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1.
Dermatology ; 238(4): 620-629, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34823247

RESUMO

BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with psoriasis that significantly impairs physical function and quality of life (QoL). Prompt therapeutic intervention is crucial for limiting PsA progression and preventing disability. OBJECTIVES: The aim of this study was to compare the efficacy of brodalumab versus ustekin-umab and the impact on QoL in patients with moderate-to-severe plaque psoriasis, by concomitant PsA status. METHODS: This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials evaluated complete skin clearance (100% improvement of Psoriasis Area and Severity Index [PASI 100]), improvement in symptom severity (Psoriasis Symptom Inventory [PSI] response), and QoL (Dermatology Life Quality Index [DLQI] score of 0/1) by concomitant PsA status. A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI 100 or inadequate response. RESULTS: This analysis included 929 patients with moderate-to-severe psoriasis. Concomitant PsA was present in 79/339 (23%) and 110/590 (19%) patients receiving brodalumab 210 mg and ustekinumab, respectively. At Week 52, odds ratios (ORs) (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekin-umab were 3.15 (1.52-6.55, p = 0.0015) in patients with concomitant PsA and 3.05 (2.19-4.26, p < 0.0001) in patients without concomitant PsA. Corresponding Week 52 ORs (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 2.05 (1.07-3.90, p = 0.0277) and 1.83 (1.32-2.53, p = 0.0002); Week 52 ORs (95% CIs) for PSI ≤8 with brodalumab versus ustekinumab were 3.42 (1.43-8.18, p = 0.0036) and 1.40 (1.01-1.95, p = 0.0434). The 52-week cumulative incidence of patients achieving PASI 100 was significantly higher for brodalumab versus ustekinumab in patients with concomitant PsA (p = 0.0001) and in those without concomitant PsA (p < 0.0001). CONCLUSIONS: Treatment with brodalumab rapidly results in high levels of complete and sustained skin clearance and greater cumulative treatment benefit in patients with moderate-to-severe psoriasis versus ustekinumab, regardless of concomitant PsA status.


Assuntos
Anticorpos Monoclonais Humanizados , Artrite Psoriásica , Psoríase , Anticorpos Monoclonais Humanizados/uso terapêutico , Artrite Psoriásica/complicações , Artrite Psoriásica/tratamento farmacológico , Ensaios Clínicos Fase III como Assunto , Método Duplo-Cego , Humanos , Psoríase/complicações , Psoríase/tratamento farmacológico , Qualidade de Vida , Índice de Gravidade de Doença , Resultado do Tratamento , Ustekinumab/uso terapêutico
2.
Dermatol Ther (Heidelb) ; 11(6): 2107-2121, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34661864

RESUMO

INTRODUCTION: Biologic treatments for psoriasis are commonly switched. Treatment persistence represents an important parameter related to long-term therapeutic performance. The objective of the study was to analyse the real-world persistence with biologics over time in the treatment of psoriasis. METHODS: A retrospective observational study of adults with psoriasis was conducted based on Swedish national registry data from 2010 to 2018. Patients included were treated with a biologic between 2010 and 2018. Treatment episodes were identified from the drug's date of dispensation recorded in the Prescribed Drug Register to the end of supply of the drug. Median persistence was estimated by Kaplan-Meier survival curves for patients who received adalimumab, etanercept, secukinumab, ustekinumab and ixekizumab. Descriptive analysis of change in persistence over time for 3-year running cohorts was also carried out. RESULTS: A total of 2292 patients were analysed. Patients who received ustekinumab had the longest median persistence [49.3 months, 95% confidence interval (CI) 38.0-59.1] and etanercept the shortest (16.3 months, 95% CI 14.5-19.0). Median persistence was longer in biologic-naive than biologic-exposed patients. Persistence for ustekinumab decreased by almost 50% over the study period, from a median of 62.3 (95% CI 45.6-∞) months in 2010-2011 to 32.7 (21.2-49.3) months in 2014-2016. CONCLUSIONS: Persistence with biologics was, on average, relatively low, given the chronic nature of psoriasis. Changes in persistence over time seemed to be attributable to changes in the therapeutic landscape, providing patients with more options to switch biologic treatments if their current management was considered suboptimal.

