British Journal of Clinical Pharmacology
This analysis of 75 observational studies (mainly retrospective) found 25-50% received off-label DOAC doses. Only three directly correlated DOAC dose adjustment with clinical outcome; both under-dosing and over-dosing were associated with an increased risk for adverse events.
American Journal of Cardiology
Review of 4 RCTs (n=42,850) reports no statistically significant increase in the risk of intraocular bleeding with dual antiplatelet therapy using potent P2Y12 inhibitors compared with clopidogrel (40 events v 45 events respectively, risk ratio 0.89, 95% CI 0.58 to 1.36).
NHS England
NHS England will commission human coagulation factor X in hereditary factor X deficiency (all ages) in accordance with the criteria outlined within the commissioning document.
Annals of Internal Medicine
Retrospective analysis of data from 39,351 patients on apixaban, and 39,351 matched patients on rivaroxaban concludes those prescribed apixaban had a lower rate of both ischaemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban.
Apixaban versus Warfarin in Patients with Atrial Fibrillation and Advanced Chronic Kidney Disease
Circulation
Study of 269 patients enrolled in ARISTOTLE found that among patients with AF and CrCl 25-30 mL/min, apixaban caused less major bleeding than warfarin (HR 0.34, 95% CI, 0.14-0.80) and major or clinically relevant non-major bleeding (HR 0.35, 95% CI 0.17-0.72).
Venous thromboembolic diseases: diagnosis, management and thrombophilia testing – guidance (NG158)
National Institute for Health and Care Excellence
This guideline covers diagnosing and managing venous thromboembolic diseases in adults. It aims to support rapid diagnosis and effective treatment for people who develop DVT or PE, and covers testing for conditions that can make a DVT or PE more likely.
Rivaroxaban in Peripheral Artery Disease after Revascularization
New England Journal of Medicine
RCT (n=6,564) found that rivaroxaban plus aspirin was superior to aspirin plus placebo for a composite cardiovascular efficacy outcome (multiple cardiovascular outcomes including cardiovascular death) – 17.3% vs 19.9%, HR 0.85, 95% CI 0.76-0.96).
Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation
New England Journal of Medicine
RCT (n=313) found that in patients undergoing TAVI, composite of death from cardiovascular causes, non–procedure-related bleeding, stroke, or myocardial infarction was lower for anticoagulation (AC) alone vs AC plus clopidogrel (31.2% vs 45.5%, -14.3%, 95% CI -25.0 to -3.6).
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer
New England Journal of Medicine
RCT (n=1,155) found that apixaban was non-inferior to subcutaneous dalteparin for recurrent VTE (5.6% vs 7.9%, p<0.001 for non-inferiority). Major bleeding rates were similar (3.8% vs 4.0%, HR 0.82, p=0.60 for difference).
Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery
New England Journal of Medicine
RCT (n=3,604) found that rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilisation after nonmajor orthopaedic surgery of the lower limbs (0.2% vs 1.1%, RR 0.25, 95%CI 0.09-0.75).
Circulation
Analysis of the COMPASS trial found that aspirin & rivaroxaban 2.5 mg twice daily provided similar relative benefits on coronary, cerebrovascular, & peripheral endpoints in those with & without diabetes. Absolute benefits in diabetes were higher due to higher baseline risk.
Circulation
Pre-specified analysis of the ODYSSEY OUTCOMES RCT (n=18,924) found that the risk of peripheral artery disease (PAD) events is related to lipoprotein(a) level, but not baseline LDL level. Alirocumab reduced PAD events (HR 0.69, 95% CI 0.54-0.89) in this study vs placebo.
The Effect of PCSK9 Inhibition on the Risk of Venous Thromboembolism
Circulation
Post-hoc analysis of FOURIER and ODYSSEY OUTCOMES trials found evolocumab provided a 31% reduction in VTE vs placebo (p=0.007). The efficacy of evolocumab was higher in patients with a higher baseline Lp(a) level, with authors suggesting Lp(a) modification may attenuate VTE risk.
