Analysis of the implementation of a personalized care model in diabetes mellitus as an example of chronic disease with information and communication technology support.

INTRODUCTION: Diabetes mellitus affects 13.8% of the adult population in Spain, representing some 8.2% of total Spanish health spending, which may be reduced by optimizing treatment and disease monitoring. Areas covered: This perspective article aims to evaluate the possible clinical and economic outcomes of implementing a theoretical personalized care model in diabetes supported by information and communications technology in Spain vs. conventional care. Moreover, we assessed the value of emminens® eConecta, a solution designed to support the operational implementation of this model, which enables the connection and participation of patients and health professionals, facilitates patient education, decision-making, access to information, and data analysis. We carried out a review of the available evidence, consultations with experts and a clinical and cost estimation. Expert commentary: The experts consulted considered that the proposed model is consistent with Spanish strategies on chronicity, supports the management of chronicity/diabetes, and may improve the most important aspects of disease management. In the literature, this type of care models improved or provided equal disease control compared with conventional care, potentiated self-management strategies and reduced the high use of resources. Cost estimation showed a reduction of -12% in total direct costs and around -34% in the costs of outpatient visits.

Cost-effectiveness analysis of sacral neuromodulation (SNM) with Interstim for fecal incontinence patients in Spain.

INTRODUCTION: Fecal incontinence (FI) is a condition with a high impact on the psychological and social life of healthy people. Interstim, the sacral neuromodulation (SNM) therapy, has shown higher effectiveness and safety rates than surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and after sphincteroplasty in patients with structurally deficient anal sphincter (SDAS). OBJECTIVE: To assess the cost-effectiveness of FI management in two scenarios - with and without SNM - and to estimate the potential budget impact of its progressive introduction in the Spanish setting. METHODS: Two decision analytical models were developed (IAS and SDAS patients) representing the possible clinical paths for each of the scenarios (with and without SNM), as well as its clinical and economic consequences in the mid-to long term with a Markov model. Clinical and resource use data were retrieved from the literature and validated by a clinician expert panel. Effectiveness was measured with both QALYs and symptom-free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon = 5 years). Prevalence figures were combined with Interstim sales forecasts to estimate the total number of patients to receive therapy over the next 5 years and the associated budget impact. RESULTS: The introduction of Interstim in the therapeutic management of FI has an associated cost-effectiveness of euro16 181 (IAS patients) and euro22 195 (SDAS patients) per QALY gained. The progressive introduction of Interstim in 75 to 100 patients/year will have an estimated budget impact of 0.1% of incremental costs in patients with FI. CONCLUSIONS: Introducing Interstim in the management of FI in IAS and SDAS patients in the Spanish setting has shown to be an efficient measure with an incremental cost-effectiveness ratio below the accepted Spanish threshold (around euro35 000/QALY), and with a relatively low additional cost for the Spanish NHS.

[Economic evaluation of a new selective COX-2 NSAID, rofecoxib, in a real practice context]. / Evaluación económica de un nuevo AINE COX-2 selectivo, rofecoxib, en un entorno de práctica real.

OBJECTIVE: To evaluate the economic and health consequences of the use of a new COX-2 anti-inflammatory drug. DESIGN: Cost-effectiveness analysis by modelling three options for prescribing non-steroidal anti-inflammatories (NSAIDs) in patients diagnosed with arthrosis and undergoing long-term NSAID treatment. Option 1: NSAID prescription without gastric protection for low-risk patients, and with gastric protection for patients running a medium or high risk of developing complications (current procedure). Option 2: exclusive prescription of rofecoxib (25 mg/day) for all patients (high and low risk). Option 3: single-therapy rofecoxib (25 mg/day) prescription for patients sensitive to combined treatment (NSAIDs and gastric protection) due to the risk of complications. In each case, resources and expected clinical benefits were accounted for by the calculation of the cost of avoidance of each moderate or high gastro-intestinal side-effect (GISE) (symptomatic ulcer or complication) avoided. The direct economic impact on the centre of passing from option 1 to any of the other two options was calculated. SETTINGS AND PARTICIPANTS: The study, conducted in the Barceloneta Primary Care Centre, included in its modelling the 124 patients diagnosed with arthrosis who received NSAIDs continuously during the year 2000. RESULTS: Option 2 supposed avoiding 1.5 cases of GISE (0.5 symptomatic ulcers and 0.9 serious complications), to an additional cost of 336 566.78 euros. Each case avoided would cost 24,641.50 euros; and each serious case avoided 38,464.79 euros. Option 3 avoided 0.25 cases of serious complication, at an additional cost of 9,015.18 euros. Avoiding one case would cost 37,262.75 euros. CONCLUSIONS: The overall health benefits arising from the universal or partial introduction of a selective COX-2 inhibitor NSAID involve a unit cost of 24,040.48 or 36,060.73 euros, depending on the option. The impact on the Centre s pharmaceutical budget would increase by 1.3% under option 2, and by 0.35% under option 3.

