80 results found
Whiteley WN, Gupta AK, Godec T, et al., 2021, Long-Term Incidence of Stroke and Dementia in ASCOT., Stroke
BACKGROUND AND PURPOSE: Management of stroke risk factors might reduce later dementia. In ASCOT (Anglo-Scandinavian Outcome Trial), we determined whether dementia or stroke were associated with different blood pressure (BP)-lowering regimens; atorvastatin or placebo; and mean BP, BP variability, and mean cholesterol levels. METHODS: Participants with hypertension and ≥3 cardiovascular disease risk factors were randomly allocated to amlodipine- or atenolol-based BP-lowering regimen targeting BP <140/90 mm Hg for 5.5 years. Participants with total cholesterol ≤6.5 mmol/L were also randomly allocated to atorvastatin 10 mg or placebo for 3.3 years. Mean and LDL (low-density lipoprotein) cholesterol, BP, and SD of BP were calculated from 6 months to end of trial. UK participants were linked to electronic health records to ascertain deaths and hospitalization in general and mental health hospitals. Dementia and stroke were ascertained by validated code lists and within-trial ascertainment. RESULTS: Of 8580 UK participants, 7300 were followed up to 21 years from randomization. Atorvastatin for 3.3 years had no measurable effect on stroke (264 versus 272; adjusted hazard ratio [HR], 0.92 [95% CI, 0.78-1.09]; P=0.341) or dementia (238 versus 227; adjusted HR, 0.98 [95% CI, 0.82-1.18]; P=0.837) compared with placebo. Mean total cholesterol was not associated with later stroke or dementia. An amlodipine-based compared with an atenolol-based regimen for 5.5 years reduced stroke (443 versus 522; adjusted HR, 0.82 [95% CI, 0.72-0.93]; P=0.003) but not dementia (450 versus 465; adjusted HR, 0.94 [95% CI, 0.82-1.07]; P=0.334) over follow-up. BP variability (SD mean BP) was associated with a higher risk of dementia (per 5 mm Hg HR, 1.14 [95% CI, 1.06-1.24]; P<0.001) and stroke (HR, 1.21 [95% CI, 1.12-1.32]; P<0.001) adjusted for mean BP. CONCLUSIONS: An amlodipine-based BP regimen reduced the long-term incidence of stroke compared with an atenolol-based regimen but ha
Gupta AK, 2021, JAHA Spotlight on Air Pollution and Cardiovascular Disease: A Call for Urgent Action, JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol: 10, ISSN: 2047-9980
Rahimi K, 2021, Pharmacological blood pressure lowering for primary and secondary prevention of cardiovascular disease across different levels of blood pressure: an individual participant-level data meta-analysis, The Lancet, Vol: 397, Pages: 1625-1636, ISSN: 0140-6736
BackgroundThe effects of pharmacological blood pressure lowering at normal or high-normal blood pressure ranges in people with or without pre-existing cardiovascular disease remains uncertain. We analysed individual participant data from randomised trials to investigate the effects of blood pressure lowering treatment on the risk of major cardiovascular events by baseline levels of systolic blood pressure.MethodsWe did a meta-analysis of individual participant-level data from 48 randomised trials of pharmacological blood pressure lowering medications versus placebo or other classes of blood pressure-lowering medications, or between more versus less intensive treatment regimens, which had at least 1000 persons-years of follow-up in each group. Trials exclusively done with participants with heart failure or short-term interventions in participants with acute myocardial infarction or other acute settings were excluded. Data from 51 studies published between 1972 and 2013 were obtained by the Blood Pressure Lowering Treatment Trialists' Collaboration (Oxford University, Oxford, UK). We pooled the data to investigate the stratified effects of blood pressure-lowering treatment in participants with and without prevalent cardiovascular disease (ie, any reports of stroke, myocardial infarction, or ischaemic heart disease before randomisation), overall and across seven systolic blood pressure categories (ranging from <120 to ≥170 mm Hg). The primary outcome was a major cardiovascular event (defined as a composite of fatal and non-fatal stroke, fatal or non-fatal myocardial infarction or ischaemic heart disease, or heart failure causing death or requiring admission to hospital), analysed as per intention to treat.FindingsData for 344 716 participants from 48 randomised clinical trials were available for this analysis. Pre-randomisation mean systolic/diastolic blood pressures were 146/84 mm Hg in participants with previous cardiovascular disease (n=157 728) and 157/89 mm
