Background Systematic data on discontinuation of statins in routine practice of medicine are limited. Objective To investigate reasons for statin discontinuation and the role of statin-related events (clinical events / symptoms thought to have been caused by statins) in routine care settings. Design A retrospective cohort study Setting Practices affiliated with one of two academic hospitals. Patients Adults who received a statin prescription between 01/01/2000 and 12/31/2008. Measurements Information on reasons for statin discontinuations was obtained from a combination of structured electronic medical record (EMR) entries and analysis of electronic provider notes by validated software. Results Statins were discontinued at least temporarily for 57,292 out of 107,835 patients. Statin-related events were documented for 18,778 (17.4%) patients. Statins were discontinued at least temporarily by 11,124 of these patients, 6,579 (59.1%) of whom were rechallenged with a statin over the subsequent 12 months. Most patients who were rechallenged (92.2%) were still taking a statin 12 months after the statin-related event. Among the 2,721 patients who were rechallenged with the same statin to which they had a statin-related event, 1,295 (47.6%) were on the same statin 12 months later, including 996 on the same or higher dose. Limitation Statin discontinuations and statin-related events were assessed in practices affiliated with two academic medical centers. Utilization of secondary data could have led to missing or misinterpreted data as a result of incomplete documentation. Natural language processing tools used to compensate for the low (30%) proportion of reasons for statin discontinuation documented in structured EMR fields are not perfectly accurate. Conclusion Statin-related events are commonly reported and often lead to their discontinuation. However, most patients who are rechallenged can tolerate statins long-term. This suggests that many of the statin-related events may have other etiologies, are tolerable or may be specific to individual statins rather than the entire drug class.
Unintentional medication discrepancies are common and more often due to errors taking an accurate medication history than errors reconciling this history with patient orders. Focusing on accurate medication histories, on potential medication errors at discharge, and on identifying high-risk patients for more intensive interventions may improve medication safety during and after hospitalization.
OBJECTIVEHypoglycemia is associated with adverse outcomes in mixed populations of patients in intensive care units. It is not known whether the same risks exist for diabetic patients who are less severely ill. In this study, we aimed to determine whether hypoglycemic episodes are associated with higher mortality in diabetic patients hospitalized in the general ward.RESEARCH DESIGN AND METHODSThis retrospective cohort study analyzed 4,368 admissions of 2,582 patients with diabetes hospitalized in the general ward of a teaching hospital between January 2003 and August 2004. The associations between the number and severity of hypoglycemic (≤50 mg/dl) episodes and inpatient mortality, length of stay (LOS), and mortality within 1 year after discharge were evaluated.RESULTSHypoglycemia was observed in 7.7% of admissions. In multivariable analysis, each additional day with hypoglycemia was associated with an increase of 85.3% in the odds of inpatient death (P = 0.009) and 65.8% (P = 0.0003) in the odds of death within 1 year from discharge. The odds of inpatient death also rose threefold for every 10 mg/dl decrease in the lowest blood glucose during hospitalization (P = 0.0058). LOS increased by 2.5 days for each day with hypoglycemia (P < 0.0001).CONCLUSIONSHypoglycemia is common in diabetic patients hospitalized in the general ward. Patients with hypoglycemia have increased LOS and higher mortality both during and after admission. Measures should be undertaken to decrease the frequency of hypoglycemia in this high-risk patient population.
A computerized medication reconciliation tool and process redesign were associated with a decrease in unintentional medication discrepancies with potential for patient harm. Software integration issues are likely important for successful implementation of computerized medication reconciliation tools.
Background VEGF signaling pathway inhibitor (anti-VEGF) therapy is associated with hypertension, but little is known about predisposing clinical characteristics. This study describes the real-world association between baseline clinical characteristics, blood pressure (BP) response, and survival in patients prescribed anti-VEGF therapies. Methods Clinical data from Partners HealthCare in Massachusetts was obtained from adults treated with anti-VEGF therapies (2002–2013). Treatment-induced hypertensive response was defined as worsening of pre-existing hypertension or new diagnosis of hypertension (if no prior hypertension history). Results Data from 1120 patients with renal cell carcinoma (32.2%), hepatocellular carcinoma (11.6%), gastrointestinal stromal tumors (12.5%) and other sarcomas (15.3%) were analyzed. Most patients received sunitinib (52%), sorafenib (25.9%) or pazopanib (18%). A treatment-induced hypertensive response was identified in 49.7% of treated patients. Pre-existing hypertension, present in 65.4%, was an independent risk factor for BP elevation (odds ratio (OR) 1.56, 95% confidence interval (CI) 1.27–1.92); other risk factors included age ≥60 years (OR 1.26, 95%CI 1.06–1.52), and body mass index (BMI) ≥25 kg/m2 (OR 1.26, 95%CI 1.04–1.53). Race, gender, anti-VEGF therapy prescribed, and baseline antihypertensive class were not significant risk factors. The absolute observed mean increase in BP was 21 mmHg (systolic) / 15 mmHg (diastolic), both in patients with and without pre-existing hypertension. The development of hypertension predicted improved survival (hazard ratio 0.76, 95%CI 0.65–0.89). Conclusions Pre-existing hypertension, age, and BMI identify patients at risk for significant anti-VEGF therapy-induced BP elevation. Hypertension appears to be a clinical biomarker of efficacy to anti-VEGF therapies in a broad range of malignancies.
