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However, there is a growing movement to take a more granular approach to more fully capture the complex array of functions through which HDL may confer cardiovascular protection. These functions include cholesterol efflux from peripheral cells, reverse cholesterol transport (RCT), anti-inflammatory, antioxidative, anti-thrombotic, and pro-endothelial actions. 4–6 Recent epidemiological work supports efforts to look beyond HDL-C, showing limited value of HDL-C for predicting vascular risk in CHD patients undergoing elective coronary artery bypass grafting 7 or cardiovascular mortality in the setting of stable or unstable CHD. 8

By ultracentrifugation, one can isolate HDL 2 -C and HDL 3 -C, or ‘large, buoyant’ and ‘small, dense’ HDL, respectively, and these variations in density of HDL are related to its functionality. 5 , 6 , 9 It is often suggested that HDL 2 is the ‘protective’ form of HDL, however, epidemiological data are conflicting with some studies showing that higher HDL 2 -C 10 , 11 but others suggesting that higher HDL 3 -C 12–15 levels are most strongly associated with lower risk. These studies varied in design, adjustment for confounders, and methods for HDL subclass separation and quantification.

To better understand the associations of HDL 2 -C and HDL 3 -C with clinical outcomes, we collaboratively analysed data from two complementary, prospective cohorts of secondary prevention patients in whom HDL-C was subclassified by a common method of ultracentrifugation: (i) the Translational Research Investigating Underlying disparities in acute Myocardial infarction Patient's Health status (TRIUMPH) study and (ii) the Intermountain Heart Collaborative Study (IHCS) of patients undergoing coronary angiography.

The TRIUMPH 16 and IHCS 17 prospective cohort studies each enrolled patients 18 years of age or older. The TRIUMPH study enrolled between 11 April 2005 and 31 December 2008 at 24 centres in the USA, while the IHCS study enrolled between 1 March 1999 and 5 November 2007 within the Intermountain Healthcare System (LDS Hospital: Salt Lake City, UT, USA; Intermountain Medical Center, Murray, UT, USA; and McKay Dee Hospital, Ogden, UT, USA). TRIUMPH participants were included on the basis of acute myocardial infarction (MI) and IHCS participants on the basis of coronary angiography for MI, unstable angina, or stable angina. Of eligible patients approached for participation, 74% of TRIUMPH and >95% of IHCS patients provided informed consent. All patients in this study provided informed consent and each enrolling site obtained Institutional Review Board approval.

In TRIUMPH, MI was defined as clinical features of ischaemia (e.g. prolonged ischaemic signs/symptoms, ST-segment changes in ≥2 contiguous leads on electrocardiogram) combined with cardiac biomarker elevation (troponin per local laboratory cutpoints) outside the setting of elective coronary revascularization. In IHCS, MI was defined similarly, and additionally, stable angina was defined as stable exertional symptoms only, and unstable angina as progressive symptoms or symptoms at rest only.

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Global iron deficiency anemia therapy marketis expected to register a CAGR of 7.2% during the forecast period, 2018 to 2023. Iron deficiency anemia is caused due to the lack of iron, which is one of the most common types of anemia. In case of women, in the child bearing age, iron loss in the blood is due to heavy menstruation or pregnancy. Certain intestinal diseases and poor diet can also cause anemia.

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Rising Cases of Haemodilution in Pregnancy

Haemodilution is a condition in which there is decreased concentration of cells and solids in the blood. It is caused due to Plasma Volume Expansion (PVE). The PVE is dependent on various factors, like weight of the mother, BMI, hormonal state of the mother during pregnancy, etc. The cases of haemodilution are rising due to changes in lifestyles, such as lack of exercise, fast food, smoking, etc. These lifestyle changes are more in developed and developing countries, which is resulting in irregular BMI, increase in abnormal weight, and also hormonal imbalance. Such factors result in disturbed physiology of a pregnant woman. As per the statistics of American Heart Association, around 44 million women are affected by cardiovascular disease in the United States, and 90% of the women have one or more risk factors associated with heart disease. Therefore, rising cases of haemodilution is fueling the iron-deficiency anemia therapy market, globally. The other factors, such as high prevalence of anemia are also driving the iron deficiency anemia therapy market to grow.

Stringent Regulatory Guidelines

Anemia is a highly prevalent disease, for which the need for drugs has grown. However, due to strict regulatory guidelines, there are some drugs that are unable to enter the market. The approval of iron-deficiency drugs, which are highly important in the market, is time consuming, moreover, the process involved is stringent. There are some cases where a drug is approved but, due to side effects or ethical issues related to its use, the market for the same does not grow because of strict regulations of regulatory authorities. Also, the fee for approval and investment in RD are quite high for these drugs. United States FDA has increased the fee for Abbreviated New Drug Approval (ANDA), by over USD 100,000 to USD 170,000 for FY 2018. The hike was approved as per the Generic Drug User Fee Amendments of 2017 (GDUFA II). This increase in approval fees is expected to restrain the iron-deficiency anemia therapy market. The other factors, such as side effects of drugs or supplements are also hindering the growth of the market.