Copland E, Canoy D, Nazarzadeh M, et al., 2021, Antihypertensive treatment and risk of cancer: an individual participant data meta-analysis, The Lancet Oncology, Vol: 22, Pages: 558-570, ISSN: 1213-9432
BackgroundSome studies have suggested a link between antihypertensive medication and cancer, but the evidence is so far inconclusive. Thus, we aimed to investigate this association in a large individual patient data meta-analysis of randomised clinical trials.MethodsWe searched PubMed, MEDLINE, The Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from Jan 1, 1966, to Sept 1, 2019, to identify potentially eligible randomised controlled trials. Eligible studies were randomised controlled trials comparing one blood pressure lowering drug class with a placebo, inactive control, or other blood pressure lowering drug. We also required that trials had at least 1000 participant years of follow-up in each treatment group. Trials without cancer event information were excluded. We requested individual participant data from the authors of eligible trials. We pooled individual participant-level data from eligible trials and assessed the effects of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), β blockers, calcium channel blockers, and thiazide diuretics on cancer risk in one-stage individual participant data and network meta-analyses. Cause-specific fixed-effects Cox regression models, stratified by trial, were used to calculate hazard ratios (HRs). The primary outcome was any cancer event, defined as the first occurrence of any cancer diagnosed after randomisation. This study is registered with PROSPERO (CRD42018099283).Findings33 trials met the inclusion criteria, and included 260 447 participants with 15 012 cancer events. Median follow-up of included participants was 4·2 years (IQR 3·0–5·0). In the individual participant data meta-analysis comparing each drug class with all other comparators, no associations were identified between any antihypertensive drug class and risk of any cancer (HR 0·99 [95% CI 0·95–1·04] for ACEIs; 0·96 [0·92&nda
Siddiqui I, Aurelio M, Gupta A, et al., 2021, COVID-19: Causes of anxiety and wellbeing support needs of healthcare professionals in the UK: A cross-sectional survey., Clin Med (Lond), Vol: 21, Pages: 66-72
BACKGROUND: COVID-19 has caused acute changes in healthcare delivery; this may impact mental health and wellbeing needs of healthcare professionals (HCPs). AIMS: We aimed to identify the causes of anxiety in HCPs during the COVID-19 pandemic, to assess whether HCPs felt they had adequate mental health and wellbeing support and to identify their unmet support needs. METHOD: We used a web-based survey utilising an online tool circulated to UK HCPs over 5 weeks. Self-perceived anxiety levels prior to and during the COVID-19 pandemic were measured on a 10-point Likert-type rating scale. RESULTS: The survey was completed by 558 HCPs. During the pandemic, self-perceived anxiety scores significantly increased from a median of 2 to 7 (paired Wilcoxon signed-rank test; p<0.001). The main reasons were concerns about exposure to SARS-CoV-2 and lack of personal protective equipment. Other wide-ranging reasons were identified. Only 41% of respondents felt there was adequate support. Thematic analysis of what support HCPs wanted identified 13 wide-ranging themes; including effective leadership and peer support. CONCLUSION: Anxiety levels in HCPs significantly increased during the COVID-19 pandemic and the main causes were identified. Many HCPs felt there was inadequate support and identified what support they needed. Implementing effective strategies to support HCPs' unmet wellbeing needs are required as a matter of urgency.
