Adherence: a major unmet need. CV Success Zone programme
Novartis Cardiovascular & Metabolism, Basel, Switzerland
Corresponding author. E-mail address: john.glasspool{at}novartis.com
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Abstract |
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 Top Abstract IntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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There are a number of reasons for the relative lack of control of cardiovascular (CV) risk world-wide. Recent research on the status of blood pressure (BP) control indicates that one major factor behind the stubbornly high rates of hypertension is insufficient information exchange between physicians and patients. Well-informed patients who are actively involved in their treatments will be better motivated to take drugs and implement life-style changes than those less well informed. The task of facilitiating communications is a huge undertaking that needs the active involvement at all levels of health-care provision. Using its knowledge and experiences of disease and its long-standing relationships with physicians, industry is in a position to contribute significantly to this process in a partnership with all stakeholders. The current review discusses how such educational partnership initiatives, exemplified by the ongoing Novartis CV Success Zone programme, can be used to increase the awareness of target levels, life-style measures, and treatments, among physicians as well as patients. This increase in the level of knowledge at all levels was shown to be associated with higher BP control rates. The continually developing CV Success Zone programme provides experiences that can be implemented in future partnerships between stakeholders in healthcare.
Key Words: Compliance • Pharmacotherapy • Hypertension • Communication
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Introduction |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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Cardiovascular (CV) disease is one of the best-known and least contained major killers in the world. The need for population control of CV disease was recognized by the Council of the European Union in a Resolution on CV Diseases on 2 June 1994.1 But it is still so insufficiently contained that every year millions die and suffer from disabilities of CV origin. In Europe, CV disease is responsible for more than 50% of deaths in people aged 65–74.2 Solving this healthcare problem is clearly beyond the ability of any single player. A concerted effort is needed from all stakeholders in the health of modern society.
Measures to reduce morbidity and mortality from CV causes need to target a variety of risk and disease factors: hypertension, dyslipidaemia, and type 2 diabetes are only a few among them. Since the problems associated with reducing risk and some of the possible solutions available are similar for several of these risk factors and diseases, this review will focus on hypertension.
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The role of antihypertensive drugs |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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Hypertension is a multifactorial problem and this is reflected in the variety of actions and tools needed to reduce blood pressure (BP) and the associated CV risk. It is recognized that successful treatment of hypertension frequently needs a combination of life-style changes and pharmacotherapy.3 As discussed in other contributions to the current supplement, life-style changes are difficult to implement, particularly long-term. In most cases, increased exercise, reduced salt intake, etc. will need to be supplemented with an antihypertensive drug regimen to be effective. Similarly, the effects of medication will be greater if combined with life-style changes; there is no magic bullet against hypertension.
Combining two or three drugs will achieve corresponding additive effects and with some antihypertensive combinations there is potential for synergistic effects, making one plus one greater than two.4 The current development trend is towards powerful, well tolerated, and convenient fixed-dose combinations of existing compounds, such as angiotensin-receptor blockers combined with calcium-channel blockers. These developments are welcome and will add to the spectrum of drugs, making it possible to target patient types more accurately with the most suitable medication. Few new drug classes will be launched in the next several years; the most notable new development is the class of direct renin inhibitors, of which the first example, aliskiren, will be launched starting in 2007.
However, in addition to new and improved antihypertensive agents and combinations which will be improvements over what is currently available, we need to use the tools we already have at our disposal more effectively. Doses are frequently suboptimal and, more importantly, treatment regimens are very often not followed.
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Poor adherence and its consequences |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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The analysis of medication-taking behaviour is a complex science and there are a number of terms, sometimes used indiscriminatingly, which can cause confusion. In the current discussion, the term ‘adherence’ will be used to signify sticking to a drug regimen over time although adherent patients may occasionally miss a dose. The term ‘compliance’ will be used to indicate the close following of prescriptions, with only minimal deviations from daily drug regimens. Thus, patients can be adherent but non-compliant if they take their medications somewhat irregularly but persistently over years.
Whatever the term, and here I will use both, it is clear that ‘poor compliance with treatment is one of the most important cause of uncontrolled BP world-wide’.5 A large percentage of hypertensive individuals stop taking their medications altogether within a year of starting therapy and this lack of compliance is a contributing factor to the high BP in two-thirds of inadequately controlled patients with hypertension.6 Conversely, increased compliance/adherence has been shown to be strongly associated with improved BP control rates: a recent study showed that 75% of compliant patients have their BP controlled, compared with only 10% of non-compliant patients.7
This failure to remain on regular treatment has severe consequences. It leads to extra medical consultations with associated costs and drain on resources. It may cause an inappropriate escalation in drug treatment when physicians attempt to reduce BP by adding drugs or increasing doses, although the initial regimen might have been sufficient to control BP had the patient taken the medications as indicated. Insufficiently controlled BP increases clinical risk and morbidity and mortality and the associated decrease in productivity has been calculated to cause an average loss of 3.5 work days per employee per year.8 It has been estimated that poorly compliant patients in the US incur an additional annual cost of US $873 per patient (1989 values).9
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The blame game |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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Physicians are often criticized for not taking hypertension seriously and for prescribing timid dosages and too much monotherapy, instead of adequately dosed combination regimens.3 The term ‘clinical inertia’ has been coined to describe a situation in which the physician recognizes that there is a problem, but fails to act. One reason may be the fear of side effects, real or imagined, although modern antihypertensive medications are overall very well tolerated. While there is agreement that inertia should be reduced, no drug regimen, however effective in the controlled circumstances of clinical trials, will bring a patient's BP under control if the patient does not adhere to therapy.