Circulation
Post-hoc analysis of AUGUSTUS RCT (P2Y12 + aspirin/placebo, and apixaban/vitamin K antagonist, VKA) found that apixaban had a lower or similar risk of bleeding & ischemic outcomes vs VKA and that there was a trade off for aspirin vs placebo for bleeding and ischaemic events.
Biospace Inc.
This medicine has been approved for the treatment and control of bleeding episodes occurring in people aged >/=12 years with haemophilia A or B with inhibitors (neutralising antibodies). The active ingredient is expressed in genetically engineered rabbits.
Annals of Internal Medicine
A haematologist and a hospital doctor reflect on care of a woman hospitalised for a rheumatologic disorder. They consider risks/benefits of chemoprophylaxis, discuss VTE risk stratification (based on US guidance), and recommend which patients should receive chemoprophylaxis.
Circulation
This retrospective, observational study found administration of prothrombin complex concentrates after apixaban or rivaroxaban-related intracranial haemorrhage was associated with excellent or good haemostasis in 81.8% (95% CI 77.9-85.2%), with a 3.8% thrombosis rate.
Attention should be paid to venous thromboembolism prophylaxis in the management of COVID-19
The Lancet
Analysis of a nationwide dataset from China (n=1099) found that among the patients with COVID-19 at high risk of VTE in this cohort, 44 (11%) of 407 also had a high risk of bleeding, highlighting need to adjust dose and duration of anticoagulants and use of mechanical compression.
Rivaroxaban Plasma Levels and Levetiracetam: A Case Report
Annals of Internal Medicine
Animal studies suggest levetiracetam acts as a P-glycoprotein inducer to reduce rivaroxaban plasma levels. This paper presents first reported case of levetiracetam affecting rivaroxaban plasma levels in a human, leading to clinically important reduction in anticoagulation effect.
Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi
JAMA Cardiology
Study (n=514) found DOAC linked to higher risk of stroke/systemic embolism vs. warfarin (HR 2.71; 95% CI, 1.31-5.57; p= 0.01), challenging assumption of DOAC equivalence with warfarin for LV thrombi and highlights need for RCTs to determine most effective treatment strategies.
Pulmonary Embolism in COVID-19 Patients: Awareness of an Increased Prevalence
Circulation
In this letter, authors describe a case-series of COVID-19 patients with pulmonary embolism (PE) admitted into ICU over a period of 1 month, at a single institution in France compared to the same period a year ago, noting a doubling in incidence of PE.
Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19
New England Journal of Medicine
In this study of 216 patients with Covid-19 and a prolonged aPTT, 91% were positive for lupus anticoagulant. In the authors opinion however, a prolonged aPTT alone should not be a barrier to the use of anticoagulation in the prevention and treatment of VTE in Covid-19.
Circulation
This policy statement provides a focused review of VTE, risk scoring systems, prophylaxis, and tracking methods. From this summary, 5 major areas of policy guidance are presented that it is hoped will lead to better implementation, tracking, and prevention of VTE events.
British Medical Journal
RCT (n=1905 in UK) found pharmaco-thromboprophylaxis alone is non-inferior to its use in combination with graduated compression stockings (imaging confirmed lower limb DVT or PE with symptoms within 90 days of surgery occurred in 1.7% on LMWH vs. 1.4% on LMWH and GCS).
Covid-19 and thrombosis: what do we know about the risks and treatment?
British Medical Journal
This BMJ news report discusses the observed increased risk of thrombosis in patients with Covid-19. One expert notes that there are still high rates of DVT, PE and immunothrombosis in Covid-19 patients despite prophylaxis, with some arguing that bigger doses should be given.
Annals of Internal Medicine
Study (n=23,515) suggests DOAC use may result in lower risk for osteoporotic fracture vs. warfarin (propensity score–weighted cumulative incidence differences: apixaban, −0.88%, dabigatran, 0.81%, rivaroxaban, −1.13%). Fracture risk does not seem to be altered by choice of DOAC.