Simon MA, Ahmad F, Eitzman DT, et al., 2020, Equity, Diversity, and Inclusiveness in Cardiovascular Medicine and Health Care, JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol: 9, ISSN: 2047-9980
London B, 2020, Diversity, Equity, and Inclusiveness in Medicine and Cardiology, JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol: 9, ISSN: 2047-9980
Gupta AK, Jneid H, Addison D, et al., 2020, Current perspectives on coronavirus disease 2019 and cardiovascular disease: a white paper by the JAHA editors, Journal of the American Heart Association, Vol: 9, Pages: 1-23, ISSN: 2047-9980
Coronavirus Disease 2019 (COVID‐19) has infected more than 3.0 million people worldwide and killed more than 200,000 as of April 27, 2020. In this White Paper, we address the cardiovascular co‐morbidities of COVID‐19 infection; the diagnosis and treatment of standard cardiovascular conditions during the pandemic; and the diagnosis and treatment of the cardiovascular consequences of COVID‐19 infection. In addition, we will also address various issues related to the safety of healthcare workers and the ethical issues related to patient care in this pandemic.
Kapil V, Gupta AK, 2020, Solar UV Radiation: A Potential Modifiable Risk Factor for Hypertension, JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol: 9, ISSN: 2047-9980
Cabrera CP, Ng FL, Nicholls HL, et al., 2019, Over 1000 genetic loci influencing blood pressure with multiple systems and tissues implicated, Human Molecular Genetics, Vol: 28, Pages: R151-R161, ISSN: 0964-6906
High blood pressure (BP) remains the major heritable and modifiable risk factor for cardiovascular disease. Persistent high BP, or hypertension, is a complex trait with both genetic and environmental interactions. Despite swift advances in genomics, translating new discoveries to further our understanding of the underlying molecular mechanisms remains a challenge. More than 500 loci implicated in the regulation of BP have been revealed by genome-wide association studies (GWAS) in 2018 alone, taking the total number of BP genetic loci to over 1000. Even with the large number of loci now associated to BP, the genetic variance explained by all loci together remains low (~5.7%). These genetic associations have elucidated mechanisms and pathways regulating BP, highlighting potential new therapeutic and drug repurposing targets. A large proportion of the BP loci were discovered and reported simultaneously by multiple research groups, creating a knowledge gap, where the reported loci to date have not been investigated in a harmonious way. Here, we review the BP-associated genetic variants reported across GWAS studies and investigate their potential impact on the biological systems using in silico enrichment analyses for pathways, tissues, gene ontology and genetic pleiotropy.
Berkelmans GFN, Gudbjornsdottir S, Visseren FLJ, et al., 2019, Prediction of individual life-years gained without cardiovascular events from lipid, blood pressure, glucose, and aspirin treatment based on data of more than 500 000 patients with Type 2 diabetes mellitus, EUROPEAN HEART JOURNAL, Vol: 40, Pages: 2899-+, ISSN: 0195-668X
MANIERO C, GUPTA AK, LOBO MD, 2019, Impact of the new ACC/AHA and ESC/ESH hypertension guidelines in the UK, European Heart Journal, Vol: 40, Pages: 2472-2475, ISSN: 0195-668X
Poulter NR, Dolan E, Gupta AK, et al., 2019, Efficacy and safety of incremental dosing of a new single-pill formulation of perindopril and amlodipine in the management of hypertension, American Journal of Cardiovascular Drugs, Vol: 19, Pages: 313-323, ISSN: 1175-3277
BACKGROUND: Angiotensin-converting enzyme inhibitors and calcium channel blockers in combination are widely recommended in hypertension guidelines. The advantages of single-pill combinations (SPCs) are increasingly recognized, so a dosage-adapted combination of perindopril and amlodipine was developed for the initial management of hypertension. OBJECTIVE: This randomized trial evaluated the blood pressure (BP)-lowering efficacy of four incremental doses of perindopril/amlodipine SPC in adults with mild-to-severe hypertension. METHODS: Eligible patients (N = 1617) were randomized to SPC perindopril 3.5 mg/amlodipine 2.5 mg (i.e., 3.5/2.5 mg) daily, uptitrating as required on a monthly basis up to 