(Fingolimod) for Multiple Sclerosis Multiple Sclerosis Pg 843 Silent Stroke Risk Could Rise with Hypertension Pg 844
Total Page：16
File Type：pdf, Size：1020Kb
BULLETIN BOARD Highlighting the latest news and research BBULLETINULLETIN BBOARDOARD Positive Phase III results of in the news... Positive Phase III results of FTY720 (fingolimod) for FTY720 (fingolimod) for multiple sclerosis multiple sclerosis pg 843 Silent stroke risk could rise with hypertension pg 844 Benefits with sirolimus-eluting stents found to continue in Preliminary results from the Efficacy and all relevant end points compared with both MISSION! Intervention study pg 844 Safety of Fingolimod in Patients With placebo and a standard of care, complemented Relapsing-Remitting Multiple Sclerosis by extensive safety data.” New biodegradable polymer stent found to be ‘noninferior’ (FREEDOMS) study, a 2-year, double-blind, The safety profile of FTY720 has been pg 845 placebo-controlled, Phase III clinical trial studied well, with more than 5300 patient- US FDA approves pitavastatin for involving 1272 relapsing–remitting multi- years of exposure, including patients now combined dyslipidemia pg 845 ple sclerosis (MS) patients in 22 countries to in their sixth year of treatment. In the assess the efficacy, safety and tolerability of FREEDOMS study, there were no cases of Recent drug approvals pg 846 oral FTY720 (fingolimod), have shown that macular edema or melanoma at the 0.5-mg the drug could reduce the MS relapse rates dose. Reversible and generally asymptomatic by 54–60% compared with placebo, and dis- liver enzyme elevations were observed more ability progression by 30–32%. frequently with FTY720 than placebo, and Multiple sclerosis is an autoimmune dis- lung infections were also slightly more com- ease in which the immune system attacks mon. Mild elevation in blood pressure was the CNS. MS is one of the leading causes of observed with FTY720. Three patients died neuro logical disability in young adults. The during the FREEDOMS study, one on a new drug FTY720 is a sphingosine 1-phos- FTY720 higher dose (1.25 mg) and two on phate receptor modulator, and has the poten- placebo. None of the deaths was related to tial to be the first in this new drug class of the study drug. MS therapies. The FREEDOMS study is the second of “As an oral therapy, it is clear three Phase III studies involving more than that fingolimod potentially 4000 MS patients worldwide. Previous results represents a significant advance in from the 1-year Trial Assessing Injectable the treatment of MS. Interferon vs FTY720 Oral in RRMS ” (TRANSFORMS) study showed a signifi- cant reduction in relapse rates compared with “The positive results from the FREEDOMS IFN-b1a, a standard of care for MS. The third study confirm the efficacy and safety of -fin study, FREEDOMS II, is currently ongoing. golimod, and provide important evidence of its effect on disability,” said Ludwig Kappos, “The positive results from the FREEDOMS Chair of Neurology and Research Group study confirm the efficacy and safety of Leader in the Department of Biomedicine at fingolimod, and provide important the University Hospital in Basel, Switzerland, and the principal investigator of the evidence of its effect on disability. ” FREEDOMS study. “As an oral therapy, it is clear that fingolimod potentially represents a “We are proud to have reached this critical significant advance in the treatment of MS.” milestone in the development of FTY720, a Future development of FTY720 in relaps- novel oral therapy that has the potential to ing–remitting MS will focus on the 0.5-mg transform the treatment of this ultimately dose. Regulatory submissions of the drug are disabling disease,” said Trevor Mundel, planned in the USA and EU at the end of Global Head of Development at Novartis 2009. Pharma AG (Basel, Switzerland). “FTY720 0.5-mg therapy offers compelling efficacy on Source: Novartis, Switzerland: www.novartis.com 10.2217/THY.09.76 © 2009 Future Medicine Ltd Therapy (2009) 6(6), 843–849 ISSN 1475-0708 843 BULLETIN BOARD BULLETIN BOARD Silent stroke risk could rise with hypertension According to a new prospective population- The group, led by Dr Sachdev, analyzed Infarcts present at both MRI scans grew based study, hypertension increases the risk findings from the 60- to 64-year-old cohort significantly over the intervening 4 years, of silent strokes, or lacunar infarct, by up of the larger prospective, longitudinal with a nonsignificant trend for correlation to 60%. PATH Through Life Study. with age. The findings from the Prince of Wales A total of 477 participants in this cohort The group added, “although this was Hospital in Sydney, Australia, have been were recruited randomly from the compul- only demonstrated in a limited number of published in Neurology, which also discusses sory electoral roll in two areas of Australia. subjects … it may indicate a progressive the prevalence of other factors such as white Among other measurements, the study process of atrophy in surrounding tissue of matter hyperintense lesions on MRI and the included two MRI brain scans carried out the lesion.” ratio of anterior ventricle to brain volume. 