Circulation
Study found prevalence of DVT is high and linked to adverse outcomes in hospitalised patients with COVID-19; of 143 patients, 66 (46.1%) developed lower extremity DVT. It suggests VTE prophylaxis may be protective in patients with Padua protection score ≥ 4 after admission.
Coagulation abnormalities and thrombosis in patients with COVID-19
The Lancet Haematology
In this Comment, the authors summarise the characteristics of COVID-19 coagulopathy, coagulation laboratory findings in affected patients, the prohaemostatic state and incidence of thromboembolic events, and potential therapeutic interventions.
BMJ Open
Study (n=361 635 with diabetes; 36 570 prescribed oral anticoagulant [OAC]) reported 50% increase in prevalence of OAC prescribing from 2001- 2015. Warfarin prescribing decreased by 14.0% and prescribing of DOACs increased (0.1 to 17.6 per 100 persons on OACs) during this period.
COVID-19-associated hyperviscosity
The Lancet
Letter describes COVID-19-associated hyperviscosity, a potentially severe consequence of infection with severe acute respiratory syndrome coronavirus 2, in 15 patients tested to date. Authors are exploring any beneficial role of therapeutic plasma exchange.
COVID-19 coagulopathy: an evolving story
The Lancet Haematology
Commentary details the increased incidence of thrombotic complications with COVID-19, and how it can resemble other systemic coagulopathies. It concludes that there is still much to be learned, but the fast and ongoing collaboration worldwide makes for a hopeful outcome.
Revised SPC: Clexane (enoxaparin) preparations
electronic Medicines compendium
SPC now states that for IV (bolus) injection (for acute STEMI indication only), in order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/ml (3 mg/ml). Instructions for subsequent administration are also given.
Low molecular weight heparins – should treatment doses be used in patients with renal impairment?
Specialist Pharmacy Service
This updated Medicines Q & A reviews and summarise the evidence available for low molecular weight heparin (LMWH) treatment doses in renal impairment. It summarises ESC advice but states that more comparative data (between LMWHs and unfractionated heparin) are required.
British Journal of Clinical Pharmacology
This study (393 cases, 1494 controls) found among new DOAC users, concurrent use of antiplatelets (adjusted odds ratio 2.01; 95% CI 1.29–3.11) and SSRIs (1.68; 1.10–2.59) was associated with increased risk of major bleeding. Pharmacokinetic interacting drugs did not increase risk.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Thrombosis Research
Database review (1.5 million hospitalisations, and 3731 major haemorrhages) found, after accounting for differences in patient characteristics, location of bleed, and traumatic injury, inpatient survival was no different in patients with major haemorrhage on DOAC or warfarin.
Management of acute ischemic stroke
British Medical Journal
This expert review discusses recent updates in secondary prevention recommendations including short term use of dual antiplatelet therapy to prevent recurrent stroke in the high risk period immediately after stroke; as well as emerging therapies and future research.
Oral Anticoagulation for Patients With Atrial Fibrillation on Long-Term Hemodialysis
Journal of the American College of Cardiology
Review of 16studies (n=71,877) concludes oral anticoagulants (OAC) are not associated with reduced risk of thromboembolism in patients with AF on long-term dialysis; warfarin, dabigatran, and rivaroxaban were associated with significantly higher bleeding risk v apixaban or no OAC.
Heart
Review of 7 studies (n=22,014) concludes when compared with clopidogrel, use of ticagrelor (RR 1.36; 95% CI 1.18 to 1.57) and prasugrel (RR 2.11; 95% CI 1.34 to 3.30) were associated with increased rates of bleeding in patients with AF on oral anticoagulants undergoing PCI.
European Heart Journal
Retrospective study suggests lower GI-bleeding during oral anticoagulant therapy should not be dismissed as benign consequence of treatment but always examined for potential underlying malignant cause (absolute 1yr risk:3.7 to 8.1% in age groups ≤65 and 76–80 yrs, respectively).
