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1.
Allergy ; 79(4): 1042-1051, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38429981

RESUMO

BACKGROUND: The German Therapy Allergen Ordinance (TAO) triggered an ongoing upheaval in the market for house dust mite (HDM) allergen immunotherapy (AIT) products. Three HDM subcutaneous AIT (SCIT) products hold approval in Germany and therefore will be available after the scheduled completion of the TAO procedure in 2026. In general, data from clinical trials on the long-term effectiveness of HDM AIT are rare. We evaluated real-world data (RWD) in a retrospective, observational cohort study based on a longitudinal claims database including 60% of all German statutory healthcare prescriptions to show the long-term effectiveness of one of these products in daily life. Aim of this analysis was to provide a per product analysis on effectiveness of mite AIT as it is demanded by international guidelines on AIT. METHODS: Subjects between 5 and 70 years receiving their first (index) prescription of SCIT with a native HDM product (SCIT group) between 2009 and 2013 were included. The exactly 3:1 matched control group received prescriptions for only symptomatic AR medication (non-AIT group); the evaluation period for up to 6 years of follow-up ended in February 2017. Study endpoints were the progression of allergic rhinitis (AR) and asthma, asthma occurrence and time to the onset of asthma after at least 2 treatment years. RESULTS: In total, 892 subjects (608 adults and 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults and 852 children/adolescents) in the non-AIT group. During the follow-up period after at least 2 years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p < .0001) for AR medication and by 42.4% for asthma medication (p = .0003). New-onset asthma risk was significantly reduced in the SCIT vs non-AIT group by 27.0% (p = .0212). The asthma-preventive effect of SCIT occurred 15 months after start of the treatment. In the SCIT group, the time to onset of asthma was prolonged compared to the non-AIT group (p = .0010). CONCLUSION: In this first product based RWD analysis on SCIT with a native HDM product, patients aged 5 to 70 years benefited from AIT in the long term in terms of reduced progression of AR and asthma after at least 2 years of treatment. The effects seemed to last for up to 6 years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment.


Assuntos
Asma , Rinite Alérgica , Criança , Adulto , Animais , Adolescente , Humanos , Pyroglyphidae , Dessensibilização Imunológica/métodos , Estudos Retrospectivos , Asma/epidemiologia , Asma/etiologia , Asma/prevenção & controle , Dermatophagoides pteronyssinus , Rinite Alérgica/epidemiologia , Rinite Alérgica/etiologia , Rinite Alérgica/prevenção & controle , Alérgenos , Antígenos de Dermatophagoides
2.
Pharmacoepidemiol Drug Saf ; 33(1): e5710, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37969030

RESUMO

PURPOSE: Naloxegol has been shown to be an efficient alternative to treat opioid-induced constipation (OIC). This study aimed at describing the characteristics of naloxegol users and assessing patterns of naloxegol use and associated factors. METHODS: This drug utilization cohort study used observational registry data on patients newly prescribed naloxegol in four European countries. Patient characteristics and patterns of naloxegol use and associated factors were described. RESULTS: A total of 17 254 naloxegol users were identified across the countries. Their median age was 56-71 years, and each country had a majority of women (ranging 57.5%-62.9%). Multiple comorbidities, including cancer, were common. Natural opium alkaloids and osmotically acting laxatives (excluding saline) were the most frequently used opioids and laxatives. Overall prior use of opioids ranged from 91.9% to 99.6% and overall prior use of laxatives ranged from 69.9% to 92.4%. Up to 77.7% had prior use of medications with interaction potential, and up to 44.5% used them concurrently with naloxegol. Naloxegol was discontinued by 55.1%-90.9% of users, typically during the first 30 days. Approximately 10%-30% switched to or augmented the treatment with another constipation medication or restarted naloxegol after discontinuation. Augmentation with another constipation medication was relatively common, suggesting that naloxegol was used for multifactorial constipation. CONCLUSION: The present study reflects real-world clinical use of naloxegol, including in vulnerable patient groups. Some naloxegol users lacked laxative or regular opioid use within six months before index date or used naloxegol concomitantly with medications presenting an interaction potential.


