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1.
Pharmacoeconomics ; 41(8): 999-1010, 2023 08.
Article in English | MEDLINE | ID: mdl-37249823

ABSTRACT

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal lung disease associated with dyspnoea, cough and impaired quality of life affecting around 7500 patients in Spain. OBJECTIVE: Our aim was to estimate the economic impact of IPF according to forced vital capacity (FVC) % predicted level in adult patients. METHODS: We conducted a prospective, observational, multicentric study of patients with confirmed IPF in Spain. Total annual IPF-related costs were estimated per patient, and categorised according to the FVC% predicted value (FVC < 50%, FVC 50-80%, FVC > 80%) and total sample. Incurred direct health- and non-health-related costs and indirect costs were calculated considering the IPF-related healthcare resource use and the corresponding unitarian costs. Results were updated to 2023 euros. RESULTS: Two hundred and four consecutive patients with IPF were included: 77% male, average age (standard deviation) 70.8 (7.6) years. At baseline, FVC% was < 50%, 50-80% and > 80% of predicted value in 10.8%, 74.5% and 14.7% of patients, respectively. The final cost-evaluable population included 180 subjects. The mean (standard deviation) total annual IPF-related cost was €26,997 (17,555), with statistically significant differences (p = 0.0002) between groups: €44,412 (33,389) for the FVC < 50%, €25,803 (14,688) for the FVC 50-80% and €23,242 (13,642) for the FVC > 80%. Annual direct health costs had the greatest weight and included pharmacological treatments [€22,324 (13,773)] and hospitalisation days [€1659 (7362)]. 14 patients had ≥ 1 acute exacerbation of IPF during the study; mean total cost of an acute exacerbation of IPF was €10,372. According to the multivariate analysis, an impaired lung function (FVC < 50%) and use of antifibrotic treatment were determinants of cost (p < 0.0001 both). CONCLUSIONS: We observed a significantly higher annual IPF-related cost at a lower level of predicted FVC%, the direct cost having the greatest weight to the total costs. Maintaining patients at early disease stages by slowing IPF progression is relevant to reduce the economic impact of IPF. CLINICAL TRIAL REGISTRATION: EU PAS register number EUPAS19387 (1 June, 2017).


Subject(s)
Financial Stress , Idiopathic Pulmonary Fibrosis , Aged , Female , Humans , Male , Idiopathic Pulmonary Fibrosis/drug therapy , Prospective Studies , Quality of Life , Spain
2.
Respir Res ; 23(1): 235, 2022 Sep 07.
Article in English | MEDLINE | ID: mdl-36071483

ABSTRACT

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive disease associated with decline in lung function and poor prognosis entailing significant impairment in quality of life and high socioeconomic burden. The aim of this study was to characterize clinical management and resources utilization of patients with IPF in Spain, according to predicted forced vital capacity (FVC) % at baseline. METHODS: Prospective, non-interventional, multicentric real-world data study in patients with IPF in Spain with 12-months follow-up. Clinical management and resources utilization during study period were recorded and compared between groups. FVC decline and acute exacerbations occurrence and associated healthcare resource use were also analysed. FVC decline after 12 months was estimated as relative change. RESULTS: 204 consecutive patients with IPF were included and divided according to baseline FVC % predicted value. At baseline, patients with FVC < 50% received significantly more pharmacological and non-pharmacological treatments, and more help from caregiver. During the 12-months follow-up, patients with FVC < 50% required more specialized care visits, emergency visits, hospitalizations, pulmonary functions tests, non-health resource use (special transportation), and pharmacological treatments (p < 0.05 for all comparisons). Moreover, patients with FVC < 50% at baseline experienced more AE-IPF (p < 0.05), requiring more health-related resources use (primary care visits, p < 0.05). FVC decline was observed in all groups over the 12 months. FVC decreased on average by 2.50% (95% CI: - 5.98 to 0.98) along the year. More patients experienced an FVC decline > 10% in the more preserved lung function groups than in the FVC < 50% group, because of their already deteriorated condition. CONCLUSIONS: We observed a significantly higher annual IPF-related resource use in patients with more impaired lung function at baseline. Since FVC decreases irrespective of FVC% predicted at baseline, slowing IPF progression to maintain patients at early disease stages is relevant to improve IPF management and to optimize resource use. TRIAL REGISTRATION: EU PAS register number EUPAS19387 [June 01, 2017].


