Risk of acute kidney injury and survival in patients treated with Metformin:an observational cohort study

Background: Whether metformin precipitates lactic acidosis in patients with chronic kidney disease (CKD) remains under debate. We examined whether metformin use was associated with an increased risk of acute kidney injury (AKI) as a proxy for lactic acidosis and whether survival among those with AKI varied by metformin exposure. Methods: All individuals with type 2 diabetes and available prescribing data between 2004 and 2013 in Tayside, Scotland were included. The electronic health record for diabetes which includes issued prescriptions was linked to laboratory biochemistry, hospital admission, death register and Scottish Renal Registry data. AKI events were defined using the Kidney Disease Improving Global Outcomes criteria with a rise in serum creatinine of at least 26.5 μmol/l or a rise of greater than 150% from baseline for all hospital admissions. Cox Regression Analyses were used to examine whether person-time periods in which current metformin exposure occurred were associated with an increased rate of first AKI compared to unexposed periods. Cox regression was also used to compare 28 day survival rates following first AKI events in those exposed to metformin versus those not exposed. Results: Twenty-five thousand one-hundred fourty-eight patients were included with a total person-time of 126,904 person years. 4944 (19.7%) people had at least one episode of AKI during the study period. There were 32.4 cases of first AKI/1000pyrs in current metformin exposed person-time periods compared to 44.9 cases/1000pyrs in unexposed periods. After adjustment for age, sex, diabetes duration, calendar time, number of diabetes drugs and baseline renal function, current metformin use was not associated with AKI incidence, HR 0.94 (95% CI 0.87, 1.02, p = 0.15). Among those with incident AKI, being on metformin at admission was associated with a higher rate of survival at 28 days (HR 0.81, 95% CI 0.69, 0.94, p = 0.006) even after adjustment for age, sex, pre-admission eGFR, HbA1c and diabetes duration. Conclusions: Contrary to common perceptions, we found no evidence that metformin increases incidence of AKI and was associated with higher 28 day survival following incident AKI

A Comparative Exploration of Community Pharmacists' Views on the Nature and Management of Over-the-Counter (OTC) and Prescription Codeine Misuse in Three Regulatory Regimes: Ireland, South Africa and the United Kingdom

Misuse of codeine containing preparations is a public health concern given the potential for associated harms and dependence. This study explores the perspectives of community pharmacists in three regulatory regimes on issues of customer misuse of over-the-counter (OTC) and prescribed codeine. A qualitative design comprising six focus groups (n = 45) was conducted in Ireland, United Kingdom, South Africa. Transcripts were analysed using the constant comparative method of content analysis. Pharmacists described popular codeine-containing products and the need for improved medicine information and warning labels. Issues around legitimate availability of codeine and regulatory status; presence of therapeutic need; difficulties in customer–pharmacist communication; business environments and retail focus were raised. Participants also discussed how they identified customers potentially misusing codeine and difficulties in relationships between pharmacists and prescribers. A number of recommendations were put forward as ways to manage the issues. The study highlights the difficulties encountered by community pharmacists operating under various regulatory regimes when supplying codeine containing preparations in negotiating patient awareness and compliance and potential ways to deal with misuse and dependence

Clinical inertia in poorly controlled elderly hypertensive patients: a cross-sectional study in Spanish physicians to ascertain reasons for not intensifying treatment

Background Clinical inertia, the failure of physicians to initiate or intensify therapy when indicated, is a major problem in the management of hypertension and may be more prevalent in elderly patients. Overcoming clinical inertia requires understanding its causes and evaluating certain factors, particularly those related to physicians. Objective The objective of our study was to determine the rate of clinical inertia and the physician-reported rea- sons for it. Conclusion Physicians provided reasons for not intensi- fying treatment in poorly controlled patients in only 30 % of instances. Main reasons for not intensifying treatment were borderline BP values, co-morbidity, suspected white coat effect, or perceived difficulty achieving target. nJCI was associated with high borderline BP values and car- diovascular diseas

Variation in antibiotic treatment for diabetic patients with serious foot infections: A retrospective observational study

