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1.
Front Immunol ; 10: 40, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30778345

RESUMO

Introduction: Subcutaneously administered immunoglobulin (SCIG) is increasingly used to treat patients with primary immunodeficiencies (PIDs). Octanorm (marketed as cutaquig® in USA and Canada) is a new 16.5% solution of human SCIG, manufactured by a process based on that of the intravenous preparation (IVIG) octagam®. Objectives: To investigate the efficacy, safety and tolerability of octanorm in a prospective, open-label, single-arm phase 3 study involving adult and pediatric patients with PIDs (NCT01888484; clinicaltrials.gov/ct2/show/NCT01888484). Methods: Patients who were previously treated with IVIG received a total of 64 weekly SCIG infusions, including 12 weekly infusions during the wash-in/wash-out period, followed by 52 weekly infusions during the evaluation period. Results: A total of 61 patients aged 2-73 years received 3,497 infusions of octanorm. The mean dose per patient was 0.175 g/kg/infusion. The mean calculated dose conversion factor from the patients' previous IVIG dose for octanorm was 1.37. No serious bacterial infections developed during the study. The rate of other infections per person-year during the primary observation period was 3.43 (upper 95% CI 4.57). All but one non-bacterial infection were mild or moderate in intensity. IgG trough levels were constant during the course of the study. Eleven patients (18.0%) experienced 14 mild or moderate systemic adverse events (AEs) related to octanorm. The rate of related AEs per infusion was 0.004. In 76.7% of infusions, no infusion site reactions were observed and only two (0.3%) reactions were deemed severe. The incidence of site reactions decreased with successive infusions. Conclusion: The new 16.5% SCIG octanorm was shown to be efficacious in preventing infections in PIDs, and was well tolerated.

3.
BMJ Open ; 8(10): e022063, 2018 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-30385438

RESUMO

OBJECTIVE: To compare the characteristics/management of acute venous thromboembolism (VTE) for patients either discharged directly from the emergency department (ED) or hospitalised throughout a year within two urban cities in Canada. DESIGN: Retrospective medical record review. SETTING: Hospitals in Edmonton, Alberta (n=4) and Regina, Saskatchewan (n=2) from April 2014 to March 2015. PARTICIPANTS: All patients discharged from the ED or hospital with acute deep vein thrombosis or pulmonary embolism (PE). Those having another indication for anticoagulant therapy, pregnant/breast feeding or anticipated lifespan <3 months were excluded. PRIMARY AND SECONDARY OUTCOMES: Primarily, to compare proportion of patients receiving traditional therapy (parenteral anticoagulant±warfarin) relative to a direct oral anticoagulant (DOAC) between the two cohorts. Secondarily, to assess differences with therapy selected based on clot burden and follow-up plans postdischarge. RESULTS: 387 (25.2%) and 665 (72.5%) patients from the ED and hospital cohorts, respectively, were included. Compared with the ED cohort, those hospitalised were older (57.3 and 64.5 years; p<0.0001), more likely to have PE (35.7% vs 83.8%) with a simplified Pulmonary Embolism Severity Index (sPESI) ≥1 (31.2% vs 65.2%), cancer (14.7% and 22.3%; p=0.003) and pulmonary disease (10.1% and 20.6%; p<0.0001). For the ED and hospital cohorts, similar proportions of patients were prescribed traditional therapies (72.6% and 71.1%) and a DOAC (25.8% and 27.4%, respectively). For the ED cohort, DOAC use was similar between those with a sPESI score of 0 and ≥1 (35.1% and 34.9%, p=0.98) whereas for those hospitalised lower risk patients were more likely to receive a DOAC (31.4% and 23.8%, p<0.055). Follow-up was most common with family physicians for those hospitalised (51.5%), while specialists/VTE clinic was most common for those directly discharged from the ED (50.6%). CONCLUSIONS: Traditional and DOAC therapies were proportionately similar between the ED and hospitalised cohorts, despite clear differences in patient populations and follow-up patterns in the community.

