The National Institutes of Health (NIH) halted a scientific trial early after discovering that each day statin remedy considerably lowered heart problems threat in folks residing with HIV. The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) examine revealed that contributors taking pitavastatin calcium lowered their threat of main opposed cardiovascular occasions by 35% in comparison with these on a placebo. The examine concerned 7,769 volunteers aged 40 to 75 from 12 nations, all of whom had been taking antiretroviral remedy and had low-to-moderate heart problems threat. The trial’s Data Safety and Monitoring Board really helpful early termination as a result of compelling proof, and the NIH accepted this suggestion. The findings might result in a typical cholesterol-lowering drugs enhancing cardiovascular outcomes for folks with HIV.
The NIH stopped a scientific trial early after discovering that each day statin remedy, pitavastatin calcium, lowered heart problems threat in folks residing with HIV by 35%. The findings might result in improved cardiovascular outcomes for this inhabitants utilizing frequent cholesterol-lowering medicines.
A National Institutes of Health (NIH) scientific trial was stopped early as a result of a each day statin remedy was discovered to cut back the elevated threat of heart problems amongst folks residing with HIV within the first large-scale scientific examine to check a major cardiovascular prevention technique on this inhabitants. A deliberate interim evaluation of information from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) examine discovered that contributors who took pitavastatin calcium, a each day statin, lowered their threat of main opposed cardiovascular occasions by 35% in contrast with these receiving a placebo. Adverse drug occasions noticed within the examine had been like these within the basic inhabitants taking statin remedy. The interim evaluation was sufficiently compelling that the examine’s impartial Data Safety and Monitoring Board (DSMB) really helpful it’s stopped early given ample proof of efficacy. The NIH accepted the DSMB suggestions.
REPRIEVE started in 2015 and enrolled 7,769 volunteers who had been 40 to 75 years of age, of whom greater than 30% had been girls. REPRIEVE volunteers had been all taking antiretroviral remedy, with CD4+ cell counts higher than 100 cells/mm3 of blood at enrollment, and had low-to-moderate conventional heart problems threat that may not usually be thought of for statin therapy. The trial was carried out in 12 nations in Asia, Europe, North America, South America, and Africa.
The REPRIEVE examine is primarily supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI) with further funding from the NIH Office of AIDS Research. The examine was carried out by the AIDS Clinical Trials Group (ACTG).
Decades of analysis and advances in HIV therapy have drastically lowered AIDS-related problems and deaths. As folks with HIV dwell longer, untimely coronary heart illness and different persistent situations have emerged as main causes of morbidity and mortality, contributing to persistent gaps in lifespan between folks with HIV and the broader inhabitants.
“The REPRIEVE examine displays the evolution of HIV science, and progress from focusing totally on approaches to deal with and management the virus to finding ways to improve the overall health of people living with HIV,” said acting NIAID Director Hugh Auchincloss, M.D. “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV.”
Statins are a class of medicines routinely prescribed to lower cholesterol and are known to prevent cardiovascular disease in those at risk in the general population. It was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk. In the REPRIEVE trial, participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or placebo. They were monitored for major adverse cardiovascular events and adverse reactions to pitavastatin, which is considered safe for use with all prescribed antiretroviral therapy regimens.
The study’s DSMB met at planned intervals throughout the study to review safety and efficacy data. In its most recent meeting, the DSMB determined that the benefits of daily pitavastatin use outweighed any risks and recommended that the study terminate early, and that a full data collection be conducted across sites for final analysis. Study participants are being notified of the findings and will continue to be monitored for several months. Study results from the DSMB review are expected to be published in the coming weeks.
“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” said NHLBI Director Gary H. Gibbons, M.D. “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”
The REPRIEVE study was funded by a grant to the Massachusetts General Hospital and led by Steven Grinspoon, M.D, professor of medicine at Harvard University, endowed chair in Neuroendocrinology and Metabolism and chief of the metabolism unit at Massachusetts General Hospital, who directed the study’s Clinical Coordinating Center. Pamela Douglas, M.D., the Ursula Geller Professor of Research in Cardiovascular Diseases in the Duke University Department of Medicine, was co-principal investigator of the Clinical Coordinating Center. Michael T. Lu, M.D., co-director of the Massachusetts General Hospital Cardiovascular Imaging Research Center, and Heather Ribaudo, Ph.D., a principal research scientist at the Center for Biostatistics in AIDS Research and the Department of Biostatistics at Harvard University, served as leads of the REPRIEVE study’s Data Coordinating Center. The study was conducted by the NIAID-funded ACTG. Additional implementation support was provided by the London-based NEAT ID Foundation, Kowa Pharmaceuticals America, Inc., Gilead Sciences, Inc. and Viiv Healthcare.
