To study the efficacy and safety of thrombolytic therapy (TLT) with the recombinant tissue plasminogen activator (rt-PA) in stroke, we treated 691 patients in 48 clinical units using systemic or selective TLT. Safety and high efficacy of TLT was shown: the three-months fatality rate was 18.2%, the symptomatic hemorrhage transformation rate related to clinical worsening was 6.1%. The good functional recovery (scores 0 or 1 on the modified Rankin scale) was observed in 48.6% of patients.
The efficacy and safety of SAISEN, a recombinant human growth hormone obtained from mammalian cells, was tested in children with hypophyseal nanism. The treatment duration was 1 year. The results indicate that SAISEN (ARES-SERONO) is a highly effective and safe preparation of growth hormone, noticeably stimulating the growth rate both in previously untreated children with somatotropic insufficiency, and in those previously treated with STH preparations. Therapy with SAISEN was not associated with any side effects, as shown by both clinical and laboratory data.
Data from randomized trials has demonstrated the superiority of bivalirudin to glycoprotein IIb/IIIa inhibitors plus heparin in patients undergoing primary percutaneous coronary intervention. Real-world performance of bivalirudin in primary percutaneous coronary intervention and the benefit of bivalirudin over heparin remain unknown in an era of routine dual antiplatelet therapy.
From July 2004 to December 2010, 2317 consecutive patients were indexed in the University of Ottawa Heart Institute ST-segment-elevation myocardial infarction registry. During this period 748 patients received bivalirudin, 699 patients received glycoprotein IIb/IIIa inhibitors, and 676 patients received unfractionated heparin alone. The primary outcome was the rate of noncoronary artery bypass graft related thrombolysis in myocardial infarction major bleeding. Bivalirudin significantly reduced the primary outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors (2.7% versus 7.3%, adjusted OR 2.96, 95% CI: 1.61-5.45, P
A Nordic multicentre, open-label, non-interventional postmarketing surveillance study was carried out during a period of 24 months evaluating safety and efficacy of ReFacto as prophylactic or on-demand replacement therapy in patients with haemophilia A treated by self-medication. Fifty-seven patients were enrolled and studied for safety; efficacy was evaluated in 39 patients who received ReFacto for 24 months and recorded sufficient diary data on a hand-held computer. The compliance of using the device was good in small children, variable in adults and poor in teenagers. The fact that the overall compliance was low constituted a limitation of the number of patients with reliable diary data. Overall safety was rated as excellent or good by the clinicians for all patients at all visits and overall efficacy at 24 months evaluated to be excellent (74%) or good (26%). It was noticed that >/=50% of patients/parents reported no absences from school or work owing to bleeding episodes during the study period. Among patients on regular prophylaxis, 6 of the 30 patients (20%) receiving ReFacto experienced no bleeding episodes. A median of four bleeding episodes occurred during the 24-month study period, and 93% of the episodes were resolved with
The term "congenital neutropenia" signifies neutropenia that is present at birth. It includes a wide variety of disorders, some transient and others life long. Some varieties of congenital neutropenia are mild, with blood neutrophil concentrations below normal but not low enough to constitute a significant host defense deficiency.Other varieties of congenital neutropenia are characterized by low blood neutrophil concentrations and a predisposition to repeated infections.
Early multimodal treatment of severe sepsis, including the use of drotrecogin alfa (activated) (DrotAA) when indicated, is considered essential for optimum outcome. However, predicting which infected patients will progress to severe sepsis and the need for aggressive intervention continues to be problematic. We therefore wished to explore whether there were any potential early markers that might predict improved survival in response to early use of DrotAA in patients with severe sepsis. In particular, in the dynamic setting of severe sepsis, we postulated that changes in markers reflecting evolving rather than baseline clinical status might guide therapy.
Data on a cohort of 305 Canadian patients from the open label ENHANCE trial of DrotAA in severe sepsis was retrospectively analyzed to search for potential clinical predictors of outcome in severe sepsis. Patients received a 96-hour infusion of DrotAA and were followed for 28 days. The association between time to treatment and mortality within subgroups defined by dynamic changes in various potential markers was explored.