Evaluación económica de un nuevo AINE COX-2 selectivo, rofecoxib, en un entorno de práctica real / Economic evaluation of a new selective cox-2 NSAID in a real practice context

Objetivo. Valorar las consecuencias económicas y sanitarias de la eventual utilización de un nuevo antiinflamatorio COX-2. Diseño. Análisis de coste-efectividad mediante modelización de tres alternativas de prescripción de antiinflamatorios no esteroideos (AINE) en pacientes diagnosticados de artrosis y sometidos a tratamientos de larga duración con AINE: a) alternativa 1: prescripción de AINE sin gastroprotección a los pacientes de bajo riesgo y de AINE con gastroprotección a los expuestos a un riesgo medio y alto de presentar complicaciones (procedimiento actual); alternativa 2: prescripción exclusiva de rofecoxib (25 mg/día) a todos los pacientes (alto y bajo riesgo), y c) alternativa 3: prescripción en monoterapia de rofecoxib (25 mg/día) a los pacientes susceptibles de recibir tratamiento combinado (AINE + gastroprotección) debido al riesgo de complicaciones. Se contabilizan, en cada caso, los recursos y los beneficios clínicos esperados mediante el cálculo del coste por cada efecto secundario gastrointestinal (ESGI) de gravedad moderada o alta (ulcus sintomáticos y complicaciones) evitado. Se cuantifica el impacto económico directo que supondría para el centro pasar de la primera alternativa a cualquiera de las otras dos. Emplazamiento y participantes. El estudio se ha realizado en el Centro de Atención primaria de la Barceloneta y ha incluido para la modelización a los 124 pacientes diagnosticados de artrosis que durante el año 2000 recibieron AINE de forma continuada. Resultados. La alternativa 2 supondría evitar 1,5 casos de ESGI (0,5 ulcus sintomáticos y 0,9 complicaciones graves), con un coste adicional de 336.566,78 euros. Cada caso evitado costaría 24.641,50 euros y cada caso grave evitado 38.464,77 euros. La alternativa 3 evitaría 0,25 casos de complicación grave, a un coste adicional de 9.015,18 euros. Evitar un caso costaría 37.262,75 euros. Conclusiones. Los eventuales beneficios sanitarios derivados de la incorporación universal o parcial de un AINE inhibidor selectivo de la COX-2 comportan un coste por unidad de beneficio de 24.000 o 36.000 euros, según la alternativa. El impacto sobre el presupuesto de farmacia del centro se incrementaría en un 1,3 per cent con la alternativa 2 y un 0,35 per cent con la 3. (AU)

Prevalence of pain in the Spanish population: telephone survey in 5000 homes.

Pain has become the most common accompanying symptom in patients seeking medical advice, and it is one of the main issues in public health. In Spain, there are no reliable data about the impact of pain in general population. The aim of the study was to estimate the prevalence of acute and chronic pain in the Spanish general population. An epidemiological observational population-based cross-sectional study was carried out by means of a telephone survey. Multistep stratified quota-adjusted sampling was performed with people aged 18-95 years. A computer-assisted questionnaire was administered, covering physical pain symptoms, site, frequency, perceived cause, therapeutic measures and interference with daily life activities. There were 11,980 useful contacts, with 5000 effective interviews (42% of useful sample). Of the interviewees, 29.6% (95% confidence interval, 28.3-30.8%) reported having had pain the day before (women, 37.6%; men, 20.9%) and 43.2% the week before. Most common pain sites were lower extremities (22.7%) and back (cervical and lumbar levels) (21.5%), followed by head (20.5%). Frequency of pain increased with age, reaching 42.6% for people older than 65 years. Among people complaining of pain during the last day or week, duration of symptoms was higher than 3 months in 54% (chronic pain), representing 23.4% of the Spanish general population; most common causes of chronic pain were arthritis, rheumatism and migraine. Regarding treatment, 61.7% of people complaining of pain said they were taking drugs. Source of drug treatment advice was a physician or a nurse in 66.4% of cases and self-prescription in 29%. It is concluded that pain, particularly chronic pain, has a high prevalence in the Spanish general population and a significant impact on occupational and social relationships.

