The heart protection study 2treatment of hdl to reduce the incidence of vascular events hps2thrive study was a randomized, multicenter, doubleblind, prospective, controlled clinical trial that recruited patients at 245 sites in the united kingdom, scandinavia, and china and was published in the new england journal of medicine in july 2014. We therefore performed a study to observe different lipidlowering strategies in northeast ne china with respect to lowdensity lipoproteincholesterol ldlc reduction and goal attainments. A growing body of evidence suggests that aggressively lowering raised lpa may improve. The study also found that using er niacinlaropiprant did cause sideeffects. Listing a study does not mean it has been evaluated by the u. The hps2thrive investigators, led by dr jane armitage oxford university, uk, randomized 25 673 patients with vascular disease to. A low level of highdensity lipoprotein cholesterol hdlc is an established predictor of the risk of coronary heart disease chd. Merck announced today that the hps2 thrive heart protection study 2. Treatment of hdl to reduce the incidence of vascular events.
Effects of extendedrelease niacin with laropiprant in. Hps2thrive showed that er niacinlaropiprant does not reduce the risk of heart attacks and strokes and furthermore it does increase the risk of side effects. Combining the outcomes of hps2thrive with the negative outcomes of trials of novel agents that increase hdl cholesterol eg, torcetrapib in illuminate and dalcetrabib in daloutcomes suggest that the previous understanding of hdl as an independent risk factor for chd is incorrect or is an oversimplification of the complex molecules true role. Many thanks as thrive moves into its final phase final issue spring 2012 hps2thrive is a remarkable study aiming to improve heart health and it is now coming to a close. Are there any patients who should take er niacinlaropiprant. Morbidity and mortality in patients at high cardiovascular risk remain high, even in those receiving the best current standards of care.
Hps2thrive showed that adding niacinlaropiprant to effective statinbased ldl cholesterollowering therapy in patients known to have vascular disease did not significantly reduce the risk of. Nutrition and nutritional supplements in the management of. Data analysis plan for early safety analyses hps2thrive. C were similar to those achieved in plant sterol studies hps2. Statin therapy has been well established as a cornerstone of cardiovascular prevention, and yet despite potent therapies for lowering low. What do the results from the hps2 thrive study show. It is well established that lipoproteina lpa is an independent cardiovascular risk factor and predictor of major adverse cardiovascular events. While little data are available right now and the press release contains scant information, boden noted that hps2thrive was an allcomers secondary. This article will discuss the studies supporting this optimal systolic blood pressure goal. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Hps2thrive is a large randomized trial assessing the effects of extended release er niacin in patients at high risk of vascular events. In the past, considerable emphasis was placed on reduction of plasma glucose as the key to lowering cardiovascular risk and there were misplaced perceptions of benefit from aspirin in all patients. Ldlcholesterol goal attainment under persistent lipidlower.
Dec 20, 2012 the largestever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Pdf nicotinic acidlaropiprant reduces platelet count but. The european medicines agency ema has recommended suspending marketing authorisations for medicines containing a combination of nicotinic acid and laropiprant for the treatment of adults with dyslipidaemia after a study did not meet its primary endpoint and showed increased risk of serious adverse events. Niacin is the oldest drug available for the treatment of dyslipidemia. In hps2thrive, the er niacin was combined with a new drug called laropiprant which is a prostaglandin receptor blocker in order to reduce problems due to flushing. While we do not yet have a description of the hsp file format and what it is normally used for, we do know which programs are known to open these files. Merck announced today that the hps2thrive h eart p rotection s tudy 2 t reatment of h dl to r educe the i ncidence of v ascular. Are the results from hps2thrive consistent with previous studies. Reducing cardiovascular risk in type 2 diabetes mellitus. However, the understanding from genetic studies and negative results from randomised trials that low hdl cholesterol might not cause cardiovascular disease as originally thought has now generated renewed.
