Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients.

BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. RESULTS: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. CONCLUSION: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).

Evaluation of dosing and clinical outcomes in patients undergoing conversion of insulin glargine to insulin detemir.

STUDY OBJECTIVES: To evaluate the dose and frequency of insulin detemir for patients with diabetes mellitus undergoing conversion from insulin glargine to insulin detemir, and to assess glycemic control, weight gain, and risk of hypoglycemia after converting to insulin detemir. DESIGN: Retrospective medical record review. SETTING: Large academic medical center. PATIENTS: Thirty-one patients with type 1 (10 patients) or type 2 (21 patients) diabetes who were converted from insulin glargine to insulin detemir by usual practice between January 1, 2006, and March 3, 2007, after an Iowa Medicaid formulary switch. MEASUREMENT AND MAIN RESULTS: Data were collected for 12 months after conversion from insulin glargine to insulin detemir. No significant change in mean basal insulin dose was noted in patients with type 1 diabetes at the end of 12 months (insulin detemir 31.1 units/day vs baseline insulin glargine 32.0 units/day, p=0.89; insulin detemir 0.41 unit/kg/day vs baseline insulin glargine 0.42 unit/kg/day, p=0.91). In patients with type 2 diabetes, however, the mean basal insulin dose was significantly higher with insulin detemir compared with baseline insulin glargine (74.2 vs 55.8 units/day, p=0.002; 0.68 vs 0.48 unit/kg/day, p=0.001) at the end of 12 months. Twice-daily administration was required in a higher proportion of patients receiving insulin detemir (15 patients [48%]) at 12 months compared with insulin glargine (4 patients [13%]) at baseline (p=0.043). A significant change in hemoglobin A(1c) was not observed in patients with type 1 diabetes (9.7% with insulin detemir vs 9.3% with insulin glargine, p=0.41) or type 2 diabetes (9.4% with insulin detemir vs 9.7% with insulin glargine at baseline, p=0.57) despite the use of higher insulin detemir doses in patients with type 2 diabetes. No significant differences in weight or frequency of hypoglycemia were noted. CONCLUSION: Treatment with insulin detemir appears to require more frequent administration and higher insulin doses compared with insulin glargine in patients with type 2 diabetes, with 33% higher doses, on average, observed in this study. These findings suggest that a unit-for-unit conversion from insulin glargine to insulin detemir, as suggested by the manufacturer of insulin detemir, may not be adequate in patients with type 2 diabetes.

Effect of a pharmacist managed smoking cessation clinic on quit rates.

OBJECTIVE: The purpose of this study was to quantify quit rates, determine factors predicting success, and analyze patients' perceptions at 3 months after participation in the pharmacist-managed Smoking Cessation Group Clinic. METHODS: This was a prospective, single group study that was conducted in patients that had participated in the Smoking Cessation Group Clinic at the University of Iowa Hospitals and Clinics. Clinic participants received structured group counseling covering various topics associated with cessation. Varenicline, bupropion and nicotine replacement therapy were used as smoking cessation aids and selection was based on patient preference and absence of contraindications. The primary outcome of this trial was smoking status at 3 months. The patients were contacted by telephone at 3, and 6 months after the start of the clinic and asked about current smoking status. At 3 months, patients were asked to rate on a Likert scale of 1 to 5 (1=not helpful; 5=very helpful) their perceptions of individual aspects of the clinic and on a scale of 1 to 10 (1=not helpful; 10=very helpful) how they perceived their cessation aid. RESULTS: From February 2007 to January 2008, 21 patients enrolled in the intent-to-treat follow up study. Analysis of data was completed in August 2008. At 3 and 6 months, 47.6% and 52.4%, of patients reported being smoke-free, respectively. At 3 months, factors consistent with success included having more previous quit attempts and type of cessation aid used. These endpoints continued to be significant at 6 months, in addition to attending more clinic sessions, and type of insurance (favoring private insurance). Patients who quit smoking rated their cessation aid as more helpful than those who did not quit smoking (8.56; SD=0.88 verses 6.71; SD=2.81, respectively; p=0.14). The aspect of the clinic most helpful to patients was group interaction (4.53; SD=0.77). CONCLUSION: This study demonstrates that pharmacists can play a vital role with smoking cessation in a group setting. Group setting patient counseling can be an effective tool for pharmacists to reach more people within the same time frame as individual counseling.

Evaluation of anticoagulation in patients with antiphospholipid syndrome.

PURPOSE: The quality of anticoagulation therapy in patients with antiphospholipid syndrome (APS) was evaluated. SUMMARY: The high risk of unnecessary anticoagulation and recent changes in the recommended International Normalized Ratio (INR) target range prompted a performance-improvement initiative to improve the care of patients with APS within the University of Iowa Hospitals and Clinics internal medicine and family medicine anticoagulation clinics. Twenty-three patients with an initial diagnosis of APS were evaluated through chart review to determine the anticoagulation indication, occurrence of thromboembolic events, and INR target range. Confirmation of APS diagnosis was made using Sapporo criteria. Recommendations were made to the patients' physicians for confirmatory APS testing and changes in the anticoagulation regimen. INR target ranges were 2.0-3.0, 2.5-3.5, and 2.5-3.0 for 57%, 39%, and 4% of patients, respectively. Only 6 (26%) of the 23 patients met Sapporo criteria for a definite diagnosis of APS. Of the 17 patients (74%) who did not meet these criteria, 8 (47%) had another indication for indefinite anticoagulation. Repeat APS testing was indicated for 7 patients, 5 of whom met Sapporo criteria for APS. A lower target INR range of 2.0-3.0 was determined appropriate for 6 (26%) of the 23 patients evaluated. CONCLUSION: A majority of patients with an initial diagnosis of APS did not meet criteria for a definite diagnosis of APS. Of those patients, approximately half had another indication for long-term anticoagulation, and one third were receiving warfarin dosages based on an INR target range that was higher than clinically indicated.

