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Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature.

ABSTRACT: OBJECTIVE:The 2018 European Society of Cardiology/European Society of Hypertension Guidelines for the management of arterial hypertension raised the need for evidence to support the use of single-pill combination (SPC) therapy in preference to free-dosed therapy for hypertension. This systematic rapid evidence assessment sought to determine if initiating SPC therapy improves adherence, blood pressure (BP) control and/or cardiovascular outcomes vs. initiation of free-dose combination therapy. METHODS:Rapid evidence assessment conducted in MEDLINE, EMBASE, and Cochrane Library (1 January 2013-11 January 2019) to identify studies investigating SPC therapy for adults with hypertension. Information on adherence/persistence, BP lowering/goal attainment, and cardiovascular outcomes/events were extracted via two-phase screening process. Studies not focusing on adherence, persistence, or compliance with SPC therapy were excluded. Methodological quality was assessed using appropriate scales. RESULTS:Of 863 citations, 752 failed to meet inclusion or were duplicates. Twenty-nine studies remained following full-text screening. Just four studies (14%) were randomized controlled studies; 25 (86%) were observational. A range of SPC therapies were studied, with calcium channel blocker/angiotensin receptor blocker combinations most common (11/29 studies). Adherence and persistence were generally higher with SPC vs. free-dose combination therapy; 15 studies (54%) directly compared adherence and four (14%) compared persistence. Patients achieving BP targets ranged from 25 to 89%. Despite all studies investigating patients with hypertension only 16 (55%) reported change in BP. Few studies reported on cardiovascular outcomes. Methodological reporting was often suboptimal. CONCLUSION:Adherence and/or persistence were generally higher in patients taking antihypertensives as SPC vs. free-dose combination; however, methodological reporting was suboptimal to facilitate comparison. Specifically designed, well reported studies are required to determine if the increased adherence/persistence seen in patients on SPC regimen leads to improved BP control and/or cardiovascular outcomes.

SUBMITTER: Tsioufis K

PROVIDER: S-EPMC7253190 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature.

Tsioufis Konstantinos K Kreutz Reinhold R Sykara Georgia G van Vugt Joris J Hassan Tarek T

Journal of hypertension 20200601 6

<h4>Objective</h4>The 2018 European Society of Cardiology/European Society of Hypertension Guidelines for the management of arterial hypertension raised the need for evidence to support the use of single-pill combination (SPC) therapy in preference to free-dosed therapy for hypertension. This systematic rapid evidence assessment sought to determine if initiating SPC therapy improves adherence, blood pressure (BP) control and/or cardiovascular outcomes vs. initiation of free-dose combination ther ...[more]

PMID: 32371789

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Project description:Background and aimsOver the last decade, regulators have taken significant steps towards tackling perceptions that regulatory systems are burdensome. There has been much international research activity in the regulation of health and care professionals. This article reports a review of studies on health professions regulation between January 2011 and March 2020. Its chief object was to provide robust and up-to-date evidence to assist regulators in policy development and implementation. The main objectives of this study were to: 1. Identify and retrieve research in the field of health and care professions regulation in English since 2011; 2. Evaluate the published research, exploring its utility to regulators and practitioners, and drawing out any key messages; 3. Draw conclusions concerning the scope and limitations of the research literature and identify areas for further research.MethodsWe undertook a rapid evidence assessment (REA) of the international literature on health and care professions regulation, including reviewing ten UK regulators' websites to identify issues of concern and strategic priorities. We retrieved 3833 references, using a four-stage screening process to select the 81 most relevant.ResultsResults are reported within six key themes: harm prevention and patient safety; fitness to practise; quality assurance of education and training; registration including maintenance of registers; guidelines and standards and relations with regulatory bodies.ConclusionsRegulation of professionals in health and care is comparatively undeveloped as a field of academic study. Consequently, the published evidence is diffuse and small-scale. Most work presents relatively weak data of low relevance to regulators, mainly reporting or describing the current position. Few studies are able to show the impact of regulation or demonstrate a causal link between regulation and its effects. To inform their research and policy agendas health and social care regulators need to commission, interpret and apply the scholarly literature more effectively; academics need to engage with regulators to ensure that their research provides high-quality evidence with practical relevance to the regulators' agendas. Further study is needed to explore how effective academic collaborations between regulators and researchers may be created and sustained.