Subject(s)
Idiopathic Pulmonary Fibrosis , Humans , Idiopathic Pulmonary Fibrosis/diagnosis , Idiopathic Pulmonary Fibrosis/epidemiology , Idiopathic Pulmonary Fibrosis/therapy , Prospective Studies , Quality of Life , Spain/epidemiology
3.
Open Respir Arch ; 4(1): 100158, 2022.
Article in Spanish | MEDLINE | ID: mdl-37497178

ABSTRACT

Introduction: Idiopathic pulmonary fibrosis (IPF) impacts the life of patients and their families, so it is necessary to ascertain their perception in the approach to their disease. Methods: Observational study by means of a specific questionnaire that includes socio-demographic and clinical variables, perception of the impact of the disease (5-point Likert scale), preferences regarding the characteristics of the medication (degree of importance/concern 1-10) and satisfaction with treatment (SATMED-Q® scale 0-100). Results: 69 individuals participated (age: 66.5 ± 7.6 years; time until diagnosis: 16.5 ± 17.4 months; diagnosis time: 49.6 ± 42.3 months). The majority state that IPF limits them physically (90%) and emotionally (75%). The most highly valued features of the treatment were: slowing down progression of the disease (7.4 ± 2.8), stabilising lung capacity (6.9 ± 2.8) and improving quality of life (6.9 ± 2.8), above stabilising/improving symptoms (6.1 ± 2.8/6.3 ± 2.8) or avoiding hospitalisation (6.6 ± 2.7). The principal factors of concern were suffering gastric disorders (7.1 ± 2.9), photosensitivity (6.6 ± 3.0) or interaction with other drugs (6.0 ± 3.0). Overall satisfaction with the current treatment scored 61.1 points, with the highest scores being for medical follow-up (79.5) and overall opinion of the medicine (74.3). Conclusions: A study conducted in Spain on the perspective of IPF patients regarding the disease and its treatment. The results show a high level of awareness in terms of the seriousness of the disease on the part of patients, whose main concern is to slow down its progression. The information provided may help to optimise the management of IPF patients.

4.
Can J Psychiatry ; 58(12): 679-86, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24331287

ABSTRACT

OBJECTIVE: To analyze the potential for different aspects of anxiety to modify the effect of impaired functioning in major depressive disorder (MDD). METHODS: Participants (n = 1226) were psychiatric outpatients with MDD. A cross-sectional, multicentre, nationwide study was designed. The 12-item version of the World Health Organization Disability Assessment Schedule II was used to assess functional limitation. Anxiety was measured using the Hamilton Anxiety Rating Scale and the State-Trait Anxiety Inventory (STAI). Depression severity was measured using the Quick Inventory of Depressive Symptomatology. RESULTS: About 43.1% of patients had a comorbid MDD and anxiety disorder. Poorer functioning correlated significantly with severity of depression (Pearson r = 0.78, P = 0.001), severity of anxiety (r = 0.65, P = 0.001), and higher anxiety trait scores (r = 0.40, P = 0.001), but not significantly with STAI-State scores (r = 0.03, P = 0.26). The overall regression model was significant and explained 66% of the functioning variability in patients with MDD, mostly attributable to depression severity. Results indicate that anxiety has a moderate impact on functioning impairment in patients with MDD. CONCLUSIONS: Our findings suggest that MDD and anxiety severity appear to be associated significantly with impaired functioning in patients with MDD but explains only a moderate proportion of variance.


