PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomized Controlled Trials as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 559 records · Page 31Linked to original sources
PubMed2005

Staphylococcal skin infections in children: rational drug therapy recommendations.

Staphylococcus aureus remains one of the most common and troublesome of bacteria causing disease in humans, despite the development of effective antibacterials and improvement in hygiene. The organism is responsible for over 70% of all skin and soft tissue infections in children and accounts for up to one-fifth of all visits to pediatric clinics. Skin and soft tissue infections that are predominantly caused by S. aureus include bullous and non-bullous impetigo, folliculitis, furunculosis, carbunculosis, cellulitis, surgical and traumatic wound infections, mastitis, and neonatal omphalitis. Other skin and soft tissue infections may also be caused by S. aureus but are often polymicrobial in origin and require special consideration. These include burns, decubitus ulcers (particularly in the perianal region), puncture wounds of the foot, as well as human and mammalian bites. Treatment of staphylococcal skin infections varies from topical antiseptics to prolonged intravenous antibacterials, depending on severity of the lesions and the health of the child. The treatment of choice for oral antibacterials remains the penicillinase-resistant penicillins such as flucloxacillin. Cefalexin and erythromycin are suitable cost-effective alternatives with broader cover, although care must be taken with the use of macrolides because of development of resistance to multiple families of antibacterials, particularly the lincosamides. Other cephalosporins such as cefadroxil and cefprozil are also effective, can be given once daily and have a better tolerability profile -- while azithromycin has a further advantage of a 3-day course. However, all of these agents are more expensive. Although the antibacterials have been given for 10 days in most clinical trials, there is no evidence that this duration is more effective than a 7-day course. In children requiring intravenous therapy, ceftriaxone has a major advantage over other antibacterials such as sulbactam/ampicillin and cefuroxime in that it can be given once daily and may, therefore, be suitable for outpatient treatment of moderate-to-severe skin infections. Newer-generation cephalosporins and loracarbef are also effective and have a broader spectrum of activity, but do not offer any added benefit and are significantly more expensive. Skin and soft tissue infections due to methicillin-resistant S. aureus (MRSA) are still relatively uncommon in children. Well children with community-acquired MRSA infections can be treated with clindamycin or trimethoprim-sulfamethoxazole (cotrimoxazole), but must be observed closely for potentially severe adverse effects. In severe infections, vancomycin remains the treatment of choice, while intravenous teicoplanin and clindamycin are suitable alternatives. Linezolid and quinupristin/dalfopristin are currently showing great promise for the treatment of multi-resistant Gram-positive infections. While the choice of antibacterial is important, supportive management, including removal of any infected foreign bodies, surgical drainage of walled-off lesions, and regular wound cleaning, play a vital role in ensuring cure.

Anti-Bacterial Agents↗
PubMed2006

Hospital cost effect of a heart failure disease management program: the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) trial.

BACKGROUND: Determine the effect on hospitalization cost of a heart failure disease management (HFDM) program delivered within a diverse provider network as demonstrated in the SPAN-CHF randomized controlled trial. METHODS: The SPAN-CHF trial was a prospective randomized assessment of the effectiveness of HFDM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients. Baseline clinical and demographic data were obtained on each patient, mortality was monitored, and hospitalizations were tracked for 90 days. Cost estimates for each hospitalization were based on a subsample of patients seen at Tufts-New England Medical Center for whom hospitalization costs were calculated. Heart failure disease management program costs were estimated using a programmatic budget model. Hospital utilization and cost data were combined to estimate medical costs for intervention and control groups. RESULTS: Heart failure disease management had a favorable effect on heart failure hospitalization, which was partially offset by noncardiac hospitalizations. The relative odds of at least one all-cause hospitalization during the intervention period trended less for the intervention group compared with the control group (0.76 [95% CI 0.38-1.51]). The point estimate of the differential hospitalization cost between control and intervention groups was a reduction in cost of $375 per patient. The net effect including the costs of the program was an increase of $488 per patient for the intervention group compared with the control group. The program would have been cost saving if HFDM costs had been 24% lower. CONCLUSION: The HFDM intervention, administered over 90 days to patients hospitalized for heart failure, succeeded in reducing the rate of heart failure hospitalizations, although this effect was partially offset by an increase in non-heart failure hospitalizations. The resulting modest reduction in all-cause hospitalization costs was exceeded by the cost of the intervention. Thus, although the reduction in heart failure may be interpreted as an improvement in health status, it could not be considered cost saving.

