Comparative Effectiveness of Ranolazine Versus Traditional Therapies in Chronic Stable Angina Pectoris and Concomitant Diabetes Mellitus and Impact on Health Care Resource Utilization and Cardiac Interventions.

Comparative studies evaluating traditional versus newer antianginal (AA) medications in chronic stable angina pectoris (CSA) on cardiovascular (CV) outcomes and utilization are limited, particularly in patients with diabetes mellitus (DM). Claims data (2008 to 2012) were analyzed using a commercial database. Patients with CSA receiving a ß blocker (BB), calcium channel blocker (CCB), long-acting nitrate (LAN), or ranolazine were identified and followed for 12 months after a change in AA therapy. Patients on traditional AA medications were required to have concurrent sublingual nitroglycerin. Therapy change was defined as adding or switching to another traditional AA medication or ranolazine to identify patients whose angina was inadequately controlled with previous therapy. Four groups were identified (BB, CCB, LAN, or ranolazine users) and matched on relevant characteristics. A DM subset was identified. Logistic regression compared revascularization at 30, 60, 90, 180, and 360 days. Negative binomial regression compared all-cause, CV-, and DM-related (in the DM cohort) health care utilization. A total of 8,008 patients were identified with 2,002 patients in each matched group. Majority were men (mean age 66 years). A subset of 3,724 patients with DM (BB, n = 933; CCB, n = 940; LAN, n = 937; and ranolazine, n = 914) resulted from this cohort. Compared to ranolazine in the overall cohort, traditional AA medication exhibited greater odds for revascularization and higher rates in all-cause outpatient, emergency room visits, inpatient length of stay, and CV-related emergency room visits. In the DM cohort, ranolazine demonstrated similar benefits over traditional AA medication. In conclusion, ranolazine use in patients with inadequately controlled chronic angina is associated with less revascularization and all-cause and CV-related health care utilization compared to traditional AA medication.

Comorbidities, healthcare service utilization and costs for patients identified with painful DPN in a managed-care setting.

OBJECTIVE: This study examined the association of comorbidities, healthcare service use, and costs for diabetes patients with and without painful diabetic peripheral neuropathy (pDPN). METHODS: This was a retrospective, cohort analysis of data from members of a health maintenance organization. Patients with pDPN identified from a previously validated algorithm that was based on inclusion ICD-9 diagnosis codes consistent with signs and symptoms of peripheral neuropathy, as well as ICD-9 diagnosis codes to exclude non-diabetic etiologies. These subjects were matched 2 : 1 to patients without pDPN on age (+/-4 years), gender, and HbA(1c) stratum (<7%, 7-9%, and >9%) based on median HbA(1c) measured in 2002. Administrative data associated with outpatient and hospital-based care for the year 2003 were used to estimate healthcare service utilization and costs. Chi-square, univariate, and multivariate regression analyses were employed to estimate the variation in healthcare service utilization and costs. RESULTS: After applying inclusion and exclusion criteria, 1543 patients with pPDN were matched to 3069 patients without pDPN among prevalent diabetes cases. Patients with pDPN had significantly higher prevalence of comorbidities, including twice as many limb infections and nearly ten-fold greater limb amputations, and had consistently higher healthcare service utilization and costs across categories of care. The likelihood of any hospital admission for pDPN patients was more than 2.5-fold higher relative to patients without pDPN, and the excess cost associated with pDPN was estimated to be almost $6000 for the calendar year. CONCLUSIONS: The presence of pDPN in patients with diabetes was associated with significantly greater comorbidity, greater healthcare service utilization, and higher costs. While this study is limited to the direct medical care costs borne by the health plan, given the association of comorbidities and cost for patients with pDPN, further investigation is needed to determine if management approaches that are effective across chronic illnesses may prove to be beneficial for high cost diabetes patients.

Painful diabetic peripheral neuropathy in a managed care setting: patient identification, prevalence estimates, and pharmacy utilization patterns.

The objectives of this study were to validate an algorithm for identifying patients with painful diabetic peripheral neuropathy (pDPN) and demonstrate its practical applications. Using the Kaiser Permanente Colorado Diabetes Registry, an algorithm was developed with selected ICD-9 diagnosis codes combined with automated pharmacy data for medications prescribed for pDPN symptoms. Medical records were reviewed to confirm pDPN presence and to inform algorithm refinement. Prevalence was estimated with a numerator of members with diabetes who had inclusion but no exclusion codes in 2003 (Method 1) and with a numerator of diabetes patients with inclusion codes between 1998 and 2003 who had no subsequent exclusion codes and who remained members in 2003 (Method 2); the denominator was all members with diabetes in 2003. Medication utilization was compared between patients with and without pDPN. A total of 19,577 members with diabetes were identified; 2612 met initial inclusion criteria. Medical record review (n = 298) demonstrated sensitivity of 94%, specificity of 55%, and positive predictive value (PPV) of 64%. Inclusion criteria were modified and pharmacy data eliminated. The revised algorithm identified 1754 additional patients meeting inclusion criteria. Medical record review (n = 190) demonstrated sensitivity of 99%, specificity of 49%, and PPV of 79%. Using the validated algorithm, pDPN prevalence was 113 (Method 1) and 208 (Method 2) per 1000 persons with diabetes. Significant differences were observed in medication prescriptions between patients with and without pDPN. Estimated pDPN prevalence among persons with diabetes was 11%-21% and pDPN patients had greater utilization of selected medications than those without pDPN. Identifying patients with pDPN is a fundamental step for improving disease management and understanding the economic impact of pDPN.

Hormone therapy initiation after the Women's Health Initiative.

OBJECTIVES: To describe hormone therapy (HT) initiation after the 2002 publication of the Women's Health Initiative. DESIGN: Observational cohort (1999-2003) of women ages 40 to 79 years, five health plans, used HT in July 2002 and subsequently discontinued or never used before August 2002. RESULTS: Of discontinuers, 15.8% (3,203 of 20,205) reinitiated HT. Reinitiation was higher among estrogen users (23.8%) versus estrogen with progestin users (11.3%), and lower among those with diabetes (relative risk [RR]=0.68, 95% CI: 0.61-0.76), cardiovascular disease (RR=0.87, 95% CI: 0.83-0.92), and hyperlipidemia (RR=0.83, 95% CI: 0.79-0.88). Only 2.3% (2,072 of 90,261) of never users initiated (August 2002 to December 2003). First-time initiation was associated with cardiovascular disease (RR=1.17, 95% CI: 1.10-1.25) and hyperlipidemia (RR=1.24, 95% CI: 1.17-1.33) and was less common among those with diabetes (RR=0.70, 95% CI: 0.63-0.79). CONCLUSIONS: After the Women's Health Initiative, a minority of women reinitiated or became first-time initiators of HT. Women with cardiovascular disease, diabetes, and hyperlipidemia were less likely to reinitiate; women with cardiovascular disease and hyperlipidemia were more likely to be first-time initiators.