Objectif : Analyser le potentiel de différents aspects de l'anxiété de modifier l'effet du fonctionnement déficient dans le trouble dépressif majeur (TDM). Méthodes : Les participants (n = 1226) étaient des patients psychiatriques externes souffrant de TDM. Une étude transversale, multicentrique, à l'échelle nationale a été conçue. La version en 12 items du questionnaire II d'évaluation de l'invalidité de l'Organisation mondiale de la santé a servi à évaluer la limitation fonctionnelle. L'anxiété a été mesurée à l'aide de l'échelle d'anxiété de Hamilton et de l'inventaire d'anxiété état-trait (STAI). L'inventaire rapide de la symptomatologie dépressive a servi à mesurer la gravité de la dépression. Résultats : Quelque 43,1 % des patients souffraient d'un TDM et d'un trouble anxieux comorbide. Un mauvais fonctionnement corrélait significativement avec la gravité de la dépression (r de Pearson = 0,78; P = 0,001), la gravité de l'anxiété (r = 0,65; P = 0,001), et les scores élevés à l'anxiété trait (r = 0,40; P = 0,001), mais pas significativement avec les scores au STAI-état (r = 0,03; P = 0,26). Le modèle de régression globale était significatif et expliquait 66 % de la variabilité du fonctionnement chez les patients souffrant du TDM, attribuable en grande partie à la gravité de la dépression. Les résultats indiquent que l'anxiété a un effet modéré sur la déficience fonctionnelle chez les patients du TDM. Conclusions : Nos résultats suggèrent que le TDM et la gravité de l'anxiété semblent être associés significativement avec le fonctionnement déficient chez les patients souffrant du TDM, mais qu'ils n'expliquent qu'une proportion modérée de la variance.


Subject(s)
Anxiety Disorders/psychology , Depressive Disorder, Major/psychology , Adolescent , Adult , Aged , Aged, 80 and over , Anxiety Disorders/physiopathology , Case-Control Studies , Cross-Sectional Studies , Depressive Disorder, Major/physiopathology , Female , Humans , Linear Models , Male , Middle Aged , Multivariate Analysis , Personality , Personality Inventory , Severity of Illness Index , Young Adult
5.
Actas esp. psiquiatr ; 41(4): 218-226, jul.-ago. 2013. ilus, tab
Article in Spanish | IBECS | ID: ibc-115233

ABSTRACT

Introducción: Los trastornos mentales en la vejez constituyen un importante problema de salud pública. No obstante, pocos estudios epidemiológicos aportan datos sobre prevalencia y factores de riesgo de enfermedades mentales en personas muy ancianas. El objetivo de este trabajo es evaluarla prevalencia de los trastornos mentales más comunes en atención primaria (AP) y sus factores asociados en pacientes mayores de 75 años. Metodología: Estudio epidemiológico trasversal con una muestra de 426 pacientes muy ancianos atendidos en AP y distribuidos proporcionalmente por provincias y centros de salud. Se utilizó la versión española de la entrevista Primary Care Evaluation of Mental Disorders (PRIME-MD) para diagnosticarlos trastornos psiquiátricos más frecuentes. Resultados: Existe una alta prevalencia y comorbilidad de los trastornos del estado de ánimo, de ansiedad y somatomorfos. El 47.4% de la muestra presenta uno o más trastornos psiquiátricos. Los más prevalentes fueron los trastornos del estado de animo (33.8%), seguidos por los somatomorfos (24.4%) y los de ansiedad (14.3). El 6.3% presenta comorbilidad psiquiátrica ente estos tres diagnósticos. La percepción del paciente sobre su estado de salud y la presencia de patologías físicas se asocia significativamente con estos trastornos mentales. Conclusiones: Los trastornos depresivos, de ansiedad y somatomorfos tienen una alta prevalencia en población muy anciana, con una elevada comorbilidad. Su detección y tratamiento es una cuestión prioritaria en AP (AU)


Background: Mental disorders in old age are a major public health problem. However, few epidemiological studies provide data on prevalence and risk factors of mental illness in older old population. The aim of this study is to assess the prevalence of common mental disorders and their associated factors in primary care patients over 75 years. Method: Cross-sectional epidemiologic study carried out in a sample of 426 older old patients who were attended at Primary Health Care settings, proportionally distributed for provinces and health centers. The Spanish version of the Primary Care Evaluation of Mental Disorders (PRIME-MD)was used in order to diagnose the most common psychiatric disorders in this field. Results: Prevalence and comorbidity rates of affective, anxiety and somatoform disorders are high. 47.4% of the sample presented one or more psychiatric disorder. The most prevalent were affective (33.8%), somatoform (24.4%) and anxiety (14.3%) disorders. 6.3% had comorbidity between affective, anxiety and somatoform disorders. Perceived health status and physical illnesses were significantly associated with these mental disorders. Conclusions: Affective, anxiety and somatoform disorders are highly prevalent in older old population with high rates of comorbidity. Their detection and treatment should be considered a relevant issue in primary care (AU)