Factors associated with increased risk of exacerbation and hospital admission in a cohort of ambulatory COPD patients: a multiple logistic regression analysis. The EOLO Study Group.

BACKGROUND AND OBJECTIVE: The aim of this study was to develop and validate two models to estimate the probabilities of frequent exacerbations (more than 1 per year) and admissions for chronic obstructive pulmonary disease (COPD) that can be used in a primary care setting. METHODS: Information was obtained in a cross-sectional observational study on ambulatory COPD patients performed in 201 general practices located throughout Spain. The model for admissions included 713 cases, 499 for the developmental sample and 214 in the validation sample; the model for frequent exacerbations included 896 patients, 627 in the developmental sample and 269 in the validation model. Candidate variables to be included in both models were: age, sex, body mass index (BMI), FEV(1) as percent predicted [FEV(1 )(% pred.)], active smoking, chronic mucus hypersecretion (CMH) and significant comorbidity. RESULTS: The admission model contained 2 readily obtainable variables: comorbidity (OR = 1.97; CI 95% = 1. 24-3.14) and FEV(1)(% pred.) (OR = 0.72; 0.58-0.88, for every 10 units), and well calibrated in developmental and validation samples (goodness-of-fit tests: p = 0.989 and p = 0.720, respectively). The model for frequent exacerbations included 3 variables: age (OR = 1. 21; 1.01-1.44; for every 10 years of increasing age), FEV(1 )(% pred. ) (OR = 0.82; 0.70-0.96, for every 10 units) and CMH (OR = 1.54; 1. 11-2.14) and also well calibrated (p = 0.411 and p = 0.340 in the developmental and validation samples, respectively). CONCLUSIONS: Our results suggest that FEV(1) impairment explains part of the risk of frequent exacerbations and hospital admissions. Furthermore, CMH and increasing age are significantly associated with the risk of frequent exacerbations, but severity of exacerbations provoking hospital admissions is associated with the presence of significant comorbidity. These important and easily measurable variables contain valuable information for optimal management of ambulatory patients with COPD.

[Factors related to drug consumption in children's population]. / Factores asociados al consumo de medicamentos en la población infantil.

BACKGROUND: To analyse the correlates of drug consumption in children's population. METHOD: Analyse interviews corresponding to children younger than 15 years old of the Catalan Health Survey (n = 2,433). RESULTS: The 25% consumed some drug in the previous 2 days. The factors related to drug consumption were low age, living in Barcelona (OR = 1.3), reporting double coverage (OR = 1.6), physician visits in the past 15 days (OR = 2.4), and reporting health problems. CONCLUSIONS: Drug consumption in children is high. It seems necessary to improve the education of families and health professionals related to drug consumption.

Treatment of chronic obstructive pulmonary disease and its exacerbations in general practice. EOLO Group. Estudio Observacional de la Limitación Obstructiva al Flujo aEreo.

The high prevalence and chronicity of chronic obstructive pulmonary disease (COPD) imply that many of these patients are treated and controlled in primary-care centres, often without contact with specialized pneumologist care. We conducted the present study to evaluate the treatment administered in stable and exacerbated COPD in GP-setting clinics and to investigate which factors could be associated with the different prescriptions. This is a cross-sectional observational study of ambulatory COPD patients. General practitioners (n = 201) were selected throughout Spain by regionally stratified sampling. We recorded the physician-reported prescription drug use in ambulatory treatment of stable COPD and acute exacerbations of COPD through a standard questionnaire. Factors independently associated with the prescription of drugs were ascertained by multiple logistic regression analysis. Of 1078 questionnaires reviewed, 1001 fulfilled quality criteria. There were 878 men (88%) and 123 women (12%); 777 (78%) were smokers or ex-smokers with a mean age of 68 years. Mean FEV1 was 47% predicted (% pred.) (SD = 13%). The median number of exacerbations was two per year (range = 0-16). Regular treatment for COPD was received by 878 (88%): the most commonly used drugs were inhaled beta 2-agonists (71%), theophyllines (53%) and inhaled corticosteroids (ICs) (50%), followed by mucolytics (25%), ipratropium bromide (23%), and oral corticosteroids (OCs) (4%). Treatment for exacerbations included inhaled bronchodilators (90%), antibiotics (89%), ICs (71%) and OCs (43%). Impairment of FEV1 was the factor most strongly associated in multiple regression analysis with increasing drug prescription in stable COPD, except for mucolytics, while the number of previous acute exacerbations was the main factor associated with exacerbation treatment except for OCs, the use of which was associated with more impaired pulmonary function. A significant number of the treatments prescribed in primary care for stable and exacerbated COPD do not follow current recommendations. Impairment in FEV1 is the factor most strongly associated with increasing prescription in stable COPD and the number of previous exacerbations is the main factor associated with exacerbation treatment.