Cardiac Output, Low↗
PubMed2005

Intraoperative effects of the coapsys annuloplasty system in a randomized evaluation (RESTOR-MV) of functional ischemic mitral regurgitation.

BACKGROUND: Functional ischemic mitral regurgitation (MR) frequently arises after myocardial infarction; it is characterized by annular enlargement or lateral displacement of the subvalvular apparatus. Coapsys is a ventricular-annular remodeling device designed to treat functional ischemic MR; it does not require cardiopulmonary bypass. Initial intraoperative results of the RESTOR-MV randomized clinical trial are presented. METHODS: Patients referred for coronary artery bypass grafting with preoperative MR grade of 2 or greater were studied, excluding those with structural valve abnormalities. The Coapsys device, which consists of two epicardial pads connected by a flexible cord, was surgically implanted in 19 patients. Under epicardial echocardiographic guidance, the cord was passed through the left ventricle and tightened externally to improve leaflet coaptation and stabilize the ventricular wall; tightening was conducted with color flow Doppler imaging. RESULTS: Patients were 64.5 +/- 9.2 years old with an ejection fraction of 0.383 +/- 0.089 and received 2.7 +/- 1.1 grafts. Intraoperative MR grade was 2.7 +/- 0.8 after induction and was reduced to 0.4 +/- 0.7 after implantation (p < 0.0001). Mean epicardial dimension was reduced from 8.5 +/- 1.2 to 6.4 +/- 0.9 cm (p < 0.0001). Intraoperative MR was reduced in 95% (18 of 19) of patients, and 84% (16 of 19) had MR grade 1 or less after implantation. All implants were performed without cardiopulmonary bypass or conversion to standard annuloplasty. No hemodynamic compromise or structural damage to the mitral apparatus was noted. Significant acute remodeling was noted in the left ventricular dimensions. CONCLUSIONS: In patients without structural valve disease, the Coapsys device acutely reduces functional MR. Further randomized evaluation will assess long-term stability and compare it with standard annuloplasty techniques.

Aged↗
PubMedDate not supplied

Exercise and regional bone mineral density in postmenopausal women: a meta-analytic review of randomized trials.

By using the meta-analytic approach, the purpose of this study was to examine the effects of exercise on regional bone mineral density in postmenopausal women. A total of 11 randomized trials yielding 40 outcome measures and a total of 719 subjects (370 exercise, 349 nonexercise) met the criteria for inclusion: (1) randomized trials; (2) exercise as a primary intervention in postmenopausal women; (3) changes in regional bone mineral density reported; (4) comparative nonexercise group included; (5) studies published in English-language journals between January 1975 and December 1995. Across all designs and categories, treatment effect changes in bone density, weighted by sample size, ranged from -17.10 to 17.30% (mean, 0.27%; 95% confidence interval, 0.16-0.37%). When analyzed separately, sample weighted decreases of approximately -0.51 and -0.86% were found for exercise and nonexercise groups, respectively. Larger effects were observed when groups that did not measure bone density specific to the site loaded and groups that received some type of supplementation (calcium or hormone replacement therapy) were deleted from the model (mean change, 0.76%; 95% confidence interval, 0.6-0.93). Both aerobic and strength training enhanced regional bone mineral density (mean change: aerobic, 1.62% and 95% confidence interval, 1.12-2.12; strength, 0.65% and 95% confidence interval, 0.48-0.83). In conclusion, meta-analytic review of included studies suggests that exercise may slow the rate of bone loss in postmenopausal women. However, it is premature to form strong conclusions regarding the effects of exercise on regional bone mineral density in postmenopausal women. A need exists for additional, well designed studies on this topic before a recommendation can be made regarding the efficacy of exercise as a nonpharmacologic therapy for maintaining and/or increasing regional bone mineral density in postmenopausal women.

Absorptiometry, Photon↗
PubMed2004

Interventions for improving adherence to treatment in patients with high blood pressure in ambulatory settings.

