Game-Changers in Cardiology: A diabetes drug that benefits the heart

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That glucose-lowering drug could benefit the heart was included as one of the top five “game-changers” in cardiology and endocrinology in 2015.

The EMPA-REG study of empagliflozin, a once-daily SGLT2 inhibitor used to treat type 2 diabetes, found that the drug cut the rate of cardiovascular death, nonfatal MI, and nonfatal stroke in type 2 diabetics.

The results were initially reported by Yale’s Silvio Inzucchi, MD, at the European Association for the Study of Diabetes meeting (and simultaneously in the New England Journal of Medicine), and then Inzucchi followed up with additional analysis of the data at the American Heart Association scientific conference last month.

Ministry of Health & Family Welfare Immunization Division

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Minutes of the meeting for tOPV to bOPV switch

A meeting to discuss tOPV to bOPV switch was held on 18th December 2015 at 3:30 p.m. under the chairpersonship of AS&MD (NHM) in Room No. 249-A, Nirman Bhawan, New Delhi. The meeting was attended by senior officials from Ministry, representatives from WHO-SEARO, WHO-India, UNICEF, CDSCO, CDL Kasauli, INCLEN, IMA and vaccine manufacturers.

The meeting initiated with welcome note by AS&MD (NHM) highlighting the importance of each partner in tOPV to bOPV switch and requesting them to fully support the Govt. of India in the successful implementation of switch. A powerpoint presentation was made by DC (I) highlighting the timeline of switch and role of various stakeholders and validation of switch.

Key issues and discussion points

1) The country has decided 25th April, 2016 as National Switch Date. After the switch date only bOPV will be used, both in routine immunization as well as polio campaigns. No supplies of tOPV will be accepted after 1 st March 2016 in Government supply chain and after 1st April 2016 in private market. After switch date, remaining tOPV will be removed from cold chain and disposed as per National Switch Plan. National Validation Day has been decided as 9 th May, 2016.

2) After 16th July 2016, no facility (including vaccine manufacturers and testing labs) other than the designated essential facility for India – NIV Pune- to retain any Sabin type 2 containing material including tOPV.

3) Communication materials for the switch will be provided by MoHFW to stakeholders, so that uniform message is conveyed across the country.

4) Role of DCG(I) DCG(I)

• DCG(I) to communicate with vaccine manufacturers and drug controllers at Zonal and District level to ensure availability of bOPV two weeks prior to switch. It must be ensured that secondary packaging of bOPV is not opened before switch date.

• DCG(I) to cancel all licenses for manufacturing as well as import of tOPV for use after 25th April 2016.

• DCG(I) to issue necessary communication to prohibit the use/storage of tOPV and ensure destruction of existing stock of tOPV after the switch day.

• DCG(I) to issue necessary instructions to clearing and forwarding agencies so as to allow the supply of tOPV to dry up and to build up supply of bOPV in view of switch date. CDL, Kasauli

• Testing for bOPV to be fast tracked to ensure timely supplies in view of switch date.

• Testing of all tOPV intended for GoI supplies to be completed and report submitted by middle of Feb, 2016 as GoI will not accept any tOPV from 1 st March, 2016 onwards.

• No batch testing of tOPV to be done after March 2016 even for private market.

5) Role of IMA/IAP

• MoHFW to provide the communication material (pamphlet, joint appeal, SMS messages) on tOPV to bOPV switch to IMA/IAP for circulation to its members nation-wide.

• IMA/IAP, in their upcoming conferences, to reserve a session for GoI representatives to sensitize the participants about the switch.

• IMA/IAP to ensure participation and cooperation of its members in switch validation. For appropriate disposal of tOPV, IMA/IAP to also ensure that disposal of tOPV from private market is linked with that of public sector.

6) Role of vaccine manufacturers

• Manufacturers to ensure tOPV supply to GoI till Feb, 2016 as per committed supply timeline and quantity.

• No supplies of tOPV after 1st March 2016 to Government stores and after 1st April 2016 in private market.

• Manufacturers to ensure availability of bOPV from 10th April, 2016 i.e. two weeks before the switch date in open market.

• All remaining tOPV and type 2 polio bulks to be destroyed in consultation with DCG(I) as per laboratory containment GAP-III plan.

7) Role of NCCPE

• NCCPE with its additional charge of “National Switch Monitoring and Validation Committee” will validate the switch in the country. IMA/IAP and DCGI to provide complete support in switch validation. To conclude, AS&MD (NHM) emphasized on the importance of the switch and that there should be no laxity on the part of any stakeholder.

Updates in Medicine

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• Children with epilepsy should have a plan in place at school for how best to respond to medical emergencies. The American Academy of Pediatrics (AAP) has released guidance suggesting prescribing providers, families, and schools collaborate develop such plans detailing the use of seizure rescue medications. The recommendations are published online December 28 in Pediatrics.

• For patients with gram-negative bloodstream infections (BSI) who present with a beta-lactam allergy, treatment with a beta-lactam (BL) antibiotic from an alternative class carries a lower risk of clinical failure than treatment with a non-beta-lactam (NBL) antibiotic, according to a new study reported online December 11 in the Journal of Allergy and Clinical Immunology.

• Administration of oral ivermectin to whole communities can significantly decrease the prevalence of scabies and impetigo. In the study published in the December 10 issue of the New England Journal of Medicine, the prevalence of scabies from baseline to 12 months went from 36.6% to 18.8% in the standard care group and from 41.7% to 15.8% in the permethrin group. The greatest reduction was noted in the ivermectin group, which went from 32.1% to 1.9%. The severity of scabies at baseline was similar across all three groups.

• As per a study from published online December 28 in the journal Pediatrics, the prevalence of asthma in the US are leveling off and possibly declining, but not among the poor. The overall prevalence of childhood asthma doubled from 1980 (3.6%) to 1995 (7.5%), increased at a slower rate from 2001 (8.7%) to 2009 (9.7%), and dipped in 2010 (9.3%). The 1980s saw no or little disparity in asthma prevalence between black and white children, but asthma prevalence doubled for black children by 2010.

• Michael M. Ward, MD, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the NIH in Bethesda, Md., and colleagues report in the journal Arthritis & Rheumatology that only about one-fourth of patients with non-radiographic axial spondyloarthritis (axSpA) progressed to ankylosing spondylitis (AS) through more than a decade of follow-up. At the end of a mean of 10.6 years of follow-up, 26% patients progressed to AS. In addition, at 5, 10, and 15 years, the probabilities of remaining as non-radiographic axSpA were 93.6%, 82.7%, and 73.6%, respectively.

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