3.
Dermatol Ther (Heidelb) ; 11(6): 2027-2042, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34606048

RESUMO

INTRODUCTION: Obesity, smoking, and alcohol consumption are prevalent in psoriasis patients and have been associated with increased disease severity and reduced treatment adherence and response. This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials compared the efficacy of brodalumab versus ustekinumab in psoriasis patients with aggravating and potentially treatment-confounding lifestyle risk factors. METHODS: This post hoc analysis evaluated complete skin clearance, as measured by a 100% reduction of Psoriasis Area and Severity Index (PASI100) and quality of life (QoL), as measured by a Dermatology Life Quality Index (DLQI) score of 0/1, by the presence of risk factors (obesity, tobacco or alcohol use). A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI100 or inadequate response. RESULTS: This analysis included 929 patients (brodalumab 210 mg, n = 339; ustekinumab, n = 590) with moderate-to-severe psoriasis. At week 52, odds ratios (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekinumab were 2.50 (1.14-5.46, P = 0.0186), 4.64 (2.80-7.69, P < 0.0001), 2.06 (1.25-3.40, P = 0.0045), and 2.55 (0.55-11.91, P = 0.2117) in patients with no, one, two, or three risk factors, respectively. Corresponding odds ratios (ORs) (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 1.72 (0.78-3.79, P = 0.1883), 2.49 (1.54-4.02, P < 0.0002), 1.57 (0.97-2.54, P = 0.0666), and 2.07 (0.45-9.57, P = 0.3438). The 52-week cumulative incidence of patients achieving PASI100 was consistently higher for brodalumab versus ustekinumab, regardless of number of risk factors (P < 0.0001 for one or two risk factors and P = 0.0029 for three risk factors). CONCLUSIONS: Higher levels of complete skin clearance and QoL were achieved and maintained with brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis, regardless of the presence of lifestyle risk factors. CLINICAL TRIAL REGISTRATION: AMAGINE-2 (NCT01708603); AMAGINE-3 (NCT01708629).

4.
J Drugs Dermatol ; 20(8): 822-828, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34397196

RESUMO

BACKGROUND: Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited. OBJECTIVE: To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis. METHODS: Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA BSA score. RESULTS: Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA BSA score. LIMITATIONS: These post hoc analyses need to be confirmed with prospective studies. CONCLUSION: Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.


Assuntos
Betametasona/análogos & derivados , Calcitriol/análogos & derivados , Psoríase , Betametasona/uso terapêutico , Calcitriol/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Formas de Dosagem , Combinação de Medicamentos , Humanos , Estudos Prospectivos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
5.
J Dermatolog Treat ; 32(4): 411-417, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31469026

RESUMO

BACKGROUND: It is unclear if there are any distinct AK patient populations that might respond best to a given treatment. OBJECTIVE: To identify if a distinct subgroup of patients with AK might respond better to treatment with ingenol mebutate (IngMeb) versus diclofenac sodium (DS). METHODS: Complete clearance of AK and mean lesion reduction at end of first treatment course and week 17 were evaluated within subgroups. RESULTS: 502 patients (255 IngMeb; 247 DS) were included in the analysis. At week 17, complete clearance was achieved by more patients treated with IngMeb versus DS within the majority of patient subgroups, including patients with <6 lesions and ≥6 lesions at baseline, aged ≥65 years, males, females, Fitzpatrick skin types II and III, and facial lesions. Mean lesion reduction at week 17 was greater with IngMeb than DS within the same subgroups, and in patients with scalp lesions. CONCLUSIONS: This responder analysis did not identify any distinct population that responded more optimally than others with IngMeb or DS. More patients achieved complete clearance and higher lesion reduction of AK with IngMeb compared with DS in most subgroups.