BACKGROUND: Lack of adherence to blood pressure lowering medication is a major reason for poor control of hypertension worldwide. Interventions to improve adherence to antihypertensive medication have been evaluated in randomised trials but it is unclear which interventions are effective. OBJECTIVES: To determine the effectiveness of interventions aiming to increase adherence to blood pressure lowering medication in adults with high blood pressure SEARCH STRATEGY: All-language search of all articles (any year) in the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, and CINAHL in April 2002. SELECTION CRITERIA: RCTs of interventions to increase adherence to blood pressure lowering medication in adults with essential hypertension in primary care, with adherence to medication and blood pressure control as outcomes DATA COLLECTION AND ANALYSIS: Two authors extracted data independently and in duplicate and assessed each study according to the criteria outlined by the Cochrane Collaboration Handbook. MAIN RESULTS: We included 38 studies testing 58 different interventions and containing data on 15519 patients. The studies were conducted in nine countries between 1975 and 2000. The duration of follow-up ranged from two to 60 months. Due to heterogeneity between studies in terms of interventions and the methods used to measure adherence, we did not pool the results. Simplifying dosing regimens increased adherence in seven out of nine studies, with a relative increase in adherence of 8 per cent to 19.6 per cent. Motivational strategies were successful in 10 out of 24 studies with generally small increases in adherence up to a maximum of 23 per cent. Complex interventions involving more than one technique increased adherence in eight out of 18 studies, ranging from 5 per cent to a maximum of 41 per cent. Patient education alone seemed largely unsuccessful. REVIEWERS' CONCLUSIONS: Reducing the number of daily doses appears to be effective in increasing adherence to blood pressure lowering medication and should be tried as a first line strategy, although there is less evidence of an effect on blood pressure reduction. Some motivational strategies and complex interventions appear promising, but we need more evidence on their effect through carefully designed RCTs.

Antihypertensive Agents↗
PubMed2006

Media-based behavioural treatments for behavioural problems in children.

BACKGROUND: Many approaches are used to address behavioural problems in childhood including medication or, more usually, psychological treatments either directly with the child and/or his/her family. Behavioural and cognitive-behavioural interventions have been shown to be highly effective but access to these treatments is limited due to factors such as time and expense. Presenting the information parents need in order to manage these behaviour problems in booklet or other media-based format would most likely reduce the cost and increase access to these interventions. OBJECTIVES: To review the effects of media-based cognitive-behavioural therapies for any young person with a behavioural disorder (diagnosed using a recognised instrument) compared to standard care and no-treatment controls. SEARCH STRATEGY: The following electronic databases were systematically searched: CENTRAL (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to August 2005), EMBASE (1980 to August 2005), PsycINFO (1887 to August 2005), CINAHL (1982 to August 2005), Biosis (1985 to August 2005) and Sociofile (1974 to August 2005). References in all selected trials were checked for other trials and experts in the field were contacted for additional information. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials (e.g. trials which used sequential randomisation) of media-based behavioural treatments for behaviour problems in children. DATA COLLECTION AND ANALYSIS: Abstracts and titles of studies identified from searches of electronic databases were read to determine whether they met the inclusion criteria. Full copies of those possibly meeting these criteria from electronic or other searches were assessed by the reviewers and queries were resolved by discussion. Data were analysed using RevMan 4.2. MAIN RESULTS: Eleven studies including 943 participants were included within this review. In general, media-based therapies for behavioural disorders in children had a moderate, if variable, effect when compared with both no-treatment controls with effects sizes ranging from -0.12 (-1.65, 1.41) to -32.60 (-49.93, -15.27) and as and adjunct to medication with effect sizes ranging from -2.71 (-5.86, -0.44) to -39.55 (-75.01, -4.09). Significant improvements were made with the addition of up to two hours of therapist time. AUTHORS' CONCLUSIONS: These formats of delivering behavioural interventions for carers of children are worth considering in clinical practice. Media-based interventions may, in some cases, be enough to make clinically significant changes in a child's behaviour, and may reduce the amount of time primary care workers have to devote to each case. They can also be used as the first stage of a stepped care approach. Consequently this would increase the number of families who could possibly benefit from these types of intervention, releasing clinician time that can be reallocated to more complex cases. Media-based therapies would therefore appear to have both clinical and economic implications as regards the treatment of children with behavioural problems.

Adolescent↗
PubMed2004

A comparison of three different sources of data in assessing the frequencies of adverse reactions to amiodarone.

