A pharmacist-run anabolic osteoporosis clinic: An abaloparatide descriptive report.

OBJECTIVES: To review the first-year experience of abaloparatide use in a pharmacist-run anabolic osteoporosis clinic. SETTING: This ambulatory-care health system endocrinology practice consists of 10 board-certified endocrinologists and 6 nurse practitioners and physician assistants. Approximately 1200 patients are seen weekly. The practice is affiliated with the Albany College of Pharmacy and Health Sciences and hosts 2 clinical pharmacy faculty members and a PGY-2 endocrinology pharmacy resident. A pharmacist-run teriparatide clinic was implemented in 2002. In 2017, the clinic was expanded to accept referrals for abaloparatide. No description of a pharmacist-run abaloparatide clinic has yet been reported. PRACTICE DESCRIPTION: Patients are referred to a clinical pharmacist for initiation and education of anabolic osteoporosis therapy. The pharmacist is responsible for assessing for contraindications to anabolic therapy, securing managed care coverage of an anabolic agent, and providing medication counseling. This pharmacist is available as a resource to patients throughout their course of anabolic osteoporosis therapy. PRACTICE INNOVATION: This is the first description of a pharmacist-run abaloparatide clinic. EVALUATION: Not applicable. RESULTS: During its first year of availability, 52 patients were referred for abaloparatide therapy. Of these, 31 patients (59.6%) initiated treatment. The population predominately consisted of postmenopausal white women. Approximately two-thirds of patients had a history of an osteoporosis-related fracture, and half of patients had previously received antiresorptive therapy for osteoporosis. Mean baseline T-scores for the lumbar spine and femoral neck were -2.41 and -2.57, respectively. Twenty-one patients did not initiate abaloparatide therapy owing to cost (9), concerns of therapy (8), or contraindication to therapy (4). An additional 5 patients discontinued abaloparatide therapy owing to adverse effects. CONCLUSION: This paper reviews the first-year experience of abaloparatide use in a pharmacist-run anabolic osteoporosis clinic. The fact that only 60% of referred patients initiated therapy indicates that significant barriers (e.g., high patient cost and safety concerns) remain.

Weekly Exenatide Therapy: A Real-World Comparison of Incretin Therapies.

Background: Traditional diabetes therapies have been associated with weight gain, hypoglycemia, and/or high secondary failure rates. Glucagon-like peptide-1 (GLP-1) analog use is associated with a minimal risk of hypoglycemia, a persistent average weight loss of 2 to 3 kg, and sustained efficacy even after 3 years of use. Presently, 3 GLP-1 analogs are commercially available in the United States. Objective: To evaluate the real-world clinical utility of once weekly exenatide in type 2 diabetes mellitus (T2DM) patients who previously received once or twice daily GLP-1 therapy. Methods: In this pre-post observational study, electronic medical records (EMRs) were reviewed to identify patients meeting all study criteria. Data collected included baseline patient demographic information, duration of diabetes, disease states, medications, pertinent laboratory data, blood pressure, height, weight, and reported adverse drug events. Primary (changes in A1C and percentage of patients reporting adverse effects of therapy) and secondary (percentage of patients with A1C of <7% and changes in weight, blood pressure, and lipids) outcomes were evaluated using appropriate statistical analysis. Results: EMRs of 78 patients met all study criteria. Baseline patient demographic information included an average age of 61 ± 12 years, an average duration of T2DM of 14 ± 6 years, 59% of patients were male, and 93.6% were Caucasian. The baseline average body mass index was 39 ± 9.2, and mean A1C was 7.47 ± 1.45%. After a minimum of 3 months (average = 5.6 months) switchover, there were significant decreases in A1C (-0.35%; P = .0067) and weight (-1.6 kg; P = .0151). There were no significant changes in blood pressure or lipid levels. Two patients (2.5%) discontinued once weekly exenatide due to adverse reactions. Conclusion: Once weekly exenatide was generally well tolerated and significantly reduced A1C levels and body weight in patients with T2DM when switched from a shorter-acting GLP-1 analog.