Atrial fibrillation patients’ experiences and perspectives of anticoagulation therapy changes
Research in Social and Administrative Pharmacy
A thematic analysis on qualitative data from 56 AF patients who experienced a therapy change identified clear opportunities to improve patients' experiences with oral anticoagulant therapy changes through improved shared decision-making and patient education/counselling.
JAMA Internal Medicine
Review of 13 RCTs (n=6060) concludes risk of VTE and adverse effects (risk of major bleeding, wound haematoma or infection) after total hip and knee replacement was not statistically significantly different when using aspirin vs other anticoagulants.
European Heart Journal
Taiwanese study (n=19,414) concludes that compared with warfarin, non-vitamin K antagonist oral anticoagulants were associated with a reduced fracture risk (Hazard Ratio = 0.84, 95% CI 0.77–0.93; P<0.001).
Thrombosis and Haemostasis
Review of 74 RCTs (n=11,322) found that compared with standard INR target (2-3), lower INR ranges (1.5-2) were associated with higher rates of thromboembolism (7.1% vs 4.4%), lower rates of major bleeding (2.2.vs. 4.4%), and similar mortality rates (4.8 v 5.2%).
JAMA Cardiology
Analysis of 5 RCTs (n = 11 542) suggests vitamin K antagonist plus dual antiplatelet therapy should generally be avoided in this population as regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness.
The Lancet Haematology
Study(n=87) confirms this population have high risk of 1st/recurrent VTE during pregnancy,with highest risk in women with +ve family history(FH), but still relevant in those with–ve FH suggesting low-molecular-weight heparin prophylaxis should also be considered in these patients.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Revised SPC: Pradaxa (dabigatran) capsules
electronic Medicines compendium
SPC now advises that concomitant administration with glecaprevir/pibrentasvir is contraindicated owing to increased risk of bleeding due to increased dabigatran levels. Also, alopecia has been added as a potential adverse effect of treatment (frequency unknown).
American Journal of Cardiology
Review of 9 studies (n=13,437) found no statistically significant difference in mortality, nonfatal myocardial infarction, stent thrombosis, and stroke between double and triple antithrombotic therapy (DATT and TATT). DATT had a lower rate of bleeding (RR 0.64, 95% CI 0.54-0.75).
JAMA Internal Medicine
Cohort study (n=11,185) concludes ticagrelor was not associated with lower risk of major adverse coronary events (HR 0.97; 95% CI, 0.85-1.10); however, it was associated with an increased risk of major bleeding (1.51; 1.29-1.78) and dyspnoea vs clopidogrel (1.98; 1.47-2.65).
Journal of the American Medical Association
RCT (n=813) reports postoperative osocimab 0.6mg/kg, 1.2mg/kg, and 1.8mg/kg met criteria for noninferiority vs enoxaparin, and the preoperative 1.8mg/kg dose of osocimab met criteria for superiority vs enoxaparin in incidence of VTE (primary outcome) at 10-13 days postoperatively.
Low molecular weight heparins – should prophylactic doses be used in patients with renal impairment?
Specialist Pharmacy Service
In contrast to unfractionated heparin, low molecular weight heparins are primarily cleared via kidney thus care needed in renal impairment (RI) because they can accumulate and increase bleeding Risk. Q&A reviews current literature on use of prophylactic doses in patients with RI.
Direct acting oral anticoagulants and alopecia: the valuable support of post marketing data
British Journal of Clinical Pharmacology
Analysis identified 1316 reports on VigiBase, most concerning rivaroxaban (58.8%). Overall, 80% of reports were related to females, in particular to those ≥65 years old (23.1%).Median time‐to‐onset was 28 days (IQR 63 days). In 54.3% of reports, causality was assessed as possible.
Thrombosis and Haemostasis
In analysis of 3 RCTs (n=2661), use of NOACs was linked to similar incidence of stroke/systemic embolism, ischaemic stroke, venous thromboembolism, all-cause death and major bleeding vs. vitamin K antagonists. Results were confirmed in secondary analysis (3 observational studies).