4.
BMJ Open ; 8(10): e022064, 2018 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-30385439

RESUMO

OBJECTIVE: To report the proportion of patients discharged directly from the emergency department (ED) on traditional therapy (parenteral anticoagulant±warfarin) or a direct oral anticoagulant (DOAC) for the management of acute venous thromboembolism (VTE). DESIGN: Retrospective medical record review across four EDs in Edmonton, Alberta, two in Regina, Saskatchewan and three in rural Alberta. SETTING: EDs from April 2014 through March 2015. PARTICIPANTS: Discharged directly from the ED with acute VTE. Patients were excluded if they had another indication for anticoagulants, were pregnant/breastfeeding or anticipated lifespan <3 months. PRIMARY AND SECONDARY OUTCOME MEASURES: Primarily, the proportion of patients discharged directly from the ED that were prescribed traditional therapy or a DOAC, with comparisons between Edmonton, Regina and rural Alberta. Secondarily, therapy selection was compared based on deep vein thrombosis (DVT) versus pulmonary embolism (PE) and clot burden. Dosing of DOACs was assessed (when applicable) and follow-up in the community was compared. RESULTS: After screening 1723 patients, 417 (24.2%) were included with DVT and PE occurring in 65.5% and 34.5%, respectively. More patients with PE were discharged from EDs in Edmonton (43%) than Regina (7%). Overall, the majority of patients were discharged on traditional therapy (70.7%), with 27.8% receiving a DOAC. Uptake of DOAC use was highest in rural Alberta (53.3%) compared with Edmonton (29.6%) and Regina (12.1%). DOACs were more commonly prescribed for PE (34.0%) than DVT (24.5%) (p=0.04), proximal versus distal DVT (28.4% and 17.3%; p<0.001), and when prescribed were appropriately dosed in 79.3%. Follow-up most commonly occurred via a VTE clinic in Edmonton or family physician in Regina and rural Alberta. CONCLUSIONS: Regional variation in discharging patients directly from the ED with PE is evident. While traditional therapy is most common, uptake of DOACs was modest given the timing of indication approval.

5.
BMJ Open ; 8(10): e022065, 2018 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-30385440

RESUMO

OBJECTIVE: To determine anticoagulant therapy at hospital discharge for patients with acute venous thromboembolism (VTE) and secondarily, to describe factors affecting choice of therapy. DESIGN: A retrospective chart review. SETTING: Canadian hospitals in Edmonton, Alberta (n=4), Regina, Saskatchewan (n=2) and rural Alberta (n=3) from April 2014 to March 2015. PARTICIPANTS: All patients discharged with an acute VTE were screened. Those with atypical clots, another indication for anticoagulation, pregnancy/breast feeding or lifespan <3 months were excluded. PRIMARY AND SECONDARY OUTCOMES: Primarily, we identified the proportion of patients discharged from hospital with acute VTE that were prescribed either traditional therapy (parenteral anticoagulant±warfarin) or a direct oral anticoagulant (DOAC). Secondarily, management based on setting, therapy choice based on deep vein thrombosis (DVT) versus pulmonary embolism (PE), clot burden and renal function was compared. DOAC dosing was assessed (when prescribed), length of hospital stay based on therapy was compared and planned follow-up in the community was described. RESULTS: Among the 695 patients included, most were discharged following a diagnosis of PE (82.9%) on traditional therapy (parenteral anticoagulant±warfarin) (70.2%) with follow-up by either a family doctor (51.5%) or specialist/clinic (46.9%) postdischarge. Regional variation was most evident between urban and rural sites. Of those prescribed a DOAC (28.3%), the majority were dosed appropriately (85.8%). DOAC use did not differ between those with DVT and PE, was proportionately higher for less severe clots and declined with worsening renal function. Patients prescribed DOACs versus traditional therapy had a shorter length of stay (4 vs 7 days, respectively). CONCLUSIONS: Uptake of DOAC therapy for acute VTE was modest and may have been influenced by the timing of the audit in relation to the approval of these agents for this indication. Future audits should occur to assess temporal changes and ongoing appropriateness of care delivery.