Assuntos
Morfinanos , Polietilenoglicóis , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Analgésicos Opioides/efeitos adversos , Estudos de Coortes , Constipação Intestinal/induzido quimicamente , Constipação Intestinal/tratamento farmacológico , Constipação Intestinal/epidemiologia , Laxantes/efeitos adversos , Morfinanos/efeitos adversos , Polietilenoglicóis/efeitos adversos , Masculino
3.
Clin Transl Allergy ; 13(5): e12245, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37227419

RESUMO

INTRODUCTION: Allergic rhinitis (AR) is a widespread disease with increasing prevalence in developed countries. The only treatment that tackles the underlying causes is allergen immunotherapy (AIT). This treatment is performed through two application routes, the subcutaneous immunotherapy (SCIT) or the sublingual immunotherapy (SLIT). However, persistence during the long course of treatment over 3 years is key for the efficacy of this treatment option. The impaired adherence significantly impacts public health resources. The aim of this study was to assess the persistence of AIT for both application routes. METHODS: IQVIATM LRx was used to identify patients starting AIT between 2009 and 2018 with grass pollen (GP), early flowering tree pollen (EFTP) and house dust mite (HDM) allergens. Patients were classified within each allergen category by AIT groups (subcutaneous depigmented polymerised allergen AIT [dSCIT], other subcutaneous AIT [oSCIT] and SLIT) and age (5-11 years, 12-17 years, 18+ years). Furthermore, they were followed up for up to 3 years until the cessation of treatment. Patients, who were still on treatment after 3 years were deemed to be censored. Kaplan-Meier curves of persistence were generated and compared by log-rank tests. RESULTS: The number of patients included in the three allergen categories was 38,717 GP, 23,183 EFTP, and 41,728 HDM AIT. In all allergen categories and for any product group, patient persistence decreased with increasing age class with the difference between 5-11 years and 12-17 years greater than between the latter and 18+ years. The percentage of patients completing the first year of AIT was low, particularly for SLIT where 22.2%-27.1% of patients remained persistent after 12 months. The equivalent figures for dSCIT were 52.0%-64.1% and for oSCIT 38.3%-50.3%. CONCLUSION: Persistence in AIT in AR was low in this retrospective prescription-based database and was clearly linked to patient age and application route.

4.
Vaccines (Basel) ; 11(4)2023 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-37112632

RESUMO

Paediatric check-ups and vaccinations are provided and free of charge in Germany. Despite being hitherto generally well-received and adhered to, it is possible that the lockdown implemented due to the COVID-19 pandemic resulted in delays or even cancellations of critical paediatric visits with healthcare providers. This study attempts to quantify the rate and time to follow-up for check-ups in Germany using the retrospective IQVIATM Disease Analyzer database. Additionally, timely administration of 4 vaccines (Hexavalent, pneumococcal, MMR-V, Rotavirus) was analysed to examine the impact of pandemic restrictions on vaccine uptake. The timeframes which were compared to determine the effects of COVID-19 were June 2018-December 2019 and March 2020-September 2021. The follow-up rates for paediatric check-ups were consistently lower in the COVID-19 phase, but generally ~90%. Follow-up rates for the vaccinations were distinctly higher during COVID-19. The time between events was almost unchanged for check-ups during the pandemic. For check-ups, age at initial event differed by less than a week between the phases. For vaccinations, the age differences were slightly higher, but exceeded one week in only two cases. The results show that the COVID-19 pandemic had little effect on paediatric check-ups and vaccinations in Germany.

5.
Hematology ; 26(1): 697-708, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34547980

RESUMO

OBJECTIVE: To assess real-world treatment patterns in patients with immune thrombocytopenia (ITP) who received thrombopoietin receptor agonists (TPO-RAs) in Germany. METHODS: This was a longitudinal, retrospective study using anonymized patient-level data (IQVIA healthcare prescription database, covering 82% of German statutory prescriptions). Eligible patients (aged ≥18 years) had received ≥1 TPO-RA prescription (romiplostim/eltrombopag) from July 2016 to June 2019 (treatment duration ≥30 days). ITP medication use was assessed for 18 months prior to, during and for ≥6 months after TPO-RA treatment. RESULTS: A total of 3553 patients (median age 64 years) were included. Median persistence on TPO-RAs was 12 months (range 1-34). In the periods before, during and after TPO-RA treatment, oral corticosteroids were the most commonly used therapy (64.4%, 43.4% and 36.1% of patients, respectively); median cumulative doses across each period were 2521.9, 2000.0 and 2277.8 mg. The median total duration of corticosteroid use before, during and after TPO-RA therapy was 15, 18 and 32 weeks, respectively. The total median cumulative corticosteroid dose was 6799.7 mg. CONCLUSION: We identified a potential overuse of corticosteroids in patients with ITP in Germany. Earlier use of TPO-RA therapy after a short course of corticosteroids could avoid side effects associated with long-term use.


