Publications

CONTEXT

The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which provided optimal medical therapy (OMT) to all patients and demonstrated no incremental advantage of percutaneous coronary intervention (PCI) on outcomes other than angina-related quality of life in stable coronary artery disease (CAD), suggests that a trial of OMT is warranted before PCI. It is unknown to what degree OMT is applied before PCI in routine practice or whether its use increased after the COURAGE trial.

OBJECTIVE

To examine the use of OMT in patients with stable angina undergoing PCI before and after the publication of the COURAGE trial.

DESIGN, SETTING, AND PARTICIPANTS

An observational study of patients with stable CAD undergoing PCI in the National Cardiovascular Data Registry between September 1, 2005, and June 30, 2009. Analysis compared use of OMT, both before PCI and at the time of discharge, before and after the publication of the COURAGE trial. Optimal medical therapy was defined as either being prescribed or having a documented contraindication to all medicines (antiplatelet agent, β-blocker, and statin).

MAIN OUTCOME MEASURES

Rates of OMT before PCI and at discharge (following PCI) between the 2 study periods.

RESULTS

Among all 467,211 patients (173,416 before [37.1%] and 293,795 after [62.9%] the COURAGE trial) meeting study criteria, OMT was used in 206,569 patients (44.2%; 95% confidence interval [CI], 44.1%-44.4%) before PCI and in 303,864 patients (65.0%; 95% CI, 64.9%-65.2%) at discharge following PCI (P < .001). Before PCI, OMT was applied in 75,381 patients (43.5%; 95% CI, 43.2%-43.7%) before the COURAGE trial and in 131,188 patients (44.7%; 95% CI, 44.5%-44.8%) after the COURAGE trial (P < .001). The use of OMT at discharge following PCI before and after the COURAGE trial was 63.5% (95% CI, 63.3%-63.7%) and 66.0% (95% CI, 65.8%-66.1%), respectively (P < .001).

CONCLUSION

Among patients with stable CAD undergoing PCI, less than half were receiving OMT before PCI and approximately two-thirds were receiving OMT at discharge following PCI, with relatively little change in these practice patterns after publication of the COURAGE trial.

Despite muscle pain being a well-described symptom in patients with diverse forms of peripheral neuropathy, the role of neuropathic mechanisms in muscle pain have received remarkably little attention. We have recently demonstrated in a well-established model of chemotherapy-induced painful neuropathy (CIPN) that the anti-tumor drug paclitaxel (Taxol) produces mechanical hyperalgesia in skeletal muscle, of similar time course to and with shared mechanism with cutaneous symptoms. In the present study, we evaluated muscle afferent neuron function in this rat model of CIPN. The mechanical threshold of muscle afferents in rats exposed to paclitaxel was not significantly different from the mechanical threshold of muscle afferents in control animals (P = 0.07). However, paclitaxel did produce a marked increase in the number of action potentials elicited by prolonged suprathreshold fixed intensity mechanical stimulation and a marked increase in the conduction velocity. In addition, the interspike interval (ISI) analysis (to evaluate the temporal characteristics of the response of afferents to sustained mechanical stimulation) showed a significant difference in rats treated with paclitaxel; there was a significantly greater ISI percentage of paclitaxel-treated muscle afferents with 0.01- and 0.02-s ISI. In contrast, an analysis of variability of neuronal firing over time (CV2 analysis) showed no effect of paclitaxel administration. These effects of paclitaxel on muscle afferent function contrast with the previously reported effects of paclitaxel on the function of cutaneous nociceptors.

OBJECTIVE

To estimate the incidence of adverse drug events (ADEs) associated with health care visits among U.S. adults across all ambulatory settings.

DATA SOURCE

We analyzed data from two nationally representative probability sample surveys: the National Ambulatory Medical Care Survey and the National Hospital and Ambulatory Medical Care Survey. From 2005 to 2007, the presence of an ADE was specifically defined, requested, and recorded in these surveys.

STUDY DESIGN

Secondary data analysis.

PRINCIPAL FINDINGS

An estimated 13.5 million ADE-related visits occurred between 2005 and 2007 (0.5 percent of all visits), the large majority (72 percent) occurring in outpatient practice settings, and the remaining in emergency departments. Older patients (age ≥65 years) had the highest age-specific ADE rate, 3.8 ADEs per 10,000 persons per year. In adjusted analyses of outpatient visits, there was an increased odds of an ADE-related visit with increased medication burden (odds ratio [OR] for six to eight medications compared with no medications, OR 3.83 [2.20, 6.65]), and increased odds of ADEs associated with primary care visits compared with specialty visits (OR 2.22 [1.70, 2.89]).

CONCLUSIONS

Approximately 4.5 million ambulatory visits related to ADEs occur each year, the majority of these in outpatient office practices. A greater focus on ADE prevention and detection is warranted among patients receiving multiple medications in primary care practices.