6.
Thromb Haemost ; 118(5): 842-851, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29564837

RESUMO

Oral factor Xa inhibitors are increasingly used for anticoagulation, but there is no approved reversal agent. Prothrombin complex concentrate (PCC) for the management of Xa-inhibitor-associated bleeding has been described in small case series and one cohort study. Patients on apixaban or rivaroxaban, suffering a major bleed, were treated at nine Canadian hospitals as per existing hospital protocol with a fixed dose of PCC 2,000 units and subsequently recruited for a 30-day follow-up. The treating physician evaluated the haemostatic effectiveness as observed during the first day as good, moderate or poor/none, using an assessment guide. Safety outcomes were thromboembolism or death. We recruited 66 patients with major bleeding who were treated with PCC and who were receiving rivaroxaban (56%) or apixaban (44%). The effectiveness was assessed as good in 65% (95% confidence interval [CI], 53-77), moderate in 20% (95% CI, 10-30) and poor/none in 15% (95% CI, 6-24). For the 36 patients with intracranial haemorrhage, the corresponding ratings were 67, 17 and 17%, and for 16 patients with gastrointestinal bleeding they were 69, 12 and 19%, respectively. There were nine deaths (14%) by 30 days, and five (8%) major thromboembolic events. In a post hoc analysis, according to International Society on Thrombosis and Haemostasis criteria, reversal was effective in 68% and ineffective in 32%. For major bleeding associated with oral Xa inhibitors, PCC may have a beneficial effect. The risk of thromboembolism after reversal of anticoagulation in patients with a prothrombotic background has to be taken into account.

7.
J Thromb Thrombolysis ; 44(4): 507-515, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28914415

RESUMO

Guidelines suggest restarting warfarin at known maintenance doses, although this may result in a delay to achieving therapeutic anticoagulation. As such, we compared the time to achieve an INR ≥ 2.0 between those restarting warfarin maintenance vs loading doses after transient interruption, and the impact on protein C, S and factor II levels. Patients requiring interruption of warfarin for elective procedures without hospitalization were randomized 1:1 to receive warfarin maintenance or loading doses (1.5 times the maintenance dose for 3 days followed by pre-procedural warfarin maintenance dosing). Protein C, S and Factor II were drawn at baseline (prior to warfarin interruption), 7 and 14 days after restarting warfarin. Among 19 patients randomized to maintenance and 20 to loading doses, nearly half in each group had mechanical heart valves with gastrointestinal endoscopic procedures most commonly performed (41%). The median number of days to reach an INR ≥ 2.0 was 7.8 days in the loading and 9.0 in the maintenance group (difference between medians 1.2 days, 95% CI -3.1 to 4.9; P = 0.19). Although levels of protein C, S and factor II were lower in the loading vs maintenance dose group, all remained above that of baseline. Warfarin resumption with loading doses shortened the time to achieve a therapeutic INR by a median of 1.2 days. Prompt warfarin dose escalation should be done in response to the INR. Protein C and S remained above pre-warfarin interruption levels, implying a lack of depletion with restarting warfarin.


Assuntos
Procedimentos Cirúrgicos Eletivos/métodos , Varfarina/administração & dosagem , Idoso , Relação Dose-Resposta a Droga , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Proteína C/análise , Proteína S/análise , Protrombina/análise , Fatores de Tempo
8.
N Engl J Med ; 376(12): 1131-1140, 2017 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-28328347

RESUMO

BACKGROUND: Hereditary angioedema is a disabling, potentially fatal condition caused by deficiency (type I) or dysfunction (type II) of the C1 inhibitor protein. In a phase 2 trial, the use of CSL830, a nanofiltered C1 inhibitor preparation that is suitable for subcutaneous injection, resulted in functional levels of C1 inhibitor activity that would be expected to provide effective prophylaxis of attacks. METHODS: We conducted an international, prospective, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase 3 trial to evaluate the efficacy and safety of self-administered subcutaneous CSL830 in patients with type I or type II hereditary angioedema who had had four or more attacks in a consecutive 2-month period within 3 months before screening. We randomly assigned the patients to one of four treatment sequences in a crossover design, each involving two 16-week treatment periods: either 40 IU or 60 IU of CSL830 per kilogram of body weight twice weekly followed by placebo, or vice versa. The primary efficacy end point was the number of attacks of angioedema. Secondary efficacy end points were the proportion of patients who had a response (≥50% reduction in the number of attacks with CSL830 as compared with placebo) and the number of times that rescue medication was used. RESULTS: Of the 90 patients who underwent randomization, 79 completed the trial. Both doses of CSL830, as compared with placebo, reduced the rate of attacks of hereditary angioedema (mean difference with 40 IU, -2.42 attacks per month; 95% confidence interval [CI], -3.38 to -1.46; and mean difference with 60 IU, -3.51 attacks per month; 95% CI, -4.21 to -2.81; P<0.001 for both comparisons). Response rates were 76% (95% CI, 62 to 87) in the 40-IU group and 90% (95% CI, 77 to 96) in the 60-IU group. The need for rescue medication was reduced from 5.55 uses per month in the placebo group to 1.13 uses per month in the 40-IU group and from 3.89 uses in the placebo group to 0.32 uses per month in the 60-IU group. Adverse events (most commonly mild and transient local site reactions) occurred in similar proportions of patients who received CSL830 and those who received placebo. CONCLUSIONS: In patients with hereditary angioedema, the prophylactic use of a subcutaneous C1 inhibitor twice weekly significantly reduced the frequency of acute attacks. (Funded by CSL Behring; COMPACT EudraCT number, 2013-000916-10 , and ClinicalTrials.gov number, NCT01912456 .).


