We developed a three-pronged complex intervention to improve selfcare and deliver whole person care for patients with heart failure, underpinned by the ‘extant cycle’ theory – a theory based on our ...formative work.
This is a 3 centre, 2-arm, 1:1, open, adaptive stratified, randomized controlled trial. We included patients aged ≥ 18 years with heart failure, taking any of the key guideline directed medical treatments, with a history of or currently on a high ceiling diuretic. We excluded end stage renal disease, clinically diagnosed severe mental illness or cognitive dysfunction and having no caregivers. Interventions included, (i) trained hospital based lay health worker mediated assessment of patients' current selfcare behaviour, documenting barriers and facilitators and implementing a plan to ‘transition’ the patient toward optimal selfcare. (ii) m-health mediated remote monitoring and (iii) dose optimization through a ‘physician supervisor’.
We recruited 301 patients between Jan 2021 and Jan 2022. Mean age was 59.8 (±11.7) years, with 195 (64.8 %) from rural or semi-urban areas and 67.1 % having intermediate to low health literacy. 190 (63.1 %) had an underlying ischemic cardiomyopathy. In the intervention arm, 142 (94.1 %) had a Selfcare in Heart Failure Index (SCHFI) score of ≤70, with significant barriers being ‘lack of knowledge’ 105 (34.5 %) and ‘behavioural passivity’ 23 (7.5 %).
This is the first South Asian trial evaluating a complex intervention underpinned by behaviour change theory for whole person heart failure care. These learnings can be applied to heart failure patient care in other resource constrained health systems.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Sinonasal papillomas are relatively rare, benign epithelial tumours of the nasal cavity. These lesions generate considerable interest because they are locally aggressive, have a tendency to ...recur and are associated with malignancy. The authors present a unique case of malignant sinonasal papilloma with neck metastasis. In the English literature only one case of such a presentation has been reported.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Rosiglitazone is a thiazolidinedione that reduces insulin resistance and might preserve insulin secretion. The aim of this study was to assess prospectively the drug's ability to prevent type 2 ...diabetes in individuals at high risk of developing the condition.
5269 adults aged 30 years or more with impaired fasting glucose or impaired glucose tolerance, or both, and no previous cardiovascular disease were recruited from 191 sites in 21 countries and randomly assigned to receive rosiglitazone (8 mg daily; n=2365) or placebo (2634) and followed for a median of 3 years. The primary outcome was a composite of incident diabetes or death. Analyses were done by intention to treat. This trial is registered at
ClinicalTrials.gov, number
NCT00095654.
At the end of study, 59 individuals had dropped out from the rosiglitazone group and 46 from the placebo group. 306 (11·6%) individuals given rosiglitazone and 686 (26·0%) given placebo developed the composite primary outcome (hazard ratio 0·40, 95% CI 0·35–0·46; p<0·0001); 1330 (50·5%) individuals in the rosiglitazone group and 798 (30·3%) in the placebo group became normoglycaemic (1·71, 1·57–1·87; p<0·0001). Cardiovascular event rates were much the same in both groups, although 14 (0·5%) participants in the rosiglitazone group and two (0·1%) in the placebo group developed heart failure (p=0·01).
Rosiglitazone at 8 mg daily for 3 years substantially reduces incident type 2 diabetes and increases the likelihood of regression to normoglycaemia in adults with impaired fasting glucose or impaired glucose tolerance, or both.
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DOBA, GEOZS, IJS, IMTLJ, IZUM, KILJ, KISLJ, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SIK, UILJ, UKNU, UL, UM, UPCLJ, UPUK, VSZLJ
There is controversy about the correct dose and form of thyroid hormone therapy for patients with hypothyroidism. Despite restoration of serum thyrotropin (TSH) concentrations to normal, many ...patients complain of excessive weight gain. We have compared weight at diagnosis of hyperthyroidism with that when euthyroid, evidenced by a stable, normal serum TSH concentration, with or without thyroxine (T4) replacement therapy, in patients treated with an 18-month course of antithyroid drugs (43 patients), surgery (56 patients), or 13I (34 patients) for Graves' disease. In addition, weights were recorded before and after treatment of 25 patients with differentiated thyroid carcinoma by total thyroidectomy, 131I, and long-term T4 suppressive therapy, resulting in undetectable serum TSH concentrations. Mean weight gain in patients with Graves' disease who required T4 replacement therapy following surgery was significantly greater than in those of the same age, sex, and severity of hyperthyroidism rendered euthyroid by surgery (3.9 kg) (p < 0.001) or at the end of a course of antithyroid drugs (4.1 kg) (p < 0.001). Weight gain was similar in those requiring T4 replacement following surgery or 131T therapy (10.4 versus 10.1 kg). In contrast, ablative therapy combined with suppression of TSH secretion by T4 in patients with differentiated thyroid carcinoma did not result in weight gain. The excessive weight gain in patients becoming hypothyroid after destructive therapy for Graves' disease suggests that restoration of serum TSH to the reference range by T4 alone may constitute inadequate hormone replacement.