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Mental Disorders/epidemiology , Depression/epidemiology , Anxiety/epidemiology , Somatoform Disorders/epidemiology , Primary Health Care/statistics & numerical data , Risk Factors
6.
Actas Esp Psiquiatr ; 41(4): 218-26, 2013.
Article in Spanish | MEDLINE | ID: mdl-23884613

ABSTRACT

BACKGROUND: Mental disorders in old age are a major public health problem. However, few epidemiological studies provide data on prevalence and risk factors of mental illness in older old population. The aim of this study is to assess the prevalence of common mental disorders and their associated factors in primary care patients over 75 years. METHOD: Cross-sectional epidemiologic study carried out in a sample of 426 older old patients who were attended at Primary Health Care settings, proportionally distributed for provinces and health centers. The Spanish version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) was used in order to diagnose the most common psychiatric disorders in this field. RESULTS: Prevalence and comorbidity rates of affective, anxiety and somatoform disorders are high. 47.4% of the sample presented one or more psychiatric disorder. The most prevalent were affective (33.8%), somatoform (24.4%) and anxiety (14.3%) disorders. 6.3% had comorbidity between affective, anxiety and somatoform disorders. Perceived health status and physical illnesses were significantly associated with these mental disorders. CONCLUSIONS: Affective, anxiety and somatoform disorders are highly prevalent in older old population with high rates of comorbidity. Their detection and treatment should be considered a relevant issue in primary care.


Subject(s)
Mental Disorders/epidemiology , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Humans , Male , Prevalence , Primary Health Care , Risk Factors
7.
PLoS One ; 7(10): e48200, 2012.
Article in English | MEDLINE | ID: mdl-23110213

ABSTRACT

OBJECTIVE: To assess sociodemographic, clinical and treatment factors as well as depression outcome in a large representative clinical sample of psychiatric depressive outpatients and to determine if melancholic and atypical depression can be differentiated from residual non-melancholic depressive conditions. SUBJECTS/MATERIALS AND METHOD: A prospective, naturalistic, multicentre, nationwide epidemiological study of 1455 depressive outpatients was undertaken. Severity of depressive symptoms was assessed by the Hamilton Depression Rating Scale (HDRS) and the Self Rated Inventory of Depressive Symptomatology (IDS-SR(30)). IDS-SR(30) defines melancholic and atypical depression according to DSM-IV criteria. Assessments were carried out after 6-8 weeks of antidepressant treatment and after 14-20 weeks of continuation treatment. RESULTS: Melancholic patients (16.2%) were more severely depressed, had more depressive episodes and shorter episode duration than atypical (24.7%) and non-melancholic patients. Atypical depressive patients showed higher rates of co-morbid anxiety disorders and substance abuse. Melancholic patients showed lower rates of remission. CONCLUSION: Our study supports a different clinical pattern and treatment outcome for melancholic and atypical depression subtypes.


Subject(s)
Depression/pathology , Depression/physiopathology , Depressive Disorder/pathology , Depressive Disorder/physiopathology , Adult , Antidepressive Agents/therapeutic use , Anxiety Disorders/drug therapy , Anxiety Disorders/pathology , Anxiety Disorders/physiopathology , Depression/drug therapy , Depressive Disorder/drug therapy , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/pathology , Depressive Disorder, Major/physiopathology , Diagnostic and Statistical Manual of Mental Disorders , Female , Humans , Male , Middle Aged , Prospective Studies
8.
BMC Med Res Methodol ; 11: 131, 2011 Sep 21.
Article in English | MEDLINE | ID: mdl-21936925

