Nielsen J.C.,Aarhus University Hospital |
Thomsen P.E.B.,Copenhagen University |
Hojberg S.,Bispebjerg Hospital |
Moller M.,University of Southern Denmark |
And 14 more authors.
European Heart Journal | Year: 2011
Aim s In patients with sick sinus syndrome, bradycardia can be treated with a single-lead pacemaker or a dual-chamber pacemaker. Previous trials have revealed that pacing modes preserving atrio-ventricular synchrony are superior to single-lead ventricular pacing, but it remains unclear if there is any difference between single-lead atrial pacing (AAIR) and dual-chamber pacing (DDDR).Methods and resultsWe randomly assigned 1415 patients referred for first pacemaker implantation to AAIR (n 707) or DDDR (n 708) pacing and followed them for a mean of 5.4 ± 2.6 years. The primary outcome was death from any cause. Secondary outcomes included paroxysmal and chronic atrial fibrillation, stroke, heart failure, and need for pacemaker reoperation. In the AAIR group, 209 patients (29.6) died during follow-up vs. 193 patients (27.3) in the DDDR group, hazard ratio (HR) 1.06, 95 confidence interval (CI) 0.881.29, P 0.53. Paroxysmal atrial fibrillation was observed in 201 patients (28.4) in the AAIR group vs. 163 patients (23.0) in the DDDR group, HR 1.27, 95 CI 1.031.56, P 0.024. A total of 240 patients underwent one or more pacemaker reoperations during follow-up, 156 (22.1) in the AAIR group vs. 84 (11.9) in the DDDR group (HR 1.99, 95 CI 1.532.59, P < 0.001). The incidence of chronic atrial fibrillation, stroke, and heart failure did not differ between treatment groups.Conclusion In patients with sick sinus syndrome, there is no statistically significant difference in death from any cause between AAIR pacing and DDDR pacing. AAIR pacing is associated with a higher incidence of paroxysmal atrial fibrillation and a two-fold increased risk of pacemaker reoperation. These findings support the routine use of DDDR pacing in these patients. Clinical Trial Registration: URL http://www.clinicaltrials.gov. Unique identifier: NCT00236158. © 2010 The Author.
Birgens H.,Copenhagen University |
Frederiksen H.,University of Southern Denmark |
Hasselbalch H.C.,Roskilde University |
Rasmussen I.H.,University of Aalborg |
And 9 more authors.
British Journal of Haematology | Year: 2013
The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse-free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab-prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first-line treatment in WAIHA increases both the rate and the duration of the response. © 2013 John Wiley & Sons Ltd.
Clinical response, drug survival and predictors thereof in 432 ankylosing spondylitis patients after switching tumour necrosis factor α inhibitor therapy: Results from the Danish nationwide DANBIO registry
Glintborg B.,Gentofte University Hospital |
Ostergaard M.,Copenhagen University |
Krogh N.S.,Zitelab Aps |
Tarp U.,Aarhus University Hospital |
And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2013
Objective: To investigate frequencies and reasons for switching, treatment responses and drug survival in patients with ankylosing spondylitis (AS) switching tumour-necrosis-factor-α inhibitor (TNFi) treatment in routine clinical care. Methods: AS patients were identified in the Danish nationwide DANBIO registry. Disease activity, treatment responses (50% or 20 mm reduction in Bath AS Disease Activity Index (BASDAI)), duration and rates of drug survival and predictors thereof were studied in patients receiving ≥2 different biological drugs. Results: Of 1436 AS patients starting TNFi treatment, 432 patients (30%) switched to a second and 137 (10%) to a third biological drug. Compared with non-switchers, switchers were more frequently women (33%/22%), had shorter disease duration (3 years/5 years) and higher BASDAI (62(52-76) mm/56(43-69) mm (median (interquartile-range))), Bath AS Functional Index (BASFI) (54(39-71) mm/47(31-65) mm) and visual-analoguescale (VAS) global, pain and fatigue scores when they started the first TNFi (all p<0.01). Main reason for switching was lack of response (56%). During the first, second and third treatment BAS- and VAS scores had decreased after 6 months' treatment (all p<0.05). Median drug survivals were 3.1, 1.6 and 1.8 years respectively ( p<0.001). After 2 years of treatment 52% of switchers and 63% of non-switchers had achieved response (number needed to treat 1.9 and 1.6, respectively, p=0.01). Drug survivals were similar regardless of the reason for switching. Male gender and low BASFI predicted drug survival of the second TNFi. Conclusions: Nearly one-third of AS patients in clinical practice switched biological treatment. Response rates and drug survivals were lower among switchers, however, half of switchers achieved treatment response.
