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Development of new treatments for childhood asthma poses particularproblems in view of safety concerns and the difficulty of accurately measuring clinical outcomes. There are several novel drugs in development forthe management of asthma, but these are always studied initially in adults,and studies in children generally follow when the drug is in advanced clini-cal development. This chapter reviews some of the new drugs in develop-ment for asthma, some of which are currently in clinical trials for asthmain adults. A few drugs that are improvements in existing classes of drugs,such as corticosteroids, are testable at an earlier stage in children andadverse effects are more predictable. Currently available therapy for asthma is highly effective and, if usedappropriately, usually has no problems in terms of adverse effects. However,some patients (~5% of asthmatic adults and children) remain poorly controlled, despite what appears to be optimal therapy. There are also continu-ing concerns about the safety of asthma therapy, particularly in thetreatment of childhood asthma, as this treatment has to be given over verylong periods. Compliance with inhaled therapy, particularly with inhaled corticosteroid therapy, is very poor and might be improved with oral ther-apy (once-daily calendar pack). Yet oral therapy presents a problem of sideeffects, since the drug exerts effects throughout the body, whereas asthmais localized to the airways. This will necessitate the development of drugsthat are specific for asthma and do not have effects on other systems or onnormal physiological mechanisms (unlike b-agonists and corticosteroids). None of the currently available therapy is curative nor has it so far beenshown to alter the natural history of the disease. Perhaps it is difficult to seek a cure for asthma until more about the molecular causes is known.
Background A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer). Methods We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting (n=850) stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220. Findings We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0·88 [95% CI 0·64–1·19], p for non-inferiority=0·003, p for superiority=0·39). Frequency of cardiac death (14 [1·6%] vs 21 [2·5%], p for superiority=0·22), myocardial infarction (49 [5·7%] vs 39 [4·6%], p=0·30), and clinically-indicated target vessel revascularisation (38 [4·4%] vs 47 [5·5%], p=0·29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20·9% vs 23·3%, difference −2·2% [95% CI −6·0 to 1·6], p for non-inferiority=0·001, p for superiority=0·26). Interpretation Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. Funding Biosensors Europe SA, Switzerland.