14/10 mg until BP < 140/90 mmHg (< 130/80 mmHg in patients with diabetes). The primary endpoint (proportion with controlled BP at each uptitrated dose) was evaluated at 6 months, and safety was evaluated at 9 months; 24-h ambulatory BP measurement and BP variability were also investigated. Control-arm participants (n = 1653) were randomized to irbesartan 150 mg daily, uptitrating over 3 months to irbesartan/hydrochlorothiazide 300/25 mg. RESULTS: Significant increases in BP control were observed with each dosage increment of perindopril/amlodipine, which was well tolerated, rising from 21% (3.5/2.5 mg) to 30% (7/5 mg), 37% (14/5 mg), and 42% (14/10 mg) after 1, 2, 3, and 6 months, respectively. Reductions in mean systolic and diastolic BP occurred with each incremental dose of perindopril/amlodipine. After 6 months, mean BP had fallen by 24.8/10.8 mmHg. Irbesartan-based therapy reduced clinic and 24-h BP similarly to perindopril/amlodipine, but perindopril/amlodipine reduced BP variability more in comparison. CONCLUSIONS: Incremental uptitration with dosage-adapted perindopril/amlodipine SPC is a safe and effective strategy for mana
Godec T, Mackay J, Whitehouse A, et al., 2018, The role of pulse pressure in comparison to systolic blood pressure in the prediction of long-term risk of all-cause-and cardiovascular-mortality, and the influence of age on these relationships, amongst hypertensive patients in the ASCOT-legacy study, Publisher: NATURE PUBLISHING GROUP, Pages: 695-696, ISSN: 0950-9240
Gupta A, Mackay J, Whitehouse A, et al., 2018, Baseline predictors of all-cause- and cardiovascular- mortality amongst 8580 hypertensive patients followed up for 16 years in the ASCOT legacy study, 27th Scientific Meeting of the International-Society-of-Hypertension, Publisher: Lippincott, Williams & Wilkins, Pages: E251-E251, ISSN: 0263-6352
Gupta A, Mackay J, Whitehouse A, et al., 2018, Long-term mortality after blood pressure-lowering and lipid-lowering treatment in patients with hypertension in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Legacy study: 16-year follow-up results of a randomised factorial trial, Lancet, Vol: 392, Pages: 1127-1137, ISSN: 0140-6736
BACKGROUND: In patients with hypertension, the long-term cardiovascular and all-cause mortality effects of different blood pressure-lowering regimens and lipid-lowering treatment are not well documented, particularly in clinical trial settings. The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Legacy Study reports mortality outcomes after 16 years of follow-up of the UK participants in the original ASCOT trial. METHODS: ASCOT was a multicentre randomised trial with a 2 × 2 factorial design. UK-based patients with hypertension were followed up for all-cause and cardiovascular mortality for a median of 15·7 years (IQR 9·7-16·4 years). At baseline, all patients enrolled into the blood pressure-lowering arm (BPLA) of ASCOT were randomly assigned to receive either amlodipine-based or atenolol-based blood pressure-lowering treatment. Of these patients, those who had total cholesterol of 6·5 mmol/L or lower and no previous lipid-lowering treatment underwent further randomisation to receive either atorvastatin or placebo as part of the lipid-lowering arm (LLA) of ASCOT. The remaining patients formed the non-LLA group. A team of two physicians independently adjudicated all causes of death. FINDINGS: Of 8580 UK-based patients in ASCOT, 3282 (38·3%) died, including 1640 (38·4%) of 4275 assigned to atenolol-based treatment and 1642 (38·1%) of 4305 assigned to amlodipine-based treatment. 1768 of the 4605 patients in the LLA died, including 903 (39·5%) of 2288 assigned placebo and 865 (37·3%) of 2317 assigned atorvastatin. Of all deaths, 1210 (36·9%) were from cardiovascular-related causes. Among patients in the BPLA, there was no overall difference in all-cause mortality between treatments (adjusted hazard ratio [HR] 0·90, 95% CI 0·81-1·01, p=0·0776]), although significantly fewer deaths from stroke (adjusted HR 0·71, 0·53-0·97, p=0·0305) occurr
Saxena M, Shour T, Shah M, et al., 2018, Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success, JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol: 7, ISSN: 2047-9980
