BURLINGTON, Mass., June 13, 2016 /PRNewswire/ -- Decision Resources Group finds that despite the many therapies available, there is an ongoing need for drugs that improve LDL-C. Positive results from Ezetimibe's outcomes trial (IMPROVE-IT) reinforced the LDL-C hypothesis and suggest that new drugs targeting LDL-C are required. Although effective, the PCSK9 inhibitors may fail to meet this need because of their premium prices and injectable nature.

Other key findings from the Unmet Needs report entitled Dyslipidemia:

  • Although dyslipidemia is a widely recognized problem and there are effective, convenient and inexpensive means of improving lipid profiles via pharmacotherapy, identifying all patients at risk, optimizing their therapy and maintaining them on treatment remain a challenge.
  • The level of unmet need for therapies that reduce rates of cardiovascular (CV) morbidity and mortality and that reverse the progression of atherosclerosis is high. Reducing CV morbidity and mortality are key treatment goals, especially in the secondary prevention dyslipidemia segment (i.e., patients who have suffered a CV event). Regulators, payers and physicians are increasingly requiring emerging therapies to demonstrate CV benefits in large outcomes trials.
  • Nonstatin therapies that improve HDL-C and TG levels are also needed. Current therapies are moderately effective at best and have yet to demonstrate benefit in terms of hard CV end points. Thought leaders call for therapies that improve biomarkers such as Apo A1, Apo B, Lp(a) and hs-CRP.
  • Physicians caution that new therapies for dyslipidemia, no matter how effective, must have a convenient dosing schedule and ideally be orally available. Otherwise patient compliance can be a problem.

Comments from Decision Resources Group Analyst Stefanie Hoffart, M. Sc.:

  • "The lack of evidence for CV benefits among nonstatin agents represents a significant unmet need and one that has become more pressing in the wake of trials such as ACCORD and HPS2-THRIVE, both of which failed to demonstrate an outcomes benefit above a statin background for fibrate and niacin drugs, respectively. However, the positive outcomes data from the IMPROVE-IT study have restored confidence in the LDL-C-lowering hypothesis, and we await the results of further CVOTs expected to finish in the next five years, particularly those for the PCSK9 inhibitors."
  • "The recently launched PCSK9 inhibitors offer an impressive LDL-C reduction of up to 60 percent when used with statin therapy; however, they are expensive and more likely to be used in later-line treatment. In view of other non-statin therapies' limited efficacy and the PCSK9 inhibitors' high price and injectable administration, opportunity exists for novel oral LDL-C-lowering therapies."

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About Decision Resources Group
DRG, a subsidiary of Piramal Enterprises Ltd., offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 1000 employees across 17 offices in North America, Europe and Asia. DRG provides the Life Sciences, Provider, Payer and Financial Services industries the data, tools, insights and advice they need to compete and thrive in an increasingly complex and value-based marketplace. decisionresourcesgroup.com.

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