Ticagrelor hits primary endpoint in the THALES Phase III trial for use in stroke
PharmaTimes
In this study, the manufacturers report that ticagrelor 90 mg twice daily plus aspirin for 30 days showed a statistically significant and clinically meaningful reduction in the risk of stroke and death vs aspirin alone.
European Medicines Agency
Treprostinil sodium is a prostacyclin analogue which has a direct vasodilatory effect on pulmonary and systemic arterial circulation, and inhibits platelet aggregation.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Circulation
Review of patients with incident NSAID use in the ARISTOTLE trial (n=2185) found that incident NSAID use was associated with an increased risk of major bleeding (HR 1.61, 95% CI 1.11-2.33) and relevant non-major bleeding (1.70, 1.16-2.48).
Heart
US-Registry shows among 4120 patients on DOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions and only 31 patients underwent dose reduction. Those without dose reduction experienced major bleeding 1.7% vs 0% at 1 year.
Apixaban and dalteparin in active malignancy‐associated venous thromboembolism: The ADAM VTE trial
Journal of Thrombosis and Haemastasis
RCT (n=300) found a lower rate of major bleeding and recurrent VTE with apixaban vs dalteparin (0% vs 1.4% and 0.7% vs 6.3%, p<0.05 for both). Rates of major bleeding or clinically relevant non-major bleeding were similar in the two groups (6%).
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Antidepressant drug use and subdural hematoma risk
Journal of Thrombosis and Haemastasis
Study (10,885 subdural hematoma (SDH) cases & 435,379 matched controls) found SSRIs (adjusted OR 1.32 [1.25‐1.38]) and non‐SSRIs (aOR 1.19 [1.13‐1.26]) were associated with higher SDH risk vs. non‐use of antidepressants; but absolute risk is judged to be small.
National Institute for Health Research
Meta-analysis (n=6857; 13 trials) found thromboprophylaxis (TP) in this setting is clinically (low-molecular-weight heparin reduced risk any VTE: OR 0.52, 95% CI, 0.37-0.71) and cost (£13,524 per QALY) effective vs. no TP. Estimates of risk of major bleeding were inconclusive.
British Journal of Clinical Pharmacology
Study (n=4427) found patients with treatment errors (ERs) hospitalised for AF/with stroke history more likely to have such ERs corrected but many ERs are still overlooked. After nontreatment, DOAC underdosing and vitamin K antagonists use instead of DOAC are most common ER types.
PharmaTimes
In trials, Hemlibra dosed once-weekly or every two weeks led to statistically significant reduction in treated bleeds compared to on-demand treatment. In pooled data a high proportion of patients, both with and without inhibitors, achieved zero treated bleeds.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
European Journal of Hospital Pharmacy
Study suggests clinical pharmacist's intervention can improve rate of thrombosis prophylaxis prescription (pre-intervention 34.8% at high VTE risk received pharmacological prophylaxis [PP] vs 100% post intervention (use of PP in low risk VTE patients reduced from 22.2% to 3.3%).
Revised SPCs: Plavix (clopidogrel) 75 and 300 mg film-coated tablets
electronic Medicines compendium
SPC now warns that as with other oral P2Y12 inhibitors, co-administration of opioid agonists has potential to delay and reduce absorption of clopidogrel, presumably because of slowed gastric emptying. The clinical relevance is unknown.
NIHR Signal: Continuing an anticoagulant at home after abdominal surgery cuts thrombosis risk
NIHR Dissemination Centre
Expert commentary is provided of updated Cochrane review of 7 studies which found 13% patients on anticoagulant treatment only during hospital stay developed thrombosis vs. 5% who continued with treatment beyond discharge, and had no increased risk of bleeding complications.