McGlone ER, Gupta AK, Reddy M, et al., 2018, Antral resection versus antral preservation during laparoscopic sleeve gastrectomy for severe obesity: Systematic review and meta-analysis, Surgery for Obesity and Related Diseases, Vol: 14, Pages: 857-864, ISSN: 1550-7289
Although laparoscopic sleeve gastrectomy is an established operation for severe obesity, there is controversy regarding the extent to which the antrum is excised. The objective of this systematic review was to investigate the effect on perioperative complications and medium-term outcomes of antral resecting versus antral preserving sleeve gastrectomy. MEDLINE, EMBASE, and Cochrane databases were searched from 1946 to April 2017. Eligible studies compared antral resection (staple line commencing 2-3 cm from pylorus) with antral preservation (>5 cm from pylorus) in patients undergoing primary sleeve gastrectomy for obesity. Meta-analyses were performed with a random-effects model, and risk of bias within and across studies was assessed using validated scoring systems. Eight studies (619 participants) were included: 6 randomized controlled trials and 2 cohort studies. Overall follow-up was 94% for the specified outcomes of each study. Mean percentage excess weight loss was 62% at 12 months (7 studies; 574 patients) and 67% at 24 months (4 studies; 412 patients). Antral resection was associated with significant improvement in percentage excess weight loss at 24-month follow-up (mean 70% versus 61%; standardized mean difference .95; confidence interval .35-1.58, P<.005), an effect that remained significant when cohort studies were excluded. There was no difference in incidence of perioperative bleeding, leak, or de novo gastroesophageal reflux disease. According to the available evidence, antral resection is associated with better medium-term weight loss compared with antral preservation, without increased risk of surgical complications. Further randomized clinical trials are indicated to confirm this finding.
Gupta AK, 2018, Hypertensive disorders in pregnancy and the risk of cardiovascular disease: a need for postpartum strategies for the primary prevention, Journal of the American Heart Association, Vol: 7, Pages: 1-1, ISSN: 2047-9980
Ferraro RA, Chang E, Shevlin E, et al., 2017, Elevated Lipocalin-2 Protein Levels in Cerebrospinal Fluid Correlate With Disease Severity in Aneurysmal Subarachnoid Hemorrhage, Scientific Sessions of the American-Heart-Association / Resuscitation Science Symposium, Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0009-7322
Gupta A, Godec T, Sever P, 2017, Concerns related to the nocebo effect Reply, LANCET, Vol: 390, Pages: 1832-1832, ISSN: 0140-6736
Gupta AK, Poulter N, Ariti C, 2017, Clinical efficacy of the combination of atorvastatin and perindopril in prevention of cardiovascular outcomes and mortality among high-risk hypertensive patients randomized to the ASCOT-LLA trial, Publisher: OXFORD UNIV PRESS, Pages: 1254-1254, ISSN: 0195-668X
Gupta A, Thompson D, Whitehouse A, et al., 2017, Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase, Lancet, Vol: 389, Pages: 2473-2481, ISSN: 0140-6736
BackgroundIn blinded randomised controlled trials, statin therapy has been associated with few adverse events (AEs). By contrast, in observational studies, larger increases in many different AEs have been reported than in blinded trials.MethodsIn the Lipid-Lowering Arm of the Anglo-Scandinavian Cardiac Outcomes Trial, patients aged 40–79 years with hypertension, at least three other cardiovascular risk factors, and fasting total cholesterol concentrations of 6·5 mmol/L or lower, and who were not taking a statin or fibrate, had no history of myocardial infarction, and were not being treated for angina were randomly assigned to atorvastatin 10 mg daily or matching placebo in a randomised double-blind placebo-controlled phase. In a subsequent non-randomised non-blind extension phase (initiated because of early termination of the trial because efficacy of atorvastatin was shown), all patients were offered atorvastatin 10 mg daily open label. We classified AEs using the Medical Dictionary for Regulatory Activities. We blindly adjudicated all reports of four prespecified AEs of interest—muscle-related, erectile dysfunction, sleep disturbance, and cognitive impairment—and analysed all remaining AEs grouped by system organ class. Rates