Assuntos
Proteína Inibidora do Complemento C1/administração & dosagem , Angioedema Hereditário Tipos I e II/prevenção & controle , Adulto , Proteína Inibidora do Complemento C1/efeitos adversos , Proteína Inibidora do Complemento C1/metabolismo , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Angioedema Hereditário Tipos I e II/classificação , Humanos , Injeções Subcutâneas , Masculino , Risco , Autoadministração , Índice de Gravidade de Doença
9.
Vasc Med ; 21(4): 361-8, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27165711

RESUMO

The feasibility of magnetic resonance venography (MRV) for measuring change in thrombus volume with a novel anticoagulation regimen versus standard anticoagulation in patients with symptomatic deep vein thrombosis (DVT) has not been assessed. Our aim was to study the feasibility of MRV to measure change in thrombus volume in patients with acute symptomatic objectively confirmed proximal DVT in an open-label multicenter trial (edoxaban Thrombus Reduction Imaging Study, eTRIS). We randomized patients in a 2:1 allocation ratio to edoxaban 90 mg/day for 10 days followed by 60 mg/day versus parenteral anticoagulation bridging to warfarin for 3 months. The primary efficacy outcome was a surrogate end point of the relative change in MRV-quantified thrombus volume from baseline to Day 14-21. A total of 85 eligible patients from 26 study sites were randomized to edoxaban monotherapy (n=56) versus parenteral anticoagulation as a 'bridge' to warfarin (n=29). The mean relative change in MRV-quantified thrombus volume from baseline to Day 14-21 was similar in patients treated with edoxaban and parenteral anticoagulation as a 'bridge' to warfarin (-50.1% vs -58.9%; 95% confidence interval of treatment difference, -12.7%, 30.2%). However, thrombus extension was observed in eight patients in the edoxaban monotherapy group and in none in the warfarin group. Rates of recurrent venous thromboembolism (3.6% vs 3.6%, p=0.45) and clinically relevant non-major bleeding (5.4% vs 7.1%, p=0.34) were also similar. No major bleeds occurred in either on-treatment group during the study period. In conclusion, MRV can assess change in thrombus volume in patients with acute DVT randomized to two different anticoagulant regimens.ClinicalTrials.gov IDENTIFIER NCT01662908: INVESTIGATIONAL NEW DRUG IND APPLICATION EDOXABAN IND # 63266.


Assuntos
Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Inibidores do Fator Xa/administração & dosagem , Heparina/administração & dosagem , Angiografia por Ressonância Magnética , Flebografia/métodos , Piridinas/administração & dosagem , Tiazóis/administração & dosagem , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/tratamento farmacológico , Varfarina/administração & dosagem , Administração Intravenosa , Administração Oral , Adulto , Idoso , Anticoagulantes/efeitos adversos , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Estudos de Viabilidade , Feminino , Heparina/efeitos adversos , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Piridinas/efeitos adversos , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Varfarina/efeitos adversos
10.
Transfus Apher Sci ; 55(1): 129-30, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27179925

RESUMO

We outline a case whereby RBCX was successfully provided over disparate geographical areas and time zones in Canada and overcame the logistical challenges of coordinating care across four different health care systems with the application of modern telecommunication technologies. We present this case as a model for other SCD providers and patients.