JAMA Neurology
Cohort study of 993 patients treated with mechanical thrombectomy, including 100 who received additional intra-arterial urokinase showed it was not linked to increased symptomatic intracranial haemorrhage (5.2 v 6.9%) and was associated with better 90-day functional independence.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Low molecular weight heparins – should prophylactic doses be used in patients with renal impairment?
Specialist Pharmacy Service
This updated Medicines Q & A reviews the evidence available and considers when prophylactic doses of low molecular weight heparins can be used in patients with renal impairment.
Impact of oral anticoagulation in patients with atrial fibrillation at very low thromboembolic risk
Heart
Study (n=2224) found 44% of low CHA2DS2-VASc patients received oral anticoagulation (OAC). Incidence of non-haemorrhagic stroke/systemic embolism were similar between OAC and not on OAC groups (0.32 vs 0.30 events per 100 person years, respectively; NS; p=0.92).
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
The Lancet Haematology
RCT (184) showed additional ultrasound-accelerated catheter-directed thrombolysis (urokinase) does not change risk of post-thrombotic syndrome 1 year after acute ilio femoral DVT vs. standard therapy (anticoagulation, stockings, early ambulation) [29 vs. 35%; respectively,p=0.42].
National Institute for Health and Care Excellence
This DRAFT guideline aims to support quick diagnosis and effective treatment for people who develop DVT or PE. It also covers testing for conditions that can make a DVT or PE more likely, such as thrombophilia (a blood clotting disorder) and cancer.
Association of Anticoagulant Therapy With Risk of Fracture Among Patients With Atrial Fibrillation
JAMA Internal Medicine
Study (n=167 275) found that relative to new users of warfarin, new users of DOACs - particularly apixaban – were at lower risk of fractures requiring hospitalisation (hazard ratio for DOAC vs. warfarin 0.87; 95% CI, 0.79-0.96).
Heart
Swedish cohort study (n= 9539) reported that warfarin vs single antiplatelet exposure was associated with lower long-term risk of ischaemic stroke and thromboembolic events, and with a higher incidence of bleeding events but with similar mortality.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
European Heart Journal
Review discusses management options for heart failure with reduced ejection fraction (HfrEF), whether anticoagulation would be protective in patients with ischaemic HfrEF, role of renin–angiotensin system, beta-blockers, mineralocorticoid receptor antagonists and diuretics.
Manufacturers report positive data from the TWILIGHT trial for ticagrelor
PharmaTimes
New data from AstraZeneca's TWILIGHT trial has found that Brilinta (ticagrelor) on its own reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) over 12 months in high-risk patients with non-ST elevation acute coronary syndromes (NSTE-ACS).
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement
New England Journal of Medicine
In 1644 pts without an established indication for oral anticoagulation after transcatheter aortic-valve replacement, treatment with rivaroxaban was associated with a higher risk of death or thromboembolic complications and higher risk of bleeding vs an antiplatelet-based strategy.
Annals of Emergency Medicine
This US-focused anticoagulant reversal and replacement guidance statement is supported by literature and consensus definitions to support evaluation and treatment of the bleeding and nonbleeding patient requiring emergency invasive procedures.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Drug and Therapeutics Bulletin
A commentary on the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) highlights that intensive antiplatelet therapy with three drugs should not be used in routine clinical practice to prevent recurrent events in patients with acute cerebral ischaemia.
JAMA Internal Medicine
Study (n=39,622) found testosterone therapy was associated with an increase in short-term risk for VTE among men with (OR 2.32; 95% CI, 1.97-2.74) and without (2.02; 1.47-2.77) hypogonadism, with some evidence that the association was more pronounced among younger men.
JAMA Cardiology
Article notes adjunctive antithrombotic therapy used to mitigate thrombotic risks in this population must be balanced against bleeding complications. Evidence for its use remains scarce and no risk prediction models have been established to guide antithrombotic therapy.
Biospace Inc.
Feedback from regulatory authorities, and from recent study site inspections indicated that additional clinical data would be required for approval. As a result, Actelion has decided to withdraw ongoing worldwide submissions based on phase 2 MERIT-1 study.
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
