Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0013395 (dyspepsia)
 4,879 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status by the U.S. Food and Drug Administration to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. This study explores the potential utility of techniques of decision analysis in evaluating the balance of these benefits and risks. Histamine H2 receptor antagonists (H2-blockers), which are currently available only by prescription, are presented as a case study and were examined to determine how OTC availability of these agents would alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders. Currently, about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would: 1) increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%; 2) increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% currently to 43.2%; 3) result in 14 additional cases of serious hematologic disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline; 4) cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care; and 5) decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia. On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the number of patient encounters with the medical care system for minor gastrointestinal complaints. This study also illustrates the potential utility of the techniques of decision analysis to the formulation of drug regulatory policy.
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PMID:The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers. 197 42

The aim of this study was to compare the direct medical costs associated with the treatment of patients with heartburn/nonulcer dyspepsia under 2 scenarios: (i) no nonprescription histamine H2 receptor antagonist (H2RA) is available (the 'status quo scenario'); and (ii) the H2RA famotidine (at a daily dosage of 10mg) is available over-the-counter (OTC) at retail pharmacies (the 'OTC scenario'). We employed a decision analysis model over a 16-week period that considered direct medical costs from 2 alternative perspectives: (i) society, including the cost of self-medication borne by patients; and (ii) a provincial third-party payer for healthcare. Data concerning direct medical costs associated with consumer self-medication and physician prescription of medication (including pharmacist dispensing fees), tests and procedures, and consultations with general practitioners and specialists were drawn from a clinician panel, published unit costs, and special surveys of institutional databases. All costs are reported in 1993 Canadian dollars ($Can; $Can1 = $US0.72, October 1995). From a societal perspective, the expected cost per patient over a 16-week period is not substantially different between the status quo and the OTC scenarios ($Can98 and $Can96, respectively). From a provincial third-party payer perspective, the expected costs per patient for the same scenarios are $Can95 and $Can89, a saving of $Can6 per patient. These results are sensitive to the proportion of patients who initially choose to see their physician rather than self-medicate, and the percentage of patients achieving successful treatment of symptoms. Changes in the rate or the cost of nonprescription medication, tests/procedures and physician visits do not affect the relative cost rankings. The total number of physician visits remained constant in both scenarios. From the societal cost perspective, the availability of famotidine in nonprescription form yields total costs that are similar to the status quo. However, from the perspective of the provincial payer, the expected costs per patient are likely to be slightly lower than the status quo if famotidine is available in unrestricted OTC scenario use. To generate significant savings to provincial payers, the number of people choosing immediate physician contact would have to be reduced, although not substantially, in the OTC scenario.
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PMID:Switching the histamine H2 receptor antagonist famotidine to nonprescription status in Canada. An economic evaluation. 1016 88

In patients with duodenal ulcer, omeprazole plus clarithromycin (OC) has achieved Helicobacter pylori eradication rates of about 80%, compared with 50% for omeprazole plus amoxicillin (OA). The drug acquisition costs for OC are 102.92 pounds sterling (pounds) compared with 38.96 pounds for OA using generic amoxicillin and 51.63 pounds using the proprietary brand 'Amoxil' (costs for 2-week regimens in 1995). The aim of this analysis was to estimate the total healthcare costs to the general practitioner (GP) of eradication therapy using a simple generalised model. Data about current practice in the UK were obtained from 502 respondents in a survey of hospital specialists and GPs. It was assumed that patients would derive no benefit from eradication therapy unless they had a duodenal ulcer, and that all OA patients received generic amoxicillin. The survey confirmed that OA was the commonest eradication therapy prescribed by UK GPs at that time. Three distinct patient groups were identified: patients with proven duodenal ulcer who were already receiving maintenance treatment with a histamine H2 receptor antagonist, and new patients with dyspepsia who were subdivided into those aged above or below 45 years. Patients receiving maintenance treatment for a duodenal ulcer would be prescribed eradication therapy by their GP without further endoscopy. If dyspepsia recurred after eradication therapy, they would be referred to a gastroenterologist, who would perform an endoscopy to confirm the recurrence of ulceration. In this model, the expected total healthcare costs (i.e. the costs of drug acquisition and subsequent treatment when required) following prescription of eradication therapy were lower for OC (157 pounds) than for OA (173 pounds). New patients aged over 45 years would be referred for endoscopy because of the risk that dyspepsia might be the initial presentation of gastric cancer. If duodenal ulceration was found, eradication therapy would be prescribed and, if dyspepsia remained or recurred, the patient would be referred back to the gastroenterologist. In this case, it was considered unlikely that a further endoscopy would be performed. Thus, the healthcare costs associated with failure of eradication in these patients were less than for patients on maintenance treatment, and the expected total healthcare costs were higher for OC (349 pounds) than for OA (335 pounds). Finally, a new patient aged under 45 years with dyspepsia would have eradication therapy prescribed on the basis of a clinical diagnosis of duodenal ulcer plus serological evidence of infection with H. pylori. Continuation or recurrence of dyspepsia would result in referral to a gastroenterologist, who would perform an endoscopy. The total expected healthcare costs were higher for OC (253 pounds) than for OA (251 pounds). The cost effectiveness of OA was sensitive to changes in the default costs (i.e. the average costs from the survey used in the decision analysis), particularly in patients < 45 years old. In these patients, OC would become the cheaper option if amoxicillin were prescribed by brand name instead of in generic form. In this patient group, the outcome was crucially dependent on the accuracy of the clinical diagnosis of duodenal ulcer; if this was at least 60%, then OC would be the cheaper regimen. Overall, the model clearly shows that the higher drug cost of OC is likely to be substantially offset by savings in other healthcare costs. If the direct healthcare costs of OC are higher than OA, then the decision maker must consider the indirect and intangible costs associated with failure of eradication therapy.
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PMID:Decision analysis of Helicobacter pylori eradication therapy using omeprazole with either clarithromycin or amoxicillin. 1016 Apr 72