AIMS: To compare the frequencies of adverse drug reactions (ADRs) to amiodarone from three separate datasets: (i) a meta-analysis of clinical trials, (ii) spontaneous reports published in medical journals, and (iii) spontaneous reports sent to the World Health Organization (WHO). METHODS: We classified the ADRs into eight categories, based on the site involved, and built a rank order of the ADRs by category (from most to least commonly reported) for each dataset. We also calculated the relative proportions for all eight ADR categories within each dataset, in order to be able to compare the distributions of ADR frequencies: we assigned an index value of 1.0 to the frequency of respiratory toxicity in each set and calculated values for the other ADRs relative to respiratory toxicity. RESULTS: Thyroid disorders were the most commonly reported ADRs in the WHO dataset. In contrast, published case reports showed a preponderance of respiratory disorders, while in the meta-analysis cardiac conduction problems were the most frequent. The rank orders of ADRs differed among the three datasets, as did the index values of specific ADR categories with respect to the respiratory category. CONCLUSIONS: The distributions of ADR rank order and relative frequencies are dissimilar among the three datasets, as each dataset compiles information in a different way. Nevertheless, each dataset has its own specific strengths, and all three should be used together in obtaining a complete picture of a drug's safety profile. Important therapeutic and regulatory decisions should not simply be based on one source of data.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Interventions used to improve control of blood pressure in patients with hypertension.

BACKGROUND: It is well recognized that patients with high blood pressure (hypertension) in the community frequently fail to meet treatment goals- a condition labeled as "uncontrolled" hypertension. The optimal way in which to organize and deliver care to patients who have hypertension so that they reach treatment goals has not been clearly identified. OBJECTIVES: To determine the effectiveness of interventions to improve control of blood pressure in patients with elevated blood pressure. To evaluate the ability of reminders to improve the follow-up of patients with elevated blood pressure. SEARCH STRATEGY: All-language search of all articles (any year) in the Cochrane Controlled Trials Register (CCTR), Medline and Embase from June 2000. SELECTION CRITERIA: Randomised controlled trials (RCTs) of patients with hypertension that evaluated the following interventions: (1) self-monitoring (2) educational interventions directed to the patient (3) educational interventions directed to the health professional (4) health professional (nurse or pharmacist) led care (5) organisational interventions that aimed to improve the delivery of care (6) appointment reminder systems. OUTCOMES ASSESSED WERE: (1) mean systolic and diastolic blood pressure (2) control of blood pressure (3) proportion of patients followed up at clinic. DATA COLLECTION AND ANALYSIS: Two authors extracted data independently and in duplicate and assessed each study according to the criteria outlined by the Cochrane Collaboration Handbook. MAIN RESULTS: 59 RCTs met our inclusion criteria. The methodological quality of included studies was variable. An organized system of regular review linked to vigorous antihypertensive drug therapy was shown to reduce blood pressure (weighted mean difference -8.2/-4.2 mmHg, -11.7/-6.5 mmHg, -10.6/-7.6 mmHg for 3 strata of entry blood pressure) and all-cause mortality at five years follow-up (6.38% versus 7.78%, difference 1.4%) in a single large RCT- the Hypertension Detection and Follow-Up study. Other interventions had variable effects. Self-monitoring was associated with moderate net reduction in diastolic blood pressure (weighted mean difference (WMD): -2.03 mmHg, 95%CI: -2.69 to -1.38 mmHg, respectively. Appointment reminders increased the proportion of individuals who attended for follow-up. RCTs of educational interventions directed at patients or health professionals were heterogeneous but appeared unlikely to be associated with large net reductions in blood pressure by themselves. Health professional (nurse or pharmacist) led care may be a promising way of delivering care, with the majority of RCTs being associated with improved blood pressure control, but requires further evaluation. AUTHORS' CONCLUSIONS: Family practices and community-based clinics need to have an organized system of regular follow-up and review of their hypertensive patients. Antihypertensive drug therapy should be implemented by means of a systematic stepped care approach when patients do not reach target blood pressure levels.

Antihypertensive Agents↗
PubMed2000

Interventions for helping patients to follow prescriptions for medications.