To address the problem of adherence, it is necessary to assess what factors lead to non-adherence with therapies. One reason for low compliance rates is complexity; not only do most patients need polypharmacy to control hypertension,3 but CV risk factors frequently cluster. Thus, the total pill burden from antihypertensive, lipid-lowering, and other drugs can become very large. Insufficient awareness (both among practitioners and among patients) of the risk from hypertension can play a role, as can insufficient patient involvement in treatment decisions and implementations. Educating and empowering patients have long been recognized as a beneficial measure.10 Whatever the reason, it is as simplistic to blame the patient for non-adherence as it is to blame the physician for the lack of success of therapeutic regimens. The experiences discussed below strongly suggest that the way forward lies in improving the communication between all stakeholders, particularly between patients and physicians, to maximize the awareness of CV risks, of appropriate treatment targets, and of strategies to achieve these. Patients do not get into the healthy CV success zone without support and doctors need to know and communicate the patients’ needs beyond that of pills.
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Communication gaps |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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An illustration of the communication gap between physicians and patients was provided by a survey of physician and patient perceptions conducted by Novartis in 2005 (Novartis, data on file). The 551 physicians surveyed reported that 60% of their patients were at target BP (defined as 140/90 mmHg or less). However, when the patients themselves were asked about their BP, only 25% reported levels within the controlled range. Not even when the term ‘goal’ was interpreted generously, as meaning either systolic or diastolic BP but not necessarily both, did patient-reported control rates reach the 60% reported by their doctors.
This does not mean that physicians are not talking to patients, but it seems patients are not hearing the same messages as physicians believe they are communicating. In the survey, 76% of physicians asked reported that they inform patients about healthy BP target rates, but when the patients were asked, only 52% were aware of their BP targets. Similarly, around 80% of physicians told the researchers that they inform their patients about the CV risk from hypertension, but only half of patients reported being informed about such risks as stroke, atherosclerosis, myocardial infarction, and diabetes or renal failure (Figure 1). In contrast, the survey found that more patients than doctors were complacent with BP, viewing it as a normal consequence of ageing.
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Such lack of recognition of the benefits from controlling hypertension among people with high BP, combined with a lack of adequately communicated information by physicians about the condition and how it can be treated, are two major factors behind low compliance rates. Thus, one of the key tasks in reducing CV risk is to increase the efficiency of information sharing to in order increase compliance and by extension increase rates of BP control.7 In order to do this, it is necessary to work with physicians, nurses, and their patients.
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How can industry contribute? |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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The pharmaceutical industry is sometimes narrowly associated with the research and development of medications to treat specific conditions. This activity is of course the raison d'etre for drug companies. In CV disease, the development of BP-lowering drugs has been identified as one of the major pharmaceutical successes in the last half-century.11 It has been calculated that without antihypertensive therapy, average BPs would be 10–12% higher for US men and women.12 However, with the changing thinking about CV risk, the role for the pharmaceutical industry is changing and widening. As an industry that works closely with doctors, there is the potential to take the experiences and relationships beyond developing and informing about drugs, towards helping doctors with providing risk reduction for patients, in a partnership with all stakeholders. Novartis is currently implementing such a programme in a number of countries world-wide. The aim of this hypertension programme is to establish a mutually beneficial partnership with all forces involved in health care: information exchange and support networks are being set up with physicians as well as with nurses and pharmacies. The roles of these professionals vary between countries; for example, nurses may be empowered to prescribe drugs in certain countries and roles of pharmacies are very different in different societies. Thus, the individual structures of the partnerships will vary locally.
But whatever the local differences, the aim of the hypertension programme is the same globally: to bring as many hypertensive individuals into the ‘healthy zone’ of between 140/80 and 120/80 mmHg or below. The first experiences from this programme have been positive with some quite interesting lessons for the future.
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The CV Success Zone programme |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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The patient-target part of the ‘CV Success Zone’ initiative, comprises patient-education and motivational programmes and tools in a continual dialogue, as well as support for medical professionals through direct mail, e-mail, internet, and other lines of communication. Depending on legal requirements in different countries, the content and media will vary, but the aim is for the communication to be individualized, as much as possible according to the audience's relevant characteristics. Examples of materials directed at patients include customized patient-education brochures highlighting the need to treat hypertension and the potential consequences of the disease, information on potential lifestyle changes that may be implemented to reduce potential CV risk, and motivational tools to help patients get into the healthy CV zone and motivate them to stay there. Examples of such tools are BP monitors, BP diaries, and educational websites to facilitate interactions and information sharing. At the time of writing in late 2006, programmes are being conducted in countries throughout the Americas, Europe, and Asia, and as this is a world-wide effort, the number is continuously increasing.
