results obtained by different endoscopists are widely divergent. Small improvements in the length of Barrett's epithelium observed in some clinical trials could be because of chance instead of therapeutic effect.

Barrett Esophagus↗
PubMed2004

The efficacy of proton pump inhibitors in nonulcer dyspepsia: a systematic review and economic analysis.

BACKGROUND AND AIMS: The evidence that proton pump inhibitor (PPI) therapy affects symptoms of nonulcer dyspepsia is conflicting. We conducted a systematic review to evaluate whether PPI therapy had any effect in nonulcer dyspepsia and constructed a health economic model to assess the cost-effectiveness of this approach. METHODS: Electronic searches were performed using the Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, and SIGLE until September 2002. Dyspepsia outcomes were dichotomized into cured/improved versus same/worse. Results were incorporated into a Markov model comparing health service costs and benefits of PPI with antacid therapy over 1 year. RESULTS: Eight trials were identified that compared PPI therapy with placebo in 3293 patients. The relative risk of remaining dyspeptic with PPI therapy versus placebo was .86 (95% confidence interval, .78-.95; P = .003, random-effects model) with a number needed to treat of 9 (95% confidence interval, 5-25). There was statistically significant heterogeneity between trials (heterogeneity chi(2) = 30.05; df = 7; P < .001). The PPI strategy would cost an extra US dollar 278/month free from dyspepsia if the drug cost US dollar 90/month. If a generic price of US dollar 19.99 is used, then a PPI strategy costs an extra US dollar 57/month free from dyspepsia. A third-party payer would be 95% certain that PPI therapy would be cost-effective, provided they were willing to pay US dollar 94/month free from dyspepsia. CONCLUSIONS: PPI therapy may be a cost-effective therapy in nonulcer dyspepsia, provided generic prices are used.

Clinical Trials as Topic↗
PubMed2004

Long-term strategies: a medico-economic perspective.

Gastro-oesophageal reflux disease is a chronic medical condition that is associated with substantial morbidity and impairment of quality of life. The long-term management of the disease requires consideration of treatment efficacy and cost and must meet the needs of patients, physicians and third-party payers.

Anti-Ulcer Agents↗
PubMed2004

Proton pump inhibitors and the time trends for esophageal dilation.

AIM: Little is known about the impact of widespread proton pump inhibitor use on the need for dilation of esophageal strictures. To determine the time trends for upper endoscopy and stricture dilation before and after the availability of proton pump inhibitors. METHODS: The computerized databases of two large community hospitals were analyzed. Annual data on dilation procedures (by all methods) and upper endoscopy were obtained and analyzed in quartiles from 1986 to 2001 to determine if the relative or absolute need for dilation changed following the introduction of proton pump inhibitors in the United States. The number of prescriptions for acid suppressive agents (H2 receptor antagonists and proton pump inhibitors) for the corresponding time period was obtained from the IMS health database. RESULTS: A total of 57,496 upper GI endoscopies and 2,868 esophageal dilations were performed. The proportion of patients undergoing esophageal dilation increased from 4% in 1986-1989 to 6% in 1990-1993 (p < 0.001), remained unchanged (5.8%) in the period from 1994 to 1997 but declined significantly to 3.9% (p < 0.001) in the next quartile (1998-2001). Absolute numbers of dilation procedures declined significantly in the last quartile (1998-2001) and the proton pump inhibitor prescriptions in the United States increased markedly from 1995 onward. CONCLUSIONS: The need for stricture dilation peaked in 1994 and has declined thereafter, corresponding to an increase in the use of proton pump inhibitors. The widespread use of proton pump inhibitors has not, however, abolished the need for esophageal dilation.

Adult↗
PubMed2004

Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection.

