REVISITING THE YEAR 2015
Dr K K Aggarwal
Medicine is a rapidly changing field with many new researches and breakthroughs coming up every day, which shape day to day practice. The year 2015 too saw several advances in medicine and release of new and/or updated guidelines. Here is a quick snapshot of some researches that made the headlines in the year gone by. This by no means is a complete list. Our readers are welcome to add to this list…
- The landmark SPRINT or Systolic Blood Pressure Intervention Trial showed that a more intensive strategy of managing BP reduces the risk for death and cardiovascular events when compared with a strategy that lowers systolic blood pressure to the conventional target of 140 mm Hg. Treating high-risk hypertensive adults aged 50 years and older to a target of 120 mm Hg significantly reduced cardiovascular events by 30% and all-cause mortality by nearly 25%. The study funded by the National Institutes of Health (NIH) was stopped early because of the benefit of the intensive strategy.
- The FDA approved two new lipid lowering drugs, human monoclonal antibody PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors - alirocumab and evolocumab - for patients with familial hypercholesterolemia (FH) and for patients at high or very high risk for CV events who are unable to reach LDL targets despite maximally tolerated statin therapy.
- The EMPA-REG OUTCOME study, a cardiovascular-outcomes trial, for the first time, showed superiority of the diabetic drug empagliflozin (Jardiance), sodium glucose cotransporter-2 (SGLT-2) inhibitor in reducing the rate of cardiovascular death, nonfatal MI, and nonfatal stroke among individuals with type 2 diabetes and established cardiovascular disease with 38% reduction in CV death and 32% reduction in all-cause mortality.
- The US Food and Drug Administration (FDA) approved the combination tablet valsartan/sacubitril (Entresto, Novartis) for the treatment of patients with heart failure. It is the first approved agent in the angiotensin receptor-neprilysin inhibitor (ARNI) class and exerts its effect within and beyond the renin-angiotensin system. Besides reducing heart failure deaths, Entresto also reduces heart failure hospitalizations.
- A head-to-head comparison of the everolimus-eluting stent with a bioresorbable scaffold (Absorb, Abbott Vascular) against a conventional everolimus-eluting cobalt-chromium stent (Xience, Abbot Vascular) in the ABSORB III trial, the two devices yielded similar rates of target lesion failure (TLF) at 1 year; 7.8% vs 6.1%, respectively. TLF is a composite end point that included cardiac death, target vessel MI, or ischemia-driven target lesion revascularization.
- A novel oral anticoagulant (NOAC) reversal agent received FDA approval this year. The dabigatran reversal agent idarucizumab (Praxbind, Boehringer Ingelheim) is the first reversal agent approved specifically for dabigatran (Pradaxa Boehringer Ingelheim). In November, the New England Journal of Medicine published results of the factor Xa reversal agent andexanet alfa, which safely reversed the anticoagulant effect of apixaban and rivaroxaban in older volunteers.
· The Institute of Medicine (IOM) gave a new name to chronic fatigue syndrome, systemic exertion intolerance disease or SEID, highlighting the role of exertion in aggravating the symptoms. IOM also defined clear and simpler diagnostic criteria for SEID
o A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for > 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest
o Post-exertional malaise
o Unrefreshing sleep
Plus, at least one of the following: Cognitive impairment or orthostatic intolerance
- The FDA announced a new policy for blood donations by gay men overturning a lifetime ban that dates to 1983. It allows gay men to donate blood and excludes only those whose last sexual contact with another man occurred in the 12 months prior to donation. But, the ban remains in place for commercial sex workers and people who use injection drugs. People with hemophilia or related clotting disorders are also still barred from donating blood for their own protection due to potential harm from large needles used during the donation process.
- The American Cancer Society (ACS) updated its breast cancer screening guidelines for women at average risk of developing the disease. ACS now recommends that women should start annual screening with mammography at age 45, not 40 as recommended earlier. At age 55, women can transition to screening every 2 years instead of annually.
- An update of the American College of Obstetricians and Gynecologists (ACOG) cervical cancer screening guidelines recommends that women aged between 30 and 65 years and at "average risk" for cervical cancer should be co-tested with cytology and HPV testing every 5 years, or screening with cytology every 3 years. It does not recommend HPV co-testing for women younger than 30 years.
- Dirty endoscopes, particularly duodenoscopes used in endoscopic retrograde cholangiopancreatography topped the list of health technology hazards in ECRI Institute's Top 10 list for 2016. Poorly cleaned flexible endoscopes prior to disinfection can increase the risk of transmitting infections. Outbreaks of multidrug resistant bacteria have been linked to duodenoscopes despite following proper reprocessing instructions.
- The WHO issued “Early Release Guideline” on when to start antiretroviral therapy and on pre-exposure prophylaxis (PrEP) for HIV. The two major recommendations are: Initiation of antiretroviral therapy (ART) in adults with HIV irrespective CD4 cell count, use of daily oral pre-exposure prophylaxis (PrEP) as a prevention option for people at substantial risk of acquiring HIV infection. The comprehensive guidelines are expected to be released in 2016.
- Immunotherapy has been identified as the game changer for oncology with studies demonstrating cancers like non-small cell lung cancer (NSCLC), breast cancer, multiple myeloma responding to immune checkpoint inhibitors. Earlier in the year, FDA approved Opdivo (nivolumab) to treat patients with advanced squamous NSCLC whose disease progressed during or after platinum-based chemotherapy. In October, FDA expanded the use of Opdivo to also treat patients with non-squamous NSCLC.
- The FDA approved new formulations for delivering carbidopa/levodopa for patients with Parkinson’s disease. Rytary is an extended-release capsule formulation of carbidopa-levodopa for the for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Duopa, enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease and is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a percutaneous endoscopic gastrostomy procedure with jejunal extension.
- The American Heart Association (AHA) new guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC)emphasize on quick action, proper training, use of technology and more teamwork - from bystanders to dispatchers, emergency responders to healthcare providers - to increase survival from cardiac arrest. The new compression rate is 100–120 a minute, while earlier it was “at least 100.” The new compression depth is 2–2.4 inches for adults and adolescents; it had been “at least 2 inches.
- The WHO report classifying red meat and processed meat as carcinogenic created controversy and panic. The International Agency for Research on Cancer (IARC), the cancer research agency of WHO classified the consumption of red meat as ‘probably carcinogenic’ to humans and processed meat as ‘carcinogenic’ to humans. Eating 50 gm portion of processed meat daily increases the risk of colorectal cancer by 18%. However, the WHO later tried to ease the panic by emphasizing that the findings only confirmed recommendations made back in 2002, which advised people to reduce their consumption of these products to reduce the risk of cancer.
- The American Academy of Pediatrics (AAP) endorsed a recommendation for early introduction of peanut-containing foods in to the diets of infants at high risk of peanut allergies. This current consensus statement from 10 medical organizations in Europe and the United States is based on findings of the Learning Early about Peanut Allergy (LEAP) randomized trial, which found that the early introduction of peanuts into the diet of high-risk infants lowered their likelihood of being allergic to them.
- Ocrelizumab, a second-generation monoclonal antibody targeting B-cells has been a major advance in multiple sclerosis. Although not available for marketing, it has shown encouraging results in clinical trials (OPERA I and II, ORATORIO) for both relapsing-remitting and primary progressive multiple sclerosis.
- Many other guidelines have been released: pediatric pulmonary HT (AHA/ATS), pediatric perioperative anesthesia (AAP), thyroid nodule diagnosis & management (ATA), polymyalgia rheumatic (EULAR/ACR), rheumatoid arthritis (ACR)