Background Adrenal tumors are commonly discovered on abdominal imaging. The majority of adrenal tumors are classified as “non-functional” and considered to pose no health risk, whereas a minority will be considered “functional” because they secrete hormones that increase risk for metabolic and cardiovascular diseases. Objective To evaluate the hypothesis that “non-functional” adrenal tumors (NFAT) increase risk for developing cardiometabolic outcomes when compared with having no adrenal tumor. Design Cohort study. Setting Integrated hospital system. Participants Exposed participants with benign NFAT (n=242) and unexposed participants with no adrenal tumor (n=1237). Measurements Medical records were reviewed from the time of abdominal imaging for development of incident outcomes (hypertension, composite diabetes [pre-diabetes or type 2 diabetes], hyperlipidemia, cardiovascular events, chronic kidney disease) (mean 7.7 years). Primary analyses evaluated independent associations between exposure status and incident outcomes using adjusted generalized linear models. Secondary analyses evaluated relationships between NFAT and cortisol physiology. Results NFAT were associated with significantly higher risk for incident composite diabetes when compared with no adrenal tumor (adjusted RR=1.87, 95% CI: 1.17, 2.98; absolute risk: 30/110 vs. 72/615, 15.6%). No significant associations between NFAT and other outcomes were observed. Higher “normal” post-dexamethasone cortisol levels (<1.8 mcg/dL) associated with larger NFAT size and a higher prevalence of type 2 diabetes. Limitations Potential bias in the selection of participants and ascertainment of outcomes. Conclusions Participants with NFAT had a significantly higher risk of developing diabetes when compared to participants without adrenal tumors. These results prompt a re-assessment of whether the classification of benign adrenal tumors as “non-functional” adequately reflects the continuum of hormone secretion and metabolic risk they may harbor.
Background More frequent patient-provider encounters may lead to faster A1c, blood pressure and LDL control and improve outcomes but there are no guidelines for how frequently patients with diabetes should be seen. Methods This retrospective cohort study analyzed 26,496 patients with diabetes and elevated A1c, blood pressure, and/or LDL cholesterol treated by primary care physicians at two teaching hospitals between 1/1/2000 and 1/1/2009. Relationship between provider encounter (defined as a note in medical record) frequency and time to A1c, blood pressure and LDL control was assessed. Results Comparing patients who had encounters with their physicians between 1-2 weeks vs. 3-6 months, median time to A1c < 7.0% was 4.4 vs. 24.9 months (not on insulin) and 10.1 vs. 52.8 months (on insulin); median time to blood pressure < 130/85 mm Hg was 1.3 vs. 13.9 months; and median time to LDL < 100 mg/dL was 5.1 vs. 36.9 months, respectively (p < 0.0001 for all). In multivariable analysis, doubling the time between physician encounters led to a 35%, 17%, 87%, and 27% increase in median time to A1c (off and on insulin), blood pressure, and LDL targets, respectively (p < 0.0001 for all). Time to control decreased progressively as encounter frequency increased up to once every two weeks for most targets, consistent with pharmacodynamics of respective medication classes. Conclusions Biweekly primary care provider encounters are associated with fastest achievement of A1c, blood pressure, and LDL targets for patients with diabetes.
OBJECTIVEHypoglycemia is associated with increased mortality in hospitalized patients. We investigated the relationship between spontaneous hypoglycemia versus insulin-associated hypoglycemia and mortality in hospitalized patients.RESEARCH DESIGN AND METHODSData for this retrospective cohort study were obtained from electronic databases of patients admitted between 1 April 2008 and 30 November 2010. Patients with one or more blood glucose values ≤50 mg/dL on point-of-care glucose testing were considered hypoglycemic. Patients treated with insulin were assumed to have insulin-associated hypoglycemia. Age-, sex-, and race-matched patients with all blood glucose values >70 mg/dL were selected as controls. The Charlson comorbidity index (CCI) was used to control for severity of illness.RESULTSThere were four groups: 1) noninsulin-treated hypoglycemia (NTH) (n = 135), 2) insulin-treated hypoglycemia (ITH) (n = 961), 3) noninsulin-treated control (NTC) (n = 1,058), and 4) insulin-treated control (ITC) (n = 736). Mortality was higher in the ITH group compared with the ITC group (20.3 vs. 4.5%, P < 0.0001), with a relatively higher CCI (1.8 vs. 1.5%, P < 0.0001), but much higher in the NTH group compared with the NTC group (34.5 vs. 1.1%, P < 0.0001), with much higher CCI (2.4 vs. 1.1%, P < 0.0001). Mortality was higher in the NTH group compared with the ITH group (P < 0.0001) but lower in the NTC group compared with the ITC group (P < 0.0001). After controlling for age, sex, CCI, and admission to the intensive care unit, insulin treatment was associated with a lower mortality among the hypoglycemic patients; hazard ratio of death in the ITH group relative to the NTH group was 0.34 (95% CI 0.25–0.47, P < 0.0001).CONCLUSIONSInsulin-associated and spontaneous hypoglycemia are associated with increased mortality among hospitalized patients.
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