Schmitz M.L.,Aarhus University Hospital |
Simonsen C.Z.,Aarhus University Hospital |
Hundborg H.,Aarhus University Hospital |
Christensen H.,Bispebjerg Hospital |
And 8 more authors.
Stroke | Year: 2014
BACKGROUND AND PURPOSE -: Data on long-term outcome after intravenous tissue-type plasminogen activator (tPA) in ischemic stroke are limited. We examined the risk of long-term mortality, recurrent ischemic stroke, and major bleeding, including intracranial and gastrointestinal bleeding, in intravenous tPA-treated patients when compared with intravenous tPA eligible but nontreated patients with ischemic stroke. METHODS -: We conducted a register-based nationwide propensity score-matched follow-up study among patients with ischemic stroke in Denmark (2004-2011). Cox regression analysis was used to compute adjusted hazard ratios for all outcomes. RESULTS -: Among 4292 ischemic strokes (2146 intravenous tPA-treated and 2146 propensity score-matched nonintravenous tPA-treated patients), with a follow-up for a median of 1.4 years, treatment with intravenous tPA was associated with a lower risk of long-term mortality (adjusted hazard ratio, 0.66; 95% confidence interval, 0.49-0.88). The long-term risk of recurrent ischemic stroke (adjusted hazard ratio, 1.05; 95% confidence interval, 0.68-1.64) and major bleeding (adjusted hazard ratio, 0.59; 95% confidence interval, 0.24-1.47) did not differ significantly between the intravenous tPA-treated and nontreated patients. CONCLUSIONS -: Treatment with intravenous tPA in patients with ischemic stroke was associated with improved long-term survival. © 2014 American Heart Association, Inc.
Gang A.O.,Herlev Hospital |
Strom C.,Rigshospitalet |
Pedersen M.,Herlev Hospital |
d'Amore F.,Arhus Hospital |
And 10 more authors.
Annals of Oncology | Year: 2012
Background: Optimal treatment of young patients with high-risk diffuse large B-cell lymphoma (DLBCL) remains a matter of debate and requires improvement. The combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) with addition of etoposide (CHOEP) has in other patient groups been shown to be effective. Further improvement has been accomplished with the use of rituximab in combination with the regimens every 2 weeks (R-CHOP-14, R-CHOEP-14). The aim of the present retrospective population-based study was to compare R-CHOP-14 with R-CHOEP-14 in a cohort of high-risk patients aged 18-60 years with two or more risk factors (stage III-IV, elevated lactate dehydrogenase levels, performance status 2-4). To our knowledge, this is the first study comparing these two regimens in this patient group. Methods: We obtained data for the period 2004-2009 from the Danish Lymphoma Database. One hundred and fiftynine patients were eligible to enter the study. Primary end point was overall survival (OS) and secondary end points were response to treatment, progression-free survival (PFS) and safety. Results: Four-year OS was superior in the R-CHOEP-14 group: 75% compared with 62% for R-CHOP-14 (P = 0.04). This superiority was also seen for PFS: 4-year PFS was 70% for the R-CHOEP-14 group compared with 58% for the R-CHOP-14 group (P = 0.02). Conclusion: R-CHOEP-14 is a promising regimen for young patients with high-risk DLBCL with improved OS and PFS compared with R-CHOP-14. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.