Use of hormone replacement therapy by postmenopausal women after publication of the Women's Health Initiative Trial.

BACKGROUND: After publication of the Women's Health Initiative (WHI) trial in July 2002, many physicians discontinued hormone replacement therapy (HRT) in most of their postmenopausal patients. However, little is known about the women who remain on HRT. METHODS: We performed a retrospective chart analysis of 1000 postmenopausal women seen at an internal medicine practice to establish the prevalence of continued HRT use after publication of the WHI trial, determine the reasons for its use, and establish the prevalence of conditions adversely affected by HRT. RESULTS: Of 1000 postmenopausal women, mean age 66 +/- 9 years, 445 (45%) had used or still were on HRT (HRT users) at the time of the review. Of 445 HRT users, 159 (36%) were still on HRT, whereas 286 women (64%) had discontinued therapy. Of the latter, 181 women (63%) had stopped using HRT after the WHI publication, and 136 women (48%) reported the study as the direct cause of HRT cessation. Of the 159 women still on HRT, the main reasons for continued use were severe menopausal symptoms in 39 women (25%), osteoporosis or osteopenia in 31 women (20%), and patient preference in 20 women (13%). Of the 159 women still on HRT, 41 had atherosclerotic disease (26%), 7 had previous venous thromboembolic disease (4%), 8 had a history of breast cancer (5%), and 12 had a family history of breast cancer (8%). CONCLUSIONS: Despite the widespread impact of the WHI trial results, many women still remained on HRT in an internal medicine practice for a variety of reasons and despite relative contraindications to its use.

Prevalence of symptomatic peripheral arterial disease, modifiable risk factors, and appropriate use of drugs in the treatment of peripheral arterial disease in older persons seen in a university general medicine clinic.

BACKGROUND: Persons with peripheral arterial disease (PAD) have a high incidence of cardiovascular morbidity and mortality. METHODS: We investigated the prevalence of symptomatic PAD, modifiable risk factors, and use of drugs in persons 60 years and older seen in a university general medicine clinic. Symptomatic PAD was documented if the person had a documented history of surgery for PAD, if the person had intermittent claudication or other lower extremity symptoms associated with absent or weak arterial pulses or an ankle-brachial index of <0.90, if the person had an abdominal aortic aneurysm, or if the person had symptomatic documented extracranial carotid arterial disease. RESULTS: There were 620 women and 386 men, mean age 72+/-9 years (range 60-95 years), and 95% were white. Symptomatic PAD was present in 103 of 386 men (27%) and in 106 of 620 women (17%) (p<.001). The prevalence of current cigarette smoking (31% versus 12% in those without PAD, p<.001) and ex-cigarette smoking (40% versus 26%) in those without PAD, p<.001) was higher among persons with PAD. Compared with persons without PAD, those with PAD also had a higher prevalence of hypertension (90% versus 76% in persons without PAD, p<.001), diabetes mellitus (45% versus 22%, p<.001), dyslipidemia (88% versus 60%, p<.001), coronary artery disease (63% versus 25%, p<.001), and stroke (36% versus 11%, p<.001). In persons with PAD, antiplatelet drugs were used in 85%, lipid-lowering drugs for dyslipidemia in 67%, beta blockers in 60%, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers in 62%. The average of the last two blood pressures was <140/90 mmHg in 55% of persons with PAD treated for hypertension. The last hemoglobin A1c in diabetics was <7% in 52% of persons with PAD. CONCLUSIONS: Older persons with PAD have a high prevalence of modifiable risk factors, CAD, and stroke. The use of antiplatelet drugs, lipid-lowering drugs for dyslipidemia, beta blockers, and ACE inhibitors or angiotensin-receptor blockers, reduction of blood pressure to <140/90 mmHg in hypertensive persons, and reduction of hemoglobin A1c in diabetics to <7% in older persons with PAD needs to be increased in all clinical settings.

Underutilization of calcium and vitamin D by older adults in a large general internal medicine practice.

The underutilization of calcium and vitamin D supplements in the prevention and treatment of osteoporosis is common among high-risk elders. Less is known about the prevalence and adequacy of calcium and vitamin D use by the general population of older adults. We performed a retrospective chart analysis of 617 women and 383 men over the age of 60 (mean age 73 +/- 9 years) seen at an internal medicine practice to establish the prevalence and evaluate the adequacy of calcium and vitamin D supplementation. Adequate supplementation was defined according to the National Osteoporosis Foundation guidelines and the National Institutes of Health Consensus Development Panel on Osteoporosis. Osteoporosis or osteopenia was documented in 207 (33.6%) women and 21 (5.5%) men (P < 0.01). Of 383 men, 116 (30.3%) used calcium, 25 (6.5%) used adequate doses of calcium, 109 (28.5%) used vitamin D, and only 8 (2.1%) used adequate doses of vitamin D. Of 617 women, 415 (67.3%) used calcium, 199 (32.3%) used adequate doses of calcium, 347 (56.2%) used vitamin D, and 83 (21.7%) used adequate doses of vitamin D. When compared with women, men were less likely to be on calcium (OR 0.21, 95% CI 0.16-0.28), on adequate calcium replacement (OR0.15, 95% CI 0.11-0.23), on vitamin D (OR 0.32, 95% CI 0.25-0.42), and on adequate vitamin D replacement (OR 0.13, 95% CI 0.07-0.26). Calcium and vitamin D were greatly underutilized among older patients in an internal medicine clinic. Inadequate replacement doses were common, and men were particularly susceptible to undertreatment.