Assuntos
Diclofenaco/uso terapêutico , Diterpenos/administração & dosagem , Ceratose Actínica/tratamento farmacológico , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
7.
J Drugs Dermatol ; 19(8): 756-762, 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32804451

RESUMO

Background: Real-world data for actinic keratosis treatment in the United States is lacking. Objectives: To understand real-world treatment patterns for actinic keratosis by type and modality, and compare effectiveness and safety of therapies, either alone or in combination. Methods: Medical charts of 429 patients were identified; clinical and outcome data were analyzed. Results: The first treatment after the index diagnosis was most frequently a procedure, followed by a topical agent. Treatment with 5-fluorouracil, ingenol mebutate, imiquimod, cryotherapy, or cryotherapy plus one topical (CRYO+One Topical) reduced actinic keratoses by 66.0%, 69.3%, 72.5%, 72.9%, and 73.0%, respectively; ≥75% clearance (AKCLEAR 75) was achieved in 57.1%, 72.7%, 57.1%, 62.4%, and 62.0% of those patients. Treatment effectiveness was positively correlated with the number of baseline actinic keratoses for topical and for procedural plus topical combination treatments, but not for procedural treatments alone. Adverse reactions (ARs) were more common with cryotherapy (9.7%); local skin responses (LSRs) were more common with field-directed (18.5%-43.1%) and CRYO+One Topical therapy (21.3%). Limitations: This was a retrospective study of limited duration and population size. Conclusions: The most commonly used treatments for patients with 6 or more actinic keratoses were topicals and a procedure plus topical combination, which also achieved higher rates of complete clearance than a procedure alone. ARs and LSRs were few in frequency and type.


Assuntos
Antineoplásicos/administração & dosagem , Crioterapia/métodos , Ceratose Actínica/terapia , Administração Cutânea , Idoso , Antineoplásicos/efeitos adversos , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Crioterapia/efeitos adversos , Diterpenos/administração & dosagem , Diterpenos/efeitos adversos , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Imiquimode/administração & dosagem , Imiquimode/efeitos adversos , Ceratose Actínica/diagnóstico , Ceratose Actínica/patologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença , Pele/efeitos dos fármacos , Pele/patologia , Resultado do Tratamento , Estados Unidos
8.
J Clin Aesthet Dermatol ; 13(5): 12-18, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32802249

RESUMO

BACKGROUND: There are a variety of treatment options currently available for plaque psoriasis affecting the scalp, yet scalp psoriasis remains one of the most frustrating and difficult-to-manage forms of the disease. OBJECTIVE: We investigated the efficacy of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam for the treatment of scalp psoriasis. METHODS: Additional (including post-hoc) analysis was conducted on data from a Phase II, randomized, double-blind, multicenter study of Cal/BD foam for the treatment of psoriasis vulgaris (NCT01536938). A total of 302 patients, ages 18 years or older, with psoriasis vulgaris of at least mild severity (scalp involvement of at least 10%) were included; 100, 101, and 101 patients were randomized to once-daily Cal/BD foam, Cal foam, or BD foam, respectively. Assessments included a severity score for lesion redness, scaliness, and plaque thickness, modified Psoriasis Area and Severity Index (mPASI) score, proportion of patients with reduction of 50 percent or greater in total sign score (TSS-50), and proportion of patients with at least a 75-percent reduction in mPASI score (mPASI-75). RESULTS: Patients achieved greater improvements in their scalp psoriasis with Cal/BD foam versus BD or Cal foam alone at Week 4 considering mPASI, mPASI-75, and TSS-50 outcomes. After four weeks of treatment, more patients receiving Cal/BD foam had a severity score for redness, scaliness, and thickness indicating "none" or "mild" versus BD foam or Cal foam alone. Improvements on the scalp appear to be consistent with those on the trunk and limbs. CONCLUSION: Scalp lesion severity improved considerably and rapidly with a four-week regimen of Cal/BD foam, suggesting that Cal/BD foam is an effective topical treatment option for scalp psoriasis.