Assuntos
Anemia Falciforme/terapia , Assistência à Saúde , Transfusão de Eritrócitos , Transfusão Total , Adulto , Canadá , Humanos , Masculino
11.
Leuk Res ; 45: 47-52, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27092851

RESUMO

Most guidelines suggest that only the bone marrow aspirate (BMA) is necessary to assess residual disease following intensive chemotherapy for Acute Myeloid Leukemia (AML) with the bone marrow trephine biopsy (BMTB) recommended in cases of a poor quality BMA. We performed a retrospective study evaluating this in a cohort of patients receiving intensive chemotherapy for AML. Residual disease was assessed by morphological examination of the BMA and BMTB±immunohistochemistry. Of the 647 marrows 32.6% were interim marrows performed prior to peripheral count recovery, 41.7% were end of induction (EOI) marrows and the remaining were 'other marrows'. The BMA and BMTB findings were concordant in 92.8% of cases. The BMTB led to a change in diagnosis from 'no leukemia' to 'residual leukemia' in 5.2% of interim, 3.7% of EOI and 2.4% of 'other' marrows. The BMA alone had a sensitivity of 86.8% in detecting residual leukemia and of 82.3%, 82.5% and 94.2% for interim, EOI and 'other marrows', respectively. Despite the high concordance between the BMA and the BMTB the poor sensitivity of the BMA in detecting residual leukemia, particularly at EOI, may lead to an overestimation of the complete remission rates which may have therapeutic and clinical trial implications.


Assuntos
Biópsia/métodos , Exame de Medula Óssea/normas , Leucemia Mieloide Aguda/diagnóstico , Neoplasia Residual/diagnóstico , Adolescente , Adulto , Idoso , Biópsia/normas , Biópsia por Agulha , Estudos de Coortes , Feminino , Humanos , Imuno-Histoquímica , Leucemia Mieloide Aguda/tratamento farmacológico , Leucemia Mieloide Aguda/patologia , Masculino , Pessoa de Meia-Idade , Neoplasia Residual/patologia , Estudos Retrospectivos , Sensibilidade e Especificidade , Adulto Jovem
12.
Eur J Haematol ; 97(5): 471-478, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27028202

RESUMO

We conducted a retrospective study assessing FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor) as first-line treatment in 56 newly diagnosed acute myeloid leukemia patients considered ineligible for anthracycline-based treatment due to advanced age, significant comorbidities, or pre-existing cardiac disease. The median age was 69 (21-80); 46% received FLAG for pre-existing cardiac disease and others due to age (32%), non-cardiac comorbidities (20%), or previous anthracycline exposure (2%). The induction mortality was 16% and, among evaluable patients, 48% achieved a complete remission after the first induction course with an additional patient achieving a remission after a second course for a total complete remission rate of 50%. Four patients proceeded to an allogeneic stem cell transplant including two with pre-existing cardiac disease. Among non-transplanted patients, the relapse rate (RR) was 47%. When censored at time of stem cell transplant, the median relapse-free survival was 14.7 months. The median overall survival was 9.3 months with 1- and 2-yr survivals of 44% and 22%, respectively. There was no difference in clinical outcomes between patients treated with FLAG for cardiac reasons vs. other reasons. In conclusion, FLAG is a useful alternative to anthracycline-based induction for Acute myeloid leukemia in those with significant comorbidities including pre-existing cardiac disease.


Assuntos
Antraciclinas/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cardiopatias/complicações , Leucemia Mieloide Aguda/complicações , Leucemia Mieloide Aguda/tratamento farmacológico , Vidarabina/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Antraciclinas/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Terapia Combinada , Comorbidade , Citarabina/efeitos adversos , Citarabina/uso terapêutico , Feminino , Fator Estimulador de Colônias de Granulócitos/efeitos adversos , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Leucemia Mieloide Aguda/mortalidade , Masculino , Pessoa de Meia-Idade , Segunda Neoplasia Primária , Estudos Retrospectivos , Resultado do Tratamento , Vidarabina/efeitos adversos , Vidarabina/uso terapêutico , Adulto Jovem
14.
Artigo em Inglês | MEDLINE | ID: mdl-25352908