ABSTRACT

BACKGROUND: Due to the high prevalence of depression, it is clinically relevant to improve the early identification and assessment of depressive episodes. The main objective of the present study was to examine the psychometric properties of the IDS-SR30 (Self-rated Inventory of Depressive Symptomatology) in a large Spanish sample of depressive patients. METHODS: This prospective, naturalistic, multicenter, nationwide epidemiological study conducted in Spain included 1595 adult patients (65.3% females) with a DSM-IV Major Depressive Disorder (MDD. IDS-SR30 and the Hamilton Depression Rating Scale (HDRS, 21 items)were administered to the sample. Data was collected during 2 routine visits. The second assessment was carried out after 10 ± 2 weeks after first assessment. RESULTS: The IDS-SR30 showed good internal consistency (α = 0.94) and high item total correlations (≥ 0.50) were found in 70% of the items. The convergent validity was 0.85. Results of the principal component analysis (PCA) and confirmatory factor analyses (CFA) showed that a three factor model (labelled mood/cognition, anxiety/somatic and sleep) is adequate for the current sample. CONCLUSIONS: The Spanish version of the IDS-SR30 seems a reliable, valid and useful tool for measuring depression symptomatology in Spanish population.


Subject(s)
Depression/diagnosis , Psychiatric Status Rating Scales , Self Report , Adolescent , Adult , Aged , Aged, 80 and over , Depression/epidemiology , Female , Humans , Male , Middle Aged , Principal Component Analysis , Psychometrics , Spain/epidemiology , Young Adult
10.
J Affect Disord ; 134(1-3): 235-41, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21676465

ABSTRACT

OBJECTIVE: Predicting treatment outcome at an early stage is clinically relevant. The main objectives are: to compare rates of remission after acute and continuation phase treatment and to determine the most common residual symptoms among remitted patients; to compare the residual symptoms in early and late remitted and to identify factors that predict early or faster remission. METHOD: It is a prospective, naturalistic, multicenter, and nationwide epidemiological study of 1595 depressive outpatients. Severity of depressive symptoms was assessed with the Hamilton Depression Rating Scale (HDRS) and the Self Rated Inventory of Depressive Symptomatology (IDS-SR(30)). Assessments were carried out after 6-8 weeks of antidepressant treatment and after 14-20 weeks of continuation treatment. Early remitters were defined with an IDS-SR(30) score ≤ 14 at first and second assessment. Late remitters were defined as those scoring IDS-SR(30) >14 at first and IDS-SR(30) score ≤ 14 at second assessment. RESULTS: 140 subjects (8.8%) were in remission after 6-8 weeks of antidepressant treatment and 862 remitted (59%) after 16-20 weeks of treatment. The mean number of residual symptoms is significantly higher among patients who remit later. Greater differences between early and late remitters were found in the following symptoms: feeling sad, reactivity of mood, interpersonal sensitivity and pleasure/enjoyment. Multivariate analysis showed that only comorbid anxiety disorder is significantly associated with late remission. CONCLUSIONS: Early remitted patients have a better "quality" of remission. Late remission is associated with residual symptoms more related to core depressive symptoms. Residual symptoms in early remitted patients may constitute a new target for the treatment of depression.


Subject(s)
Antidepressive Agents/therapeutic use , Depressive Disorder/psychology , Adult , Comorbidity , Depression , Depressive Disorder/drug therapy , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/therapy , Emotions , Epidemiologic Studies , Female , Humans , Longitudinal Studies , Male , Middle Aged , Personality Inventory , Prognosis , Prospective Studies , Psychiatric Status Rating Scales , Remission Induction , Sensitivity and Specificity , Severity of Illness Index , Time Factors , Treatment Outcome
11.
Compr Psychiatry ; 52(1): 26-32, 2011.
Article in English | MEDLINE | ID: mdl-21220062

