3 research outputs found
A Multicenter, Randomized, PlaceboâControlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis
Objective:
Rheumatoid arthritis (RA) is associated with increased cardiovascular event (CVE) risk. The impact of statins in RA is not established. We assessed whether atorvastatin is superior to placebo for the primary prevention of CVEs in RA patients.
Methods:
A randomized, doubleâblind, placeboâcontrolled trial was designed to detect a 32% CVE risk reduction based on an estimated 1.6% per annum event rate with 80% power at P 50 years or with a disease duration of >10 years who did not have clinical atherosclerosis, diabetes, or myopathy received atorvastatin 40 mg daily or matching placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization. Secondary and tertiary end points included plasma lipids and safety.
Results:
A total of 3,002 patients (mean age 61 years; 74% female) were followed up for a median of 2.51 years (interquartile range [IQR] 1.90, 3.49 years) (7,827 patientâyears). The study was terminated early due to a lower than expected event rate (0.70% per annum). Of the 1,504 patients receiving atorvastatin, 24 (1.6%) experienced a primary end point, compared with 36 (2.4%) of the 1,498 receiving placebo (hazard ratio [HR] 0.66 [95% confidence interval (95% CI) 0.39, 1.11]; P = 0.115 and adjusted HR 0.60 [95% CI 0.32, 1.15]; P = 0.127). At trial end, patients receiving atorvastatin had a mean ± SD lowâdensity lipoprotein (LDL) cholesterol level 0.77 ± 0.04 mmoles/liter lower than those receiving placebo (P < 0.0001). Câreactive protein level was also significantly lower in the atorvastatin group than the placebo group (median 2.59 mg/liter [IQR 0.94, 6.08] versus 3.60 mg/liter [IQR 1.47, 7.49]; P < 0.0001). CVE risk reduction per mmole/liter reduction in LDL cholesterol was 42% (95% CI â14%, 70%). The rates of adverse events in the atorvastatin group (n = 298 [19.8%]) and placebo group (n = 292 [19.5%]) were similar.
Conclusion:
Atorvastatin 40 mg daily is safe and results in a significantly greater reduction of LDL cholesterol level than placebo in patients with RA. The 34% CVE risk reduction is consistent with the Cholesterol Treatment Trialistsâ Collaboration metaâanalysis of statin effects in other populations
Stay on the ambulance long enough and youâll go full circle: an evaluation of the clinical safety and effectiveness of non-emergency and multi-occupancy ambulance conveyance in non-emergency percutaneous coronary intervention patients
Abstract published with permission. Mechanisms to facilitate rapid ambulance transport of diagnosed STEMI patients from the community and emergency departments (ED) settings directly to primary percutaneous coronary intervention (PPCI) facilities are well established within NHS Ambulance Services. Direct challenge of inter-hospital transfer requests for non-emergency percutaneous coronary intervention (PCI) patients by a regional NHS Ambulance Service identified disagreement between peripheral feeder hospitals and the NHS Ambulance Service on what level of ambulance transport is most appropriate. To reduce unnecessary peripheral feeder hospital requests for paramedic emergency service transfer and resource utilisation in non-emergency PCI patients and to assess the clinical safety of both non-emergency transport and multi-occupancy conveyance for this patient group. A process was established with a regional cardiothoracic centre to support pre-screening of non-emergency PCI patients for conveyance via non-emergency ambulance resources and multi-occupancy. This included centralisation of all non-emergency PCI ambulance transport booking practices and dissemination of learning materials on the process to all stakeholders. During the three-year period 3172 patients were identified as suitable for conveyance by both non-emergency ambulance transports. Of this, 36% (n=1767) were conveyed as part of a multi-occupancy journey and 56% (n=782) were conveyed by non-emergency resources. Overall, 69% (n=782) of all multi-occupancy conveyances were undertaken by non-emergency resources. Two clinical incidents were noted during this period, both of which were managed via clinical telephone advice. Non-emergency ambulances can be safely used to transport non-emergency PCI patients via multi-occupancy, following appropriate pre-screening by the receiving PCI unit. Further work is needed to understand the feasibility of this across other patient groups in the inter-hospital transfer scenario and its transferability to other NHS Ambulance Services
Clinical navigation for beginners: the clinical utility and safety of the Paramedic Pathfinder
Background English Ambulance Services are faced with annual increases in emergency demand. Addressing the demand for low acuity emergency calls relies upon the ability of ambulance clinicians to accurately identify the most appropriate destination or referral pathway. Given the risk of undertriage, the challenge is to develop processes that can safely determine patient dispositions, thereby increasing the number of patients receiving care closer to home. Aims The aim of the study was to evaluate the clinical utility and safety of triage support tools (Paramedic Pathfinders). Methods Two triage filters (Pathfinders) were developed (one medical, one trauma). These were applied by ambulance clinicians to 481 patients who had been transported to emergency departments (EDs). Preferred (gold standard) patient dispositions were established by senior medical practitioners using both ambulance and ED clinical records. The clinical utility of ambulance clinicians using Pathfinders was evaluated against this gold standard. Results The Medical Pathfinder was applied to 367 patients (76.3%) and the Trauma Pathfinder to 114 (23.7%). Agreement between ambulance clinician and gold standard was achieved in 387 cases (80.5%) giving the tools a combined sensitivity of 94.83% and specificity of 57.9%. 20.9% of medical patients and 30.7% of trauma patients who had been transported to hospital could have been safely cared for elsewhere. Conclusions Ambulance clinicians using Pathfinders have demonstrated acceptable levels of sensitivity in identifying patients who require ED care. The actual impact of the tools in clinical practice will be dependent on the provision of suitable alternatives to ED. https://emj.bmj.com/content/emermed/31/e1/e29.full.pdf This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ http://dx.doi.org/10.1136/emermed-2012-20203