Nelson M.,St Stephens Center |
Stellbrink H.-J.,Infektionsmedizinisches Centrum |
Podzamczer D.,Hospital Bellvitge |
Banhegyi D.,Szt Laszlo Hospital |
And 6 more authors.
AIDS | Year: 2011
Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P < 0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Macaya A.,Hospital Bellvitge
Cochrane database of systematic reviews (Online) | Year: 2012
Anal canal intraepithelial neoplasia (AIN) is a pre-malignant condition of the anal canal transitional epithelium that is associated with human papillomavirus (HPV) infection. The incidence and prevalence of AIN and anal cancer are increasing rapidly in HIV-positive men who have sex with men (MSM). Other groups like HIV-negative MSM, immunosuppressed patients and people affected by other HPV diseases like genital warts and cervical intraepithelial neoplasia (CIN) may also develop AIN. The condition is complicated by its multicentric and multifocal nature and high rates of relapse and morbidity. Targeted excisions using ablative treatments such as cautery, infrared coagulation (IRC) and cryotherapy have been used as first-line therapeutic strategies, and there are many other options. There is no consensus about the optimal management of AIN. To evaluate the effects of therapeutic interventions for anal canal intraepithelial neoplasia (AIN). We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2011, Issue 4), MEDLINE and EMBASE (to October 2011). We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies, and contacted experts in the field and manufacturers of any AIN and HPV-specific treatments. Randomized controlled trials (RCTs) that assessed any type of intervention for AIN. Two review authors independently abstracted data and assessed risk of bias. If it was possible, the data were synthesised in a meta-analysis. We found only one RCT, which included 53 patients, that met our inclusion criteria. This trial reported data on imiquimod versus placebo. There was no statistically significant difference in the risk of disease cure but there was a trend for imiquimod to downgrade the AIN to a low-risk stage. The lack of statistical power of the trial may be due to the small number of patients in each group. The risk of bias was estimated as moderate. The included trial failed to demonstrate any statistically significant efficacy of imiquimod in the management of anal intraepithelial neoplasia (AIN). The absence of reliable evidence for any of the interventions used in AIN precludes any definitive guidance or recommendations for clinical practice. Prospective cohort studies and retrospective studies have not been included in this review as they are considered to provide lower quality evidence. Well designed RCTs are needed.
Molina-Infante J.,Hospital San Pedro de Alcantara |
Lucendo A.J.,Hospital General |
Angueira T.,Hospital General |
Rodriguez-Tellez M.,Hospital Virgen Macarena |
And 15 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2015
Background Empiric triple therapy for Helicobacter pylori should be abandoned when clarithromycin resistance rate is >15-20%. Optimisation of triple therapy (high-dose acid suppression and 14-day duration) can increase eradication rates by 10%. Aim To compare the efficacy and safety of optimised triple (OPT-TRI) and nonbismuth quadruple concomitant (OPT-CON) therapies. Methods Prospective multicentre study in 16 Spanish centres using triple therapy in clinical practice. In a 3-month two-phase fashion, the first 402 patients received an OPT-TRI therapy [esomeprazole (40 mg b.d.), amoxicillin (1 g b.d) and clarithromycin (500 mg b.d) for 14 days] and the last 375 patients an OPT-CON treatment [OPT-TRI therapy plus metronidazole (500 mg b.d)]. Results Seven-hundred seventy-seven consecutive patients were included (402 OPT-TRI, 375 OPT-CON). The OPT-CON therapy achieved significantly higher eradication rates in the per-protocol [82.3% (95% CI = 78-86%) vs. 93.8% (91-96%), P < 0.001] and intention-to-treat analysis [81.3% (78-86%) vs. 90.4% (87-93%), P < 0.001]. Adverse events (97% mild/moderate) were significantly more common with OPT-CON therapy (39% vs. 47%, P = 0.016), but full compliance with therapy was similar between groups (94% vs. 92%, P = 0.4). OPT-CON therapy was the only significant predictor of successful eradication (odds ratio, 2.24; 95% CI: 1.48-3.51, P < 0.001). The rate of participating centres achieving cure rates ≥90% favoured OPT-CON therapy (OPT-TRI 25% vs. OPT-CON 62%). Conclusions Empiric OPT-CON therapy achieved significantly higher cure rates (>90%) compared to OPT-TRI therapy. Addition of metronidazole to OPT-TRI therapy increased eradication rates by 10%, resulting in more mild adverse effects, but without impairing compliance with therapy. © 2015 John Wiley & Sons Ltd.
Ferreira-Gonzalez I.,University of Barcelona |
Ferreira-Gonzalez I.,CIBER ISCIII |
Marsal J.R.,University of Barcelona |
Marsal J.R.,CIBER ISCIII |
And 24 more authors.
Journal of the American College of Cardiology | Year: 2012
Objectives: The goal of this study was to assess the risk associated with double antiplatelet therapy (DAT) discontinuation, and specifically, temporary discontinuation, during the first year after drug-eluting stent (DES) implantation. Background: Doubts remain about the risk of temporary DAT discontinuation within 1 year after DES implantation. Methods: A total of 1,622 consecutive patients undergoing DES implantation at 29 hospitals were followed up at 3, 6, 9, and 12 months to record the 1-year antiplatelet therapy discontinuation (ATD) rate, the number of days without DAT, and the rate of 1-year major cardiac events. Cox regression was used to analyze the association between ATD considered as a time-dependent covariate and 1-year cardiac events. Results: One hundred seventy-two (10.6%) patients interrupted at least 1 antiplatelet drug during the first year after DES implantation, although only 1 during the first month. Most (n = 111, 64.5%) interrupted DAT temporarily (median: 7 days; range: 5 to 8.5): 79 clopidogrel (31 temporarily), 38 aspirin (27 temporarily), and 55 both drugs (53 temporarily). Discontinuation was followed by acute coronary syndrome in 7 (4.1%; 95% confidence interval [CI]: 1.7 to 8.2), a similar rate of major cardiac events to that in patients without ATD (n = 80; 5.5%; 95% CI: 4.4 to 6.8; p = 0.23). ATD was not independently associated with 1-year major cardiac events (hazard ratio: 1.32 [95% CI: 0.56 to 3.12]). Conclusions: ATD within the first year and beyond the first month after DES is not exceptional, is usually temporary, and does not appear to have a large impact on risk. © 2012 American College of Cardiology Foundation.
Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio en Ancianos) randomized trial and pooled analysis with previous studies
Bueno H.,Hospital General Universitario Gregorio Maran |
Betriu A.,Hospital Clnic |
Heras M.,Hospital Clnic |
Alonso J.J.,Hospital de Fuenlabrada |
And 5 more authors.
European Heart Journal | Year: 2011
Aims To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce. Methods and resultsPatients <75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enroling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9) and 34 (25.4) in the fibrinolysis arm [odds ratio (OR), 0.69; 95 confidence interval (CI) 0.381.23; P 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2, P 0.43), re-infarction (5.3 vs. 8.2, P 0.35), or disabling stroke (0.8 vs. 3.0, P 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95 CI 0.450.91). Conclusion Primary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available.Clinicaltrials.gov NCT00257309. © 2010 The Author.