Caught in the vice-like grip of COVID-19, what has been on the minds of everyone in Sri Lanka in the past two years has been the new coronavirus. But scientific studies begun before the pandemic hit Sri Lanka in March 2020, have now come under the spotlight with immense benefit for those facing the danger [...]

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A simple Triple Pill to control high blood pressure and prevent death

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Caught in the vice-like grip of COVID-19, what has been on the minds of everyone in Sri Lanka in the past two years has been the new coronavirus.

But scientific studies begun before the pandemic hit Sri Lanka in March 2020, have now come under the spotlight with immense benefit for those facing the danger of the silent killer that is uncontrolled hypertension, simply known as ‘high blood pressure’ (HBP).

Prof. Asita de Silva

Not only has the study team’s findings been picked up by the top peer-reviewed scientific journal ‘Nature Medicine’ based in Britain but a bugle call has been sounded for a global shift in the management and treatment of HBP.

It is all about the ‘Triple Pill’ for HBP rather than the usual trial-and-error care of trying this drug or that and this dose or that, the Sunday Times understands.

The study findings provide a strong rationale for considering initial or early use of a ‘fixed-dose combination therapy’ for the treatment of mild-to-moderate-HBP, says Prof. Asita de Silva of the Faculty of Medicine, University of Kelaniya.

The findings are based on a 2018 clinical trial involving 700 patients with HBP conducted at several hospitals including the National Hospital of Sri Lanka (NHSL), Colombo; the Kandy National Hospital; the Colombo North (Ragama) and Colombo South (Kalubowila) Teaching Hospitals and the Sri Jayewardenepura General Hospital, Kotte.

It had been coordinated by the University of Kelaniya under the guidance of Prof. de Silva and held in collaboration with the George Institute for Global Health part of the Global Alliance for Chronic Disease (GACD). The GACD brings under one umbrella major international research funding agencies to address the growing burden of non-communicable diseases (NCDs) in low and middle-income countries.

The Sunday Times understands that as a follow-up of the 2018 trial in Sri Lanka, a large multi-centre study with thousands of participants is ongoing worldwide including in Australia, the United States of America and Sri Lanka.

Sri Lanka’s earlier trial had shown that the new combination therapy in a single pill or the Triple Pill revolutionized HBP treatment. Patients who were part of the trial had been randomly assigned to either receive the combination pill or the so-called ‘usual’ care.

The Triple Pill contains three commonly used HBP lowering drugs at half their standard doses. These drugs are telmisartan, amlodipine and chlorthalidone.

“The trial showed better blood pressure control in a shorter time and for a longer duration with the Triple Pill,” says Prof. de Silva, explaining that “targets” were achieved in controlling HBP, which is a killer.

Getting down to specifics, he says that the trial had found that:

n  A ‘significantly’ higher proportion of patients receiving the Triple Pill achieved their target blood pressure compared to those receiving usual care.

n  7 of 10 patients treated with the Triple Pill reached blood pressure targets, compared to just about half receiving usual care.

n  Initiating treatment with the Triple Pill was more effective at controlling HBP rather than the current practice of starting with one medication and increasing the number and dose of blood pressure lowering medicines incrementally over a long period of time.

n  Those who were given the Triple Pill also achieved their BP targets faster (in a shorter time) than those who were given the usual treatment.

With these ‘revealing’ results, the study team also reiterated that such a low-dose combination therapy in a single pill could be prescribed at primary care level as Sri Lanka has a very strong system at the grassroots. Then it would ensure better adherence to treatment.

The results of this study had first been published in the Journal of the American Medical Association (JAMA) in 2019, followed by these findings being picked up by ‘Nature Medicine’. This journal had invited Prof. de Silva to write an editorial on the matter in collaboration with colleagues from the George Institute for Global Health, a medical research institute headquartered in Australia.

Prof. de Silva and his co-authors have pointed out that the “sheer scale” of the number of under-treated people with HBP should open the world’s eyes to the need for new approaches to this major public health problem.

Earlier, over the past 7-8 years, clinical trials in countries across the economic spectrum had shown significant improvements in reducing the risk of cardiovascular disease (CVD) including controlling HBP, with drug combinations offered as a single pill – ‘polypills’– compared to usual care. Polypills are two or three medicines in a single pill.

Since this concept had been discussed many years before there has been substantial activity relating to its development, research and advocacy. However, as Prof. de Silva and his co-authors point out the scaling up of this treatment approach has remained “elusive”.

But the World Health Organization (WHO) has listed dual-combination BP lowering drugs for initial treatment of HBP in its Model List of Essential Medicines in 2019. This has been followed more recently by a matching recommendation in the updated WHO hypertension guidelines and this is “very encouraging”, says Prof de Silva.

He points out that with the World Heart Federation setting an “ambitious” goal that by 2025 there should be a 25% reduction in HBP levels globally, the Triple Pill could be a low-cost and safe way of helping countries including Sri Lanka to meet this target.

While urging a global shift in treatment guidelines and solutions and spreading the message among doctors and policymakers on the full potential of the Triple Pill, Prof. de Silva adds that it will save people from avoidable premature death due to poorly-controlled HBP. “It’s doable.”

Single, once-a-day, low-cost pill;

Here are the specific advantages of the Triple Pill for HBP:

  • Simplifying treatment to provide all necessary generic components in a single, once-a-day, low-cost pill.
  • Currently, patients once diagnosed with HBP are put on separate medicines. Then their doctors monitor the blood pressure usually once a month. This is a recipe for under-treatment.
  • For underprivileged people, many visits to doctors or hospitals and out-of-pocket expenses cause a treatment gap.

COBRA came before 

These latest findings on the Triple Pill are built on a firm foundation of extensive interventions carried out using primary healthcare workers to improve blood pressure (BP) control in rural communities.

The Control of Blood Pressure and Risk Attenuation – Bangladesh, Pakistan, Sri Lanka (COBRA-BPS), was a community-based three-year research study conducted by the Faculty of Medicine, University of Kelaniya, in collaboration with centres of excellence in Pakistan and Bangladesh.

The study focused on the efficacy of an intervention delivered door-to-door by trained public health midwives to improve BP control in rural Puttalam.

The results that a low-cost, intervention comprising home visits by community healthcare workers to monitor BP and provide lifestyle coaching, coupled with physician training and coordination with existing public health care were published in the prestigious New England Journal of Medicine.

The Sunday Times on October 14, 2018, in an exclusive piece headlined ‘A closer look at COBRA’ reported this study.


 

Chilling data In Sri Lanka:

  • The prevalence of HBP in adults in Sri Lanka is estimated to be between 20-25%.
  •  It is only in about 1/3rd of the known persons with HBP is this condition controlled.
  • The problem is particularly bad in rural communities, where 1 in 4 adults is estimated to suffer from HBP.
  • Studies in different communities in South Asia including Sri Lanka suggest an “alarmingly” high prevalence exceeding 60% of inadequate HBP control.

Across the world:

  • Cardiovascular diseases (CVDs) are the biggest killers worldwide – around 18 million people die per year globally. High blood pressure (HBP) is the leading attributable risk factor for CVD and premature death globally.
  • Of these 18 million deaths, 70% are in low- and middle-income countries (LMICs).
  • Around 20% of all these 18 million deaths are estimated to be attributable to non-optimal BP which means that the BP is not at the best possible level.

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