BACKGROUND BACKGROUND: Efforts to assist patients with adherence to prescribed, self-administered medications might improve the benefits and efficiency of health care. OBJECTIVES OBJECTIVE: To update an ongoing review summarising the results of randomised controlled trials (RCTs) of interventions to help patients follow prescriptions for medications, focusing on trials that measured both adherence and clinical outcomes. SEARCH STRATEGY: Computerised searches to July 1998 in MEDLINE, CINAHL, The Cochrane Library, International Pharmaceutical Abstracts (IPA), PsychInfo, Sociofile, and HSTAR; bibliographies in articles on patient adherence; articles in the reviewers' personal collections; and contact with authors. SELECTION CRITERIA: Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. DATA COLLECTION AND ANALYSIS: Information on study design features, interventions and controls, and findings were extracted by one reviewer (PM) and a research assistant and confirmed by two of the other reviewers. The studies were too disparate to warrant meta-analysis. MAIN RESULTS: For short-term treatments, one study, of counselling and written information, showed an effect on adherence and clinical outcome. Ten of 19 interventions for long-term treatments reported in 17 RCTs were associated with improvements in adherence, but only nine interventions led to improvements in treatment outcomes. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, counselling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention. Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. Two studies showed that telling patients about adverse effects of treatment did not affect their adherence. REVIEWER'S CONCLUSIONS: The full benefits of medications cannot be realised at currently achievable levels of adherence. Current methods of improving adherence for chronic health problems are mostly complex and not very effective. More studies of innovative approaches to assist patients to follow medication prescriptions are needed.

Drug Prescriptions↗
PubMed2003

From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.

BACKGROUND: A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol. OBJECTIVE: To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes. DESIGN: A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group). METHODS: An incremental cost-effectiveness analysis and comparison of outcomes was performed using chi-squared tests and Kaplan-Meier survival analysis. A survey was carried out using a questionnaire in the five hospitals on local guidelines for management of ulcer bleeding, and its results were analysed qualitatively. The measure of effectiveness is the number of prevented rebleedings. Further variables were length of hospital stay and length of intensive care unit (ICU) stay. RESULTS: The cost for the prevention of one additional rebleeding by repeated fibrin glue treatment amounts to 14,316 +/- 4981 euros (incremental cost-effectiveness ratio). There were no significant differences in length of stays in ICU or in hospital. The physicians did not change their management plans for patients with upper-gastrointestinal bleeding. In a survey, it was seen that other factors, such as local guidelines, attitudes towards new treatment options, and ease of handling of drugs, are more important than a result of a single study for a behavioural change of the doctors. CONCLUSIONS: The study was not designed prospectively to address a pharmacoeconomic question. As relevant variables (e.g. length of ICU stay) could not be reliably ascertained retrospectively, this may lead to biased estimates of the incremental cost-effectiveness ratio.

Cost-Benefit Analysis↗
PubMed2003

[The impact of the Multicenter Automatic Defibrillator Implantation Trial II in a university hospital--do all patients with myocardial infarction and reduced left ventricular function need an implantable cardioverter-defibrillator?].

BACKGROUND AND OBJECTIVES: Patients with coronary artery disease (CAD) and severely compromised left ventricular ejection fraction are at high risk to die from sudden cardiac death. The Multicenter Automatic Defibrillator implantation Trial II (MADIT II) shows a significant benefit of a cardioverter-defibrillator (ICD) therapy compared to standard treatment alone in this selected group of patients. The objective of the present study was to investigate the number of patients who will fulfil the MADIT II criteria and are candidates for prophylactic ICD implantation. METHODS AND MATERIAL: From January to December 2001 a total of 2653 patients underwent coronary angiography at our institution due to angina pectoris, positive exercise stress testing, pathological SPECT myocardial perfusion images, suspected dilated cardiomyopathy or ventricular arrhythmias. According to the MADIT II inclusion criteria patients with significant coronary artery disease (diameter stenosis > 50%), ejection fraction < 0.31% and previous myocardial infarction were included. Exclusion criteria were acute coronary syndromes, patients with ventricular tachyarrhythmias or an existing indication for ICD therapy, and patients with coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within the past or following three months. RESULTS: Out of 2653 patients 185 (7%) had an ejection fraction less than 0.31, 149 (5.6%) showed significant coronary artery stenosis and 70 (2.6%) patients fulfilled the MADIT II criteria. The mean age of these patients was 68 +/- 9 years, the left ventricular ejection fraction 24 +/- 6. In 37 patients an ICD system was implanted according to the existing guidelines. 70 patients met the MADIT II inclusion criteria, resulting in an increase of 189% of ICD implantations per year. CONCLUSION: 2.6% out of 2653 patients who were referred to coronary angiography fulfilled the criteria of MADIT II. The expanding indication for ICD therapy will result in an annual increase of 70 (189%) prophylactic ICD implantations in our study population.