<p>Abstract</p> <p>Background</p> <p>Diabetic foot infections are common, serious, and diverse. There is uncertainty about optimal antibiotic treatment, and probably substantial variation in practice. Our aim was to document whether this is the case: A finding that would raise questions about the comparative cost-effectiveness of different regimens and also open the possibility of examining costs and outcomes to determine which should be preferred.</p> <p>Methods</p> <p>We used the Veterans Health Administration (VA) Diabetes Epidemiology Cohorts (DEpiC) database to conduct a retrospective observational study of hospitalized patients with diabetic foot infections. DEpiC contains computerized VA and Medicare patient-level data for VA patients with diabetes since 1998, including demographics, ICD-9-CM diagnostic codes, antibiotics prescribed, and VA facility. We identified all patients with ICD-9-CM codes for cellulitis/abscess of the foot and then sub-grouped them according to whether they had cellulitis/abscess plus codes for gangrene, osteomyelitis, skin ulcer, or none of these. For each facility, we determined: 1) The proportion of patients treated with an antibiotic and the initial route of administration; 2) The first antibiotic regimen prescribed for each patient, defined as treatment with the same antibiotic, or combination of antibiotics, for at least 5 continuous days; and 3) The antibacterial spectrum of the first regimen.</p> <p>Results</p> <p>We identified 3,792 patients with cellulitis/abscess of the foot either alone (16.4%), or with ulcer (32.6%), osteomyelitis (19.0%) or gangrene (32.0%). Antibiotics were prescribed for 98.9%. At least 5 continuous days of treatment with an unchanged regimen of one or more antibiotics was prescribed for 59.3%. The means and (ranges) across facilities of the three most common regimens were: 16.4%, (22.8%); 15.7%, (36.1%); and 10.8%, (50.5%). The range of variation across facilities proved substantially greater than that across the different categories of foot infection. We found similar variation in the spectrum of the antibiotic regimen.</p> <p>Conclusions</p> <p>The large variations in regimen appear to reflect differences in facility practice styles rather than case mix. It is unlikely that all regimens are equally cost-effective. Our methods make possible evaluation of many regimens across many facilities, and can be applied in further studies to determine which antibiotic regimens should be preferred.</p

Outcomes associated with matching patients' treatment preferences to physicians' recommendations: study methodology

<p>Abstract</p> <p>Background</p> <p>Patients often express strong preferences for the forms of treatment available for their disease. Incorporating these preferences into the process of treatment decision-making might improve patients' adherence to treatment, contributing to better outcomes. We describe the methodology used in a study aiming to assess treatment outcomes when patients' preferences for treatment are closely matched to recommended treatments.</p> <p>Method</p> <p>Participants included patients with moderate and severe psoriasis attending outpatient dermatology clinics at the University Medical Centre Mannheim, University of Heidelberg, Germany. A self-administered online survey used conjoint analysis to measure participants' preferences for psoriasis treatment options at the initial study visit. Physicians' treatment recommendations were abstracted from each participant's medical records. The Preference Matching Index (PMI), a measure of concordance between the participant's preferences for treatment and the physician's recommended treatment, was determined for each participant at t₁(initial study visit). A clinical outcome measure, the Psoriasis Area and Severity Index, and two participant-derived outcomes assessing treatment satisfaction and health related quality of life were employed at t₁, t₂(twelve weeks post-t₁) and t₃(twelve weeks post-t₂). Change in outcomes was assessed using repeated measures analysis of variance. The association between participants' PMI scores at t₁and outcomes at t₂and t₃was evaluated using multivariate regressions analysis.</p> <p>Discussion</p> <p>We describe methods for capturing concordance between patients' treatment preferences and recommended treatment and for assessing its association with specific treatment outcomes. The methods are intended to promote the incorporation of patients' preferences in treatment decision-making, enhance treatment satisfaction, and improve treatment effectiveness through greater adherence.</p

The counseling african americans to control hypertension (caatch) trial: baseline demographic, clinical, psychosocial, and behavioral characteristics