of AEs are given as percentages per annum.ResultsThe blinded randomised phase was done between February, 1998, and December, 2002; we included 101 80 patients in this analysis (5101 [50%] in the atorvastatin group and 5079 [50%] in the placebo group), with a median follow-up of 3·3 years (IQR 2·7–3·7). The non-blinded non-randomised phase was done between December, 2002, and June, 2005; we included 9899 patients in this analysis (6409 [65%] atorvastatin users and 3490 [35%] non-users), with a median follow-up of 2·3 years (2·2–2·4). During the blinded phase, muscle-related AEs (298 [2·03% per annum] vs 283 [2·00% per annum]; hazard ratio 1·03 [
Marcano Belisario JS, Gupta AK, O'Donoghue JM, et al., 2017, Implementation of depression screening in antenatal clinics through tablet computers: results of a feasibility study, BMC Medical Informatics and Decision Making, Vol: 17, ISSN: 1472-6947
BackgroundMobile devices may facilitate depression screening in the waiting area of antenatal clinics. This can present implementation challenges, of which we focused on survey layout and technology deployment.MethodsWe assessed the feasibility of using tablet computers to administer a socio-demographic survey, the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to 530 pregnant women attending National Health Service (NHS) antenatal clinics across England. We randomised participants to one of two layout versions of these surveys: (i) a scrolling layout where each survey was presented on a single screen; or (ii) a paging layout where only one question appeared on the screen at any given time.ResultsOverall, 85.10% of eligible pregnant women agreed to take part. Of these, 90.95% completed the study procedures. Approximately 23% of participants answered Yes to at least one Whooley question, and approximately 13% of them scored 10 points of more on the EPDS. We observed no association between survey layout and the responses given to the Whooley questions, the median EPDS scores, the number of participants at increased risk of self-harm, and the number of participants asking for technical assistance. However, we observed a difference in the number of participants at each EPDS scoring interval (p = 0.008), which provide an indication of a woman’s risk of depression. A scrolling layout resulted in faster completion times (median = 4 min 46 s) than a paging layout (median = 5 min 33 s) (p = 0.024). However, the clinical significance of this difference (47.5 s) is yet to be determined.ConclusionsTablet computers can be used for depression screening in the waiting area of antenatal clinics. This requires the careful consideration of clinical workflows, and technology-related issues such as connectivity and security. An association between survey layout and EPDS scoring intervals needs to be ex
McGlone ER, Gupta A, Maclean W, et al., 2016, Antral-preserving or antral-resecting sleeve gastrectomy for morbid obesity: a systematic review and meta-analysis, 19th Annual Scientific Meeting of the Association-of-Upper-Gastrointestinal-Surgeons-of-Great-Britain-and-Ireland, Publisher: WILEY-BLACKWELL, Pages: 13-14, ISSN: 0007-1323
Sever P, Gupta A, Thompson D, et al., 2016, LBOS 01-04 THE TRUE INCIDENCE OF STATIN -RELATED ADVERSE EVENTS IN HYPERTENSIVE PATIENTS REVEALED BY COMPARISON OF BLINDED AND UN-BLINDED USE OF STATIN IN THE ANGLO-SCANDINAVIAN CARDIAC OUTCOMES TRIAL (ASCOT)., J Hypertens, Vol: 34 Suppl 1, Pages: e547-e548, ISSN: 1473-5598
OBJECTIVE: To test the hypothesis that adverse effects of statins are only reported in excess in observational studies and not in blinded randomized trials. DESIGN AND METHOD: We collated all reported AEs in hypertensive patients in the Lipid-Lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) during the randomised, double-blind phase (when atorvastatin was compared with placebo) and the subsequent non-randomised un-blinded LLA-extension phase (when patients were offered open-label statin). Among them we blindly and independently adjudicated 4 prespecified AEs (outcomes) that have been claimed to be associated with statin use: muscle-related, erectile dysfunction (ED), sleep disturbance and cognitive impairment . We also performed a sensitivity analysis for all reported AEs. RESULTS: During 5.5 years of follow-up, 20.8% of 