RESUMO

Hereditary angioedema (HAE) is a disease which is associated with random and often unpredictable attacks of painful swelling typically affecting the extremities, bowel mucosa, genitals, face and upper airway. Attacks are associated with significant functional impairment, decreased Health Related Quality of Life, and mortality in the case of laryngeal attacks. Caring for patients with HAE can be challenging due to the complexity of this disease. The care of patients with HAE in Canada is neither optimal nor uniform across the country. It lags behind other countries where there are more organized models for HAE management, and where additional therapeutic options are licensed and available for use. The objective of this guideline is to provide graded recommendations for the management of patients in Canada with HAE. This includes the treatment of attacks, short-term prophylaxis, long-term prophylaxis, and recommendations for self-administration, individualized therapy, quality of life, and comprehensive care. It is anticipated that by providing this guideline to caregivers, policy makers, patients and their advocates, that there will be an improved understanding of the current recommendations regarding management of HAE and the factors that need to be considered when choosing therapies and treatment plans for individual patients. The primary target users of this guideline are healthcare providers who are managing patients with HAE. Other healthcare providers who may use this guideline are emergency physicians, gastroenterologists, dentists and otolaryngologists, who will encounter patients with HAE and need to be aware of this condition. Hospital administrators, insurers and policy makers may also find this guideline helpful.

16.
Pharmacotherapy ; 32(2): 112-9, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22392419

RESUMO

STUDY OBJECTIVES: To determine whether the impact of anticoagulant control achieved in an Anticoagulation Management Service (AMS) is sustained after transfer of anticoagulation management to the primary care physician (PCP), and to assess patient satisfaction with their anticoagulation management by both the AMS and PCP. DESIGN: Prospective, randomized trial. SETTING: Pharmacist-directed ambulatory AMS located in a tertiary medical care facility and PCP practices in Canada. PATIENTS: Sixty-two adults who had received at least 6 months of warfarin therapy managed by the AMS. INTERVENTION: Patients were randomly assigned to remain with AMS care (32 patients) or to transfer their anticoagulation management care to their PCP (30 patients). After 4.5 months of care, patients in both groups completed a validated survey instrument assessing their satisfaction with the management of their warfarin therapy. MEASUREMENTS AND MAIN RESULTS: Of 295 patients screened, most were excluded from the study for denying consent or for having previous bleeding or clotting complications while taking warfarin. Patients in the AMS and PCP groups who completed the study were similar in age (median 70 and 76 yrs, respectively), and most had atrial fibrillation as an indication for warfarin (75% and 83%, respectively). The primary outcome measure-mean percentage of time within the desired international normalized ratio (INR) range after 6 months-was compared between the two groups, using both the actual range (INR 2.5 ± 0.5) and an expanded range (INR 2.5 ± 0.7). No significant difference was noted in this outcome between the groups (73.5 ± 19.1% vs 76.9 ± 24.5% for the AMS vs PCP groups, p=0.54). Other outcome measures were rates of thrombotic and hemorrhagic events resulting in emergency department visits or hospitalizations, patients' overall satisfaction with warfarin therapy, and patients' preferred anticoagulation management strategy. Two hemorrhagic events and one thrombotic event occurred in each group. Patients were more satisfied with their anticoagulant management by the AMS relative to PCP care (p=0.01), and given the choice, patients preferred AMS care (p=0.001). CONCLUSION: During this 6-month trial, anticoagulation control did not significantly differ between patients who continued to receive anticoagulation management by the AMS and those who transferred to their PCP for anticoagulation management, indicating that the effects of AMS care were sustained. Although patients were more satisfied and preferred to stay with AMS care, this study shows that select patients could have their anticoagulation care transferred to their PCP without compromising anticoagulation control.


Assuntos
Assistência Ambulatorial/normas , Anticoagulantes/uso terapêutico , Médicos de Atenção Primária/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/tendências , Anticoagulantes/sangue , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/tratamento farmacológico , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Coeficiente Internacional Normatizado/métodos , Coeficiente Internacional Normatizado/normas , Masculino , Pessoa de Meia-Idade , Médicos de Atenção Primária/tendências , Estudos Prospectivos
17.
World Allergy Organ J ; 5(12): 182-99, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23282420

RESUMO

: Hereditary Angioedema (HAE) is a rare disease and for this reason proper diagnosis and appropriate therapy are often unknown or not available for physicians and other health care providers. For this reason we convened a group of specialists that focus upon HAE from around the world to develop not only a consensus on diagnosis and management of HAE, but to also provide evidence based grades, strength of evidence and classification for the consensus. Since both consensus and evidence grading were adhered to the document meets criteria as a guideline. The outcome of the guideline is to improve diagnosis and management of patients with HAE throughout the world and to help initiate uniform care and availability of therapies to all with the diagnosis no matter where the residence of the individual with HAE exists.