Assuntos
Benzoatos/administração & dosagem , Bases de Dados Factuais , Prescrições de Medicamentos , Hidrazinas/administração & dosagem , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Pirazóis/administração & dosagem , Receptores Fc/administração & dosagem , Receptores de Trombopoetina/agonistas , Proteínas Recombinantes de Fusão/administração & dosagem , Trombopoetina/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Alemanha/epidemiologia , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Púrpura Trombocitopênica Idiopática/epidemiologia , Estudos Retrospectivos
6.
Eur J Neurol ; 28(6): 1840-1848, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33657269

RESUMO

BACKGROUND AND PURPOSE: Several epidemiological studies from Taiwan, all using the same data resource, found significant associations between herpes virus infection, antiherpetic medication, and subsequent dementia. We conducted a multicenter observational cohort study using health registry data from Wales, Germany, Scotland, and Denmark to investigate potential associations between antiherpetic medication and incident dementia, and also to comprehensively investigate such associations broken down according to medication type and dose, type of herpes virus, and dementia subtype. METHODS: A total of 2.5 million individuals aged 65 years or more were followed up using linked electronic health records in four national observational cohort studies. Exposure and outcome were classified using coded data from primary and secondary care. Data were analyzed using survival analysis with time-dependent covariates. RESULTS: Results were heterogeneous, with a tendency toward decreased dementia risk in individuals exposed to antiherpetic medication. Associations were not affected by treatment number, herpes subtype, dementia subtype, or specific medication. In one cohort, individuals diagnosed with herpes but not exposed to antiherpetic medication were at higher dementia risk. CONCLUSIONS: Short-term antiherpetic medication is not markedly associated with incident dementia. Because neither dementia subtype nor herpes subtype modified the association, the small but significant decrease in dementia incidence with antiherpetic administration may reflect confounding and misclassification.


Assuntos
Demência , Infecções por Herpesviridae , Estudos de Coortes , Demência/epidemiologia , Humanos , Incidência , Sistema de Registros , Fatores de Risco
7.
Pulm Ther ; 6(2): 333-350, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33064273

RESUMO

INTRODUCTION: Maintenance treatment strategies in COPD recommend inhaled corticosteroid (ICS) + long-acting muscarinic antagonist (LAMA) + long-acting ß2-agonist (LABA) triple therapy after initial dual therapy. Little is known about how treatment pathways to triple therapy vary across countries in clinical practice. METHODS: This multi-country, retrospective cohort study (conducted 1 January 2005-1 May 2016) included patients with a COPD diagnosis, and (UK only) evidence of smoking history, or (France, Italy, Germany, and Australia) an indicator confirming COPD diagnosis, a first instance of triple therapy recorded during the study period and ≥ 12 months of data prior to this date. Treatment pathways to triple therapy were analyzed in patients whose first instance of triple therapy was on or after the initial COPD diagnosis. The proportion of patients who initiated triple therapy prior to initial COPD diagnosis was also estimated. Meta-analyses of the main results were performed. RESULTS: In 130,729 patients across all countries, mean age (standard deviation) ranged from 63.4 (10.4) years (Germany) to 69.8 (9.9) years (Italy), and median time (interquartile range) from initial COPD diagnosis to first prescription of triple therapy ranged from 16.9 (5.7-36.2) months (Australia) to 42.5 (13.9-87.4) months (UK). ICS + LABA was the most common treatment pathway prior to triple therapy in the UK, Germany, and Italy (27.3%-31.6%); no previous maintenance therapy prior to triple therapy was the most common pathway in France and Australia (32.5% and 37.9%, respectively). Meta-analyses provided a pooled estimate of 20.4% (95% confidence interval: 13.8%-29.1%) for the proportion of patients initiating triple therapy at or before initial COPD diagnosis. CONCLUSIONS: In this retrospective cohort study, treatment pathways to triple therapy were diverse within and between countries. The differing impact of treatments may affect quality of life and disease control in patients with COPD. Further analyses should investigate factors influencing pathways to triple therapy.