Triglyceridelowering therapies reduce cardiovascular disease. The hps2 thrive investigators, led by dr jane armitage oxford university, uk, randomized 25 673 patients with vascular disease to 2 g of extendedrelease niacin and 40 mg. Although a relationship between elevated triglycerides tg and cardiovascular diseases is generally accepted, its extent is still discussed. Hps2thrive, the worlds largest study into the bene. Nicotinic acidlaropiprant reduces platelet count but increases mean platelet volume in patients with primary dyslipidemia. Is a biocompatible and eto, steam, ebeam and gamma sterilizable grade containing higher amount of mold release than hps2. Hps2 thrive is a large randomized trial assessing the effects of extended release er niacin in patients at high risk of vascular events. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events.
Apr 18, 2007 treatment of hdl to reduce the incidence of vascular events hps2 thrive hps2 thrive the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. While little data are available right now and the press release contains scant information, boden noted that hps2 thrive was an allcomers secondaryprevention study and did not preselect patients. Genomewide association study identifies a novel genetic risk factor for recurrent venous thrombosis hugoline g. Questions and answers about the results hps2thrive. Fibrates fibric acid derivates are synthetic ligands for ppar. Lipoprotein apheresis is currently the most effective approved treatment available, with minimal effect conferred by conventional lipid lowering agents. Hps2 thrive treatment of hdl to reduce the incidence of vascular events concluded that adding er niacinlaropiprant to current standard treatment did not produce worthwhile reductions in the risk of heart attacks, strokes and operations to open blocked arteries. Owing to their complexity, apolipoprotein disorders will not be covered. Niacin and progression of ckd american journal of kidney. If you use mozilla firefox, and see the warning this pdf document might not be displayed correctly choose to open with different viewer. The good news means this study your study is ontrack to report its.
The impact of lipoprotein apheresis in patients with. Hermanskypudlak syndrome hps is a rare autosomal recessive disease characterized by platelet defects and oculocutaneous albinism. Every day thousands of users submit information to us about which programs they use to open specific types of files. There has been renewed interest in nicotinic acid owing to the need for improved prevention of atherosclerosis in patients already taking. Cardiovascular disease risk reduction by raising hdl. What do the results from the hps2thrive study show. Offers mediumhigh flow, formulation control, good ductility, toughness and clarity. After the introduction of statins, clinical emphasis first focussed on ldl cholesterollowering, then on the potential for raising hdl cholesterol, with less focus on lowering triglycerides. Hps2thrive randomized placebocontrolled trial in 25673 high. Three cetp inhibitors have failed in phase 3 trials, bringing into question hdlc as a therapeutic target.
The heart protection study 2treatment of hdl to reduce the incidence of vascular events hps2. Current guidelines support lowering of the systolic blood pressure in diabetic patients with hypertension to less than 140 mmhg. It has been studied extensively and tested in clinical trials of atherosclerotic cardiovascular disease prevention and regression in the general population, but not specifically in patients with chronic kidney disease ckd, who are at extremely high residual risk despite current therapy. Triglycerides and cardiovascular disease the lancet. Safety assessment of niacin in the us food and drug. Hdl promotes cellular cholesterol efflux and reverse cholesterol transport from lipidladen macrophages figure 1, and prevents lipoprotein oxidation. Treatment of hdl to reduce the incidence of vascular events hps2thrive hps2thrive the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling. Hps2thrive randomized placebocontrolled trial in 25673. Hps2thrive was independently conducted by the clinical trial service unit at oxford university and funded by merck. Hps2thrive treatment of hdl to reduce the incidence of vascular events concluded that adding er niacinlaropiprant to current standard treatment did not produce worthwhile reductions in the risk of heart attacks, strokes and operations to open blocked arteries. The primary aim of hps2thrive is to assess the effect of er niacin.
