2014年11月17日讯 /生物谷BIOON/ --长期以来，生物医药公司在进行相关药物研发时主要都专注于对疾病的疗效和副作用等方面。这也导致了许多药物在研发之初就未能考虑到患者和市场多种多样的需求。因此，许多药物在最终上市后的表现并未如预计的那样出色也就在预料之中了。
有鉴于此，制药巨头勃林格殷格翰公司最近宣布将与保健巨头WellPoint公司开展关于其正在研发的治疗心房颤动药物Pradaxa的临床实效研究。不同于传统临床研究，此次开展的临床实效研究将全方位关注患者的用药体验。包括对疾病的预防，医院复诊率等等。通过这些数据，勃林格殷格翰公司将可以更直接的掌握药物在患者群体中的表现。
而这也是勃林格殷格翰公司和WellPoint公司最近刚刚达成为期五年的合作研究协议的一部分。勃林格殷格翰公司官员希望通过这一研究最大限度的保证公司医药研发的质量。
而最近心血管疾病药物研究领域正在酝酿的大变革恰好为这一研究的进行提供了契机。近年来相关研究暗示，降低胆固醇含量能够在很大程度上改善心血管病患者的病情。不光是勃林格殷格翰，赛诺菲、安进和辉瑞等研究巨头都纷纷把目光集中在这一领域。
下周，默沙东公司开发的同类药物Zetia的临床研究结果即将公布，这也将直接反应胆固醇含量是否与心脏病发作有着直接紧密的联系。一旦结果成功，则必然引起PCSK9拮抗剂类药物新一轮的研发热潮。反之，则会对这一领域造成重大冲击。
详细英文报道：
Boehringer Ingelheim is working with managed care giant WellPoint in an effort to use real-world data to inform the development of new treatments of atrial fibrillation, keeping up with a sweeping trend in cardiovascular R&D.
Teaming up with HealthCore, WellPoint's outcomes research arm, Boehringer plans to examine a-fib from every direction, looking at disease prevalence, rates of hospital readmission and other data on the disease. The plan is to create a go-to registry of a-fib information that Boehringer can tap as it develops new drugs for the condition, a resource the company said will allow it to better address unmet needs and craft therapies of greater value.
"It's this holistic approach to identifying the needs of all stakeholders that will allow us to produce the kind of information used to develop therapies and interventions that provide the most value to members, providers, insurers and medical product developers and manufacturers," HealthCore Vice President Mark Cziraky said in a statement.
The project is part of a 5-year agreement between Boehringer and WellPoint under which the pair plan to establish similarly deep pools of outcomes data on a group of undisclosed diseases. The companies decided to start with a-fib in light of the exploding popularity of next-generation anticoagulants--including Boehringer'sPradaxa--that promise to chip away at the widespread use of warfarin.
The collaboration comes amid a sea change in the cardiovascular space, as regulators, physicians and payers are increasingly looking to outcomes data in their evaluation of cardiovascular treatments. Many makers of newfangled cardio drugs have succeeded in demonstrating efficacy against surrogated endpoints, like cholesterol reduction, but whether those treatments reach their full market potential will likely depend on results from expansive, expensive trials designed to determine their ability to significantly improve patients' lives.
Such is the case for Sanofi ($SNY), Regeneron ($REGN), Amgen ($AMGN) and Pfizer ($PFE), companies developing drugs that block the expression of PCSK9 to lower bad cholesterol. Each contender is carrying on a longitudinal outcomes study to demonstrate that its drug spells meaningful benefits, hoping to convince payers to shell out for the injectable therapies instead of relying on cheap statins alone.
And, next week, the world will get a peak at long-awaited results from IMPROVE-IT, a nearly decade-long trial looking at whether Merck's ($MRK) Zetia can reduce rates of heart attack, stroke and other calamities. If the study is a success, it will serve as a sign that lowering bad cholesterol can prolong cardiovascular health; if it fails, the sky-high sales projections for new cardio drugs may fade considerably.