OBJECTIVE: There is uncertainty about the best method of testing patients for Helicobacter pylori (H. pylori) infection while they are taking proton pump inhibitors. The aim of this study was to determine: (i) if the decreased sensitivity of the urea breath test during proton pump inhibitor is corrected by different techniques for breath testing and (ii) if the sensitivity of stool test is decreased with the administration of proton pump inhibitors. METHODS: Prospective randomized single-blind study was performed in a tertiary care university hospital. Out of 72 H. pylori infected patients endoscoped for upper abdominal symptoms 48 were randomized to proton pump inhibitors (omeprazole 20 mg each day or esomeprazole 40 mg each day) and 24 to antacid (aluminum hydroxide 800 mg each day) for 14 days. Several breath tests (standard 75 mg (13)C-UBT with citric acid, with orange juice, a tablet breath test with 100 and 50 mg of (13)C), and a stool test were carried out. Baseline samples were collected before and after treatment. RESULTS: The baseline sensitivity for all breath tests was 100% in both groups; for stool test it was 97.8% (95% CI: 88.7-96.6) and 90% (95% CI: 69.9-97.2) in the proton pump inhibitor and antacid group, respectively. After treatment, the sensitivity of tests was significantly low (UBTs range: 77.1%-85.4%; stool test: 83%; 95% CI: 63.9-91.1), while it was unchanged in the antacid group. CONCLUSIONS: False negative breath and stool tests are equally common in patients taking proton pump inhibitors. Antacids do not impair the sensitivity of the breath tests or the stool test.

Administration, Oral↗
PubMed2004

Use of intravenous proton pump inhibitors in community practice: an explanation for the shortage?

BACKGROUND: Since 2001, one intravenous proton pump inhibitor (pantoprazole) has been available in the United States. A drug shortage bulletin was issued for this agent in 2003. AIM: To evaluate the patterns of use of intravenous proton pump inhibitors (IV PPIs) in routine clinical practice. METHODS: Prospective evaluation of IV PPI use in two community-based teaching hospitals. A computerized pharmacy ordering system was used to identify all patients for whom an IV PPI was ordered. Trained investigators obtained clinical data from patient records and these data were mapped to establish clinical criteria for the use of IV PPIs. RESULTS: Intravenous PPIs were prescribed in 238 patients over a 30-day period and a total of 1,631 doses were prescribed. Primary care providers prescribed 46% of prescriptions. Fifty-six percent of patients who received IV PPIs had no acceptable indication for their use. Of the 126 (81%) patients who were started on PPIs for the first time during their hospital stay, 102 were discharged on a PPI. CONCLUSIONS: Intravenous PPIs are widely used for poor indications, which may contribute to the shortage of these agents.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2004

Serological markers for gastric atrophy in asymptomatic patients infected with Helicobacter pylori.

OBJECTIVE: Atrophic gastritis is a precancerous condition that is commonly caused by chronic Helicobacter pylori (H. pylori) infection. This blinded, controlled study was designed to determine if serum gastrin and pepsinogens were reliable markers of atrophy in asymptomatic patients. METHODS: One hundred and forty-seven asymptomatic patients underwent endoscopy with multiple gastric biopsies obtained for histology, culture, and rapid urease test. Fasting serum gastrin (total and G-17) and serum pepsinogens (I-II) were determined by standard immunoassays. Gastric atrophy was histologically assessed in accordance with internationally accepted criteria; three main patterns of gastritis were distinguished: (a) nonatrophic gastritis, (b) atrophic antrum-restricted and antrum-predominant gastritis, and (c) corpus-restricted gastritis. Receiving operating characteristic (ROC) analysis was used to determine the best cut-off for each serum test in nonatrophic gastritis versus antrum-restricted/antrum-predominant atrophic gastritis. RESULTS: No significant differences in serum gastrin and pepsinogens I-II were detected in nonatrophic gastritis versus patients with antrum-restricted/antrum-predominant atrophic gastritis. The positive likelihood ratios for an abnormal serum test to detect antrum-restricted/antrum-predominant atrophy in the gastric body were total serum gastrin 2.13 (95% CI 0.99, 4.6), gastrin-17: 1.55 (95% CI 0.75, 36.17), pepsinogen I: 2.74 (1.4, 5.4), pepsinogen II: 1.74 (1.27, 2.39), and the ratio of pepsinogen I and II: 1.8 (1.2-2.8). Negative likelihood ratios ranged from 0.20 to 0.65. CONCLUSION: In an asymptomatic population, serum gastrin (total and G-17) and pepsinogens I-II (and their ratio) do not discriminate nonatrophic versus antrum-restricted/predominant atrophic gastritis.

