Eplerenone for hypertension.

BACKGROUND: Eplerenone is an aldosterone receptor blocker that is chemically derived from spironolactone. In Canada, it is indicated for use as adjunctive therapy to reduce mortality for heart failure patients with New York Heart Association (NYHA) class II systolic chronic heart failure and left ventricular systolic dysfunction. It is also used as adjunctive therapy for patients with heart failure following myocardial infarction. Additionally, it is indicated for the treatment of mild and moderate essential hypertension for patients who cannot be treated adequately with other agents. It is important to determine the clinical impact of all antihypertensive medications, including aldosterone antagonists, to support their continued use in essential hypertension. No previous systematic reviews have evaluated the effect of eplerenone on cardiovascular morbidity, mortality, and magnitude of blood pressure lowering in patients with hypertension. OBJECTIVES: To assess the effects of eplerenone monotherapy versus placebo for primary hypertension in adults. Outcomes of interest were all-cause mortality, cardiovascular events (fatal or non-fatal myocardial infarction), cerebrovascular events (fatal or non fatal strokes), adverse events or withdrawals due to adverse events, and systolic and diastolic blood pressure. SEARCH METHODS: We searched the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registers up to 3 March 2016. We handsearched references from retrieved studies to identify any studies missed in the initial search. We also searched for unpublished data by contacting the corresponding authors of the included studies and pharmaceutical companies involved in conducting studies on eplerenone monotherapy in primary hypertension. The search had no language restrictions. SELECTION CRITERIA: We selected randomized placebo-controlled trials studying adult patients with primary hypertension. We excluded studies in people with secondary or gestational hypertension and studies where participants were receiving multiple antihypertensives. DATA COLLECTION AND ANALYSIS: Three review authors independently reviewed the search results for studies meeting our criteria. Three review authors independently extracted data and assessed trial quality using a standardized data extraction form. A fourth independent review author resolved discrepancies or disagreements. We performed data extraction and synthesis using a standardized format on Covidence. We conducted data analysis using Review Manager 5. MAIN RESULTS: A total of 1437 adult patients participated in the five randomized parallel group studies, with treatment durations ranging from 8 to 16 weeks. The daily doses of eplerenone ranged from 25 mg to 400 mg daily. Meta-analysis of these studies showed a reduction in systolic blood pressure of 9.21 mmHg (95% CI -11.08 to -7.34; I2 = 58%) and a reduction of diastolic pressure of 4.18 mmHg (95% CI -5.03 to -3.33; I2 = 0%) (moderate quality evidence).There may be a dose response effect for eplerenone in the reduction in systolic blood pressure at doses of 400 mg/day. However, this finding is uncertain, as it is based on a single included study with low quality evidence. Overall there does not appear to be a clinically important dose response in lowering systolic or diastolic blood pressure at eplerenone doses of 50 mg to 400 mg daily. There did not appear to be any differences in the number of patients who withdrew due to adverse events or the number of patients with at least one adverse event in the eplerenone group compared to placebo. However, only three of the five included studies reported adverse events. Most of the included studies were of moderate quality, as we judged multiple domains as being at unclear risk in the 'Risk of bias' assessment. AUTHORS' CONCLUSIONS: Eplerenone 50 to 200 mg/day lowers blood pressure in people with primary hypertension by 9.21 mmHg systolic and 4.18 mmHg diastolic compared to placebo, with no difference of effect between doses of 50 mg/day to 200 mg/day. A dose of 25 mg/day did not produce a statistically significant reduction in systolic or diastolic blood pressure and there is insufficient evidence for doses above 200 mg/day. There is currently no available evidence to determine the effect of eplerenone on clinically meaningful outcomes such as mortality or morbidity in hypertensive patients. The evidence available on side effects is insufficient and of low quality, which makes it impossible to draw conclusions about potential harm associated with eplerenone treatment in hypertensive patients.

Telecare for diabetes, CHF or COPD: effect on quality of life, hospital use and costs. A randomised controlled trial and qualitative evaluation.

OBJECTIVES: To assess the effect of telecare on health related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals. METHODS: Patients were randomly assigned either to usual care or to additionally entering their data into a commercially-available electronic device that uploaded data once a day to a nurse-led monitoring station. Patients had congestive heart failure (Site A), chronic obstructive pulmonary disease (Site B), or any long-term condition, mostly diabetes (Site C). Site C contributed only intervention patients - they considered a usual care option to be unethical. The study took place in New Zealand between September 2010 and February 2012, and lasted 3 to 6 months for each patient. The primary outcome was health-related quality of life (SF36). Data on experiences were collected by individual and group interviews and by questionnaire. RESULTS: There were 171 patients (98 intervention, 73 control). Quality of life, self-efficacy and disease-specific measures did not change significantly, while anxiety and depression both decreased significantly with the intervention. Hospital admissions, days in hospital, emergency department visits, outpatient visits and costs did not differ significantly between the groups. Patients at all sites were universally positive. Many felt safer and more cared-for, and said that they and their family had learned more about managing their condition. Staff could all see potential benefits of telecare, and, after some initial technical problems, many staff felt that telecare enabled them to effectively monitor more patients. CONCLUSIONS: Strongly positive patient and staff experiences and attitudes complement and contrast with small or non-significant quantitative changes. Telecare led to patients and families taking a more active role in self-management. It is likely that subgroups of patients benefitted in ways that were not measured or visible within the quantitative data, especially feelings of safety and being cared-for. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000269033.

