A small but clinically important trial of a new ultra-low dose four-in-one pill to treat high blood pressure is said to have produced remarkable results. Every patient on the pilot trial conducted by The George Institute for Global Health saw their blood levels drop to normal levels in just four weeks. The four medicines used in the pill are already in use.
Recognizing the need to check whether trial results were Ã¢ÂÂtoo good to be trueÃ¢ÂÂ, the researchers also completed a systematic review of past trials, including 36 trials with 47,500 patients testing single and dual quarter-dose therapy. This previous evidence also indicated little or no side effects with very low doses, and important benefits with three or four drug combinations.
According to Prof Clara Chow of the George Institute the results, published in The Lancet, were exciting but larger trials were still needed to see if these high rates could be maintained and repeated. Hypertension or high blood pressure affects about 119 million adults in India.
Ã¢ÂÂMost people receive one medicine at a normal dose but that only controls blood pressure about half the time. In this small trial blood pressure control was achieved for everyone. Trials will now test whether this can be repeated and maintained long-term. Ã¢ÂÂMinimising side effects is important for long-term treatments Ã¢ÂÂ we didnÃ¢ÂÂt see any issues in this trial, as you would hope with very low dose therapy, but this is the area where more long-term research is most needed.
Ã¢ÂÂWe know that high blood pressure is a precursor to stroke, diabetes and heart attack. The need for even lower blood pressure levels has been widely accepted in the last few years. So, this could be an incredibly important step in helping to reduce the burden of disease globally,Ã¢ÂÂÃ¢ÂÂ Prof Clara said.
Over four weeks 18 patients in Sydney were either given a quadpill Ã¢ÂÂ a single capsule containing four of the most commonly used blood pressure-lowering drugs each at a quarter dose Ã¢ÂÂ or a placebo. This was then repeated for a further four weeks with the patients swapping their course of treatment. Blood pressure levels were measured hourly over a 24-hour period at the end of each treatment, allowing researchers to significantly reduce the number of patients normally required in a clinical trial.
During trials 100 per cent of patients saw their blood levels drop below 140 over 90. Just 33 per cent of patients on the placebo achieved this rate. Also, none of the patients experienced side effects commonly associated with hypertension lowering drugs, which can vary from swollen ankles to kidney abnormalities depending on the type of class of the drug, the researchers have claimed.
Professor Chow said: Ã¢ÂÂWhat makes these result every more exciting is that these four blood pressure medications are already in use. We are increasingly finding there are opportunities to treat many commons diseases hiding in plain sight. This ultimately means we will be able to deliver life changing medications much more quickly, and more affordably.Ã¢ÂÂ
Researchers at the George Institute are just about to commence a much larger trial into the “”quadpill”” which has been funded by the National Health and Medical Research Council of Australia.The project was funded by The National Heart Foundation of Australia and the University of Sydney. The project was started in January 2016 with an aim to investigate in a double blind randomised controlled trial whether initiating treatment with ultra-low dose quadruple combination therapy will low blood pressure more effective.
The George Institute India partners with over sixty national and international institutions such as the Public Health Foundation of India, the Postgraduate Institute of Medical Education and Research, University of Hyderabad; and affiliations with University of Sydney, Oxford and Peking.”