18.
J Clin Immunol ; 31(6): 952-61, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21932110

RESUMO

Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.


Assuntos
Anti-Infecciosos/administração & dosagem , Imunoglobulinas/administração & dosagem , Síndromes de Imunodeficiência/tratamento farmacológico , Adolescente , Adulto , Idoso , Anti-Infecciosos/efeitos adversos , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Imunoglobulina G/sangue , Imunoglobulinas/efeitos adversos , Imunoglobulinas Intravenosas/administração & dosagem , Imunoglobulinas Intravenosas/efeitos adversos , Síndromes de Imunodeficiência/sangue , Síndromes de Imunodeficiência/imunologia , Síndromes de Imunodeficiência/fisiopatologia , Lactente , Injeções Subcutâneas , Itália , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
19.
Allergy Asthma Proc ; 32(1): 36-42, 2011 Jan-Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21262096

RESUMO

Time to onset of symptom relief in hereditary angioedema (HAE) is a common primary end point in clinical studies but it has never been validated by correlation with the course of HAE symptoms. This study was designed as a retrospective validation of the primary end point for a placebo-controlled phase II/III study in patients with HAE. Ninety-eight abdominal attacks were treated with 10 or 20 U/kg of a highly purified C1 esterase inhibitor (C1-INH) concentrate or placebo. The primary end point was the time to onset of symptom relief, as determined by the patients. Patients assessed the intensity of the symptoms of pain, nausea, vomiting, cramps, and diarrhea over time. By Spearman rank correlation, the primary end point was compared with the time to first reduction of (1) any symptom intensity, (2) the sum of symptom intensity scores, and (3) the intensity of the last symptom present at baseline. The C1-INH, 20 U/kg, and placebo groups were compared by one-sided two-sample Wilcoxon tests. The time to first reduction in intensity of the last symptom present at baseline had the highest correlation with the primary end point (r = 0.77). The time to onset of symptom relief and the time to the first reduction in intensity of the last symptom were significantly shorter for the C1-INH, 20 U/kg, group compared with placebo (p = 0.009 and p = 0.0036, respectively). The association with the intensity of single symptoms confirmed that the time to onset of symptom relief is an appropriate end point for assessing the efficacy of C1-INH therapy.


Assuntos
Angioedemas Hereditários/tratamento farmacológico , Proteína Inibidora do Complemento C1/uso terapêutico , Determinação de Ponto Final , Proteína Inibidora do Complemento C1/administração & dosagem , Humanos , Estimativa de Kaplan-Meier , Estudos Retrospectivos , Resultado do Tratamento
20.
Biol Ther ; 1: 3, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-24392293

RESUMO

Subcutaneous immunoglobulin (SCIG) treatment provides stable serum immunoglobulin G (IgG) levels, is associated with fewer systemic adverse events than intravenous immunoglobulin (IVIG) treatment, and offers the convenience of home therapy. In clinical practice, IVIG is still used preferentially for initiation of treatment in newly diagnosed patients with primary immunodeficiency (PI) and for immunomodulatory therapy, such as treatment of peripheral neuropathies, when high doses are believed to be necessary. The authors discuss recent experience in using SCIG in place of IVIG in these settings. SCIG has been successfully used for initiation of therapy in previously untreated PI patients. Seventeen of 18 PI patients achieved serum IgG levels ≥5 g/L after the loading phase. Daily treatment was well tolerated and provided opportunities for patient/parent training in self-infusion. SCIG has been used for maintenance therapy in multifocal motor neuropathy (MMN) in three recent clinical trials, with good efficacy and tolerability results. Seven of eight MMN patients maintained serum IgG levels of 14-22 g/L with a mean dose of 272 mg/kg/week, had stable muscle strength, and felt comfortable with self-administration. Four patients with polymyositis or dermatomyositis achieved improvement in serum creatine kinase levels and muscle strength with SCIG therapy. Recent experience with SCIG suggests that traditional concepts of immunoglobulin therapy may be challenged to increase available therapy options. SCIG can be used to achieve high IgG levels within several days in untreated PI patients and to maintain high serum levels, as shown in patients with MMN.

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