ABSTRACT

BACKGROUND: Depressive disorder is one of the most common mental disorders in primary care. Depression is often a chronic disorder with recurrent episodes. Little is known about the differences in clinical profile between first and recurrent episodes. The aim of the study is to analyze the differences between clinical presentation of first and subsequent episodes of depressive disorders in primary care patients. METHOD: A cross-sectional epidemiologic study in primary care centers in Spain was designed. A total of 10,257 primary care patients having a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition major depressive episode were analyzed. Clinical symptoms were measured using the Montgomery Asberg Depression Scale. Patient Health Questionnaire was used to assess somatic symptoms. RESULTS: There were 40.6% of patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for recurrent depression. Compared with those diagnosed of their first major depressive disorder, recurrent patients had greater rates and severity of depressive (t = -7.85, P < .001) and somatic symptoms (t = 5.64, P < .001). The severity of symptoms also increases with number of episodes (F = 40.2, P < .001, for depressive symptoms; F = 27.8, P < .001, for somatic symptoms). First-episode patients were more likely to experience reduced appetite (adjusted odds ratio, 1.2) and suicidal thoughts (adjusted odds ratio, 1.2). CONCLUSION: There are differences in the clinical profile of initial and recurrent episodes in primary care depressive patients. Each recurrent depressive episode seems to have a greater impact on symptoms and well-being. The identification of a specific depression symptom profile in first or recurrent episodes is needed to improve the long-term management of major depressive episode patients in primary care settings.


Subject(s)
Depressive Disorder, Major/psychology , Adolescent , Adult , Aged , Analysis of Variance , Chi-Square Distribution , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Odds Ratio , Psychiatric Status Rating Scales , Recurrence , Severity of Illness Index , Socioeconomic Factors , Surveys and Questionnaires , Young Adult
12.
Gastroenterol. hepatol. (Ed. impr.) ; 32(8): 542-548, oct. 2009. tab, graf
Article in Spanish | IBECS | ID: ibc-72825

ABSTRACT

Introducción y objetivoRecientemente se dispone de una nueva formulación de lansoprazol en forma de comprimidos bucodispersables (CBD) que puede contribuir a mejorar la aceptabilidad y el cumplimiento con este tipo de medicación. El objetivo del presente estudio fue evaluar la preferencia del paciente con enfermedad por reflujo gastroesofágico (ERGE) y disfagia por los CBD en comparación con las cápsulas de lansoprazol.Material y métodosSe diseñó un estudio clínico fase IV, multicéntrico, cruzado, abierto y aleatorizado en pacientes con síntomas de ERGE y disfagia asociada. Los pacientes se trataron durante 3 días con cápsulas de lansoprazol (30mg) y otros 3 días con CBD de lansoprazol (30mg). El orden del tratamiento (primero cápsulas y después CBD o al revés) fue determinado mediante aleatorización en bloques de forma centralizada. La variable principal del estudio fue la puntuación en una escala visual analógica (EVA), en la que se solicitaba al paciente que valorara su grado de preferencia por los CBD o las cápsulas.ResultadosSe incluyó a 145 pacientes y se evaluó finalmente a 126 por protocolo. Un 47% (59 de 126) de los pacientes prefirió los CBD, un 33% (42 de 126) prefirió las cápsulas y al resto (25 de 126) le fue indiferente. El valor medio de preferencia en la EVA fue de 5,31 (4,72±5,90), favorable a los CBD aunque sin significación estadística. En general, las diferencias a favor de los CBD se acentuaron en los pacientes de mayor edad. El porcentaje de pacientes libres de pirosis al final de ambas secuencias de tratamiento estuvo alrededor del 75% y no fue distinto entre los que habían empezado con cápsulas o los que habían empezado con CBD. Finalmente, la valoración de preferencia mediante las técnicas de disponibilidad para pagar obtuvo resultados similares, que de nuevo fueron más favorables a los CBD (4,18±6,86 euros frente a 3,47±5,78 euros)(AU)


ConclusiónLas formulaciones farmacéuticas en cápsulas y CBD de lansoprazol tienen una aceptación comparable entre los pacientes con ERGE que presentan disfagia. Sin embargo, y aunque sin potencia suficiente para demostrar significación estadística, se ha observado una clara tendencia hacia la preferencia por los CBD entre los pacientes de mayor edad(AU)