9.
Dermatol Ther (Heidelb) ; 10(5): 1099-1109, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32761560

RESUMO

INTRODUCTION: Clinical trials have shown that psoriasis patients who achieve complete skin clearance are more likely to report no impairment in health-related quality of life (HRQoL) and no psoriasis symptoms versus patients who achieve almost complete skin clearance. However, real-world data are lacking. The objective of this study was to estimate the real-world proportion of moderate-to-severe psoriasis patients on biologic treatment who achieved a Psoriasis Symptom Inventory (PSI) total score of 0 (PSI 0; no symptoms) and a Dermatology Life Quality Index (DLQI) score of 0/1 (DLQI 0/1; no impact on HRQoL), and to study the relationship between patient-reported symptoms and HRQoL versus physician-reported psoriasis severity (Psoriasis Area and Severity Index [PASI]). METHODS: The PSO-BIO-REAL study was a multinational, prospective, real-world, non-interventional study that included patients aged ≥ 18 years with moderate-to-severe plaque psoriasis who had initiated biologic therapy (either biologic-naïve or had switched biologics [biologic-experienced]). Psoriasis symptoms were evaluated using the PSI, and HRQoL was assessed using the DLQI. Assessments were conducted at baseline and at 6 and 12 months after initiating biologic treatment. Associations between PSI and DLQI with PASI were evaluated using Spearman correlation coefficients. Post-hoc analyses evaluated individual PSI items and the association to PASI response, DLQI and PSI by index biologic. RESULTS: At 12 months, 25.5% of patients achieved PSI 0, and 51.2% achieved DLQI 0/1, with greater proportions achieving these scores among biologic-naïve than among biologic-experienced patients. There was a moderate-to-strong correlation between PSI and DLQI scores and PASI scores, with 64.8% of patients with absolute PASI 0 and 19.4% with absolute PASI > 0 ≤ 2 achieving PSI 0 (6 and 12 months pooled). Achievement of response varied by index biologic. CONCLUSION: This study demonstrates that in a real-world setting patients' QoL improves with skin clearance. The results also demonstrate that the correlation between skin clearance and improvements in HRQoL (DLQI) and psoriasis symptoms (PSI) is not complete, which highlights the importance of considering both patient- and physician-reported outcomes in the assessment of psoriasis treatment outcomes.

10.
J Am Acad Dermatol ; 83(1): 131-138, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32430142

RESUMO

BACKGROUND: The product of the Physician Global Assessment and body surface area (PGA×BSA) is simpler to use than the Psoriasis Area and Severity Index (PASI), which lacks sensitivity in patients with mild psoriasis. OBJECTIVE: To compare the PGA×BSA versus the modified PASI (mPASI) for assessing disease severity and therapeutic response to calcipotriol/betamethasone dipropionate (Cal/BD) foam. METHODS: This post hoc analysis evaluated the efficacy of Cal/BD foam in mild, moderate, and severe psoriasis, as assessed by the PGA×BSA and mPASI, using data from 3 randomized controlled trials (NCT01536886, NCT01866163, NCT02132936). Spearman correlation and Bland-Altman plots were used to compare the PGA×BSA with the mPASI. RESULTS: Proportions of patients receiving Cal/BD foam achieving 75% response for PGA×BSA and mPASI at weeks 1, 2, and 4 were similar and significantly greater than with vehicle (P ≤ .002 at all timepoints); at week 4, mean improvements were 51.0% and 50.7%, respectively. Spearman correlations for mild, moderate, and severe psoriasis were moderate to high between PGA×BSA and mPASI at baseline (r = .51, .72, and .86, respectively; n = 126, 465, and 58, respectively) and high at week 4 (r = .80, .81, and .89, respectively; n = 121, 452, and 58, respectively) (P < .001). LIMITATIONS: Pooled data from different trials were not prespecified for post hoc analysis. Interrater reliability was not assessed. CONCLUSION: Pooled data analysis showed that the PGA×BSA and mPASI correlation was higher with increasing psoriasis severity.


