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“Clear evidence” of aspirin benefits in VTE
RESEARCHERS, including a group from Australia, have found “clear evidence” that aspirin reduces the risk of recurrent venous thromboembolism (VTE) in patients with a first unprovoked VTE and is a “very safe and effective” therapy. The research, published in Circulation, was a prospective, combined analysis of the Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) and the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trials, which had both showed aspirin reduces VTE risk, but were not individually powered to detect treatment effects for particular outcomes or subgroups. The analysis included data from 1224 patients, with the 402 participants from the WARFASA study older, more likely to be male and be smokers, but less likely to be obese. During the median 30.4-month follow-up period, VTE occurred in 112 of 608 patients (18.4%) assigned to placebo and 81 of 616 (13.1%) assigned to aspirin, a 32% relative reduction (7.5% v 5.1% per year). Aspirin reduced the risk of major vascular events (symptomatic VTE, myocardial infarction, stroke and cardiovascular death) by 34% (8.7% v 5.7% per year). Clinically relevant bleeding occurred in 12 patients assigned placebo (seven with a major bleed) and in 18 patients assigned aspirin (nine with a major bleed). The researchers said this rate of bleeding was considered to be low and did not differ significantly between the groups (0.7% per year for placebo and 1.1% per year for aspirin). “The net clinical benefit (symptomatic VTE, myocardial infarction, stroke, all-cause mortality, and major bleeding) was improved with aspirin by 33% (9.8% per year versus 6.5% per year)”, they wrote. Although aspirin did not reduce the rate of VTE by as much as vitamin K antagonists or newer oral anticoagulants (direct thrombin inhibitors or factor Xa inhibitors), the researchers wrote that “among patients for whom such therapies are not considered appropriate or are discontinued, aspirin should be strongly considered”.
Clinical success with DIY BP monitoring
HIGH-risk patients with hypertension and significant cardiovascular comorbidity are able to successfully self-monitor blood pressure (BP) and self-titrate antihypertensive treatment by following a prespecified algorithm developed with their family physician, according to research published in JAMA. The researchers found patients who did self-monitor and self-titrate achieved a “clinically significant” reduction in systolic and diastolic blood pressure without an increase in adverse events. The unblinded, randomised clinical trial included 450 patients aged at least 35 years with a history of stroke, coronary heart disease, diabetes or chronic kidney disease being treated at 59 UK primary care practices. The target BP measurements in the trial were 130/80 mmHg for GP visits and 120/75 mmHg for home measurement. Mean baseline BP was 143.1/80.5 mmHg in the intervention group and 143.6/79.5 mmHg in the control group. After 12 months, the mean BP had decreased to 128.2/73.8 mmHg in the intervention group and 137.8/76.3 mmHg in the control group. The researchers wrote that the results were sustained and increasing during the 12-month study period. They said that based on systematic reviews of clinical outcome trials, the BP difference observed in those self-managing would be associated with an approximate 30% reduction in stroke risk if it was sustained. “This is a population with the most to gain in terms of reducing future cardiovascular events from optimized blood pressure control”, they wrote. With validated semi-automated BP monitors now readily available, the intervention could be widely implemented in association with training delivered by nurses, the researchers wrote. An accompanying editorial said although the trial did not settle all questions regarding self-titration based on self-measurement, “it is an important step toward adaptation of treatment for patients who want to actively take part in their own risk-factor control”.
Questions raised over obesity interventions
AN Australian program using smartphone technology with adolescent school boys as part of an obesity prevention intervention has had no significant effects on body mass index (BMI), waist circumference, percentage of body fat or physical activity. The results of the Active Teen Leaders Avoiding Screen-time (ATLAS) intervention, published in Pediatrics, did show significant intervention effects for reduced screen-time among the intervention group, who reported spending 30 minutes less per day engaged in screen-based recreation at follow-up compared with controls. ATLAS was a 20-week, cluster randomised controlled trial of 361 boys aged 12‒14 years considered at risk of obesity who attended 14 secondary schools in low-income communities in NSW. The researchers wrote that there was “a clear need for innovative obesity prevention programs that target adolescents at risk of obesity”. They said smartphone technology had the potential to change health behaviour but strategies were needed to identify and recruit participants, and increases in the intervention dose were needed. An accompanying editorial by two Australian child health experts said millions of dollars and participant and researcher hours were spent seeking effective preventive and treatment interventions, but childhood obesity rates were yet to fall. The authors wrote that this was in part due to “ingrained overoptimism as to how much population change can really be achieved” through educational and motivational means. The cost of this was that schools and health departments would continue to implement ineffective interventions. “The research opportunity cost is that, until we call it as it is, researchers may not make the bold paradigm shifts that the child obesity epidemic demands”, they wrote.