[Treatment of chronic bronchitis and chronic pulmonary obstructive disease in primary care]. / Tratamiento de la bronquitis crónica y la EPOC en atención primaria.

In spite of the recent publication of various guidelines for the treatment of chronic bronchitis and chronic obstructive pulmonary disease (COPD), no studies have investigated whether or not they are being implemented by caregivers. Our aim was to determine what treatment protocols for patients with chronic bronchitis and COPD are most commonly applied by general practitioners in Spain and to identify factors associated with the prescription of certain drugs. A standardized questionnaire was administered to 268 general practitioners working in the 17 autonomous communities of Spain. The stratified sample of respondents was selected to reflect the population of each community. Valid information on 2,414 patients was collected. Men accounted for 74% of the patients. Mean age was 67 years (SD = 10). Lung function data were available for 1,130 (47%) and mean FEV1 was 1,523 ml (56% of the theoretical reference value). Patients without lung function data in spite of having signs of severe symptoms had suffered more acute exacerbations and generated more visits to the emergency room and to their primary care doctors in the preceding year than had patients who had undergone lung function testing (p < 0.03; p < 0.001; p < 0.003, respectively). The treatments most often prescribed were short-acting inhaled beta-2 agonists (56%), inhaled corticoids (47%), theophylline-containing drugs (43%), and long-lasting beta-2 agonists (41%). Patients who had not undergone function tests received more mucolytics (47% versus 27%, p < 0.001) and fewer anticholinergics (20% versus 35%, p < 0.001). The factor most highly associated with prescription of all drugs was severity of disease measured by dyspnea. Treatment protocols for chronic bronchitis and COPD in general practice in many aspects show differences from current guidelines. Noteworthy is the extensive use of inhaled corticoid therapy and long-lasting beta-2 adrenergic agonists and the infrequent prescription of anticholinergics. The lack of lung function data is associated with poor pharmacologic management of disease and higher rates of morbidity.

Should antibacterials be deregulated?

Deregulation of antibacterials is a recurrent topic in the debate on pharmaceutical policy. This article focuses on one aspect of pharmaceutical regulation, namely the requirement of a medical prescription for purchasing antibacterials. However, a strategy of deregulation should not only concern the switch from prescription-only status to nonprescription status for a given drug, but should consider some complementary measures to minimise potentially harmful effects on health and costs. Risk-benefit and economic evaluations, which are possible approaches to assess the convenience of antibacterial deregulation, force the empirical evidence, the assumptions, as well as the value judgements on which the options are evaluated, to be made explicit. We outline the basic traits of an economic-evaluation approach to assess the issues related to the public interest and the feasibility of a deregulation policy. However, the answer cannot be a generic one, but should address the question for each particular country, and for each antibacterial and indication. Given the limitations of existing evidence on that issue, a tentative research agenda is also proposed.

Cost-effectiveness analysis of different strategies for treating duodenal ulcer. Helicobacter pylori eradication versus antisecretory treatment.

Helicobacter pylori has recently been recognised as a causative agent for duodenal ulcer, and the efficacy of various combinations of antibacterials and antisecretory agents in eradicating this pathogen has been assessed. The objective of this study was to determine the efficiency of 2 treatment strategies for patients with H. pylori-positive duodenal ulcer. Cost effectiveness was analysed for antisecretory therapy (omeprazole 20 mg/day for 4 weeks), and eradication therapy (triple therapy: omeprazole 40 mg/day plus clarithromycin 1 g/day plus amoxicillin 2 g/day for 1 week). In a Markov model, a hypothetical cohort of 5000 patients was followed for 10 years through 6 disease states. Cyclic eradication therapy (i.e. in the first duodenal ulcer episode and in relapses) was the most cost effective [21 Spanish pesetas (Pta) per day free of symptoms (DFS); Pta128 = $US1 (October 1995)] of the eradication options evaluated [antisecretory in the first episode, then eradication for relapses (Pta22.3/DFS), and eradication therapy first, then antisecretory therapy (Pta27.3/DFS)]. Antisecretory therapy alone was less cost-effective (Pta39/DFS) than each of the 3 eradication options. Eradication treatment in the first episode of duodenal ulcer and relapses has savings in direct costs per patient of up to 56% compared with antisecretory therapy alone. Sensitivity analyses showed the model to be very robust. It is, therefore, advisable to treat initial episodes of H. pylori-positive duodenal ulcer and relapses with triple therapy. The improved cost-effectiveness ratio was largely explained by the long term reduction in relapses obtained with the eradication strategies.