Efficacy of teriparatide in patients with resolved secondary hyperparathyroidism due to vitamin D deficiency.

OBJECTIVE: To determine the efficacy of at least 1 year of teriparatide therapy on bone mineral density (BMD), T-scores, and rates of occurrence of fractures in patients with a history of resolved secondary hyperparathyroidism due to vitamin D deficiency and to compare its efficacy with that in patients without a history of resolved secondary hyperparathyroidism. METHODS: In this retrospective study based on a search of electronic medical records, we collected the following data: patient demographics, doses of calcium and vitamin D supplementation, duration of teriparatide treatment, history and treatment of secondary hyperparathyroidism, BMD information, T-scores, and any history of fractures. Paired and unpaired t tests, the Fisher exact test, and the Wilcoxon rank sum test were used for statistical analysis. RESULTS: Ninety-five patients (7 with a history of resolved secondary hyperparathyroidism due to vitamin D deficiency and 88 without such a history) fulfilled the study inclusion criteria. Baseline characteristics (demographics, median calcium and vitamin D supplementation doses, mean BMD, mean T-scores, and fracture rates before teriparatide therapy) were similar between the 2 groups. In comparison with baseline data, after a mean of 21 months of teriparatide therapy: (1) hip BMD and T-scores did not change in either study group (with no significant differences between the 2 groups), (2) spine BMD and T-scores significantly improved in both study groups (with no significant differences between them), and (3) wrist T-scores significantly worsened in both study groups (with wrist BMD significantly lower in patients without a history of secondary hyperparathyroidism). No patients with a history of secondary hyperparathyroidism sustained a fracture while receiving teriparatide therapy versus 6 of 88 patients without a history of secondary hyperparathyroidism (P = .624). CONCLUSION: Patients with a history of resolved secondary hyperparathyroidism attributable to vitamin D deficiency responded to teriparatide therapy in a fashion similar to patients without such a history.

Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro.

PURPOSE: This study compared the accuracy and precision of four value-added glucose meters. METHODS: Finger stick glucose measurements in diabetes patients were performed using the Abbott Diabetes Care (Alameda, CA) Optium, Diagnostic Devices, Inc. (Miami, FL) DDI Prodigy, Home Diagnostics, Inc. (Fort Lauderdale, FL) HDI True Track Smart System, and Arkray, USA (Minneapolis, MN) HypoGuard Assure Pro. Finger glucose measurements were compared with laboratory reference results. Accuracy was assessed by a Clarke error grid analysis (EGA), a Parkes EGA, and within 5%, 10%, 15%, and 20% of the laboratory value criteria (chi2 analysis). Meter precision was determined by calculating absolute mean differences in glucose values between duplicate samples (Kruskal-Wallis test). RESULTS: Finger sticks were obtained from 125 diabetes patients, of which 90.4% were Caucasian, 51.2% were female, 83.2% had type 2 diabetes, and average age of 59 years (SD 14 years). Mean venipuncture blood glucose was 151 mg/dL (SD +/-65 mg/dL; range, 58-474 mg/dL). Clinical accuracy by Clarke EGA was demonstrated in 94% of Optium, 82% of Prodigy, 61% of True Track, and 77% of the Assure Pro samples (P < 0.05 for Optium and True Track compared to all others). By Parkes EGA, the True Track was significantly less accurate than the other meters. Within 5% accuracy was achieved in 34%, 24%, 29%, and 13%, respectively (P < 0.05 for Optium, Prodigy, and Assure Pro compared to True Track). Within 10% accuracy was significantly greater for the Optium, Prodigy, and Assure Pro compared to True Track. Significantly more Optium results demonstrated within 15% and 20% accuracy compared to the other meter systems. The HDI True Track was significantly less precise than the other meter systems. CONCLUSIONS: The Abbott Optium was significantly more accurate than the other meter systems, whereas the HDI True Track was significantly less accurate and less precise compared to the other meter systems.

Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus.

OBJECTIVE: To evaluate the 1-year efficacy and safety of treatment with exenatide in combination with insulin (a use not approved by the US Food and Drug Administration). METHODS: Electronic medical records of 3 private-practice endocrinologists were reviewed to identify patients with type 2 diabetes mellitus (T2DM) receiving insulin who subsequently began exenatide therapy. Patients' baseline hemoglobin A1c (A1C) levels, weights, lipid profiles, blood pressures, and medication utilization were compared with corresponding data obtained after a minimal duration of 12 months. RESULTS: We identified 134 patients with T2DM initiating exenatide therapy in combination with insulin between April 2005 and April 2006. One-year follow-up information was available for 124 patients. Exenatide use resulted in a significant 0.87% reduction in A1C (P<.001), despite a 45% discontinuation of premeal insulin use (P<.001), a 9-U reduction in mean premeal insulin doses (P = .0066), a reduction in the median number of daily insulin injections from 2 to 1 (P = .0053), and a 59% discontinuation rate of sulfonylurea use (P = .0088). Exenatide use was associated with a mean weight loss of 5.2 kg (P<.001), with 72% of evaluable patients losing weight. Forty-eight patients (36%) discontinued exenatide therapy during the first year, primarily attributable to gastrointestinal intolerance. Fourteen patients (10%) experienced hypoglycemia, most of which was mild. CONCLUSION: Exenatide in combination with insulin in patients with T2DM was associated with significant reductions in A1C and weight after 1 year of therapy. This was offset, however, by an exenatide discontinuation rate of 36%, primarily due to adverse gastrointestinal effects.

A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic.

BACKGROUND: This study compared the accuracy and precision of five blood glucose (BG) meters. METHODS: Diabetes patients undergoing venipuncture for glucose testing were randomized to one of two groups consisting of three meters: FreeStyle Flash (Abbott Diabetes Care, Alameda, CA), Accu-Chek Advantage (Roche Diagnostics Corp., Indianapolis, IN), and Accu-Chek Compact Plus (Roche Diagnostics) or FreeStyle Flash, Ascensia Contour (Bayer Healthcare, Diagnostic Division, Tarrytown, NY), and BD Logic (BD Diabetes Care, Franklin Lake, NJ). Within 5 min following venipuncture, duplicate finger BG measurements from three ipsilateral fingers were taken. Finger glucose measurements were compared with laboratory reference values. Accuracy was assessed by a Clarke error grid analysis (EGA) and within 10% of the laboratory value criteria. Meter precision was determined by calculating the absolute mean differences in glucose values between duplicate samples. RESULTS: Finger sticks were obtained from 202 patients. Mean venipuncture BG was 148 mg/dL (SD +/- mg/64 dL; range 25-439 mg/dL). Accuracy by Clarke EGA (Zone A results) was demonstrated in 69% of Advantage samples, 75% of Compact Plus, and 96% of the first group of Flash versus 88% of the Contour, 67% of the Logic, and 91% of the second Flash samples (P < 0.05 for both Flash and Contour). Meter accuracy using the 10% criteria was demonstrated in 30%, 38%, 70%, 46%, 48%, and 68% of the samples, respectively (P < 0.05 for both Flash groups compared to each of the other meters). There were no differences in meter precision. CONCLUSIONS: No statistically significant differences in accuracy were evident using the Clarke EGA criteria (pooled results of Zone A and B), though the more strict 20% accuracy criteria (Zone A results only) found the Flash and Contour to have significantly greater accuracy compared to the Advantage, Compact Plus, and the Logic. Using the 10% accuracy criteria found the Flash to have significantly greater accuracy than each of the other four meters. All five meters demonstrated similar precision.

Colesevelam hydrochloride-ezetimibe combination lipid-lowering therapy in patients with diabetes or metabolic syndrome and a history of statin intolerance.

