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Biomedical subjects

Laura L Mulloy

Publications and source records attributed to Laura L Mulloy.

9 recordsLinked to original sources

Fibromuscular dysplasia: an uncommon cause of secondary hypertension.

Fibromuscular dysplasia is a noninflammatory vascular disease that commonly affects the distal two thirds of the renal artery and branch vessels, but occasionally involves other arteries. Progression of stenosis occurs in 16%-38% of renal arteries. Although the etiology is unknown, genetic studies suggest a relationship to the angiotensin-converting enzyme I allele. Thin, young Caucasian women without a family history of hypertension are most commonly affected. An abdominal or flank systolic-diastolic bruit is an important clue for the diagnosis. Most noninvasive screening tests are not sensitive or reproducible to be used to rule out renal artery stenosis, but digital subtraction renal angiography usually confirms the diagnosis. Percutaneous renal artery angioplasty is the treatment of choice, but may not result in normalization of blood pressure if diagnosis is delayed. Since restenosis occurs, continued follow-up is necessary.

Fibromuscular Dysplasia↗

Patient factors associated with adherence to immunosuppressant therapy in renal transplant recipients.

PURPOSE: Factors associated with adherence to immunosuppressant therapy (IST) in renal transplant recipients were studied. METHODS: The Immunosuppressant Therapy Adherence Scale (ITAS) was completed by adult renal transplant recipients in Georgia. Those completing the ITAS were classified as adherent to IST if their ITAS score were 12 and nonadherent if their score was less than 12. The relationship between the dichotomized ITAS scores and patient variables that are readily available to clinicians, such as sex, age, kidney donor type, income, marital status, race or ethnicity, and time since transplantation, was assessed. The relationship of ITAS scores to patients' clinical and pharmacy data (e.g., graft rejection, serum IST concentrations, serum creatinine [SCr] concentrations, and pharmacy refill-based adherence rates) was also assessed. RESULTS: One hundred thirty-seven patients completed the ITAS. Eighty-nine patients (65%) were adherent to IST, and the remaining 48 (35%) were nonadherent. Patient sex was unrelated to adherence. Compared with nonadherent patients, adherent patients tended to be younger, to take cyclosporine, to have lower incomes, to have received their transplant more recently, to have targeted immunosuppressant concentrations, to have greater refill-based adherence rates, and to be less likely to exhibit an increase in SCr concentration (p < 0.05). There was no significant difference in the number of rejections between adherent and nonadherent patients. CONCLUSION: Patient age, income, time since transplantation, and the immunosuppressant agent prescribed were associated with IST adherence.

Cyclosporine↗

Development and validation of the immunosuppressant therapy adherence instrument (ITAS).

A five-item scale was developed that asked respondents to indicate how often they were non-adherent to immunosuppressant therapy (IST) given a particular circumstance. Two hundred and twenty-two recipients completed the instrument. Validity of the scale was assessed by correlating composite item scores with refill record adherence rates (RRARs), serum immunosuppressant (IS) concentrations, graft rejection, and increased serum creatinine (SCr) levels. One scale item was deleted due to lack of response variability. Cronbach's alpha coefficient for the four-item scale was 0.81, demonstrating that the scale has acceptable reliability. All items loaded on a single principal component, suggesting that the scale measures a single adherence construct, which accounted for 64% of the scale items' variance. The four-item scale, adherence measured by IS RRARs, and "target" IS serum concentrations had positive correlations (p < 0.01). Item scores were shown to be negatively related to rejection occurrence and increased SCr (p < 0.05). The immunosuppressant therapy adherence scale is the first published, valid and reliable instrument that measures recipients IST adherence.

Attitude to Health↗

Comparing renal transplant patients' adherence to free cyclosporine and free tacrolimus immunosuppressant therapy.

BACKGROUND: The purpose of this study is to determine if there is a difference in renal transplant patients' (RTPs) adherence to cyclosporine compared to tacrolimus when medications are supplied free to the RTPs. METHODS: Adult primary RTPs were included in the study if they received a renal transplant at the Medical College of Georgia (MCG) from June 1998 through August 2001 and received their first post-transplant year of follow-up care at MCG and free cyclosporine or free tacrolimus from the MCG outpatient pharmacy. Adherence was estimated by comparing each RTPs' tacrolimus or cyclosporine pharmacy refill records to the prescribed regimen for 12 months after transplant. Patients' cyclosporine and tacrolimus serum concentrations were used to validate adherence. Kaplan-Meier analysis was used to estimate the fraction of RTPs remaining adherent and to compare the mean time RTPs were adherent in each group (cyclosporine vs. tacrolimus). RESULTS: Thirty-three RTPs were included in the study, 25 (76%) received cyclosporine and eight received tacrolimus. The mean time to the first non-adherent month was 8 months post-transplant. At 12-months post-transplant, approximately 42% of the patients remained adherent. A greater percentage of the patients who received tacrolimus remained adherent compared with those who were taking cyclosporine (63% vs. 33%, p < 0.05). Approximately 75% of non-adherent patients were found to have subtarget drug concentrations, and only 24% of adherent patients had subtarget levels (p < 0.01). CONCLUSIONS: When provided free, patients are more adherent to tacrolimus than cyclosporine. Regardless of treatment, intensive efforts to increase adherence should be implemented.