10,180 patients reported one (or more) of the 4 AEs. During the double- blind phase, those on statins (vs. placebo) reported a similar incidence of muscle- related AEs (HR 1.03[0.88 to1.21, p = 0.72]), a non significant reduction in ED(0.88 [0.75 to 1.04, p = 0.13]) and a significant reduction in sleep disturbance (0.60 [0.56 to 0.85, p < 0.001]). During the un-blinded phase, a significant increase in muscle related AEs was reported among statin users (vs. non-users) (1.41 [1.10 to 1.79, p = 0.006]). There were no significant differences in the reporting of ED or sleep disturbance among users and non-users. There were too few cases of cognitive impairment to warrant analysis. On sensitivity analyses, during the blinded phase, there was no significant difference in the proportion of patients reporting one or more of all AE's among those allocated to a statin (87.8%) or a placebo (88.8%) (p = 0.12). CONCLUSIONS: These data show that under blinded conditions there is no true increase in AEs with the use of statin. However, with un- blinded observations, there was a significant increase in reporting of muscle-related AEs -an e
Stam-Slob MC, Visseren FLJ, Jukema JW, et al., 2016, Statins for primary and secondary prevention of vascular disease in the elderly: estimation of individual absolute treatment effects, Congress of the European-Society-of-Cardiology (ESC), Publisher: OXFORD UNIV PRESS, Pages: 940-940, ISSN: 0195-668X
Stam-Slob MC, Visseren FL, Wouter Jukema J, et al., 2016, Personalized absolute benefit of statin treatment for primary or secondary prevention of vascular disease in individual elderly patients, Clinical Research in Cardiology, Vol: 106, Pages: 58-68, ISSN: 1861-0692
OBJECTIVE: To estimate the absolute treatment effect of statin therapy on major adverse cardiovascular events (MACE; myocardial infarction, stroke and vascular death) for the individual patient aged ≥70 years. METHODS: Prediction models for MACE were derived in patients aged ≥70 years with (n = 2550) and without (n = 3253) vascular disease from the "PROspective Study of Pravastatin in Elderly at Risk" (PROSPER) trial and validated in the "Secondary Manifestations of ARTerial disease" (SMART) cohort study (n = 1442) and the "Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm" (ASCOT-LLA) trial (n = 1893), respectively, using competing risk analysis. Prespecified predictors were various clinical characteristics including statin treatment. Individual absolute risk reductions (ARRs) for MACE in 5 and 10 years were estimated by subtracting on-treatment from off-treatment risk. RESULTS: Individual ARRs were higher in elderly patients with vascular disease [5-year ARRs: median 5.1 %, interquartile range (IQR) 4.0-6.2 %, 10-year ARRs: median 7.8 %, IQR 6.8-8.6 %] than in patients without vascular disease (5-year ARRs: median 1.7 %, IQR 1.3-2.1 %, 10-year ARRs: 2.9 %, IQR 2.3-3.6 %). Ninety-eight percent of patients with vascular disease had a 5-year ARR ≥2.0 %, compared to 31 % of patients without vascular disease. CONCLUSIONS: With a multivariable prediction model the absolute treatment effect of a statin on MACE for individual elderly patients with and without vascular disease can be quantified. Because of high ARRs, treating all patients is more beneficial than prediction-based treatment for secondary prevention of MACE. For primary prevention of MACE, the prediction model can be used to identify those patients who benefit meaningfully from statin therapy.
Marcano Belisario JS, Gupta A, O'Donoghue J, et al., 2016, Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study, BMJ Open, Vol: 6, ISSN: 2044-6055
Introduction Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices.Methods and analysis We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages.Ethics and dissemination This study has been approved by the National Research Ethics Service Committee South East Coast—Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers.
Watson S, Gupta AK, Poulter N, 2014, Influence of a short-term school-based intervention on the health behaviours and prevalence of obesity among schoolchildren and their parents: results of the RATIONAL HEALTH pilot programme, DIABETIC MEDICINE, Vol: 31, Pages: 23-23, ISSN: 0742-3071
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