Aged↗
PubMedDate not supplied

Systematic reviews and their application to research in speech and language therapy: a response to T. R. Pring's 'Ask a silly question: two decades of troublesome trials' (2004).

BACKGROUND: The advent of evidence-based healthcare has seen a rise in the use of systematic reviews to bring together the findings from research studies. The use of systematic reviews in speech and language therapy (SLT) was criticized in this journal in 2004 by T. R. Pring. It was claimed that their findings are misleading due to the potential inclusion of biased data, and uninformative due to a lack of detail in the reporting of interventions. It is argued that outcome research should be carried out in a series of phases in which small-scale research precedes large-scale research. This, it is argued, is most likely to demonstrate statistically significant effects and also help to ensure that therapies become sufficiently defined so that clinicians can apply them in practice. AIMS: This paper argues that the above criticism of systematic reviews is based on a narrow conception of their capabilities: on the popular misapprehension that all systematic reviews answer effectiveness questions using only experimental studies and contain meta-analyses. Different methods for systematic reviews are described and their application within clinical outcome research is discussed with reference to a phased structure for empirical enquiry. MAIN CONTRIBUTION: Systematic reviews seek to identify and synthesize information within a given topic area. They are used to answer a wide range of research questions and the studies they include are not limited exclusively to experimental designs. Methods of synthesis can include both statistical approaches, such as meta-analysis, and 'qualitative' approaches, such as meta-ethnography and thematic analysis. Knowledge of the current state of research is essential for a sequentially phased approach within outcome research to operate. Since systematic reviews are summaries of research activity, they can provide this knowledge and should therefore be considered a valuable tool within outcome research. CONCLUSIONS: A systematic review using 'qualitative' and/or statistical methods for combining studies can be carried out within or across any of the phases within outcome research. Far from being uninformative, this can help bring together what is, and what is not, known and indicate the kinds of therapies that may be beneficial in the clinical setting and therapies which would benefit from further research and development.

Evidence-Based Medicine↗
PubMed1997

How to apply the experience from the diabetes control and complications trial to children and adolescents?

The Diabetes Control and Complications Trial (DCCT) taught us to set target blood glucose (BG) and glycohaemoglobin (GHb) goals, to ensure safety regarding hypoglycaemia, to be flexible with insulin and meal planning and to offer frequent contact with diabetes educators, dieticians, psychologists and social workers as well as with diabetologists skilled in intensified management. Insulin dosage should be individualized based upon frequent BG monitoring results. Co-ordinated multidisciplinary health care teams provide optimum problem-solving rather than disaster control working with children, adolescents and their families. The patient and the family should form the central core of the diabetes team with outpatient follow-up every month and frequent telephone contact between visits. GHb should be obtained at least every 1-2 months to provide feedback as based on the DCCT intensified treatment cohort. Insulin lispro helps minimize hypoglycaemia and makes insulin administration more convenient and timely. Barriers to improvement should be identified: learning problems, concomitant significant illnesses (epilepsy, coeliac and thyroid disease, asthma) and family problems. Ensure age-appropriate transfer of self-care but continue adult supervision. Educate, motivate and re-educate. Meal planning includes not only carbohydrate counting but also maintaining normal lipids and energy needs for growth and development as well as strategies for activity compensation and hypoglycaemia prevention. Consideration of protein restriction may be required in adolescents with microalbuminuria. Individualized multidose insulin algorithms allow reactive (corrective) decisions based upon capillary BG results plus proactive (anticipatory) decisions to compensate for expected BG changes from changes in activity, food and/or illness using a multidose insulin schedule. The number of insulin injections does not define an intensified insulin treatment programme but rather the ability to target and achieve near-normal BG values as often as possible - without severe episodes of hypoglycaemia. Self BG monitoring is a key to success. Long-term monitoring should include not only frequent GHb but also at least annual fasting lipids, thyroid functions and microalbuminuria as well as dilated retinal exams, blood pressure, growth charting and Tanner staging.