Atrophy↗
PubMed2004

Clinical guidelines: the blind leading the deaf?

Clinical guidelines are developed by most specialist societies but the available data suggest that their impact on physician behavior is limited. National guidelines may need modification at the local level to account for local conditions and need regular updates to ensure that they continue to be based on the best available evidence. Measures to involve community practitioners in guideline development may enhance their uptake in the community.

Endoscopy, Gastrointestinal↗
PubMed2004

Antimicrobial resistance incidence and risk factors among Helicobacter pylori-infected persons, United States.

Helicobacter pylori is the primary cause of peptic ulcer disease and an etiologic agent in the development of gastric cancer. H. pylori infection is curable with regimens of multiple antimicrobial agents, and antimicrobial resistance is a leading cause of treatment failure. The Helicobacter pylori Antimicrobial Resistance Monitoring Program (HARP) is a prospective, multicenter U.S. network that tracks national incidence rates of H. pylori antimicrobial resistance. Of 347 clinical H. pylori isolates collected from December 1998 through 2002, 101 (29.1%) were resistant to one antimicrobial agent, and 17 (5%) were resistant to two or more antimicrobial agents. Eighty-seven (25.1%) isolates were resistant to metronidazole, 45 (12.9%) to clarithromycin, and 3 (0.9%) to amoxicillin. On multivariate analysis, black race was the only significant risk factor (p < 0.01, hazard ratio 2.04) for infection with a resistant H. pylori strain. Formulating pretreatment screening strategies or providing alternative therapeutic regimens for high-risk populations may be important for future clinical practice.

Adolescent↗
PubMed2004

Non-invasive tests for the diagnosis of H. pylori infection.

Helicobacter pylori infection can be diagnosed by invasive techniques requiring endoscopy and biopsy (eg, histological examination, culture, polymerase chain reaction) and by non-invasive techniques such as serology, urea breath test, urine/blood test, or detection of H. pylori antigen in stool specimen. Some non-invasive tests, such as the urea breath test and the stool antigen test, detect active infection; these are called "active tests." Non-invasive tests (eg, serology) are markers of exposure to H. pylori but do not indicate if active infection is ongoing; these are called "passive tests." Non-invasive test-and-treat strategies are widely recommended in primary care settings. The choice of an appropriate test depends on the pre-test probability of infection, the characteristics of the test being used, and the cost-effectiveness of the test. This article reviews available non-invasive tests.

Antibodies, Bacterial↗
PubMed2004

Treatment of gastroesophageal reflux disease: defining endpoints that are important to patients.

Patients with gastroesophageal reflux disease (GERD) seek treatment to obtain relief of their symptoms. Symptoms are important to patients because they interfere with activities of daily living and impair quality of life. Clinical trials in GERD have traditionally focused on the healing of erosive esophagitis, and symptom endpoints have been relegated to a secondary role. In primary care, however, patients typically are treated empirically without definition of the presence or absence of esophagitis. Patient-centered endpoints such as complete symptom resolution, patient satisfaction, and improvement in quality of life therefore provide more meaningful results in the broad population of patients with GERD, provided they are coupled with objective data on mucosal healing. This article reviews the importance of patient-centered endpoints in the assessment of the treatment of GERD and concludes that complete resolution of symptoms is the most rigorous endpoint in clinical trials and provides a meaningful endpoint for therapy in clinical practice.

Gastroesophageal Reflux↗
PubMed2003

Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis.