<p>Abstract</p> <p>Background</p> <p>Effectiveness of combined physician and patient-level interventions for blood pressure (BP) control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH) Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC) in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs).</p> <p>Methods</p> <p>Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (<it>e.g</it>., BP, anti-hypertensive medications), psychosocial (<it>e.g</it>., depression, medication adherence, self-efficacy), and behavioral (<it>e.g</it>., exercise, diet) characteristics were gathered through direct observation, chart review, and interview.</p> <p>Results</p> <p>The sample was primarily female (71.6%), middle-aged (mean age = 56.9 ± 12.1 years), high school educated (62.4%), low-income (72.4% reporting less than $20,000/year income), and received Medicaid (35.9%) or Medicare (12.6%). Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs). One-quarter (25.6%) of the sample had resistant hypertension; one-half (55.7%) reported medication non-adherence. Most (79.7%) reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes mellitus was common (35.8%), and moderate/severe depression was present in 16% of participants. Participants were sedentary (835.3 ± 1,644.2 Kcal burned per week), obese (59.7%), and had poor global physical health, poor eating habits, high health literacy, and good overall mental health.</p> <p>Conclusions</p> <p>A majority of patients in the CAATCH trial exhibited adverse lifestyle behaviors, and had significant medical and psychosocial barriers to adequate BP control. Trial outcomes will shed light on the effectiveness of evidence-based interventions for BP control when implemented in real-world medical settings that serve high numbers of low-income hypertensive African-Americans with multiple co-morbidity and significant barriers to behavior change.</p

Risk of subsequent ischemic and hemorrhagic stroke in patients hospitalized for immune-mediated diseases: a nationwide follow-up study from Sweden

Background: Certain immune-mediated diseases (IMDs) have been associated with increased risk for cardiovascular disorders. The aim of the present study was to examine whether there is an association between 32 different IMDs and first hospitalization for ischemic or hemorrhagic stroke. Methods: All individuals in Sweden hospitalized with a main diagnosis of IMD (without previous or coexisting stroke), between January 1, 1987 and December 31, 2008 (n = 216,291), were followed for first hospitalization for ischemic or hemorrhagic stroke. The reference population was the total population of Sweden. Adjusted standardized incidence ratios (SIRs) for ischemic and hemorrhagic stroke were calculated. Results: Totally 20 and 15 of the 32 IMDs studied, respectively, were associated with an increased risk of ischemic and hemorrhagic stroke during the follow-up. The overall risks of ischemic and hemorrhagic stroke during the first year after hospitalization for IMD were 2.02 (95 % CI 1.90-2.14) and 2.65 (95 % CI 2.27-3.08), respectively. The overall risk of ischemic or hemorrhagic stroke decreased over time, to 1.50 (95 % CI 1.46-1.55) and 1.83 (95 % CI 1.69-1.98), respectively, after 1-5 years, and 1.29 (95 % CI 1.23-1.35) and 1.47 (95 % CI 1.31-1.65), respectively, after 10+ years. The risk of hemorrhagic stroke was >= 2 during the first year after hospitalization for seven IMDs: ankylosing spondylitis (SIR = 8.11), immune thrombocytopenic purpura (SIR = 8.60), polymyalgia rheumatica (SIR = 2.06), psoriasis (SIR = 2.88), rheumatoid arthritis (SIR = 3.27), systemic lupus erythematosus (SIR = 8.65), and Wegener ' s granulomatosis (SIR = 5.83). The risk of ischemic stroke was >= 2 during the first year after hospitalization for twelve IMDs: Addison's disease (SIR = 2.71), Crohn's disease (SIR = 2.15), Grave's disease (SIR = 2.15), Hashimoto's thyroiditis (SIR = 2.99), immune thrombocytopenic purpura (SIR = 2.35), multiple sclerosis (SIR = 3.05), polymyositis/dermatomyositis (SIR = 3.46), rheumatic fever (SIR = 3.91), rheumatoid arthritis (SIR = 2.08), Sjgren's syndrome (SIR = 2.57), systemic lupus erythematosus (SIR = 2.21), and ulcerative colitis (SIR = 2.15). Conclusions: Hospitalization for many IMDs is associated with increased risk of ischemic or hemorrhagic stroke. The findings suggest that several IMDs are linked to cerebrovascular disease