Introduction and objectiveRecently, a new lansoprazole formulation consisting of orally disintegrating tablets has become available, which could improve acceptability and compliance with this type of medication. The aim of the present study was to evaluate preferences in patients with gastroesophageal reflux disease concerning lansoprazole orally disintegrating tablets compared with lansoprazole capsules.Material and methodsA phase IV, multicenter, crossed, open and randomized clinical trial was performed in patients with symptoms of gastroesophageal reflux disease and associated dysphagia. The patients were treated with 30mg lansoprazole capsules for 3 days and with 30mg lansoprazole orally disintegrating tablets for another 3 days. The order of treatment (first capsules followed by orally disintegrating tablets or vice versa) was determined by centralized block randomization. The main measure was the visual analog scale (VAS) score in which patients was asked to rate their degree of preference for the orally disintegrating tablets or the capsules.ResultsOf the 145 patients included, 126 could be evaluated by the protocol. A total of 47% (59/126) of the patients preferred the orally disintegrating tablets, 33% (42/126) preferred the capsules and the remainder (25/126) had no preference. The mean preference value in the VAS was 5.31 (4.72 ± 5.90) in favor of the orally disintegrating tablets, although this difference was not statistically significant. In general, differences in favor of the orally disintegrating tables were more marked in older patients. The percentage of patients free of pyrosis at the end of both treatment sequences was approximately 75% with no differences according to which treatment was administered first. Finally, preference evaluation through willingness to pay techniques showed similar results, again in favor of the orally disintegrating tablets (4.18 € ± 6.86 € vs 3.47 € ± 5.78 €)(AU)


ConclusionThe acceptability of pharmaceutical formulations of lansoprazole in capsules and orally disintegrating tables is similar among patients with gastroesophageal reflux disease and associated dysphagia. However, a clear, but nonsignificant, trend was observed in favor of orally disintegrating tablets among older patients(AU)


Subject(s)
Humans , Gastroesophageal Reflux/drug therapy , Deglutition Disorders/drug therapy , Proton Pump Inhibitors/therapeutic use , Patient Satisfaction , Anti-Ulcer Agents/therapeutic use , Benzimidazoles/therapeutic use , Antacids/therapeutic use
13.
Gastroenterol Hepatol ; 32(8): 542-8, 2009 Oct.
Article in Spanish | MEDLINE | ID: mdl-19595483

ABSTRACT

INTRODUCTION AND OBJECTIVE: Recently, a new lansoprazole formulation consisting of orally disintegrating tablets has become available, which could improve acceptability and compliance with this type of medication. The aim of the present study was to evaluate preferences in patients with gastroesophageal reflux disease concerning lansoprazole orally disintegrating tablets compared with lansoprazole capsules. MATERIAL AND METHODS: A phase IV, multicenter, crossed, open and randomized clinical trial was performed in patients with symptoms of gastroesophageal reflux disease and associated dysphagia. The patients were treated with 30mg lansoprazole capsules for 3 days and with 30mg lansoprazole orally disintegrating tablets for another 3 days. The order of treatment (first capsules followed by orally disintegrating tablets or vice versa) was determined by centralized block randomization. The main measure was the visual analog scale (VAS) score in which patients was asked to rate their degree of preference for the orally disintegrating tablets or the capsules. RESULTS: Of the 145 patients included, 126 could be evaluated by the protocol. A total of 47% (59/126) of the patients preferred the orally disintegrating tablets, 33% (42/126) preferred the capsules and the remainder (25/126) had no preference. The mean preference value in the VAS was 5.31 (4.72 +/- 5.90) in favor of the orally disintegrating tablets, although this difference was not statistically significant. In general, differences in favor of the orally disintegrating tables were more marked in older patients. The percentage of patients free of pyrosis at the end of both treatment sequences was approximately 75% with no differences according to which treatment was administered first. Finally, preference evaluation through willingness to pay techniques showed similar results, again in favor of the orally disintegrating tablets (4.18 euro +/- 6.86 euro vs 3.47 euro +/- 5.78 euro). CONCLUSION: The acceptability of pharmaceutical formulations of lansoprazole in capsules and orally disintegrating tables is similar among patients with gastroesophageal reflux disease and associated dysphagia. However, a clear, but nonsignificant, trend was observed in favor of orally disintegrating tablets among older patients.


Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage , Deglutition Disorders/drug therapy , Gastroesophageal Reflux/drug therapy , Patient Preference , Proton Pump Inhibitors , Cross-Over Studies , Female , Humans , Lansoprazole , Male , Middle Aged , Tablets
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