Assuntos
Anti-Inflamatórios/uso terapêutico , Betametasona/análogos & derivados , Superfície Corporal , Calcitriol/análogos & derivados , Fármacos Dermatológicos/uso terapêutico , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Adulto , Idoso , Betametasona/uso terapêutico , Calcitriol/uso terapêutico , Interpretação Estatística de Dados , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
11.
J Med Econ ; 23(6): 641-649, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31985301

RESUMO

Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion.Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis.Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated.Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294).Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.


Assuntos
Fármacos Dermatológicos/economia , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Administração Cutânea , Adulto , Idoso , Betametasona/análogos & derivados , Betametasona/economia , Betametasona/uso terapêutico , Calcitriol/análogos & derivados , Calcitriol/economia , Calcitriol/uso terapêutico , Clobetasol/análogos & derivados , Clobetasol/economia , Clobetasol/uso terapêutico , Fármacos Dermatológicos/administração & dosagem , Combinação de Medicamentos , Humanos , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ácidos Nicotínicos/economia , Ácidos Nicotínicos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença
12.
Diabetes Res Clin Pract ; 105(2): 192-8, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24925134

RESUMO

UNLABELLED: To evaluate if improvements in the quality of diabetes care in Indian clinics can be obtained by simple self-surveillance PC-based software. METHOD: Nineteen Indian diabetes clinics were introduced to the principles of quality assurance (QA), and to a software program, the Steno Quality Assurance Tool (SQAT). Data was entered for an initial 3 months period. Subsequently data were analyzed by the users, who designed plans to improve indicator status and set goals for the upcoming period. A second data entry period followed after 7-9 months. RESULTS: QA data was analyzed from 4487 T2DM patients (baseline) and 4440 (follow-up). The average examination frequency per clinic of the following indicators increased significantly: lipid examination (72-87%) (p=0.007), foot examination (80-94%) (p=0.02), HbA1c investigation (59-77%) (p=0.006), and urine albumin excretion investigation (72-87%) (p=0.006). Outcome parameters also improved significantly: mean (SD) fasting and post prandial BG reduced from 144(16) to 132(16)mg/dl (p=0.02) and 212(24)-195(29)mg/dl (p=0.03), respectively. Systolic BP reduced from 139(6) to 133(4) (p=0.0008)mmHg and diastolic BP from 83(3) to 81(3)mmHg (p=0.002). CONCLUSION: Quality of diabetes care can be improved by applying SQAT, a QA self-surveillance software that enables documentation of changes in process and outcome indicators.


Assuntos
Diabetes Mellitus/prevenção & controle , Garantia da Qualidade dos Cuidados de Saúde/normas , Qualidade da Assistência à Saúde , Autocuidado/métodos , Autoavaliação (Psicologia) , Software , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde
13.
Curr Med Res Opin ; 29(6): 601-9, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23488447

RESUMO

BACKGROUND: Early initiation of insulin therapy has widely been associated with numerous benefits, including improved glycaemic control and reduced long-term risk of developing microvascular diseases. Biphasic insulins offer a convenient option for insulin initiation, addressing both basal and postprandial insulin requirements with one injection, making them relatively simple for patients to dose. Development of biphasic insulin aspart (BIAsp) has further offered improved postprandial glycaemic control and lower rates of nocturnal and major hypoglycaemia than biphasic human insulin. METHODS: The safety and efficacy of the 30/70 rapid-acting/intermediate-acting formulation of BIAsp (BIAsp 30) in patients with type 2 diabetes was examined in the IMPROVE study, a 26-week, international, observational trial. In this subanalysis, baseline clinical factors that predicted treatment success, defined as HbA1c <7% (<53 mmol/mol) without experiencing hypoglycaemia after 26 weeks on BIAsp 30 therapy, were assessed. RESULTS: The composite endpoint was defined for 44,010 (77%) patients from the total cohort of 57,478, and 28,696 of these were included in the statistical examination. The results of the analysis suggest that those with lower baseline HbA1c of ≤8% (≤64 mmol/mol), shorter duration of diabetes at baseline (<5 years) and no incidence of major hypoglycaemia at 13 weeks, or minor hypoglycaemia at 4 weeks, before the beginning of the trial were more likely to achieve treatment success. CONCLUSION: Lower baseline HbA1c, shorter duration of diabetes and no incidence of hypoglycaemia up to 13 weeks prior to initiation are predictors of achieving HbA1c <7% without hypoglycaemia with a BIAsp 30 regimen. These results suggest that it is easier to reach target without hypoglycaemia with BIAsp 30 when prescribed earlier. As this was an observational study, lack of control groups or randomisation, as well as varying clinical practices in study countries, potentially introduced bias. TRIAL REGISTRATION: ClinicalTrials.gov NCT00659282.