4 years apart. Baseline results indicated The authors concluded that “none- The researchers noted that these so-called that 7.8% had at least one lacunar infarct theless, this study provides invaluable silent strokes “...are not truly silent, as they on MRI, at second MRI the prevalence rose information on the healthy population have been associated with cognitive deficits to 8.8%. in their 60s, which is the main target of and their accumulation, or presence in stra- Results indicated that those with lacu- primary prevention in vascular disease.” tegic brain regions, has also been suggested nar infarcts were significantly more likely as an important pathologic substrate of to have hypertension, as well as higher vascular dementia.” The researchers hope average systolic blood pressure and mean Source: Chen X, Wen W, Anstey KJ, Sachdev PS: that by finding a modifiable risk factor they arterial pressure. However, the degree of Prevalence, incidence, and risk factors of lacunar could gain an insight into the prevention of hyper tension did not appear to impact the infarcts in a community sample. Neurology 73, cerebrovascular disease. volume of the lesions. 266–272 (2009). Benefits with sirolimus-eluting stents found to continue in MISSION! Intervention study Researchers from Leiden University male), who were followed for a median of benefit in STEMI patients occurred entirely Medical Center (the Netherlands) have 38 months. A total of 158 patients received within the first year”. Rates of target vessel presented the 3-year outcomes of the SES, with 152 receiving BMS. The clini- revascularization, death and nonfatal recur- MISSION! Intervention study at the cal end points of the trial included: death, rent myocardial infarction were similar in recent European Society of Cardiology myocardial infarction, target vessel/lesion the second and third years. (ESC) Congress. They found that patients revascularization, target vessel failure However, the cumulative incidence of with ST-elevation myocardial infarction (composite of all end points related to the definite stent thrombosis was higher in the (STEMI) treated with sirolimus-eluting target vessel) and stent thrombosis. The SES group compared with the BMS group stents (SES) continued to experience bene- patients were treated with life-long aspirin (4 vs 0.7%; p = 0.11), and was statistically fits in terms of requiring significantly fewer and clopidogrel for 1 year after the stent significant for very late stent thrombosis target vessel revascularization procedures was implanted. (3.3 vs 0%; p = 0.05). compared with those treated with bare- After 3 years the researchers found that the The researchers concluded that at 3 years metal stents (BMS). However, this was at cumulative incidence of cardiac death and the SES-treated patients continued to show the cost of a higher incidence of very late myocardial infarction were similar between a trend towards a favorable clinical outcome stent thrombosis. the SES- and BMS-treated patients. There compared with the BMS-treated group. The MISSION! Intervention study was a slightly lower cumulative incidence of was a single-blind, single-center, rand- target vessel revascularization, target lesion Source: Atary JZ, Van Der Hoeven BL, Liem SS omized study to compare the use of drug- revascularization and target vessel failure et al.: Drug-eluting vs bare-metal stents for the eluting stents with BMS in the treatment in the SES group. However, this advantage treatment of ST-elevation myocardial infarction: of acute STEMI in terms of efficacy and mainly occurred within the first year of three-year clinical outcome of the MISSION- safety. The study included 310 consecu- treatment. Jael Z Atary, who presented the Intervention study. Eur. Heart J. 30(Abstract tive patients (age: 59 ± 11 years, 78% results at the ESC Congress said: “The SES Suppl.), 676 (2009). 844 Therapy (2009) 6(6) future science group BULLETIN BOARD BULLETIN BOARD New biodegradable polymer stent found to be ‘noninferior’ According to the results of the Intracoronary lesion. This end point was met in 13.8% of advantages of a biodegrable polymer, this Stenting and Angiographic Results: patients treated with the biodegrable stent, report must be viewed only as an initial Test Efficacy of 3 Limus-Eluting Stents compared with 14.4% for those treated encouragement for this technology. It is (ISAR-TEST4) trial, a new type of stent with a permanent polymer stent. naive to believe that a novel technologic coated with a rapamycin-eluting biodegrad- The results were presented by Julinda breakthrough will be free of a yet to be deter- able polymer is noninferior to the two lead- Mehilli from the Technische University in mined new limitation”. Mehilli commented ing permanent polymer-based drug-eluting Munich (Germany), who said: “This study that a further 2-year ana lysis is planned to stent (DES) platforms. The trial represents shows the noninferiority of the biodegrad- investigate this technology further.