OBJECTIVE: To determine the effectiveness and safety of colesevelam hydrochloride (HCl) and ezetimibe combination therapy in statin-intolerant patients with dyslipidemia and diabetes mellitus (DM) or metabolic syndrome (MS). METHODS: We identified potential study subjects through a computerized text search of patient electronic medical records using the terms colesevelam, WelChol, ezetimibe, and Zetia. Medical records were subsequently reviewed to identify all patients with DM or MS. Baseline total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglyceride levels immediately before the initiation of therapy with colesevelam HCl (1.875 g twice a day) or ezetimibe (10 mg daily) were compared with those after a minimum of 3 months of single drug therapy and after a minimum of 3 months of combination therapy. Drug safety was evaluated by review of transaminase levels and reports of side effects or drug discontinuation. RESULTS: The computerized search initially identified 91 electronic medical records; 16 patients fulfilled all study criteria. Baseline patient demographics included a mean age of 62.5 (+/-11.8) years and a mean body mass index of 31.4 (+/-5.2) kg/m2; 50% of patients were female, 75% had type 2 DM, and 25% had MS. In comparison with baseline, colesevelam HCl-ezetimibe combination therapy was associated with significant reductions in mean levels of total cholesterol (27.5%), LDL-C (42.2%), and non-HDL-C (37.1%). In addition, 50% of patients achieved the National Cholesterol Education Program Adult Treatment Panel III LDL-C target of less than 100 mg/dL. Therapy was well tolerated, with no significant changes in mean transaminase levels, no reports of myalgia, and no discontinuation of therapy. CONCLUSION: Colesevelam HCl-ezetimibe combination therapy was associated with improved TC, LDL-C, and non-HDL-C lipid profiles and was well tolerated. Such therapy may be a reasonable consideration for statin-intolerant patients with DM or MS who have elevated cholesterol levels.

Precision and accuracy of two blood glucose meters: FreeStyle Flash versus One Touch Ultra.

PURPOSE: The precision and accuracy of two blood glucose meters were evaluated using finger and forearm blood samples. METHODS: Duplicate blood glucose measurements on the same forearm and finger as venipuncture were performed with the FreeStyle Flash and the One Touch Ultra. Accuracy was assessed by error-grid analysis and the number of values within 10% of the laboratory reference value. Precision was determined by calculating the absolute mean percent differences in glucose values between the first and second fingers and forearm test results. Forearm testing success was defined as an accurate glucose reading obtained with one lance. RESULTS: A total of 100 patients completed the study; 93% had diabetes and 53% were female. Patients' mean +/- S.D. age was 63 +/- 12 years, and glucose measurements ranged from 69 to 354 mg/dL. All finger-stick samples fell within error-grid zones A and B; 72% and 57% of FreeStyle Flash and One Touch Ultra values fell within 10% of the laboratory reference values, respectively (p = 0.027). Forearm samples were successfully obtained in 99 and 74 patients using the FreeStyle Flash and One Touch Ultra (p < 0.001), with 64 and 36 samples, respectively, falling within 10% of the laboratory reference values (p = 0.035). There was no difference in meter precision. CONCLUSION: The FreeStyle Flash and the One Touch Ultra are precise glucose meters; however, the FreeStyle Flash was associated with greater accuracy. Success rates of forearm glucose sampling were significantly greater when the FreeStyle Flash meter was used.

Substitution of pioglitazone for troglitazone in patients with type 2 diabetes.