Adult↗

Development and validation of an immunosuppressant therapy adherence barrier instrument.

BACKGROUND: To decrease allograft rejection as a result of non-adherence to immunosuppressant therapy (IST), a valid and reliable instrument that measures solid organ transplant patients' adherence barriers is needed. METHODS: An immunosuppressant therapy barrier scale (ITBS) was developed to assess transplant patients' perceived barriers to IST adherence and was completed by 222 transplant patients who lived in Georgia, USA. A renal transplant population subset was used to test the ITBS reliability and validity. Scale reliability was estimated using Cronbach's alpha coefficient of internal consistency; scale dimensionality was assessed using principal components analysis. The criterion-related validity of the scale was assessed by relating subscale scores to adherence measures and graft rejection. Nomological validity was assessed by relating barrier subscales to specific patient factors. RESULTS: Two subscales that represented 'controllable' and 'uncontrollable' barriers were found. Cronbach's alpha coefficients demonstrated acceptable reliabilities of 0.93, 0.86 and 0.91 for the 'uncontrollable' and 'controllable' subscales, and for the entire ITBS, respectively. The ITBS subscales correlated negatively with a self-reported measure of IST adherence, IST serum concentrations and IST pharmacy refill adherence rate (P<0.01). The 'uncontrollable barrier' subscale was positively correlated to kidney graft rejection (P<0.01), thus demonstrating the ITBS's validity. Males and older patients reported more adherence barriers (P<0.05). CONCLUSIONS: The ITBS is a reliable and valid instrument that can be used to measure patients' perceived barriers to IST adherence.

Adult↗

Randomized double-blind study of immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with mycophenolate mofetil-containing triple therapy in renal transplantation.

BACKGROUND: Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. METHODS: In a randomized, double-blind, placebo-controlled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. RESULTS: Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or posttransplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3% vs. 26.6%, P=NS) and of acute rejection treated with antibody (5.1% vs. 15.6%, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsy-confirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100% in both groups; graft survival was 94.9% with basiliximab and 92.2% with placebo. CONCLUSIONS: Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.

Adult↗

Effect of clinical pharmacy services on the blood pressure of African-American renal transplant patients.

OBJECTIVE: The objective of this study was to determine if African-American renal transplant patients who received direct patient care from a clinical pharmacist had better blood pressure control compared to African-American renal transplant patients who did not have clinical pharmacy services. METHODS: Renal transplant patients were prospectively randomized into an intervention group or a control group. Patients in the intervention group received clinical pharmacy services that included a clinical pharmacist performing patient medication reviews, with emphasis on preventing or resolving medication-related problems and providing medication recommendations. Patients in the control group received routine clinic services, but had no clinical pharmacist interaction. Analysis was performed to detect differences between the intervention and control groups in baseline and quarterly systolic blood pressure (SBP) and diastolic blood pressure (DBP) for one year post-study enrollment. RESULTS: There were no differences between the intervention (N = 13) and control (N = 10) groups in baseline blood pressures or in the percentage of hypertensive patients. Significant differences in the change in SBP and DBP from baseline between the intervention and control groups were observed at the second, third, and fourth quarters of the study, favoring the intervention group (P < .01). Mean SBP was significantly lower in the intervention group at the second (137.8 +/- 15.0 vs 168.9 +/- 15.3), third (135.9 +/- 11.7 vs 164.6 +/- 20.1), and fourth (145.3 +/- 16.8 vs 175.8 +/- 33.9) quarters of the study (P < .05). Mean DBP was significantly lower in the intervention group at the second (76.0 +/- 11.8 vs 84.9 +/- 6.1) and fourth (77.0 +/- 10.2 vs 91.8 +/- 12.0) quarters (P < .05). CONCLUSION: Direct patient care services provided by a clinical pharmacist, in addition to routine clinical services, have a positive effect on the blood pressure of African-American renal transplant patients. A multidisciplinary team that includes a clinical pharmacist is beneficial to patient care.

Adult↗

Scleroderma renal crisis.

Abrupt onset of severe uncontrolled hypertension and rapidly progressive oliguric renal failure characterizes scleroderma renal crisis. The etiology is unclear, but very high renin levels are present. While scleroderma is more common in women and whites, there is no difference in the prevalence of scleroderma renal crisis by gender. However, there appears to be a higher prevalence of scleroderma renal crisis among African Americans than whites. Survival was dismal prior to the introduction of the vigorous treatment of hypertension and use of converting-enzyme inhibitors. However, most data on the benefit of these medications are derived from uncontrolled and unblinded studies. Prospective, randomized controlled trials are needed to assess the role of angiotensin receptor blockers. Prevention trials could define the role of various drugs in decreasing the rate of scleroderma renal crisis.

Angiotensin-Converting Enzyme Inhibitors↗