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Our objectives were to explore the association between phosphodiesterase 5 inhibitor use and lumbar decompression surgery by evaluating the prevalence of lumbar decompression surgery in a treatment group of patients with lumbar spinal stenosis compared with a control group.We performed database review and extracted data including lumbar decompression surgery prevalence, phosphodiesterase 5 inhibitor dosage, and fill dates. Treatment group was defined as those with phosphodiesterase 5 inhibitor fill dates of less than 30 days before surgery, and control group was defined as those with phosphodiesterase 5 inhibitor fill dates at any other time. Lumbar decompression surgery prevalence rates for both groups were calculated.Our study found 599 lumbar spinal stenosis patients who were prescribed phosphodiesterase 5 inhibitor. Three hundred thirty-eight underwent lumbar decompression surgery. Of these, 71 (21%) filled their prescription of less than 30 days before surgery, whereas 267 (79%) filled their prescription during a different period. The majority (94.6%) of surgical patients received decompression at two or more spinal levels.Prevalence of lumbar decompression surgery for lumbar spinal stenosis was significantly lower in patients in the treatment group on phosphodiesterase 5 inhibitor therapy compared with the control group. Among many potential explanations, the vasodilatory effect of phosphodiesterase 5 inhibitor may have contributed to a lower surgical rate. This is the first study to explore this novel association. Future prospective studies are necessary to better define the utility of phosphodiesterase 5 inhibitor in lumbar spinal stenosis.

Background: Studies have shown an association between metformin use and vitamin B12 deficiency. Since 2017, the American Diabetes Association (ADA) Standards of Medical Care in Diabetes Guideline has included a recommendation for periodic vitamin B12 measurements in metformin-treated patients, especially those with anemia or peripheral neuropathy. Objective: To determine the overall incidence and impact of the ADA Guideline on vitamin B12 monitoring in a veteran population on long-term metformin therapy. Methods: Retrospective chart review was performed for patients on metformin who started therapy prior to 2005 at the VA North Texas Health Care System (VANTXHCS). The primary outcome was the proportion of patients with at least 1 vitamin B12 level drawn during 2016 versus 2018. Metformin dose and duration, vitamin B12 supplementation, and incident neuropathy prescriptions or diagnosis were also analyzed. Results: Of 394 patients included for the primary outcome, 136 (34.5%) had at least 1 vitamin B12 level in 2016 versus 198 (50.3%) patients in 2018 (odds ratio: 1.94, P < .001). Of the 394 patients, 157 were diagnosed with neuropathy or prescribed a medication for neuropathy without a vitamin B12 level in the previous year or with a low level that was not supplemented. Conclusion: Vitamin B12 monitoring significantly increased between 2016 and 2018, aligning with the release of the 2017 ADA guidelines. However, a large proportion of patients were identified who were diagnosed with or treated for neuropathy without adequate vitamin B12 monitoring.

PURPOSE: To determine the influence of body weight on the international normalized ratio (INR) response to a fixed dose of vitamin K in overanticoagulated patients. METHODS: Retrospective review of records of patients who received 1 mg of vitamin K subcutaneously to correct excessive INR. Dose of vitamin K in milligrams per kilograms plotted against change in INR in 24 hours. RESULTS: Fifteen patients were identified who met all inclusion criteria. Linear regression analysis plotted INR response at 24 hours versus dose of vitamin K adjusted for body weight. Pearson's product moment correlation ( R = 0.85) indicated a significant relationship between INR response at 24 hours to an adjusted body weight dose of subcutaneous vitamin K ( P = 0.0000523). A strong correlation ( r = 0.69) also existed between INR response at 24 hours and the actual body weight dose of subcutaneous vitamin K ( P = 0.004). CONCLUSIONS: In overanticoagulated patients, variability in response to vitamin K may be explained by variability in body weight. Dosing vitamin K according to body weight may result in a more predictable INR response.

The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease.Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus.We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents5 mm in diameter and60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography.Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89).Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Background Type 2 diabetes mellitus (T2DM) is a coronary heart disease (CHD) risk equivalent warranting aggressive management of dyslipidemia and tight glycemic control. Recent reports demonstrate a paradoxic decrease in high-density lipoprotein cholesterol (HDL-C) with thiazolidinedione (TZD) and fibrate combination therapy. Objective Evaluate change in HDL-C from start of combination therapy to 1 year and assess the proportion, characteristics, and regimens of patients who developed a ≥20% decrease in HDL-C from baseline. Methods Patients with T2DM treated concurrently with a combination of TZD and fibrate were identified through retrospective query from a Veterans Affairs medical center database. HDL-C was recorded for 1 year after patients started combination therapy. Logistic regression analysis was performed to determine any predictors of HDL-C change. Results A total of 322 patients were included in the analysis. There was no significant differences in mean ± standard deviation HDL-C from baseline to end point (36.8 ± 8.5 to 40.3 ± 11.8 mg/dL; P = 0.097). There was a subset of patients identified (13%; n=43) on combination therapy who experienced a ≥20% reduction in HDL-C. Of these patients, a decrease in HDL-C was more likely to occur with fenofibrate-based regimens (odds ratio 3.08, 95% confidence interval 1.22 to 7.75; P = 0.018). There was a trend toward more of these patients in this subset to have the combination of rosiglitazone and fenofibrate in their profiles (odds ratio 2.82, 95% confidence interval 0.98 to 8.0; P = 0.064). Conclusion Our study demonstrated that a subset of patients with T2DM experienced a paradoxic decrease in HDL-C when taking a fibrate and TZD combination.

To determine the relative costs associated with the exclusive use of celecoxib versus rofecoxib in a large managed care system.A retrospective review of all calendar year 2000 prescriptions dispensed for celecoxib and rofecoxib in the Veterans Affairs (VA) system.The primary data points included drug strength, quantity dispensed, and days supply for the prescription. The cost minimization model described in Federal Practitioner (1999;16[4]:41-44) was used to calculate the cost savings. The mean once-daily dosing rates and their 95% confidence intervals were determined by binomial data analysis. Calendar year 2001 utilization and cost projections were derived by linear regression trend analysis.Current VA system costs per dose are celecoxib 100 mg $0.66; celecoxib 200 mg $1.32; rofecoxib (12.5 or 25 mg) $1.32; rofecoxib 50 mg $2.14. During calendar year 2000, the VA spent $13.8 million and $4.2 million on celecoxib and rofecoxib, respectively. The percentage of once-daily or less than once-daily dosing was celecoxib 100 mg (17%), celecoxib 200 mg (67%), celecoxib overall (49%), rofecoxib 12.5 mg (86%), rofecoxib 25 mg (94%), rofecoxib 50 mg (100%), and rofecoxib overall (93%). Based on current utilization, if all celecoxib prescriptions were changed to rofecoxib, the VA would have realized annual cost savings of $2.1 million in calendar year 2000. In calendar year 2001, projected cost savings could total $5.2 million. This potential savings is largely due to the high prevalence of twice-daily celecoxib dosing.The results of the cyclooxygenase-2 cost minimization analysis provide a compelling argument for the preferred use of rofecoxib in the VA system, and potentially in other managed care systems.