OBJECTIVE: To evaluate the clinical utility of pioglitazone therapy in patients who previously received troglitazone. METHODS: We undertook an observational study involving patients with type 2 diabetes, who were originally treated with troglitazone and subsequently converted to pioglitazone therapy. Drug efficacy was evaluated by comparing baseline hemoglobin A1c (HbA1c) levels, weight, blood pressure, and lipid profiles (during troglitazone treatment) with corresponding values 6 months after final pioglitazone dose titration. Drug safety was evaluated by review of hepatic enzyme levels and documented reports of side effects. RESULTS: The study cohort consisted of 316 patients in whom pioglitazone therapy was initiated after they had received troglitazone for at least 1 year. Discontinuation of pioglitazone treatment subsequently occurred in 43 patients; in 7 additional patients, no follow-up occurred. We found no significant difference between baseline and follow-up mean HbA1c values. Aspartate aminotransferase levels did not significantly change after 6 months of pioglitazone therapy; however, alanine aminotransferase levels increased by a statistically significant 3.8 U/L (95% confidence interval, 2.6 to 4.9). Pioglitazone treatment was discontinued because of edema in 29 of the 309 evaluable patients (9.4%). CONCLUSION: Pioglitazone was as effective as troglitazone in maintaining HbA1c levels. The hepatic safety of pioglitazone was also demonstrated.

The utility of insulin glargine in the treatment of diabetes mellitus.

STUDY OBJECTIVES: To compare hemoglobin A1c (A1C) values at baseline with those after 1 year of insulin glargine therapy and, secondarily, to compare insulin dosage and patients' body weight at baseline and at 1 year. DESIGN: Retrospective study. SETTING: Private endocrinology practice. PATIENTS: One hundred ninety-seven patients with diabetes mellitus who were first prescribed insulin glargine from May 2001-April 2002 and were evaluable after 1 year of therapy INTERVENTION: Patients received insulin glargine instead of NPH insulin or in addition to their oral drug therapy MEASUREMENTS AND MAIN RESULTS: Patients with diabetes type 1 (receiving insulin therapy) or type 2 (receiving oral drug therapy only, a combination of oral drug therapy and insulin, or insulin only) who had been treated with insulin glargine for 1 year were evaluated. Overall, A1C values decreased significantly (p<0.001) by 0.53 +/- 1.4% from a baseline mean of 8.1 +/- 1.7%. In 129 patients with type 2 diabetes previously treated with NPH insulin, A1C decreased significantly (p<0.001) 0.57 +/- 1.5% from baseline. The A1C decreased by 0.71 +/- 1.3% (p=0.0043) from baseline in 33 patients with type 2 diabetes who previously received oral agents only Thirty-five patients with type 1 diabetes demonstrated no significant change in A1C (-0.22 +/- 1.0%, p=0.217) from baseline. In patients receiving insulin at baseline, the number of daily injections increased significantly (p<0.0001) from a median of two at baseline to three at 1 year. Overall, no significant change was noted in total daily insulin requirement or in body weight in any of the patient groups over the 1-year period. CONCLUSION: Compared with baseline, insulin glargine therapy at 1 year was associated with an overall significant reduction in A1C of 0.53 +/- 1.4%.

Accuracy of home blood glucose monitors using forearm blood samples: FreeStyle versus One Touch Ultra.

The accuracy of two home blood glucose monitors using forearm blood samples was studied. Blood samples were obtained from adults by venipuncture and analyzed for glucose concentration. Within five minutes after venipuncture, peripheral blood glucose measurements were taken in duplicate with the FreeStyle and One Touch Ultra monitors by using the same forearm as used for venipuncture. Accuracy was assessed by comparing the results for each first peripheral stick obtained by each monitor with the laboratory reference value. Monitor precision was evaluated by evaluating the mean difference in glucose values between the first and second peripheral sticks. Blood samples were obtained from 250 subjects, 170 (68%) of whom had diabetes mellitus. A total of 98.8% and 98.4% of the blood glucose readings obtained with FreeStyle and One Touch Ultra, respectively, were clinically acceptable, and 65.2% and 59.2% of the measurements, respectively, were within 10% of the laboratory reference values. The average difference between the first and second glucose measurements was 9.7 mg/dL for FreeStyle and 5.2 mg/dL for One Touch Ultra. One peripheral stick was needed to obtain an adequate blood sample in 95.6% of subjects using FreeStyle, compared with 83.2% of subjects using One Touch Ultra. Forearm blood glucose measurements obtained with the FreeStyle and One Touch Ultra devices were similar to laboratory reference values obtained by venipuncture.