In a 2-by-2 factorial design, participants without cardiovascular disease but with impaired fasting glucose levels or impaired glucose tolerance received ramipril or placebo (with or without ...rosiglitazone) for a median of 3 years. The results suggest that ACE inhibitors may modestly improve glucose metabolism, though ramipril failed to change the rate of death or newly diagnosed diabetes.
ACE inhibitors may modestly improve glucose metabolism, though ramipril failed to change the rate of death or newly diagnosed diabetes.
Diabetes, ranked as the fifth leading cause of death worldwide, is a major risk factor for various cardiovascular and renal disorders.
1
The prevalence of diabetes is increasing, which in turn increases the risk of premature cardiovascular disease and death.
2
Therefore, strategies to reduce the incidence of diabetes are needed.
Physical activity, weight loss,
3
,
4
and some glucose-lowering agents
4
,
5
reduce the incidence of diabetes in people with elevated glucose levels that are just below the diagnostic threshold for diabetes. Several trials involving people with hypertension or cardiovascular disease have suggested that agents that block or inhibit the renin–angiotensin system may . . .
Effects of Ramipril and Rosiglitazone on Cardiovascular and Renal Outcomes in People With Impaired Glucose Tolerance or Impaired
Fasting Glucose
Results of the Diabetes REduction Assessment with ...ramipril and rosiglitazone Medication (DREAM) trial
The DREAM Trial Investigators *
DREAM Trial Study Group, Population Health Research Institute, Hamilton, Canada
Corresponding author: Gilles R. Dagenais, MD, Laval University Heart and Lung Institute, 2725 Chemin Ste-Foy, Quebec, Quebec
City, Canada G1V 4G5. E-mail: gilles.dagenais{at}crhl.ulaval.ca
Abstract
OBJECTIVE —Impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) are risk factors for diabetes, cardiovascular disease
(CVD), and kidney disease. We determined the effects of ramipril and rosiglitazone on combined and individual CVD and renal
outcomes in people with IGT and/or IFG in the Diabetes REduction Assessment With ramipril and rosiglitazone Medication (DREAM)
trial.
RESEARCH DESIGN AND METHODS —A total of 5,269 people aged ≥30 years, with IGT and/or IFG without known CVD or renal insufficiency, were randomized to
15 mg/day ramipril versus placebo and 8 mg/day rosiglitazone versus placebo. A composite cardiorenal outcome and its CVD and
renal components were assessed during the 3-year follow-up.
RESULTS —Compared with placebo, neither ramipril (15.7% 412 of 2,623 vs. 16.0% 424 of 2,646; hazard ratio HR 0.98 95% CI 0.84–1.13;
P = 0.75) nor rosiglitazone (15.0% 394 of 2,635 vs. 16.8% 442 of 2,634; 0.87 0.75–1.01; P = 0.07) reduced the risk of the cardiorenal composite outcome. Ramipril had no impact on the CVD and renal components. Rosiglitazone
increased heart failure (0.53 vs. 0.08%; HR 7.04 95% CI 1.60–31.0; P = 0.01) but reduced the risk of the renal component (0.80 0.68–0.93; P = 0.005); prevention of diabetes was independently associated with prevention of the renal component ( P < 0.001).
CONCLUSIONS —Ramipril did not alter the cardiorenal outcome or its components. Rosiglitazone, which reduced diabetes, also reduced the
development of renal disease but not the cardiorenal outcome and increased the risk of heart failure.
CVD, cardiovascular disease
DREAM, Diabetes REduction Assessment with ramipril and rosiglitazone Medication
ECG, electrocardiogram
eGFR, estimated glomerular filtration rate
HOPE, Heart Outcomes Prevention Evaluation
IFG, impaired fasting glucose
IGT, impaired glucose tolerance
MI, myocardial infarction
Footnotes
Published ahead of print at http://care.diabetesjournals.org on 11 February 2008. DOI: 10.2337/dc07-1868. Clinical trial reg. no. NCT00095654, clinicaltrials.gov.
G.R.D., E.L., and A.B. have received honoraria and grant/research support from sanofi-aventis and GlaxoSmithKline. H.G., R.H.,
and S.Y. have received honoraria and consulting fees from GlaxoSmithKline, King Pharmaceuticals, and sanofi-aventis. M.M.
has received honoraria from sanofi-aventis and GlaxoSmithKline.
*
↵ * A complete list of the DREAM Trial Investigators can be found in the appendix .
↵ The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore
be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
Accepted February 2, 2008.
Received September 24, 2007.
DIABETES CARE
Investigations including a computed tomography of the brain, full blood count, erythrocyte sedimentation rate, plasma biochemistry, serum vitamin B12 concentration, thrombophilia screen, and an ...autoantibody screen were all normal, and clinical examination by a neurologist detected no additional abnormalities.
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