2 Minute Medicine Rewind May 28, 2018

Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial

Renal denervation has been proposed as a way to address treatment-resistant hypertension. There is, however, uncertainty surrounding its efficacy in patients concurrently using antihypertensive pharmacotherapy. In this randomized controlled trial, investigators randomized 467 patients with hypertension on stable antihypertensive drug doses to renal denervation or sham control in order to examine the effect of renal denervation on blood pressure change from baseline at 6 months. An interim analysis of the first 80 randomized patients showed that at 6 months, the mean change in ambulatory 24 hour systolic blood pressure (SBP) measurement was -9.0 mm Hg for the renal denervation group and -1.6 mm Hg for the sham control group (mean baseline-adjusted difference -7.0 mm Hg, 95% CI -12.0 mm Hg to -2.1 mm Hg, p=0.0059). The mean change in ambulatory 24-hour diastolic blood pressure (DBP) was also significantly greater in the intervention group (baseline-adjusted mean difference -4.3 mm Hg, 95% CI -7.8 mm Hg to -0.8 mm Hg, p=0.0174). There were no significant differences observed between the groups for 24-hour heart rate at 6 months, and no adverse events were recorded for either group. Adherence to antihypertensive drugs was not significantly different between groups. Taken together, results from this study indicate that renal denervation in the setting of concurrent medical treatment for hypertension can be efficacious. It is important to note, however, that this study was limited in that it did not assess sodium intake or implement restrictions for dietary or lifestyle habits.

Higher Lung Cancer Incidence in Young Women Than Young Men in the United States

Previous research has shown that young women in the United States have a higher incidence of lung cancer than young men. It is unclear whether the higher incidence can be explained by differences in smoking behaviors. In this retrospective cohort study, investigators analyzed data covering 96% of the U.S. population in order to look at the incidence of invasive lung cancer, calculate female-to-male incidence rate ratios, and examine the prevalence of smoking. Researchers found that from 1995 to 2014, the incidence of lung cancer decreased for both men and women, but the decrease was greater for men. The female-to-male incidence rate ratios exceeded 1.0 for age groups between 30 to 49 years. Analysis of ethnic groups showed that the higher incidence of cancer among women was confined to whites and Hispanics, as incidence rates for men and women among blacks and Asians or Pacific Islanders did not cross over. In terms of smoking prevalence, sex differences in white individuals disappeared among people born during the 1960s and afterwards, with prevalence minimally higher for women born around 1965; daily cigarette use has remained substantially higher for white men than for white women. For Hispanics, smoking prevalence among Hispanic women was found to be lower than among Hispanic men. Overall, this study shows that higher female-to-male incidence rate ratios of lung cancer that are not explained by the prevalence of smoking. This study was limited in that individual-level information on smoking behavior and other risk factors were not present in medical records, and that information on smoking habits was self-reported.

Risk of Being Subjected to Crime, Including Violent Crime, After Onset of Mental Illness

While research has shown an association between mental illness and the risk of offense perpetuation, little data has been assembled on the relationship between mental illness and the risk of being subjected to crime. In this cohort study, investigators analyzed data from 2,058,063 individuals diagnosed with mental illness in order examine the incidence rate of crime events reported to police after the onset of mental illness. Researchers found that the rate of being subjected to crime was higher in both men (RR 1.68, 95% CI 1.65 to 1.71) and women (RR 1.71, 95% CI 1.68 to 1.73) with mental illness compared to individuals without a diagnosis. For both men and women, substance use disorders had the highest association with being subjected to a crime event (RR of 2.61, 95% CI 2.53 to 2.69 for men; RR of 3.18, 95% CI 3.06 to 3.32 for women). Personality disorders also produced a strong association (RR 2.23, 95% CI 2.15 to 2.32 for men; RR 2.00, 95% CI 1.95 to 2.06 for women). Both men and women with mental disorders had a higher rate of being subjected to violent crime (RR 2.10, 95% CI 2.05 to 2.15 for men; RR 2.99, 95% CI 2.92 to 3.06 for women), with the strongest associations found for substance abuse disorders. When data was adjusted for incident rates for cohort member’s own criminal offense rates, the strength of association observed between mental disorders and being subjected to crime was attenuated, with the confounding effect varying with diagnosis. Overall, results from this study show that individuals with mental disorders are at a higher risk of being subjected to any crime and violent crime in general, and that women with mental disorders are at especially higher risk. This study was limited in that only individuals who had been diagnosed and receiving treatment were included. In addition, only crimes that were reported to the police could be studied.

Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System

The effects of short-term opioid use in hospitals on opioid-related adverse drug events (ORADEs) have not been well studied. In this retrospective cohort study, investigators analyzed information from 135,379 patients undergoing hospital-based surgical or endoscopic procedures in order to study the effect of short-term opioid use on ORADEs, including respiratory, gastrointestinal, and central nervous system complications. Researchers found that 88% of patients received opioids, and 10.6% of the patients studied experienced at least one ORADE. The median daily dose and type of opioids were similar for patients who experienced ORADEs and those who did not, but patients with ORADEs received opioids for a greater number of days during hospitalization (median 3.0 vs. 2.0 days, p<0.001), and received higher morphine equivalent doses (median morphine milligram equivalent dose, 46.8 vs. 30.0 mg, p<0.001). In terms of procedures, endoscopic procedures had the greatest number of patients with ORADEs, while open thoracic procedures had the highest rate (37.6%) of ORADEs. Patients who experienced ORADEs were at a higher risk for inpatient mortality (OR 28.8, 95% CI 24.0 to 34.5), discharge to another care facility (OR 2.9, 95% CI 2.7 to 3.0), and 30-day readmission (OR 1.3, 95% CI 1.2 to 1.4). After adjustment, ORADES were associated with a higher cost ($8225 increase), longer length of stay (1.6 days), and increase in absolute mortality (2.9%). Taken together, the results from this study show that ORADEs occur at a relatively high rate with short-term opioid use after procedures, which can, in turn lead to increased mortality, hospitalization cost, and length of stay. This study was limited, however, in that it did not examine specific prescribing patterns of physicians or timing of opioid administration.

Patterns of Potential Opioid Misuse and Subsequent Adverse Outcomes in Medicare, 2008 to 2012

Although prescription drug monitoring programs are designed to help providers assess a patient’s risk of opioid misuse, it is unclear what specific use patterns indicate a higher risk for adverse opioid-related patient outcomes. In this cohort study, investigators analyzed data from 627,391 Medicare recipients who received opioids without a cancer diagnosis between 2008 and 2012 in order to examine the effect of 6 measures of potential opioid misuse on adverse opioid-related outcomes during the following year. Measures of potential opioid misuse included >210 days of opioids supplied in 180 days, any overlapping claims for opioids, multiple prescribers, multiple dispensing pharmacies, any out-of-state prescriber, and any out-of-state pharmacy. Adverse opioid-related outcomes were defined as any occurrence of opioid overdose. Results showed that the prevalence of possible misuse indicators ranged from 0.6% to 8.5% of patients per half year. Patients obtaining opioids from 5 or more pharmacies had the highest adjusted absolute risk (aAR) for subsequent overdose (aAR 12.9, 95% CI 11.3 to 14.5). All misuse measures were positively correlated with a higher risk of adverse opioid-related outcome (adjusted risk ratios ranging from 1.77 to 5.46), with higher numbers of prescribers, pharmacies, or days supplies associated with increasing risk.  Overall, results from this study suggest that a number of measures can be used to identify patients at risk for opioid misuse and adverse outcomes. 

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