8.
Patient Prefer Adherence ; 14: 817-827, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32494127

RESUMO

PURPOSE: Allergen immunotherapy (AIT), when continued for 3 years, is the only disease-modifying treatment for AR and asthma. Adherence is a key to ensure effectiveness, and poor adherence is a contraindication for AIT. The objective of this study was to evaluate real-world adherence to AIT with subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) preparations in patients allergic to grass or tree pollen. The impact of AIT on the consumption of asthma and rhinitis medication was also analyzed. PATIENTS AND METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, the adherence of a grass and tree pollen allergoid was examined and compared to two sublingual AIT tablets/drops. Patients receiving grass or tree allergen-specific immunotherapy prescriptions were compared with non-AIT patients receiving symptomatic allergic rhinitis (AR) and asthma prescriptions. The study endpoints included therapy adherence, AR progression, and asthma progression. Multivariate regression analyses were used to estimate the effects of SCIT or SLIT, adjusting for variables related to demographics and prescriptions. RESULTS: SCIT adherence was 60.1-61.8% at 2 years and 35.0-37.5% at 3 years for the two allergens. SLIT adherence was distinctly lower (29.5-36.5% and 9.6-18.2%, respectively). Adherence in children was higher compared to adolescents or adults. All products were highly efficacious at reducing symptomatic AR medication consumption. SCIT also reduced asthma medication use for both allergens, whereas for SLIT these results were significant only for grasses but not trees. CONCLUSION: Subcutaneous AIT in a real-world setting achieved significantly higher adherence rates compared to sublingual administration. SCIT reduced the use of rhinitis and asthma medication significantly for both allergens, while SLIT reduced the use of rhinitis medication for both allergens and the use of asthma medication for grasses only.

9.
Allergy ; 75(8): 2050-2058, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32080856

RESUMO

BACKGROUND: The objective of this study was to analyze the effectiveness of allergen immunotherapy (AIT) with an allergoid in the treatment of house dust mites (HDM)-induced allergic rhinitis and/or asthma based on recent real-life data. The outcomes were measured using asthma incidence and consumption of corresponding medications as the indicator of persisting symptoms. METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, patients who received at least two relevant mite AIT prescriptions in two different successive seasonal cycles were compared with non-AIT patients who received at least three symptomatic allergic rhinitis (AR) prescriptions in successive mite seasons. Study endpoints included AR progression, asthma progression, asthma occurrence, and therapy adherence. We used multivariate regression analyses to estimate the effects of AIT, adjusting for relevant variables. RESULTS: This study included 2350 patients receiving a mite allergoid and 64 740 control patients. After up to 6 years of follow-up, patients treated with mite allergoid required significantly fewer AR and asthma prescriptions (59.7% vs 10.8%) than the control group, and the probability of asthma development was significantly lower. The adherence of patients receiving allergoid was 63.8% at the end of the second year and 38.6% at the end of the third year. CONCLUSIONS: This real-world evidence confirms the good efficacy of subcutaneous AIT with HDM mite allergoid in the treatment of allergic rhinitis and/or asthma. Up to 6 years of follow-up revealed significant effects in allergic rhinitis by measuring the number of AR medications and demonstrating significant reductions in asthma medications.


Assuntos
Asma , Rinite Alérgica , Alergoides , Animais , Asma/epidemiologia , Asma/terapia , Dessensibilização Imunológica , Poeira , Humanos , Pyroglyphidae , Estudos Retrospectivos , Rinite Alérgica/epidemiologia , Rinite Alérgica/terapia
10.
Future Oncol ; 16(8): 317-328, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32050787

