Red Heart Pill

Published

dm+d

Unassigned

New Medicines

Cardiovascular disease

Information

New formulation
Dr Reddys Laboratories
Dr Reddys Laboratories

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
01. Jan 16; No recent reports of development identified, and not listed in Dr Reddys development streams [6].

Category

Two versions of the red heart pill have been investigated in clinical trials: Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide
In England 2013/14 there were 1.4 million hospital episodes for CVD, including 197,000 inpatient episodes for stroke, 146,000 for acute MI, 137,000 for HF, and 101,000 cases of angina. In 2014, there were 127,000 deaths from CVD in England [5].
Cardiovascular disease
Oral

Trial or other data

01. May 10: The two-year UMPIRE (Use of a Multidrug Pill in Reducing cardiovascular Events) trial of the new fixed-dose Red Heart Pill is underway in the UK and three other countries. International phase III trial will assess whether a low-cost, once-daily polypill can reduce the risks of heart attacks, strokes and other cardiovascular conditions. Parallel trials were launched earlier this year in New Zealand and Australia, and there are plans for further studies in other countries. These trials will involve some 7000 patients in 10 countries. The target population for the UMPIRE study is around 1000 adults with established cardiovascular disease (CVD) or a high CVD risk. Patients will receive either their usual individual cardiovascular medicines, or one of the two versions of the Pill: (1) Version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg [mainly for pts with history of coronary heart disease] OR(2) Version 2: aspirin 50mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide [mainly for pts with history of stroke or cerebrovascular disease]. The primary outcome measures are adherence to medication, changes in blood pressure and changes in total cholesterol. Trial scheduled to complete in Jan 2013. (1)
02. June 11: RCT in 378 patients (Australia (n = 21), Brazil (n = 8), India (n = 109), Netherlands (n = 102), New Zealand (n = 12), United Kingdom (n = 113) and United States (n = 13)). At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to 12.1) mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9) mmol/L. The discontinuation rates in the polypill group compared to placebo were 23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00, p = 0.2). There was an excess of side effects known to the component medicines (58% vs 42%, p = 0.001), which was mostly apparent within a few weeks, and usually did not warrant cessation of trial treatment. [2]
03. The SPACE group includes collaborators conducting or planning a series of clinical trials of a polypill strategy for cardiovascular disease prevention. The polypill being evaluated in these trials is the Red Heart Pill made by Dr Reddy’s Laboratories (Hyderabad, India) [3].
04. May 14: Three trials have either completed or are close to completion: The IMPACT trial in New Zealand (funded by the New Zealand Health Research Council) has completed recruitment of 513 participants from both Maori and non-Maori populations and is awaiting publication of results; The UMPIRE (funded by the European Commission´s Seventh Framework Programme – 1004 participants in Europe (UK, Ireland and The Netherlands), 1000 patients in India) is complete; The Kanyini-GAP trial in Australia (funded by the National Health and Medical Research Council, 623 patients from both indigenous and non-indigenous populations) has completed and is awaiting publication of results; Funding from the Brazilian government´s Ministry of Health has been secured by the Hospital do Coracao Sao Paulo to recruit 2000 patients. This trial is currently on hold awaiting trial supply [3].
05. May 14: In order to review key issues regarding regulatory approval, and other major issues such as cost-effectiveness, implementation and research priorities, the SPACE group convened the 2nd Cardiovascular Combination Pharmacotherapy Global Summit, in Melbourne, Australia on May 8th, 2014 [4].