Carolyn Elley

Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care

Objective To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care. Design Open label randomised control trial: IMPACT (IMProving Adherence using Combination Therapy). Setting 54 general practices in the Auckland and Waikato regions of New Zealand, July 2010 to August 2013. Participants 513 adults (including 257 indigenous Māori) at high risk of cardiovascular disease (established cardiovascular disease or five year risk ≥15%) who were recommended for treatment with antiplatelet, statin, and two or more blood pressure lowering drugs. 497 (97%) completed 12 months’ follow-up. Interventions Participants were randomised to continued usual care or to fixed dose combination treatment (with two versions available: aspirin 75 mg, simvastatin 40 mg, and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg). All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists. Main outcome measures Primary outcomes were self reported adherence to recommended drugs (antiplatelet, statin, and two or more blood pressure lowering agents) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months. Results Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months (81% v 46%; relative risk 1.75, 95% confidence interval 1.52 to 2.03, P<0.001; number needed to treat 2.9, 95% confidence interval 2.3 to 3.7). Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group: for antiplatelet treatment it was 93% fixed dose combination v 83% usual care (P<0.001), for statin 94% v 89% (P=0.06), for combination blood pressure lowering 89% v 59% (P<0.001), and for any blood pressure lowering 96% v 91% (P=0.02). Self reported adherence was highly concordant with dispensing data (dispensing of all four recommended drugs 79% fixed dose combination v 47% usual care, relative risk 1.67, 95% confidence interval 1.44 to 1.93, P<0.001). There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months: the difference in systolic blood pressure was −2.2 mm Hg (−4.5 v −2.3, 95% confidence interval −5.6 to 1.2, P=0.21), in diastolic blood pressure −1.2 mm Hg (−2.1 v −0.9, −3.2 to 0.8, P=0.22) and in low density lipoprotein cholesterol −0.05 mmol/L (−0.20 v −0.15, −0.17 to 0.08, P=0.46). The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups (fixed dose combination 16 v usual care 18 (P=0.73), 99 v 93 (P=0.56), respectively). Fixed dose combination treatment was discontinued in 94 participants (37%). The most commonly reported reason for discontinuation was a side effect (54/75, 72%). Overall, 89% (227/256) of fixed dose combination participants’ general practitioners completed a post-trial survey, and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment (206/227, 91%), blood pressure control (180/220, 82%), cholesterol control (170/218, 78%), tolerability (181/223, 81%), and prescribing according to local guidelines (185/219, 84%). When participants were asked at 12 months how easy they found taking their prescribed drugs, most responded very easy or easy (224/246, 91% fixed dose combination v 212/246, 86% usual care, P=0.09). At 12 months the change in other lipid fractions, difference in EuroQol-5D, and difference in barriers to adherence did not differ significantly between the treatment groups. Conclusions Among this well treated primary care population, fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance. Acceptability was high for both general practitioners and patients, although the discontinuation rate was high. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Glycated haemoglobin and cardiovascular outcomes in people with Type 2 diabetes: a large prospective cohort study

Aims  To investigate the association between long‐term glycaemic control, measured by glycated haemoglobin (HbA1c), and time to first cardiovascular disease (CVD) event for people with Type 2 diabetes in New Zealand.

The assessment and management of insomnia in primary care

#### Summary points Insomnia affects about a third of the general population according to a recent longitudinal study in the UK1 and cross sectional studies estimate the prevalence in patients attending primary care to be between 10% and 50%.2 3 According to the American Sleep Disorders Association International Classification of Sleep Disorders coding manual, insomnia refers to “a repeated difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment and lasting for at least one month.”4 Although some patients who have this problem may not report it as such, inadequate sleep has been associated with reduced physical health3 4 5 6 and mental health.7 8 9 The continued widespread use of sedative medication to treat insomnia raises concern about the potential for long term tolerance and addiction, particularly where insomnia is the presenting complaint of missed diagnoses such as depression, or when adverse effects might be a problem—for example, falls in older adults.10 11 12 The normal range of sleep is seven to nine hours per night,13 although some individuals claim they can function on as little as four hours, whereas others need up to …

Cost-effectiveness of exercise on prescription with telephone support among women in general practice over 2 years

Aim To assess the cost-effectiveness of exercise on prescription with ongoing support in general practice. Methods Prospective cost-effectiveness study undertaken as part of the 2-year Womens lifestyle study randomised controlled trial involving 1089 ‘less-active’ women aged 40–74. The ‘enhanced Green Prescription’ intervention included written exercise prescription and brief advice from a primary care nurse, face-to-face follow-up at 6 months, and 9 months of telephone support. The primary outcome was incremental cost of moving one ‘less-active’ person into the ‘active’ category over 24 months. Direct costs of programme delivery were recorded. Other (indirect) costs covered in the analyses included participant costs of exercise, costs of primary and secondary healthcare utilisation, allied health therapies and time off work (lost productivity). Cost–effectiveness ratios were calculated with and without including indirect costs. Results Follow-up rates were 93% at 12 months and 89% at 24 months. Significant improvements in physical activity were found at 12 and 24 months (p<0.01). The exercise programme cost was New Zealand dollars (NZ

An association between ethnicity and cardiovascular outcomes for people with Type 2 diabetes in New Zealand

) 93.68 (€45.90) per participant. There was no significant difference in indirect costs over the course of the trial between the two groups (rate ratios: 0.99 (95% CI 0.81 to 1.2) at 12 months and 1.01 (95% CI 0.83 to 1.23) at 24 months, p=0.9). Cost–effectiveness ratios using programme costs were NZ

Ethnicity and risk of lower limb amputation in people with Type 2 diabetes: a prospective cohort study

687 (€331) per person made ‘active’ and sustained at 12 months and NZ

Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trial

1407 (€678) per person made ‘active’ and sustained at 24 months. Conclusions This nurse-delivered programme with ongoing support is very cost-effective and compares favourably with other primary care and community-based physical activity interventions internationally.

Wāhine hauora: linking local hospital and national health information datasets to explore maternal risk factors and obstetric outcomes of New Zealand Māori and non-Māori women in relation to infant respiratory admissions and timely immunisations

Aims  To investigate the association between ethnicity and risk of first cardiovascular (CV) event for people with Type 2 diabetes in New Zealand.

Should we prescribe diuretics for patients with prediabetes and hypertension

Lower limb amputation is a serious complication of diabetic foot disease and there are unexplained ethnic variations in incidence. This study investigates the risk of amputation among different ethnic groups after adjusting for demographic, socio‐economic status and clinical variables.

Exploring the perceptions of patients and health professionals of asthma education and rehabilitation management in New Zealand

IntroductionMāori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a “polypill”) improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this.MethodsExperienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-sampling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished.ResultsA total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per month. Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment. Differences between randomized Māori and non-Māori were evident (e.g. Maori were less likely to have established coronary artery disease).ConclusionsRecruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported.Trial registrationThe trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572