RESUMO

Aim: There is a growing body of data on real-world use of talimogene laherparepvec (T-VEC). We aimed to characterize real-world T-VEC use using a nationally representative German prescription database covering 60% of prescriptions reimbursed. Patients & methods: A retrospective analysis was conducted using the German IMS® LRx prescription database, analyzing patients aged ≥18 years with an initial T-VEC prescription at 106 plaque-forming units (PFU)/ml and ≥1 subsequent prescription at 108 PFU/ml. Median time on T-VEC treatment, patient characteristics and patterns of T-VEC use were described. Results: Of 127 patients prescribed T-VEC, 72 patients (57%) met study criteria. About two-thirds of these patients initiated T-VEC in 2017. Median age at T-VEC initiation was 74 years (range: 44 to 91). Most prescriptions (88%) were dispensed from hospitals. At study end, 26 (36%) patients remained on T-VEC; 46 (64%) had ended treatment. Median duration of T-VEC treatment for all patients was 18.7 weeks (95% CI: 15.3-26.9) and was longer among those who initiated treatment in 2017 versus 2016 (26.7 vs 15.6 weeks, respectively). Median volume administered for the first 106 PFU/ml and second 108 PFU/ml was 4 ml; the volume decreased for subsequent administrations (2 ml by the eighth administration and 1 ml by the 16th administration). Conclusion: This real-world prescription database study showed that patients who initiated treatment in 2017 had a treatment duration in clinical practice that corresponded with the European Summary of Product Characteristics guideline of continuing T-VEC for ≥6 months. Additional long-term data linking drug use with clinical outcomes are needed.


Assuntos
Produtos Biológicos , Herpesvirus Humano 1 , Terapia Viral Oncolítica/métodos , Terapia Viral Oncolítica/estatística & dados numéricos , Vírus Oncolíticos , Adulto , Idoso , Idoso de 80 Anos ou mais , Produtos Biológicos/uso terapêutico , Terapia Combinada , Bases de Dados Factuais , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Melanoma/epidemiologia , Melanoma/terapia , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Resultado do Tratamento
11.
Curr Med Res Opin ; 35(5): 893-901, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30328731

RESUMO

OBJECTIVE: This retrospective database analysis complements previous research to understand treatment patterns for German patients newly-initiating or switching to subsequent GLP-1 RAs. METHODS: Adult patients (≥18 years) initiating GLP-1 RA (Cohort 1 [C1]) or switching from a previous GLP-1 RA (Cohort 2 [C2]) to exenatide twice-daily (exBID), exenatide once-weekly (exQW), dulaglutide (DULA), or liraglutide (LIRA) were included in this analysis using IQVIA LRx from January 1, 2014-March 31, 2017. Patients were required to have ≥1 oral anti-hyperglycemic prescription during the 6-month pre-index period and ≥12 months follow-up. Persistence and treatment modifications were assessed within and beyond 12 months follow-up. Average daily/weekly dosage (ADD/AWD) was calculated during persistence. RESULTS: C1 included 13,417 patients, while C2 included 4,264 patients. Mean ± standard deviation (SD) age was similar (57.7 ± 11.1 years [C1], 58.9 ± 10.1 years [C2]). Most patients using DULA in C2 had switched from LIRA (56.6%). For C1, mean ADD for LIRA was 1.41 ± 0.10 mg, slightly higher in C2, and increased over time. ADD for exBID was 16.9 ± 1.0 mcg, slightly greater in C2. AWD was 2.00 ± 0.05 mg for exQW users and 1.42 ± 0.03 mg for DULA users in C1, similar to C2. For C1, 27.0% exBID, 35.3% exQW, 50.9% DULA, and 48.1% LIRA users remained persistent at 12 months. Patients using DULA had a higher probability of remaining persistent over time (Kaplan-Meier) for both cohorts. CONCLUSIONS: Patients using DULA had the highest probability of remaining persistent over time, followed by LIRA. ADD/AWD for DULA, exQW, and exBID were aligned with the recommended combination therapy dose; LIRA ADD suggests some patients use the 1.8 mg dose.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hipoglicemiantes/uso terapêutico , Adulto , Idoso , Feminino , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Humanos , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Liraglutida/uso terapêutico , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes de Fusão/uso terapêutico , Estudos Retrospectivos
12.
Allergy ; 74(3): 594-604, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30183091