Mortality at 28 days was 22.6% and the variables of age, time to treatment, and early changes in serum creatinine and platelet count were identified by logistic regression as independent predictors of mortality. Across all age ranges, 28-day mortality was lower when DrotAA was administered within 24 hours of first sepsis-induced organ dysfunction compared to administration after 24 hours for both subgroups of patients defined by changes in platelet count and creatinine within the first day.
These findings suggest that when indicated, treatment with DrotAA should be initiated as soon as possible, regardless of age.
Previous trial registration number: NCT00568893.
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OBJECTIVE: Intracranial haemorrhage (ICH) is associated with high morbidity and mortality. Our aim was to explore the use of recombinant activated factor VII (rFVIIa NovoSeven Novo Nordisk, A/S, Bagsvaerd, Denmark) for the management of ICH in the operating theater and intensive care unit. PATIENTS AND METHODS: We reviewed all the records of nonhaemophilic patients entered into the haemostasis.com database who received rFVIIa for ICH. RESULTS: Sixteen suitable patients were identified (mean age: 23.3 years; range: 1-58 years). The total dose of rFVIIa administered ranged from 31 to 270 microg/kg. Indications were stabilization of ICH (n=6), control of peri- or post-operative haemorrhage associated with neurosurgical procedures (n=8), or correction of coagulopathy prior to neurosurgical intervention (n=2). The majority (13/16 [81.25%]) required one dose of rFVIIa. A clinical effect (stabilization of bleed, reduction of peri- or post-operative haemorrhage, or prevention of excessive blood loss during neurosurgery) was seen in 14/16 (87.5%) patients. Some improvement in coagulation status was noted. No thromboembolic events were reported. One patient experienced massive elevation of D-dimer levels-an effect possibly due to rFVIIa. Two patients suffered adverse events unrelated to rFVIIa. Six deaths occurred, all attributable to underlying brain injury. CONCLUSION: This observational study suggests that rFVIIa is of value for the management of ICH in nonhaemophilic patients secondary to a range of aetiologies. These findings justify further investigation.
Prader-Willi syndrome (PWS) is characterized by short stature, muscular hypotonia, cognitive dysfunction, and hyperphagia usually leading to severe obesity. Patients with PWS share similarities with growth hormone deficiency (GHD). Few studies have dealt with growth hormone (GH) treatment in PWS adults. The purpose of the Scandinavian study was to evaluate the effects of GH on body composition, lipid and glucose metabolism, physical performance and safety parameters in adults with PWS. Twenty-five women and 21 men with PWS were randomized to treatment with GH or placebo during 1 year followed by 2 years of open labeled GH treatment. At baseline 1/3 had normal BMI, six patients severe GHD, ten impaired glucose tolerance and seven diabetes. At 1 year insulin-like growth factor I (IGF-I) SDS had increased by 1.51 (P
We used Danish registers to identify patients with osteoporosis, who had been treated with parathyroid hormone and evaluated the probability of developing cancer. We did not find an increased risk of cancer among the patients treated with parathyroid hormone.
We evaluated the incidences of malignancies and mortality in osteoporotic patients treated with rPTH.
Using Danish nationwide registers, we identified patients diagnosed with osteoporosis in the period 1995 through 2010. Each patient treated with rPTH ("case") was compared with 10 gender- and age-matched patients who did also have osteoporosis but did not receive rPTH ("control").
A total of 4,104 cases (80.3 % females) were identified. The mean age at the beginning of rPTH treatment was 70.9 (SD 9.7) years. During a follow-up time of 10,118 person-years for the cases and 88,005 person-years for the controls, a total of 255 cases (6.2 %) compared with 2,103 controls (5.1 %) experienced a cancer (Chi square, p = 0.003). We found an adjusted cancer related HR of 1.1 (95 %CI 0.9-1.4) among the cases. Lung cancer was the only cancer type with a significantly increased rate among patients receiving rPTH (HR 1.7; 95 % CI 1.3-2.3). No cases developed osteosarcomas and nine controls developed osteosarcoma. During follow-up, 627 (15.3 %) cases died and 4,175 (10.2 %) controls died, which yielded an excess mortality risk of 26 % (95 % CI 16-37 %). This could be due to differences in the prevalence of vertebral fractures between the rPTH-treated and non-treated patients.
This study did not support the hypothesis describing a possible link between rPTH treatment and the development of cancer. We also conclude that osteosarcoma has not been diagnosed in any Danish patient receiving rPTH since the year 2003 when it was introduced on the market.