(data safety monitoring board) articles in PubMed
- ME 02-3 EXTENDING SPRINT RESULTS TO DIABETICS. [Journal Article]
- J Hypertens 2016; 34 Suppl 1:e197JH
- The Systolic Blood Pressure Intervention Trial (SPRINT), sponsored by the National Heart, Lung and Blood Institute in the USA, allocated 9361 hypertensive patients (mean age 68 years) to two systolic...
The Systolic Blood Pressure Intervention Trial (SPRINT), sponsored by the National Heart, Lung and Blood Institute in the USA, allocated 9361 hypertensive patients (mean age 68 years) to two systolic blood pressure treatment targets (either < 120mmHg or < 140mmHg). Although SPRINT intended to enrol hypertensive patients at high cardiovascular risk, it specifically excluded patients with diabetes mellitus or prior stroke. SPRINT was stopped earlier than planned, after a mean follow-up of 3.26 years, on the recommendation of its data and safety monitoring board, and data were published on 9 November 2015. A mean systolic blood pressure reduction to 121.4 mmHg in the intense-treatment group, compared with a mean systolic blood pressure reduction to 136.2 mmHg, was reported to significantly decreasethe primary outcome (the composite of myocardial infarction, acute coronary syndrome, stroke, heart failure or death from cardiovascular disease) by 25% and all-cause mortality by 27%. Although the SPRINT trial provided important information, a number of criticisms has been raised regarding some results of the study. For example the patients included in SPRINT, although all had to have 'increased' cardiovascular risk, cannot be considered at a particularly high level of risk. Indeed, the group with standard treatment had an overall incidence of major cardiovascular events (inclusive of myocardial infarction, acute coronary syndrome, stroke, heart failure and cardiovascular death) just above 2% per year. In particular, incidence of death from cardiovascular disease was rather low (0.43% per year) and only about a quarter of all-cause death, against an expectation of about 50%. A further element of criticisms came from the evidence that the cause-specific event most importantly reduced by intense treatment in SPRINT appears to be heart failure (38 heart failure events prevented of a total of 76 cardiovascular events prevented; a marked reduction in sudden cardiac death, known to be particularly prevalent in heart failure patients). Heart failure is certainly a clinically relevant outcome, but at clear difference from myocardial infarction and stroke, not to say mortality, heart failure in trials is not defined by really 'hard' measures, but on the basis of symptoms diagnosed by hospital physicians the patients are referred to. Furthermore, of all cardiovascular outcomes, heart failure is the one that is not only influenced by blood pressure-lowering per se but also by the class of blood pressure-lowering drugs being used.With this critical background in mind this presentation will examine whether and to what extent the SPRINT trial results can be of help in the treatment of the diabetic hypertensive patients, well known to be characterized by a very high cardiovascular risk as well as by the need of obtaining an effective blood pressure control by antihypertensive treatment. This because international guidelines on hypertension recommend maintaining blood pressure below 140 mmHg systolic and 90 mmHg diastolic in the general hypertensive population up to the age of 80 years. A more aggressive blood pressure target is recommended when the hypertensive patient has an additional risk for cardiovascular disease, such as if the patient has diabetes, renal disease, or a prior history of cardiovascular disease. In these situations, guidelines encourage decreasing blood pressure below 130/80 mmHg to grant additional cardiovascular protection. The possibility that the SPRINT trial results might be applied in diabetic hypertensive patients will be critically examined by reviewing three sets of relevant studies: randomized trials, post-hoc analysis of prospective studies, and studies on organ damage.
- Reporting on Data Monitoring Committees in Neonatal Randomised Controlled Trials is inconsistent. [Journal Article]
- Acta Paediatr 2016 Sep 16AP
- CONCLUSIONS: While the majority of neonatal RCTs report on DMC involvement and interim analysis there is still scope for improvement. Clear documentation of safety related issues should be a central component of reporting in neonatal trials involving newborn infants. This article is protected by copyright. All rights reserved.
- Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department. [Journal Article]
- BMJ Open 2016; 6(9):e012190BO
- Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opio...
Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage.
- Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. [Journal Article]
- J Clin Endocrinol Metab 2016 Sep 2; :jc20162534JC
- CONCLUSIONS: Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.
- [OP.8D.01] CONTROLLING AND LOWERING BLOOD PRESSURE WITH THE MOBIUSHD DEVICE: FIRST-IN-MAN INTERIM RESULTS (CALM-FIM STUDY). [Journal Article]
- J Hypertens 2016; 34 Suppl 2:e105JH
- CONCLUSIONS: : So far, implanting the MobiusHD device in patients with resistant hypertension seems to be safe and shows promising results in BP lowering.
- Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial. [Journal Article]
- Trials 2016; 17:384T
- CONCLUSIONS: The TARTARE-2S trial will provide important clinical data on treatment targets in septic shock, evaluating the impact of clinical tissue perfusion-guided hemodynamic treatment on a surrogate outcome combining resolution of shock (hyperlactatemia and vasopressors/inotropes), and 30-day mortality.
- Chondroitin sulfate plus glucosamine sulfate shows no superiority over placebo in a randomized, double-blind, placebo-controlled clinical trial in patients with knee osteoarthritis. [Journal Article]
- Arthritis Rheumatol 2016 Jul 31AR
- CONCLUSIONS: CS+GS failed to demonstrate superiority over placebo in reducing pain and function impairment in patients with symptomatic KOA at 6 months. Further research may contribute to fully elucidate the suitability of CS+GS combination as therapy in OA. This article is protected by copyright. All rights reserved.
- Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial. [Journal Article]
- Clin Infect Dis 2016 Jul 20CI
- CONCLUSIONS: These findings support the current World Health Organization recommendation of LPV/r in first-line ART regimens for HIV-infected children.
- Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. [Journal Article]
- AIDS Res Hum Retroviruses 2016 Sep 7AR
- Lenalidomide, an oral immunomodulating agent, has shown promising activity in HIV-infected individuals with Kaposi's sarcoma (KS). This single-arm, multicenter, open-label, Gehan's two-stage phase II...
Lenalidomide, an oral immunomodulating agent, has shown promising activity in HIV-infected individuals with Kaposi's sarcoma (KS). This single-arm, multicenter, open-label, Gehan's two-stage phase II trial evaluated the efficacy and safety of lenalidomide in HIV-infected patients with progressive KS despite previous chemotherapy (NCT01282047, ANRS 154 Lenakap trial). The primary endpoint was the rate of partial response (PR) or complete response (CR) at week 24, evaluated by both the study investigators and the patients using the Physical Global Assessment (PGA). AIDS Clinical Trials Group (ACTG) criteria for KS treatment evaluation were used as a secondary endpoint. The data and safety monitoring board recommended that enrollments be halted on April 24, 2013, because of lack of responses. We enrolled 12 antiretroviral-treated HIV-infected men with progressive KS despite previous chemotherapy. Their HIV plasma viral load was <50 copies/ml and their median CD4 cell count 444/mm(3). One patient stopped taking lenalidomide because of hives at week 1 and a second patient died at week 7. The remaining 10 patients were assessable at week 24, when none had PGA-defined CR or PR and one had ACTG-defined PR. There were no additional PGA responses at week 48, but an additional three patients had ACTG responses, for a total of four patients with ACTG PR at week 48 (40%; 95% confidence interval: 12.2-73.8). Fourteen grade 3-4 adverse events were considered at least possibly related to lenalidomide during a total of 101 cycles. Lenalidomide was well tolerated in antiretroviral experienced patients with progressive KS previously treated with chemotherapy. The ACTG-defined response rate at week 48 was 40%, while it was 0% using PGA criteria.
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- Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. [Journal Article]
- BMJ Open 2016; 6(7):e011705BO
- Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ...
Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours.