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Vit D has been‘ overhyped’: expert
‘ Think twice’ with vitamin D, says Professor Neale. |
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JOCELYN WRIGHT HIGH-dose vitamin D supplements do not reduce rates of fracture or falls in healthy older people, a New Zealand study shows.
The findings have prompted calls for doctors to“ think twice” before prescribing vitamin D to patients who are not deficient in the vitamin.
The four-year prospective study followed more
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than 5000 healthy men and women aged 50-84 who were taking monthly oral doses of vitamin D— 30 % of whom had vitamin D levels below 50nmol / L.
The study found no difference in the number of fractures or falls in those taking cholecalciferol 2.5mg( 100,000 IU) monthly compared with those receiving a placebo.
The University of Auckland
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researchers said the results showed that vitamin D had no effect on bone health, even in high doses and in populations where one-third of people were deficient.
When looking at the findings alongside previous studies, the study also cast doubt on the benefit of vitamin D in frail elderly patients, they said.
Associate Professor Rachel
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Neale, an epidemiologist at the QIMR Berghofer Medical Research Institute in Brisbane, said she hoped the findings would make clinicians“ think twice” before prescribing high-dose vitamin D to people who were not deficient.
“ Vitamin D has probably been overhyped. I don’ t believe there is currently sufficient evidence to warrant taking these supplements
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unless you have no sun exposure, and you’ re frankly deficient,” she told Australian Doctor.
“ Certainly, some GPs are pushing people to take fairly high-dose supplements to get their [ patient’ s ] levels up to 75 or 100nnm / L and that is actually not supported by what our guidelines suggest should happen,” she said. Lancet Diabetes and Endocrinology 2017; online.
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RCT = randomised controlled trial; SPAF = stroke prevention in atrial fi brillation; PE = pulmonary embolism; DVT = deep vein thrombosis; NOAC = non-vitamin K antagonist oral anticoagulant. Calculation based on IMS Health MIDAS, Database: Monthly Sales June 2016.
PBS Information: Authority Required( STREAMLINED). Refer to PBS Schedule for full authority information.
PLEASE REVIEW THE FULL PRODUCT INFORMATION( PI) BEFORE PRESCRIBING. APPROVED PI AVAILABLE AT WWW. BAYERRESOURCES. COM. AU / RESOURCES / UPLOADS / PI / FILE9466. PDF OR UPON REQUEST FROM BAYER AUSTRALIA LTD.
Minimum Product Information. XARELTO ®( rivaroxaban) INDICATIONS: Prevention of venous thromboembolism( VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs( elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks); 10 mg tablet once daily. Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke; 20 mg tablet once daily( 15 mg for patients with CrCl 30-49 mL / min). Treatment of deep vein thrombosis( DVT) and pulmonary embolism( PE) and for the prevention of recurrent DVT and pulmonary embolism( PE); 15 mg tablet twice daily for 3 weeks, followed by 20 mg tablet once daily. Xarelto 15 mg and 20 mg tablets should be taken with food. Tablets may be crushed and administered orally( mixed with water or applesauce) or given through gastric tubes. See full PI for details. CONTRAINDICATIONS: Hypersensitivity to rivaroxaban or to any of the excipients, clinically significant active bleeding, lesions at increased risk of clinically significant bleeding and patients with spontaneous impairment of haemostasis, significant hepatic disease which is associated with coagulopathy, dialysis or severe renal impairment with a creatinine clearance < 15 mL / min for Xarelto 10 mg or < 30 mL / min for Xarelto 15 mg and 20 mg, concomitant treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein, Pregnancy, Lactation. PRECAUTIONS: Increased bleeding risk such as general haemorrhagic risk( see PI for list), bronchiectasis or history of pulmonary bleeding, renal impairment, hepatic impairment, surgery and interventions, spinal / epidural anaesthesia or puncture, patients with prosthetic valves( no clinical data), haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy, lactose intolerance. INTERACTIONS WITH OTHER MEDICINES: Care to be taken if concomitantly used with medicines affecting haemostasis; concomitant administration with NSAIDs, platelet aggregation inhibitors, other anticoagulants. ADVERSE EFFECTS: Please refer to PI for a complete list. Very common and common adverse reactions( � 1 %) include post procedural haemorrhage, increased transaminases, gingival bleeding, constipation, diarrhoea, nausea, pyrexia, oedema peripheral, contusion, pain in extremity, headache, dizziness, haematuria, menorrhagia, epistaxis, haematoma, anaemia, rectal haemorrhage, fatigue and ecchymosis, haemoptysis, pruritus, conjunctival haemorrhage, abdominal pain, dyspepsia, gastrointestinal haemorrhage, syncope, hypotension, increased gamma-glutamyltransferase, tachycardia, vomiting, asthenia, wound haemorrhage, subcutaneous haematoma and rash. Less frequent but serious adverse reactions include: urticaria, hypersensitivity, hyperglycaemia, cerebral, cerebellar and intracranial haemorrhage, haemorrhagic transformation stroke, jaundice, eye haemorrhage, loss of consciousness, angioedema, allergic oedema, cholestasis, hepatitis and thrombocytopaenia. DOSAGE AND ADMINISTRATION: see INDICATIONS above. BASED ON PI DATED: 01 June 2016.
References: 1. Patel MR et al. N Engl J Med 2011; 365:883 – 91. 2. Camm J et al. Eur Heart J. 2015 Sep 1. pii: ehv466. [ Epub ahead of print ]. 3. Tamayo S et al. Clin Cardiol 2015; 38:63 – 8. 4. Prins MH et al. Thrombosis J 2013; 11( 1): 21. 5. Beyer-Westendorf J et al. Blood 2014; 124:955 – 62. 6. IMS Health MIDAS, Database: Monthly Sales June 2015. 7. Calculation based on IMS Health MIDAS, Database: Monthly Sales June 2016. 8. Xarelto ®( rivaroxaban) Product Information, 01 June 2016.
Bayer Australia Ltd. ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073. Xarelto ® is a registered trademark of Bayer Group, Germany. BAY3962 / AD / L. AU. MKT. GM. 12.2015.0386
Confidence from Evidence and Real World Experience *
* Xarelto has evidence for its efficacy and safety profile for eligible patients from RCTs and real world studies in SPAF 1-3 and PE / DVT. 4, 5 Xarelto is the world’ s most prescribed NOAC, 6 with over 23 million patients treated across multiple indications. 7, 8
Doctors reject PBS online from page 1
laborious and too timeconsuming and clunky.”
The Department of Human Services has launched a satisfaction survey in an attempt to find out what is triggering GP frustration.
And the department’ s general manager Hank Jongen has promised that the system will be fixed so that prescribers can use it with their practice software.
“ Interest from these software companies is growing, and we will work with interested parties to get the functionality in place as soon as possible,” he said.
He denied that there were any plans to“ overhaul” the system.
Mr Jongen said he expects to see a rise in the number of prescribers using the system after it is integrated with prescriber software.
Statin pain a nocebo: study from page 1
of Cardiology at Mater Hospital, Brisbane, said in his experience, fewer than 1 % of statin users had experienced drug-related muscle pain.
“ It is a common problem but, in the majority of cases, it is not really due to the statin therapy because muscle-related effects are very common in an ageing population with osteoarthritis and general fatigue,” he told Australian Doctor.
“ When we start children with FH [ familial hypercholesterolaemia ] on statins, we very rarely see muscle side effects. They obviously don’ t read the side effects warnings,” he added.
Dr Kostner said statinrelated muscle pain was more likely to occur with higher doses of the more potent statins, in Asian patients and in patients who were dehydrated or had renal impairment. Lancet 2017; online.
6 | Australian Doctor | 12 May 2017 www. australiandoctor. com. au