A key characteristic of the CV Success Zone is the continual nature of the programme, with follow-up activities and updates of available materials. This aspect is crucial for keeping patients (and their physicians) motivated and improving adherence with the life-long medication regimens needed to control hypertension.
The initial results from the CV Success Zone programme have yielded some interesting insights. Surveys of patients in the USA (Novartis, data on file) have shown that the satisfaction with the individualized, continual support materials is greater than with financially based initiatives such as free drug trials, discounts on prescription drugs, and similar activities (Figure 2). It can of course be argued that these are data from a rich country and that cost would have a greater influence on adherence in poorer countries, but experience so far does not appear to bear this out. Adherence data since June 2005 from Brazil, where drugs are frequently paid for out of pocket, indicate that education programmes, through mailings and telephone contacts, have a greater positive impact on adherence than pricing incentives such as discount programmes, which link adherence to a discount on the cost of medication. Interestingly, a flat discount on the drug price had the worst outcome in terms of adherence, suggesting that price of medication is not the major factor determining adherence. Although these are preliminary findings, they may provide useful insights for policy makers. Also from Brazil, the programme had enrolled more than 85 000 individuals by September 2006. Initial signs across programs within South America show that mean treatment time is substantially increased with the addition of the programme: a mean of 4.5 months with the programme compared with a mean of 3.0 months without it.
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A problem encountered by all awareness programmes is how to compete with the overwhelming amount of information the general public encounters daily in today's media-dominated world. However, experiences from Turkey show that it is possible to penetrate the wall of background noise. In 2006, the Turkish Society of Cardiology, with support from Novartis, launched an awareness-raising programme ‘12/8’, a simplification of 120/80 aimed at both physicians and patients. To achieve a broad reach, the campaign made use of print media and television and tied in with the celebration of the World Hypertension Day with a press conference and special interviews in mass media.
After two months of the 12/8 campaign, the number of patients who knew the BP target levels was increased by 79%. This was from a low baseline of only 19% of surveyed patients, but the success in such a short time span demonstrates what can be done if patients and physicians have access to adequately presented medical information.
Direct-to-consumer advertizing is a contentious subject in many countries and it is imperative that the pharmaceutical industry work closely and openly with medical societies on any awareness programme. The Turkish experiences set an encouraging example of how this can be done.
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The awards from improving adherence |
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TopAbstractIntroductionThe role of antihypertensive...Poor adherence and its...The blame gameCommunication gapsHow can industry contribute?The CV Success Zone...The awards from improving...References |
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This short overview has tried to show that concerted efforts involving all stakeholders, targeted at improving the dialogue and information exchange between patients and physicians, can have substantial beneficial effects on compliance with pharmacotherapy for hypertension. The positive experiences from the first phase of the Novartis CV Success Zone programme indicate that well-informed patients who are actively involved in their treatments will be better motivated to take drugs and implement life-style changes than those less well informed.
The benefits to patients and society from improved adherence to medication cannot be overstated. Ogden et al.13 have calculated that a 12 mmHg reduction in systolic BP over 10 years would lead to the prevention of one in 27 CV deaths, one in 16 all-cause deaths, and one in 11 CV events. A back-of-the-envelope calculation might put such numbers in perspective for the average general physician:
An average primary care physician can be assumed to have 3000 patients, one in four of whom is hypertensive. Of those 750 patients, 70% or 525 individuals are not controlled. If BP control could be achieved in those patients, this would save two CV deaths, three all-cause deaths, and five CV events every year, in each average physician's practice.
These are impressive numbers for any medical activity and they need no expensive equipment or hospital resources. Instead, the gains can be achieved by information, co-operation between all partners in the provision of health care, and by the judicial, personalized use of drugs and life-style measures.
Perhaps it is time to discard the implied dichotomy between ‘pharmacotherapy’ and ‘life style measures’. A patient at high CV risk, but with an active interest in his or her well-being, will probably view diet, exercise, and medication as integral parts of the ‘package’ of a healthy life style. There is no reason why one part of such a package should be approached with a different mindset than any other part and the difficulties with adherence, as well as the beneficial effects of awareness and information, are likely to be similar for all measures.
We are living in the information age, where everything is linked. CV health rests on information. But the linking up still has some way to go. A comprehensive program such as the CV Success Zone can clearly help the communication and connectivity needed.
Conflict of interest: J.G. is an employee of Novartis.
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  A. Rieder Getting into a healthy `CV success zone': effective strategies to prevent CVD Eur. Heart J. Suppl., May 1, 2007; 9(suppl_B): B4 - B7. [Full Text] [PDF]
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