RESUMO

BACKGROUND: Real-world evidence is sparse on the benefits of allergen immunotherapy [AIT; subcutaneous/sublingual immunotherapy (SCIT/SLIT)], the only disease-modifying intervention for allergic rhinitis (AR) with long-term efficacy. This real-life study evaluated the effect of six AITs (native pollen SLIT/SCIT, four allergoid SCITs) vs symptomatic medication use, on AR symptoms and asthma symptoms/onset, in patients with birch pollen-associated AR and/or asthma. METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, AIT patients received ≥2 successive seasonal treatment cycles; non-AIT patients had ≥3 AR prescriptions in three seasons or previous month. Patients were matched for: index year, age, gender, main indication at index, number of seasonal cycles within treatment period, baseline AR/asthma treatment prescriptions. Multiple regression analysis compared prescription data in AIT and non-AIT groups as proxy for clinical status/disease progression. RESULTS: Up to 6 years of follow-up, significantly more AIT (65.4%) vs non-AIT (47.4%) patients were AR medication-free; odds ratio (OR) [95% confidence interval (CI)]: 0.51 [(0.48-0.54); P < 0.001] (28.6% covariate-adjusted reduction vs non-AIT; P < 0.001), and significantly more AIT (49.1%) vs non-AIT (35.1%) patients were asthma medication-free [OR (95% CI): 0.59 (0.55-0.65); P < 0.001] (32% reduction vs non-AIT; P < 0.001), or reduced existing asthma medication use (32% covariate-adjusted reduction vs non-AIT; P < 0.001). During treatment, new-onset asthma risk was significantly reduced in the AIT vs non-AIT group (OR: 0.83; P = 0.001). CONCLUSIONS: Birch pollen AIT demonstrated real-world benefits up to 6 years post-treatment cessation through significantly reduced AR and asthma medication intake, and significantly decreased risk of new-onset asthma medication use on-treatment.


Assuntos
Alérgenos/imunologia , Asma/imunologia , Asma/terapia , Betula/imunologia , Dessensibilização Imunológica , Pólen/imunologia , Rinite Alérgica/imunologia , Rinite Alérgica/terapia , Administração Sublingual , Progressão da Doença , Feminino , Seguimentos , Humanos , Masculino , Razão de Chances , Estudos Retrospectivos , Resultado do Tratamento
13.
Diabetes Ther ; 7(3): 483-96, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27262995

RESUMO

INTRODUCTION: Preliminary data suggest that dipeptidyl peptidase-4 (DPP-4) inhibitors may reduce microvascular events, but there is a little evidence to support this from adequate real-world studies. This study aimed to compare microvascular outcomes between patients-prescribed vildagliptin and those prescribed sulfonylurea (SU). METHODS: This retrospective cohort study was conducted on a large sample from the German electronic medical records database IMS Lifelink Disease Analyzer. We used propensity score-matched samples of patients prescribed either vildagliptin or SU. Exposure was defined as therapy (SU or vildagliptin); primary outcomes were a diagnosis of retinopathy, nephropathy, neuropathy, or diabetic foot ulcer over the observation period in patients with no previous record of these outcomes. Secondary outcome was a composite of any primary outcome occurring in the observation period. RESULTS: In total, 16,321 patients prescribed SU and 4481 prescribed vildagliptin met the inclusion criteria. After propensity score matching, each sample comprised 3015 patients. Mean age was 63.7/64.6 years for SU/vildagliptin, respectively, with mean disease duration of 3.2/3.1 years, and mean treatment duration of 2.5/2.3 years. Treatment with vildagliptin was associated with a significant lower incidence of retinopathy [odds ratio (OR) = 0.55, P = 0.0004], neuropathy (OR 0.71, P = 0.0001), and composite outcome (OR 0.70, P < 0.0001). Incidences of nephropathy and diabetic foot ulcer were lower for vildagliptin, but not significantly so (OR 0.90, P = 0.3920; OR 0.76, P = 0.0742, respectively). There were no significant differences in incident rate ratios (all P > 0.05). CONCLUSION: Treatment with vildagliptin was associated with a reduced incidence of microvascular complications, especially neuropathy and retinopathy, compared to treatment with SU in this clinical practice setting. FUNDING: Novartis Pharma AG.