BACKGROUND: Once-in-a-lifetime screening for Barrett esophagus has been proposed for patients with gastroesophageal reflux disease (GERD), but there is little evidence of its cost-effectiveness. OBJECTIVE: 1) To determine the cost-effectiveness of screening high-risk groups for Barrett esophagus and providing surveillance to patients with Barrett esophagus and dysplasia or to all patients with Barrett esophagus and 2) to compare the results with the cost-effectiveness of no screening or surveillance. DESIGN: A decision analytic model was developed to examine no screening or surveillance and screening and surveillance for Barrett esophagus with dysplasia only or Barrett esophagus without dysplasia every 2 to 5 years. Low- or high-grade dysplasia received surveillance every 6 or 3 months, respectively. DATA SOURCES: Published literature and the Health Care Financing Administration. TARGET POPULATION: 50-year-old white men with symptoms of GERD. TIME HORIZON: 50 years of age until 80 years of age or death. PERSPECTIVE: Third-party payer. OUTCOME MEASURE: Incremental cost-effectiveness ratio. RESULTS OF BASE-CASE ANALYSIS: Screening with surveillance limited to patients with Barrett esophagus with dysplasia required $10 440 per quality-adjusted life-year (QALY) saved compared to no screening or surveillance. The incremental cost-effectiveness ratio of surveillance every 5 years in patients with Barrett esophagus without dysplasia compared to surveillance of patients with Barrett esophagus with dysplasia was $596 000 per QALY saved. RESULTS OF SENSITIVITY ANALYSIS: The annual incidence of adenocarcinoma must exceed 1 case per 54 patient-years of follow-up (1.9%) for surveillance of Barrett esophagus without dysplasia every 5 years to yield an incremental cost-effectiveness ratio less than $50 000 per QALY saved. CONCLUSIONS: Screening 50-year-old men with symptoms of GERD to detect adenocarcinoma associated with Barrett esophagus is probably cost-effective. However, subsequent surveillance of patients with Barrett esophagus but no dysplasia, even at 5-year intervals, is an expensive practice.

Adenocarcinoma↗
PubMed2003

Clinical effectiveness of laparoscopic fundoplication in a U.S. community.

BACKGROUND: The aim of our study was to determine the outcome of laparoscopic fundoplication for reflux disease in a cohort of patients who underwent this procedure in routine clinical practice. METHODS: We identified 151 patients who had undergone laparoscopic fundoplication in a managed care organization in Milwaukee. Symptoms were evaluated using a validated questionnaire. Postoperative medication use and endoscopic and surgical procedures were recorded. RESULTS: Eighty-seven patients agreed to participate, of whom 80 (41 [51%] men) were eligible. Their mean (+/- SD) age was 45 +/- 12 years, and the mean duration after surgery was 20 +/- 10 months. Thirty-six patients (45%) underwent the procedure because their physician recommended it, and 22 (27%) because they thought it would cure their disease. Forty-three patients (61%) were satisfied with the outcome of the procedure. Twenty-six patients (32%) were taking medications on a regular basis for treatment of heartburn, 9 (11%) required esophageal dilation for dysphagia, and 6 (7%) had repeat surgical procedures. Of the 54 patients (67%) who reported new symptoms after surgery, 38 reported excessive gas, 22 reported abdominal bloating, and 22 reported dysphagia. Health-related quality of life was significantly lower in patients with these symptoms. CONCLUSION: Medical therapy is required for control of heartburn in approximately one third of patients after laparoscopic fundoplication. New symptoms are common after surgery. Patients need to be better informed about the indications and outcomes of surgery.

Adult↗
PubMed2003

An overview of the success and failure of surgical therapy: standards against which the outcome of endoscopic therapy is measured.

Medical therapy for reflux disease has evolved from frequent antacid use to once daily proton pump inhibitor therapy. Despite the efficacy of these agents in healing erosive esophagitis, there are several short-comings with medical therapy including incomplete symptom relief, the need for continuous maintenance therapy, and cost. Endoscopic and laparoscopic treatments for reflux disease are appealing because they could reduce or eliminate the need for chronic maintenance therapy with medications. While there is evidence of high quality on the efficacy of medical therapy from randomized controlled trials, data on endoscopic procedures and surgery is more limited. This article summarizes the needed studies and the standards against which these procedures should be measured.

Clinical Trials as Topic↗