Lyophilized aqueous extract of Maytenus ilicifolia leaves (LAEMIL) is commonly used in Brazilian folk medicine in the treatment of dyspepsia as well as gastric ulcers. We have investigated the effect and the possible mechanism of action of the LAEMIL on acid secretion in isolated frog gastric mucosa incubated in an Ussing chamber. It was observed that LAEMIL (7-28 mg%) as well as cimetidine (125-4,000 microM), a well-known histamine H2 receptor antagonist, decreased basal acid secretion in a concentration-dependent manner. Similarly to cimetidine (190 microM), LAEMIL (21 mg%) also inhibited gastric acid secretion induced by increasing concentrations of histamine (50-800 microM). The EC50 values for histamine alone and histamine in the presence of LAEMIL or cimetidine were 94.6 microM (71.1-125.9 microM), 244.9 microM (209.4-286.4 microM) and 142.2 microM (23.6-855.0 microM), respectively. LAEMIL, histamine and cimetidine were effective on acid secretion only when added to the serosal surface of the mucosa. Furthermore, simultaneous addition of LAEMIL and cimetidine at concentrations, per se, ineffective, caused a 16% reduction in the basal acid secretion [from 8.3 +/- 0.3 to 6.9 +/- 0.2 microEq g(-1) (15 min)(-1), n=4]. Although effects such as inhibition of histamine biosynthesis and/or histamine release can not be ruled out, our data suggest that LAEMIL, like cimetidine, reduces acid secretion in the isolated frog gastric mucosa by antagonising histamine H2 receptors.
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PMID:A lyophilized aqueous extract of Maytenus ilicifolia leaves inhibits histamine-mediated acid secretion in isolated frog gastric mucosa. 1501 95

The modern therapy for peptic ulcer disease and other acid peptic diseases is based on administration of proton pump inhibitors (PPI) which have fully replaced anacids, parasympatholytics and histamine H2 receptor antagonists. The most effective way is to administer proton pump inhibitors in the morning on an empty stomach in a single daily dose. It is a very safe therapy, despite the fact that a potential adverse effect of long-term PPI treatment on the efficacy of other medications (clopidogrel), on bone metabolism and development of respiratory infections have been discussed recently. PPI also play an essential role in the eradication treatment of Helicobacter pylori infection, the prevention and treatment of gastropathy induced by nonsteroidal anti-inflammatory drugs and in relation to some rare hypersecretory conditions. The role of proton pump inhibitors in the therapy for functional dyspepsia is contradictory. Massive bleeding from the peptic ulcer is a relatively frequent complication of NSAID gastropathy. Endoscopic hemostasis and parenteral administration of PPI for at least 72 hours are used in therapy. Key words: acid peptic diseases - gastric secretion - peptic ulcer - proton pump inhibitors.
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PMID:Therapy for peptic ulcer disease. 3022 56