Project description:BackgroundMedication adherence plays an essential role in controlling blood pressure to reduce morbidity and mortality of hypertension disease. Thus, this study aimed to determine the association of medication adherence measured by self-reported pill count with blood pressure levels among patients at several community health centers in Surabaya.MethodsAdherence was assessed using the pill count method by comparing the total number of antihypertension drugs taken with the prescribed drugs. The inclusion criteria involved hypertensive patients who received antihypertension drugs, specifically adults and elderly, except the pregnant woman. The patient blood pressure was measured by healthcare workers in the targeted community health centers. Descriptive and multivariable logistic regression analyses were performed to assess factors associated with medication adherence with blood pressure levels.ResultsA total of 264 hypertensive outpatients participating in this study, 77.65% of participants were adherent to antihypertensive drugs based on the pill count method, and 40.91% of participants had controlled blood pressure. Patients with uncontrolled blood pressure were about six times (adjusted odds ratio [AOR]: 6.15; 95% confidence interval [CI]: 2.694-14.039; P = 0.000) more likely to have non-adherent medication than patients with controlled blood pressure. Reciprocally, non-adherent participants (pill count < 80%) were about six times (AOR: 6.081; 95% CI: 2.672-13.838; P = 0.000) more likely to have uncontrolled blood pressure compared to adherent patients (pill count ≥ 80%). Age less than 40 years old (AOR: 5.814; 95% CI: 1.519-22.252; P = 0.01) and having middle school educational level (AOR: 0.387; 95% CI: 0.153-0.974; P = 0.045) were found to be independent factors associated with uncontrolled blood pressure.ConclusionsThe result showed that non-adherence to antihypertension drugs is associated with uncontrolled blood pressure. Then, age could be associated with uncontrolled blood pressure. Thus, pharmacists and other healthcare providers should pay attention to improving medication adherence and maintaining the controlled blood pressure.

Project description:This multicenter, phase 4, Prospective Randomized Open, Blinded End-point (PROBE) study aimed to evaluate safety and efficacy of telmisartan/rosuvastatin single-pill combination (SPC) therapy on lowering central blood pressure (BP) compared with telmisartan monotherapy in hypertensive patients with dyslipidemia in Korea. Study was terminated earlier than planned due to COVID-19 pandemic, thus should be considered as a pilot study. Among 125 patients who met the inclusion criteria of hypertension and dyslipidemia (defined as 10-year Atherosclerotic Cardiovascular Disease risk score over 5%), 80 patients went through 4-week single-group run-in period with telmisartan 40-80 mg, then randomized to telmisartan 80 mg + rosuvastatin (10 or 20 mg) SPC group or telmisartan 80 mg monotherapy group. The central/brachial BP, brachial-ankle pulse wave velocity (baPWV), and augmentation index (AIx) were assessed at baseline and 16 weeks later. Mean brachial SBP changed from 135.80 ± 14.22 mmHg to 130.69 ± 13.23 mmHg in telmisartan/rosuvastatin group and from 134.37 ± 12.50 mmHg to 133.75 ± 12.30 mmHg in telmisartan monotherapy group without significant difference (between-group difference p = .149). Mean central SBP were reduced significantly in the telmisartan/rosuvastatin group with change from 126.72 ± 14.44 mmHg to 121.56 ± 14.56 mmHg while telmisartan monotherapy group showed no significant change (between-group difference p = .028). BaPWV changed from 1672.57 ± 371.72 m/s to 1591.75 ± 272.16 m/s in telmisartan/rosuvastatin group and from 1542.85 ± 263.70 m/s to 1586.12 ± 297.45 m/s in telmisartan group with no significance (between-group difference p = .078). Change of AIx had no significant difference (between-group difference p = .314). Both groups showed excellent compliance rate of 96.9 ± 4.5% with no significant difference in adverse rate. Telmisartan/rosuvastatin SPC therapy was more effective in lowering central BP compared with the telmisartan monotherapy. The results of this study showed benefit of additive statin therapy in hypertensive patients combined with dyslipidemia.

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Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature.

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Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature.

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