Ernlrpt was also associated with an excess of serious adverse experiences aes, some of which were unexpected infections and bleeding. Hps2thrive treatment of hdl to reduce the incidence of. This article provides an overview of the different types of familial hyperlipidaemia that may be encountered in clinical practice, namely, familial combined hyperlipidaemia fch and familial hypercholesterolaemia fh. A crosssectional study dysischina was conducted in 2012, involving 25,317 patients from 122 centers across china who were diagnosed with hyperlipidemia and treated with lipidlowering. Over 25,000 patients with preexisting cardiovascular disease from the uk, scandinavia and china were recruited into hps2thrive. Hps2 differs from the other forms of hps in that it includes immunodeficiency, and patients with hps2 have an increased susceptibility to infections due to congenital neutropenia jung et al. Thrive due in 20 will hopefully provide answers on the efficacy and safety of niacin plus laropiprant in cardiovascular disease armitage et al. Prior to randomization, 42 424 patients with occlusive arterial disease were given simvastatin 40 mg plus, if required, ezetimibe 10 mg daily to standardize their lowdensity lipoprotein. The heart protection study 2treatment of hdl to reduce the incidence of vascular events hps2thrive showed that adding extendedrelease niacinlaropiprant ernlrpt to statin provided no incremental cardiovascular benefit vs placebo pbo. Nicotinic acid niacin has been used for decades to prevent and treat atherosclerosis. The results of hps2thrive were disappointing but clear, said jane armitage, who presented the results this morning at the acc in san francisco. Plant sterol enriched functional food and atherosclerosis. The primary endpoint was the time to first major vascular event mve, defined as the composite of nonfatal mi or coronary death, any stroke, or any arterial. Hps2thrive involved over 25,000 volunteers aged between 50 and 80 with a history of heart disease, stroke or other circulatory disease recruited from almost 250 hospitals in 6 countries china, denmark, finland, norway, sweden and the united kingdom.
Merck announced today that the hps2 thrive h eart p rotection s tudy 2 t reatment of h dl to r educe the i ncidence of v ascular e vents study did not meet its primary endpoint. Familial hyperlipidaemia british journal of cardiac nursing. While we do not yet have a description of the hps file format and what it is normally used for, we do know which programs are known to open these files. Atherosclerosis is a chronic, inflammatory disease of the arterial wall that underlies many of the common causes of cardiovascular morbidity and mortality, including myocardial infarction mi, and cerebrovascular and peripheral vascular disease. Nicotinic acid plus laropiprant suspended for dyslipidaemia. The following pdf documents describe the data analysis plan for the thrive study. The largestever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Thrive has followed the health of more than 25,000 people in six countries to study the effects of raising good cholesterol on the prevention of heart attacks and strokes. The study subjects were all on simvastatin 40 mgday. Cardiovascular outcomes trials of fibrates, niacin, or omega3 fatty acids alone, or added to a statin, have not consistently demonstrated reduced risk, but larger, statistically significant clinical benefits have been reported in subgroups with elevated triglycerides tg andor elevated tg plus low highdensity lipoprotein cholesterol hdlc. This retrospective study analyzed the incidence of cardiovascular events cve and pancreatitis as well as the therapeutic regimen in patients being treated for hypertriglyceridemia htg at an outpatient department. Easily share your publications and get them in front of issuus. Laropiprant itself has no cholesterol lowering effect, but it reduces facial flushes induced by niacin. Targeting plasma lipids is a mainstay of preventing and treating cardiovascular disease.
The last decade has seen a radical change in our assumptions about the best ways to lower cardiovascular risk in patients with type 2 diabetes mellitus. Of those enrolled, 14,741 were from europe the united kingdom and scandinavia and 10,932 were from china. Mar 09, 20 the results of hps2 thrive were disappointing but clear, said jane armitage, who presented the results this morning at the acc in san francisco. C in patients with very high baseline levels or statin intolerance, or iii. A randomized trial of the longterm clinical effects of raising hdl cholesterol with extended release niacinlaropiprant does extended release er niacinlaropiprant prevent vascular events in highrisk. Thrive trial found higher incidence rates of adverse reactions, including bleeding, in patients receiving the combination of extended. The selection of antihypertensive drug therapy in patients with diabetes mellitus. Combining the outcomes of hps2 thrive with the negative outcomes of trials of novel agents that increase hdl cholesterol eg, torcetrapib in illuminate and dalcetrabib in daloutcomes suggest that the previous understanding of hdl as an independent risk factor for chd is incorrect or is an oversimplification of the complex molecules true role. Hps2thrive randomized placebocontrolled trial in 25 673.