Assuntos
Insulinas Bifásicas/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas/análise , Hipoglicemia/diagnóstico , Hipoglicemiantes/uso terapêutico , Insulina Aspart/uso terapêutico , Insulina Isófana/uso terapêutico , Insulinas Bifásicas/efeitos adversos , Glicemia/análise , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Insulina Aspart/efeitos adversos , Insulina Isófana/efeitos adversos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
14.
Diabetes Res Clin Pract ; 86(2): e15-8, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19747748

RESUMO

The relationship between fasting glucose (FG) variability and nocturnal hypoglycemia was assessed using longitudinal data from PREDICTIVE, the large-scale observational study of insulin detemir. An HbA(1c)-corrected correlation was found between these endpoints, suggesting FG variability can serve as a useful marker for this risk in clinical practice.


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Hipoglicemia/epidemiologia , Adulto , Idoso , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Esquema de Medicação , Jejum , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prevalência
15.
J Rheumatol ; 34(12): 2481-5, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18050366

RESUMO

OBJECTIVE: Anti-tumor necrosis factor (TNF) therapy is known to decrease disease activity of juvenile idiopathic arthritis (JIA), but its effect on longitudinal growth in relation to puberty is not clear. We studied longitudinal growth in response to etanercept treatment in prepubertal and pubertal patients with JIA. METHODS: Out of 52 children treated with etanercept, we studied 20 prepubertal and 11 early/midpubertal patients adherent to treatment for at least 1 year. We collected data on growth and glucocorticoid medication and calculated each patient's height standard deviation score (SDS) in relation to the mid-parental height, the change of this value (DeltahSDS) from 1 to 0 and 0 to 1 year of treatment, and the change between the DeltahSDS values to assess growth improvement. RESULTS: In the prepubertal group, the relative height SDS (mean +/- standard error of the mean) was 1.8 +/- 0.2, 2.1 +/- 0.3, and 1.9 +/- 0.3, and in the pubertal group 1.1 +/- 0.4, 1.3 +/- 0.3, and 1.1 +/- 0.3 at 1, 0, and +1 year of treatment, respectively. The DeltahSDS before etanercept was 0.3 +/- 0.1 in prepubertal and 0.2 +/- 0.2 in pubertal patients. Over the first year with etanercept, DeltahSDS was +0.2 +/- 0.1 in prepubertal (p = 0.001 vs before etanercept; paired Student t-test) and +0.2 +/- 0.1 in pubertal patients (p = 0.071). Nevertheless, most prepubertal (17/20) and pubertal (8/11) patients had improved growth (DeltahSDS) in response to etanercept treatment when analyzed individually. The need for intraarticular glucocorticoid injections was negatively correlated to the improved growth (p = 0.001). CONCLUSION: TNF inhibition with etanercept improved growth in a majority of patients with JIA. Our data demonstrate that growth improvement with etanercept was independent of the pubertal growth spurt.


Assuntos
Antirreumáticos/farmacologia , Artrite Juvenil/tratamento farmacológico , Estatura/efeitos dos fármacos , Imunoglobulina G/farmacologia , Puberdade , Adolescente , Antirreumáticos/uso terapêutico , Criança , Pré-Escolar , Etanercepte , Feminino , Humanos , Imunoglobulina G/uso terapêutico , Masculino , Receptores do Fator de Necrose Tumoral/uso terapêutico , Resultado do Tratamento
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