Economic assessment of drugs in Spain.

In order to assess the characteristics and influence on healthcare decision making of the economic assessment of drugs in Spain, pharmacoeconomic studies carried out between 1982 and 1992 were examined. We identified and analysed 16 pharmacoeconomic studies. The commonnest type of economic assessment was cost-effectiveness analysis. Only one study included measures of health-related quality of life. Only one study was carried out in conjunction with a controlled clinical trial. Evidence of influence on decision making was found in 6 studies. Two studies implemented hepatitis vaccination programmes, one set up a telephone follow-up of antituberculosis chemoprophylaxis, one developed the official procedures for using epoetin (recombinant human erythropoietin), one initiated clinical discussion meetings about the cost effectiveness of cholesterol-lowering therapy, and one strengthened the decision to register nebacumab (HA-1A, Centoxin), the monoclonal antibody against endotoxin. The quality of the studies was acceptable according to generally agreed checklists, although somewhat lower than those in other countries with longer traditions in this field. Improvement of the scientific quality of the studies and an increased use of the results for decision making need to be promoted. At present the number of studies of economic assessment of drugs in Spain is low, as is the influence of these studies on healthcare decision making. The movement of the Spanish healthcare authorities towards a selective drugs funding policy is likely to increase the number of studies and their impact on healthcare decision making.

[The cost of arterial hypertension in Spain]. / El coste de la hipertensión arterial en España.

BACKGROUND: High blood pressure has a high incidence and produces a high morbidity and mortality due to associated diseases: cerebrovascular disease, ischemic cardiopathy, and cardiac failure. The socioeconomic impact of high blood pressure in Spain was estimated during 1985 in primary, hospitalary and pharmaceutical health care, to provide a framework for decision making and to determine strategies for reducing the costs of this entity. METHODS: The methodology of analysis of the cost of the disease was followed with the aim of quantifying the socioeconomic consequences of an entity, disease or risk factor with prevalence being the focus of the study. RESULTS: The socioeconomic impact estimated was situated between 95,000 and 124,000 millions of pesetas according to the different hypothesis adopted in the analysis of sensitivity. The direct health care costs represented between 2.6 and 3.9% of the global health care costs for Spain in 1985. Health care funding consumed by high blood pressure in primary health care was higher (between 4.5 and 6.7%) than hospital attendance (between 1.0 and 1.5%) and pharmaceutical care (between 2.3 and 3.5%), with respect to the total costs of each category. CONCLUSIONS: The reduction of the costs related with high blood pressure in Spain must be obtained from improvement of efficacy of interventions carried out in health care education and primary health care. The economic evaluation of the primary and secondary prevention programs may aid in determining more cost-effective strategies.

[The norms for good clinical practice in drug trials performed in Spain. A survey of the pharmaceutical industry]. / Normas de buena práctica clínica en los ensayos con medicamentos realizados en España. Encuesta a la industria farmacéutica.

BACKGROUND: The objective of this survey was to assess the state of the art of the implementation of Good Clinical Practice in the Spanish Pharmaceutical Industry. METHODS: A questionnaire was sent to the sixty first laboratories according to their sales of ethical products. In the questionnaire there were questions concerning nationality of the company, personnel in clinical research, use and characteristics of standard operating procedures (SOPs), auditing and quality assurance as well as questions in connection with the future implications of SOPs implementation. RESULTS: The level of answer was 42%. Twenty one out of the 24 companies that answered the questionnaire had SOPs implemented. In total 150 clinical research projects were carried out in 1990. One hundred one out of this 150 were performed under GCP. Fourteen companies agreed that with their current structure were able to accomplish 100% of the projects with GCP. The most frequent estimation of cost increase due to GCP was 30% (min. 10%; max. 70%). In overall 26 external audits were performed in 1990. Twenty one laboratories stated that they had not acceptance problems of GCP among the investigators. CONCLUSIONS: The sample seems to be representative of the Spanish pharmaceutical industry attitude with respect to GCP implementation. Although the exigency level was not detailed, around 42% of the clinical trials sponsored by the pharmaceutical industry are performed according to GCP. There is a positive impression as to the possibility to implement GCP as well as to the attitude of the investigators to this respect.