14.
Ger Med Sci ; 13: Doc14, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26339224

RESUMO

Large epidemiological databases are often used to examine matters pertaining to drug utilization, health services, and drug safety. The major strength of such databases is that they include large sample sizes, which allow precise estimates to be made. The IMS® LRx database has in recent years been used as a data source for epidemiological research. The aim of this paper is to review a number of recent studies published with the aid of this database and compare these with the results of similar studies using independent data published in the literature. In spite of being somewhat limited to studies for which comparative independent results were available, it was possible to include a wide range of possible uses of the LRx database in a variety of therapeutic fields: prevalence/incidence rate determination (diabetes, epilepsy), persistence analyses (diabetes, osteoporosis), use of comedication (diabetes), drug utilization (G-CSF market) and treatment costs (diabetes, G-CSF market). In general, the results of the LRx studies were found to be clearly in line with previously published reports. In some cases, noticeable discrepancies between the LRx results and the literature data were found (e.g. prevalence in epilepsy, persistence in osteoporosis) and these were discussed and possible reasons presented. Overall, it was concluded that the IMS® LRx database forms a suitable database for pharmacoepidemiological studies.


Assuntos
Bases de Dados Factuais , Diabetes Mellitus/epidemiologia , Prescrições de Medicamentos/estatística & dados numéricos , Epilepsia/epidemiologia , Anticonvulsivantes/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Epilepsia/tratamento farmacológico , Alemanha/epidemiologia , Fator Estimulador de Colônias de Granulócitos , Humanos , Hipoglicemiantes/uso terapêutico , Incidência , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Osteoporose/tratamento farmacológico , Farmacoepidemiologia , Prevalência
16.
Adv Ther ; 27(11): 859-69, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20949340

RESUMO

INTRODUCTION: This retrospective study used data from a primary care database to compare two insulin products in routine clinical practice for the treatment of type 2 diabetes in the UK. PATIENTS AND METHODS: Records were analyzed for patients with type 2 diabetes who had been initiated on biphasic insulin aspart 30 (BIAsp30) (n=632) or biphasic isophane human insulin 30 (BHI30) (n=762) and who had a glycated hemoglobin (HbA1(c)) measurement at baseline (up to 6 months before the index date) and end of study (6-12 months after index date). Regression analyses were used to test for a statistically significant interaction between reduction in HbA1(c) from baseline to end of study and the log-transformed average daily dose (logADD) of insulin. RESULTS: With BIAsp30 a significantly lower dose of insulin (47.74 insulin units [IU]/day vs. 66.63 IU/day, P<0.0001) was required to obtain a similar HbA1(c) reduction (1.71%-point vs. 1.55%-point, P=0.24). To achieve an additional reduction of 0.1 percentage points in HbA1(c) (eg, reduction from 9% to 7.9% HbA1(c) instead of from 9% to 8%), the dose of BIAsp30 would need to be increased by a factor of 1.15. For BHI30, a greater increase in dose would be needed to achieve the same additional HbA1(c) reduction (dose increase by a factor of 1.74). CONCLUSION: Clinically meaningful reductions in HbA1(c) can be achieved at lower insulin doses with BIAsp30 treatment than with BHI30. Lower insulin doses may have important implications for medication costs.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/farmacologia , Insulina Isófana/farmacologia , Insulina/análogos & derivados , Insulinas Bifásicas , Relação Dose-Resposta a Droga , Feminino , Hemoglobinas Glicadas/efeitos dos fármacos , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Insulina/farmacologia , Insulina Aspart , Insulina Isófana/administração & dosagem , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Reino Unido
17.
Appl Opt ; 43(13): 2722-9, 2004 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-15130012

RESUMO

The next generation of optical data storage system beyond DVDs will use blue laser light and an objective lens with a high numerical aperture of 0.85 to increase storage capacity. Such high numerical aperture systems have an inherent higher sensitivity to aberrations. In particular, the spherical aberration caused by cover layer thickness tolerances and--more obvious--by dual-layer disks with a typical separation of approximately 20 microm between the two layers must be compensated. We propose a novel transmissive nematic liquid-crystal device, which is capable of compensating spherical aberration that occurs during the operation of optical pickup systems.

18.
Angew Chem Int Ed Engl ; 38(12): 1763-1765, 1999 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-29711188

RESUMO

The direct determination of the elemental compositions of the components of compound collections from combinatorial chemistry is achieved by ESI-FT-ICR mass spectrometry. Coupling with HPLC opens up a new dimension in high-resolution, informative analysis. The improved resolution of ESI-FT-ICR mass spectrometry in comparison to quadrupole mass spectrometry in the measurement of a compound obtained by solid-phase synthesis is illustrated.

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