Validity Evidence for FASTHUG-MAIDENS, a Mnemonic for Identifying Drug-Related Problems in the Intensive Care Unit.

BACKGROUND: The mnemonic FASTHUG (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, stress Ulcer prophylaxis, Glucose control) was developed by intensive care unit (ICU) physicians to ensure that key aspects of care are addressed during each patient encounter. Because this tool does not specifically target pharmacotherapy assessments, a modified version, FASTHUG-MAIDENS, was created, by changing the H to mean Hypoactive or Hyperactive delirium and adding M for Medication reconciliation; A for Antibiotics or Anti-infectives; I for Indications for medications; D for drug Dosing; E for Electrolytes, hematology, and other laboratory tests; N for No drug interactions, allergies, duplication, or side effects; and S for Stop dates. OBJECTIVE: To validate the use of FASTHUG-MAIDENS as a tool for identifying drug-related problems (DRPs) in the ICU. METHODS: This randomized, prospective validation study took place between January and May 2011 in the ICUs of 4 hospitals: 2 community-level ICUs and 2 tertiary referral ICUs. Each ICU had a dedicated ICU pharmacist and one or more pharmacy residents completing an ICU rotation as part of their pharmacy practice residency (total of 6 residents). The 6 pharmacy residents were randomly assigned to assess patients admitted to the ICU using FASTHUG-MAIDENS or standard monitoring practice. The mean proportion of DRPs per patient encounter identified by the residents (relative to DRPs identified by the ICU pharmacists) was the primary outcome, and the proportion of total DRPs identified in each group was assessed as a secondary end point. RESULTS: Pharmacy residents using the FASTHUG-MAIDENS mnemonic identified a significantly greater mean proportion of DRPs per patient encounter (73.2% versus 52.4%, p = 0.008) and a greater proportion of total DRPs (77.1% versus 52.5%, p < 0.001) than those assessing patients according to standard monitoring practice. CONCLUSION: In this sample, the mnemonic FASTHUG-MAIDENS was a useful tool to facilitate the capture of DRPs by pharmacy residents working in the ICU.

CONTEXTE: Le code mnémonique anglais FASTHUG (Feeding [alimentation], Analgesia [analgésie], Sedation [sédation], Thromboembolic prophylaxis [prophylaxie thromboembolique], Head of bed elevation [élévation de la tête du lit], stress Ulcer prophylaxis [prophylaxie des ulcères de stress], Glucose control [régulation de la glycémie]) a été imaginé par des médecins intensivistes pour s'assurer que certains aspects clés des soins sont pris en compte pour chaque consultation avec un patient. Comme cet outil ne vise pas spécifiquement les évaluations pharmacothérapeutiques, une version modifiée, FASTHUG-MAIDENS, a été créée, où l'on a remplacé le sens du H par Hypoactive or Hyperactive delirium (délire hypoactif ou hyperactif) et ajouté MAIDENS : Medication reconciliation (bilan comparatif des médicaments); Antibiotics or Anti-infectives (antibiotiques ou anti-infectieux); Indications for medications (indications des médicaments); drug Dosing (posologie des médicaments); Electrolytes, hematology and other laboratory tests (électrolytes, hématologie et autres épreuves de laboratoire); No drug interactions, allergies, duplication, or side effects (absence d'interactions médicamenteuses, d'allergies, de chevauchement ou d'effets secondaires); et Stop dates (dates de fin). OBJECTIF: Valider l'emploi du code mnémonique FASTHUG-MAIDENS comme outil pour dépister les problèmes pharmacothérapeutiques à l'unité des soins intensifs (USI). MÉTHODES: Cette étude de validation aléatoire et prospective a été menée entre janvier et mai 2011 dans les USI de quatre hôpitaux : deux USI de niveau communautaire et deux autres de référence de niveau tertiaire. Chaque USI possédait un pharmacien attitré et au moins un résident en pharmacie complétant un stage à l'USI dans le cadre de leur résidence en pratique pharmaceutique (pour un total de six résidents). Les six résidents en pharmacie ont été assignés au hasard pour évaluer les patients admis à l'USI au moyen du code FASTHUG-MAIDENS ou d'une méthode de suivi standard. Le pourcentage de problèmes pharmacothérapeutiques par consultation avec un patient cernés par les résidents (comparativement à ceux constatés par les pharmaciens intensivistes) était le principal paramètre d'évaluation et le pourcentage de problèmes pharmacothérapeutiques totaux relevés dans chaque groupe était le paramètre d'évaluation secondaire. RÉSULTATS: Les résidents en pharmacie qui ont utilisé le code mnémonique FASTHUG-MAIDENS ont cerné un pourcentage moyen significativement supérieur de problèmes pharmacothérapeutiques par consultation avec un patient (73,2 % contre 52,4 %, p = 0,008) et un pourcentage supérieur de problèmes pharmacothérapeutiques totaux (77,1 % contre 52,5 %, p < 0,001) que ceux qui ont évalué les patients au moyen d'une méthode de suivi standard. CONCLUSION: Dans cet échantillon, le code mnémonique FASTHUG-MAIDENS s'est révélé être un outil utile facilitant la détermination des problèmes pharmacothérapeutiques par les résidents en pharmacie travaillant dans une USI. [Traduction par l'éditeur].