[Comparative study of sucralfate and ranitidine in the treatment of bleeding duodenal ulcer]. / Estudio comparativo de sucralfato y ranitidina en el tratamiento de la úlcera duodenal sangrante.

Sixty patients with bleeding duodenal ulcers were randomized to treatment with sucralfate or ranitidine. Endoscopy was performed in all patients within 24 hours from admission. Acute phase outcome was similar in both groups. Four patients in the sucralfate group and 1 patient in the ranitidine group rebled and required surgical treatment (NS). Healing rate at 6 weeks was 88% with sucralfate and 96.6% with ranitidine. Relapsing rate without maintenance therapy at 6 and 12 months was 21.1% and 42.1% for sucralfate-treated patients and 33.3% and 56.5% for ranitidine-treated patients (NS). Sucralfate-treated patients had a significantly lesser relapsing rate at 12 months compared to ranitidine treated patients, in the smokers group.

[Meta-analysis of the prevalence of peptic ulcer in relation to tobacco consumption]. / Metaanálisis de la prevalencia de úlcera péptica en relación al consumo de tabaco.

The reported studies of the association between smoking and the incidence of peptic ulcer have had nonconclusive results. Therefore, we have carried out a quantitative review including and evaluating all the factors related to that association. To this end, the techniques of meta-analysis suggested by Rosenthal have been used, and it has been found that the type of study design acted as a moderating variable. A correlation of 0.22 was found for studies with a case-control design, and 0.07 for studies with a sampling survey design. The small power of this association can be attributed to the great variety of factors which, in addition to smoking, may play a role in the etiology and pathogenesis of peptic ulcer.

Sucralfate versus ranitidine in the treatment of gastric ulcer. Randomized clinical results in short-term and maintenance therapy.

This clinical study compared the healing capacities of sucralfate and ranitidine in the treatment of gastric ulcer. Sixty patients were assigned at random to treatment with either sucralfate (1 g four times per day) or ranitidine (150 mg twice per day). The patients underwent endoscopy before inclusion in the study, after four weeks, and after eight weeks if the ulcers had not completely healed after the fourth week (phase I). Patients whose ulcers had healed were invited to participate in phase II, consisting of maintenance treatment for one year. The dosage was 1 g sucralfate twice per day or 150 mg ranitidine before going to bed. The patients underwent a clinical examination every three months and endoscopy every six months, and whenever symptoms suggested a relapse. After four weeks, the ulcers in 53 percent of the sucralfate-treated patients (16 of 30) had healed, compared with 56 percent of the ranitidine-treated patients (17 of 30). After eight weeks, the cumulative healing rates were 83 percent (25 of 30) and 86 percent (26 of 30), respectively. At the six-month follow-up visit, the relapse rates were seven of 21 (33.3 percent) in the sucralfate group and nine of 18 (50 percent) in the ranitidine group. After 12 months, the accumulative relapse rates were eight of 18 (44.4 percent) and nine of 18 (50.0 percent). The only side effects worth noting were mild constipation in four patients treated with sucralfate. One patient in the ranitidine group had myalgia and one reported headache in phase I. In conclusion, sucralfate appears to be as effective as ranitidine in the short-term treatment of gastric ulcers and in relapse prophylaxis.

Sucralfate and cimetidine as maintenance treatment in the prevention of duodenal ulcer recurrence.

This multicenter trial investigated the ability of the cytoprotective agent sucralfate and the antisecretory agent cimetidine to prevent ulcer relapses. Seventy-one patients with recently healed duodenal ulcer were included, randomly assigned to one of the two treatment groups, and administered sucralfate 2 g per day or cimetidine 400 mg per day for six months; the treatment period was followed by another six months of follow-up without treatment. The response to therapy was evaluated by systematic single-blind endoscopy controls during the sixth and the 12th months. Quantitative (42 percent relapse rate with sucralfate and 52 percent with cimetidine) as well as qualitative (20 percent silent relapses with sucralfate and 47 percent with cimetidine) differences were observed, although these could not be demonstrated to be statistically significant.