Adolescent↗
PubMed2006

The role of angiotensin II type 1 receptor antagonists in elderly patients with hypertension.

Hypertension is a major risk factor for stroke and coronary events in elderly people and clinical trials have shown that treatment of hypertension with various drugs can result in a substantial reduction in cerebrovascular and cardiovascular events. The angiotensin II type 1 (AT1) receptor antagonists are the newest class of antihypertensive agents to be used widely in clinical practice. AT1 receptor antagonists can generally be given once-daily. They are also extremely well tolerated with minimal first-dose hypotension and an incidence of adverse effects similar to that seen with placebo. Adverse event rates are significantly lower than with other classes of antihypertensive drugs including ACE inhibitors. These factors result in improved compliance and increased rates of continuance on therapy. AT1 receptor antagonists show similar efficacy in lowering blood pressure to other classes of antihypertensive agents and their antihypertensive effect is potentiated when they are given concomitantly with low-dose thiazide diuretics. AT1 receptor antagonists are eliminated predominantly by the hepatic route but most are not subject to extensive metabolism and interactions with other drugs are uncommon. This is an advantage in the elderly, who are often receiving multiple medications which increases the risk for adverse drug interactions. Dose adjustments are not usually required in the elderly unless there is plasma volume depletion. Although plasma AT1 receptor antagonist concentrations are generally higher in the elderly than in younger subjects, this pharmacokinetic difference may be balanced by decreased activation of the circulating renin-angiotensin-aldosterone system in the elderly. Recent clinical studies in high-risk hypertensive patients with left ventricular hypertrophy or in patients with diabetic nephropathy or heart failure have demonstrated that AT1 receptor antagonists can improve clinical outcomes to a similar or sometimes greater extent than other antihypertensive agents. Many of these studies have included large numbers of older patients and have confirmed the excellent tolerability profile of these drugs. Thus, AT1 receptor antagonists should be considered as a possible first-line treatment or as a component of combination therapy in patients with type 2 diabetes mellitus and microalbuminuria or nephropathy and as an alternative or additional treatment to ACE inhibitors in patients with heart failure or left ventricular dysfunction. AT1 receptor antagonists also appear to reduce the onset of new diabetes compared with some other antihypertensive drugs. The benefits in terms of organ protection have mainly been seen in studies using higher doses of particular AT1 receptor antagonists and it is not certain at present whether these results can be extrapolated to other members of the class. As the elderly are more likely to have developed organ damage related to hypertension or to have heart failure or diabetes as concomitant conditions, AT1 receptor antagonists represent an appropriate option for many elderly patients. The main disadvantage of these drugs is the cost of the medication but this may be offset by their improved tolerability with fewer adverse reactions and thus increased compliance, resulting in better blood pressure control and fewer clinical events. Overall, AT1 receptor antagonists are well tolerated and efficacious for blood pressure-lowering when given as a single daily dose in elderly patients and have many potential benefits in high-risk hypertensive subjects.

Age Factors↗
PubMed2005

Efficacy of aspirin plus extended-release dipyridamole in preventing recurrent stroke in high-risk populations.

OBJECTIVE: To assess the efficacy of aspirin plus extended-release dipyridamole compared with aspirin alone for the prevention of recurrent stroke among high-risk groups. DESIGN: A post hoc analysis was conducted using data from the European Stroke Prevention Study 2. Rates of annual strokes and vascular events were determined for the aspirin plus extended-release dipyridamole group (n = 1650) and the aspirin-only group (n = 1649), and were stratified by risk subgroup and univariate risk factors. Stroke models from the Framingham Study and the Stroke Prognostic Instrument II were applied to subjects in the European Stroke Prevention Study 2 to categorize patients into risk groups. RESULTS: Compared with aspirin alone, aspirin plus extended-release dipyridamole demonstrated a more pronounced efficacy in reducing the risk for stroke and vascular events among patients younger than 70 years; those with hypertension, prior stroke, or transient ischemic attack; current smokers; and those with any prior cardiovascular disease. Relative hazard reductions favored the combination of aspirin plus extended-release dipyridamole, and were greatest for the high-risk Framingham Study group and the moderate-risk Stroke Prognostic Instrument II subgroup. CONCLUSION: Aspirin plus extended-release dipyridamole is more effective than aspirin alone at preventing stroke, and the difference in efficacy increases in higher-risk patients.

Adult↗