Little benefit for patients after knee arthroscopy
A SYSTEMATIC review and meta-analysis has found moderate level evidence suggesting that there is no benefit to arthroscopic meniscal debridement for degenerative meniscal tears in comparison with non-operative or sham treatments in middle-aged patients with mild or no concomitant osteoarthritis. The research, published in CMAJ, found little, if any, effect on short-term (less than 6 months) and long-term (less than 2 years) outcomes in comparison with non-operative management. The review included seven randomised controlled trials with a total of 805 patients. The researchers found the pooled treatment effect of arthroscopic surgery did not show a significant or minimally important difference (MID) between treatment arms for long-term functional outcomes. Although differences in short-term functional outcomes between groups were statistically significant they did not exceed the threshold for MID. Arthroscopic surgery did not result in a significant improvement in pain scores in the short or long term. “Our findings extend the evidence to show a lack of clinical efficacy in surgical débridement of meniscal tears in the setting of mild or no osteoarthritis”, the researchers wrote. They wrote that the MID was the smallest effect that an informed patient would perceive as valuable enough to justify a change in therapeutic management when weighing the anticipated benefits against the possible harms of an intervention. “Future research is required to identify how indications and patient selection influence outcomes following surgical and conservative treatment”, they wrote.
Consequences of sleep arousal underestimated
RESEARCHERS have warned that underestimating the importance of confusional arousal (CA) can lead to a misunderstanding of the disorder and its effects. In research published in Neurology, the authors wrote that CAs received considerably less attention than sleepwalking even though the consequences could be equally serious. CA, also known as sleep drunkenness or severe sleep inertia, was defined as mental confusion or confusional behaviour during or following arousal from sleep, typically from slow-wave sleep in the first part of the night, but also upon attempted awakening from sleep in the morning. It was accompanied by temporospatial confusion, inappropriate behaviour, diminished mentation and memory impairment, with complete or partial amnesia of the episodes in some cases. In a cross-sectional study with a representative sample of 19 136 non-institutionalised individuals in the US general population aged 18 years or older, the researchers found 15.2% of the sample reported episodes of CAs in the previous year; with 8.6% having complete or partial amnesia of the episodes and 14.8% having nocturnal wandering episodes. They found 84% of CAs were associated with sleep/mental disorders or psychotropic drugs. Individuals with a circadian rhythm sleep disorder or a long sleep duration (more than 9 hours) were at higher risk of CAs. Mental disorders were observed in 37.4% of people who had CAs, with the highest odds observed in individuals with bipolar disorders or panic disorder. They found nearly 20% of the subjects were getting less than 6 hours sleep a night. Most people experiencing CAs were not using any medication, and among those who were, antidepressants were most common.
e-cigarette concerns highlighted in statement
IN a policy statement published in Circulation, the American Heart Association says electronic cigarettes (e-cigarettes) which contain nicotine should be regulated as a tobacco product and discouraged as a primary means of giving up smoking. The AHA said that it reviewed current evidence to develop the statement, which provided policy recommendations in areas such as clean indoor air laws, taxation, regulation, preventing youth access, marketing and advertising to youth, counselling for cessation, surveillance and defining e-cigarettes. “As of early 2014, there were 466 brands and 7764 unique flavors of e-cigarette products”, the statement says. The statement said that, to date, there had been little research conducted on the human health effects of e-cigarettes. “However, although firm evidence is lacking, there are concerns that e-cigarette use and acceptance of e-cigarettes has the potential to renormalize smoking behavior, sustain dual use, and initiate or maintain nicotine addiction. Their use also could serve as a gateway to reinitiation of smoking by ex-smokers”, the statement said. “E-cigarettes represent a major change in the tobacco control landscape.” The statement said the AHA would continue to monitor the impact of e-cigarettes on population health, cardiovascular disease and stroke and would give special attention to the effect on youth and adolescents. Last week the US Centers for Disease Control and Prevention issued a media release about a study that showed a threefold increase in the number of US youth who had never smoked a cigarette using e-cigarettes, from 79 000 in 2011 to more than 263 000 in 2013.
Treat otitis media the same in patients with cleft palate
PATIENTS with cleft lip and/or palate (CLP) should be treated with ventilation tubes (VT) for acute otitis media (AOM) and otitis media with effusion (OME) in the same way as patients without CLP, according to research publish in JAMA Otolaryngology—Head & Neck Surgery. The researchers said their findings could provide an argument for a shift towards more aggressive treatment in patients with CLP as they were already vulnerable to speech and social developmental delay. The comparison study included 60 paediatric patients with CLP who underwent VT insertion and a control group of age- and sex-matched patients undergoing the same procedure. They found 151 documented cases of otorrhoea in the control group compared with 121 in the CLP group (ratio 1.25:1), a difference considered not statistically significant. There was no significant difference in mean otorhinolaryngology clinic visits per patient for complications between groups (0.80 in the CLP group v 0.78 for controls), and more complications, other than otorrhoea, were reported in the control group than the CLP group (43 v 25). The researchers wrote that despite earlier evidence suggesting higher complication rates from VT insertion in patients with CLP, their study had shown that complications were not higher, and that patients with CLP should be treated for AOM and OME in the same way as non-CLP patients.