Publications by authors named "Maggie M Abbassi"

13 Publications

  • Page 1 of 1

Retraction Note to: The EQ-5D-5L Valuation Study in Egypt.

Pharmacoeconomics 2021 Jun 15. Epub 2021 Jun 15.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.

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http://dx.doi.org/10.1007/s40273-021-01055-0DOI Listing
June 2021

The EQ-5D-5L Valuation Study in Egypt.

Pharmacoeconomics 2021 May 12;39(5):549-561. Epub 2021 Mar 12.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.

Introduction: No value sets exist for either the EQ-5D-3L or the EQ-5D-5L in Egypt, despite local pharmacoeconomic guidelines recommending the use of the EQ-5D to derive utility. Most published Egyptian economic evaluation studies have used utility values from other published studies and systematic reviews.

Objective: Our objective was to develop an Egyptian EQ-5D-5L value set using the international EuroQol standardized protocol (EQ-VT-2.1).

Methods: Adult Egyptian participants were recruited from public places using multi-stratified quota sampling based on age, sex, and geographical distribution. Two elicitation techniques were applied: the composite time trade-off (cTTO) and discrete-choice experiments (DCEs). Before actual data collection, interviewers' performance was assessed in a pilot phase. Data were modelled using generalized least square, Tobit, heteroskedastic, logit, and hybrid models, and the best fitting model was selected based on the value range between observed and predicted values, logical consistency of the parameters, significance level, and prediction accuracy.

Results: A total of 1378 interviews were conducted, of which 188 were excluded because they were incomplete or did not comply with protocol, 216 were pilot interviews, and 974 were included in the final analysis. The heteroskedastic model (model 4) based on the cTTO data was selected as the preferred model to generate the value set. Values ranged from - 0.93 for the worst health state (55555) to 1 for full health (11111), with 1136 (36.3%) of all predicted health states being worse than dead. Mobility had the largest impact on health state preference values.

Conclusion: This is the first value set for the EQ-5D-5L based on social preferences obtained from a nationally representative sample in Egypt or any Arabic-speaking country. The value set can be used as a scoring system for economic evaluations and to improve the quality of health technology assessment in the Egyptian healthcare system.
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http://dx.doi.org/10.1007/s40273-021-01002-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952144PMC
May 2021

The potential hepatoprotective effect of metformin in hepatitis C virus-infected adolescent patients with beta thalassemia major: Randomised clinical trial.

Int J Clin Pract 2021 Jun 17;75(6):e14104. Epub 2021 Mar 17.

Department of Pediatrics and Pediatric Hematology/Oncology Unit, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Background: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C virus (HCV) infection are the main reasons of liver damage in beta thalassemia major (β-TM).

Objectives: Based on metformin's hepatic benefits in nondiabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected β-TM adolescent patients.

Methods: This was a prospective, randomised, parallel, controlled, open-label study in which 60 HCV-infected β-TM adolescent patients aged 11 to 18 years and receiving no antiviral therapy were selected and randomly assigned to treatment or control group in 1:1 allocation. Both groups were receiving β-TM standard-of-care regimen, whereas metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed up for 6 months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptom improvement and metformin's adverse effects.

Results: Aspartate aminotransferase serum level decreased significantly over time in the treatment group only (P = .013). However, improvement was not clinically significant and did not attain normality. Change in total antioxidant capacity and malondialdehyde serum levels indicated significantly improved oxidative stress status in the treatment group versus significant deterioration in the control group (P < .001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group.

Conclusion: The use of metformin in HCV-infected β-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.
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http://dx.doi.org/10.1111/ijcp.14104DOI Listing
June 2021

Pharmacokinetics of daclatasvir in Egyptian adolescents with genotype-4 HCV infection.

Antivir Ther 2020 ;25(2):101-110

Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Background: Daclatasvir has potent antiviral activity against HCV infection when used in combination with sofosbuvir, however, its pharmacokinetics have not been described in adolescents. The aim is to determine the pharmacokinetic parameters of daclatasvir in adolescents, and to develop a population pharmacokinetic (PopPK) model.

Methods: Seventeen adolescent patients with genotype-4 chronic HCV infection received once daily oral daclatasvir 60 mg in combination with 400 mg sofosbuvir for 12 weeks. Steady state concentrations were determined. Non-compartmental and population PK were determined.

Results: The average PK parameters calculated by non-compartmental analysis (NCA): maximum plasma concentration (C), area under the curve (AUC), apparent oral volume of distribution (V/F), apparent oral clearance (CL/F) and half-life (T) were 1,092 ng/ml, 11,178 ng/ml•h, 55 l, 4.5 l/h and 8.5 h, respectively. Daclatasvir was best described by one compartment structural PK model with zero order absorption and first-order elimination. The absorption rate constant (K), V/F, and CL/F of the final PopPK model of daclatasvir were 1.5/h, 52 l and 4.7 l/h, respectively. Body weight and serum albumin had significant effect on the V/F parameter.

Conclusions: Body weight and serum albumin were the major determinants of daclatasvir V/F in this population. PK parameters were comparable to those reported in adult HCV patients, demonstrating that 60 mg daclatasvir is an appropriate dose for adolescents. ClinicalTrials.gov NCT03540212.
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http://dx.doi.org/10.3851/IMP3357DOI Listing
January 2020

The impact of active vitamin D administration on the clinical outcomes of acne vulgaris.

J Dermatolog Treat 2020 Jan 3:1-6. Epub 2020 Jan 3.

Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

Acne vulgaris is one of the most common chronic inflammatory skin disorder affecting millions of people worldwide. Vitamin D deficiency has a role in various inflammatory skin diseases as acne. This study aimed to investigate the serum level of 25 hydroxy vitamin D in acne patients and to assess the efficacy and safety of active vitamin D in management of acne. This study was conducted on 100 patients with acne and 100 healthy controls, then the 100 acne patients were randomized to either the study group that received 0.25ug alfacalcidol daily or the placebo group that received oral placebo during the 3 months study period. Serum levels of 25-hydroxy-vitamin D were significantly lower in acne patients than in healthy control and were inversely correlated to the severity of acne. After alfacalcidol administration, the study group showed significant higher level of 25(OH) D levels ( < .05) compared to placebo group. In addition, median serum level of IL6 and TNFα significantly decreased ( < .05) in the study group in comparison to placebo group and as compared to their baseline results. Acne patients are more commonly to have vitamin D deficiency as compared to healthy people and hence, alfacalcidol might have a beneficial role in the acne management with no reported side effects.
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http://dx.doi.org/10.1080/09546634.2019.1708852DOI Listing
January 2020

The Effect of Telephone-Based Follow-Up on Adherence, Efficacy, and Toxicity of Oral Capecitabine-Based Chemotherapy.

Telemed J E Health 2019 06 26;25(6):462-470. Epub 2018 Jul 26.

1 Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

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http://dx.doi.org/10.1089/tmj.2018.0077DOI Listing
June 2019

Nebulized Versus IV Amikacin as Adjunctive Antibiotic for Hospital and Ventilator-Acquired Pneumonia Postcardiac Surgeries: A Randomized Controlled Trial.

Crit Care Med 2018 01;46(1):45-52

Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Objective: Nebulized antibiotics offer high efficacy due to significant local concentrations and safety with minimal blood levels. This study evaluates the efficacy and nephrotoxicity of nebulized versus IV amikacin in postcardiothoracic surgical patients with nosocomial pneumonia caused by multidrug-resistant Gram- negative bacilli.

Design: Prospective, randomized, controlled study on surgical patients divided into two groups.

Setting: Postcardiac surgery ICU.

Interventions: The first gtroup was administered IV amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered IV piperacillin/tazobactam empirically.

Patients: Recruited patients were diagnosed by either hospital-acquired pneumonia or ventilator-associated pneumonia where 56 (42.1%) patients were diagnosed with hospital-acquired pneumonia, 51 (38.34%) patients were diagnosed with early ventilator-associated pneumonia, and 26 (19.54%) patients with late ventilator-associated pneumonia.

Measurements And Main Results: Clinical cure in both groups assessed on day 7 of treatment was the primary outcome. Efficacy was additionally evaluated through assessing the length of hospital stay, ICU stay, days on amikacin, days on mechanical ventilator, mechanical ventilator-free days, days to reach clinical cure, and mortality rate. Lower nephrotoxicity in the nebulized group was observed through significant preservation of kidney function (p < 0.001). Although both groups were comparable regarding length of hospital stay, nebulizer group showed shorter ICU stay (p = 0.010), lower number of days to reach complete clinical cure (p = 0.001), fewer days on mechanical ventilator (p = 0.035), and fewer days on amikacin treatment (p = 0.022).

Conclusion: Nebulized amikacin showed better clinical cure rates, less ICU stay, and fewer days to reach complete recovery compared to IV amikacin for surgical patients with nosocomial pneumonia. It is also a less nephrotoxic option associated with less deterioration in kidney function.
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http://dx.doi.org/10.1097/CCM.0000000000002695DOI Listing
January 2018

Randomized comparative efficacy and safety study of intermittent simvastatin versus fenofibrate in hemodialysis.

J Comp Eff Res 2017 Jul 19;6(5):413-424. Epub 2017 Jun 19.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Aim: Compare the safety and efficacy of intermittent fenofibrate versus simvastatin in chronic hemodialysis patients.

Patients & Methods: Sixty patients received either fenofibrate 100 mg or simvastatin 20 mg after their dialysis session (parallel study). The safety and efficacy of drugs on lipid profile, oxidized low-density lipoprotein (Ox-LDL), glutathione peroxidase and C-reactive protein were compared before and after 16-week treatment.

Results: After treatment, significant increase in glutathione peroxidase, significant decrease in total cholesterol, triglycerides, low density lipoprotein (LDL) and ox-LDL (p < 0.05) and no significant changes in C-reactive protein (p > 0.05) were observed in both groups. Both drugs were well tolerated with no serious side effects reported by the patients.

Conclusion: Both drugs have comparable efficacy and safety when used as intermittent low dose regimen in hemodialysis. Larger studies with longer follow-up periods are needed to confirm our new findings.
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http://dx.doi.org/10.2217/cer-2016-0076DOI Listing
July 2017

Effect of alfacalcidol on the pulmonary function of adult asthmatic patients: A randomized trial.

Ann Allergy Asthma Immunol 2017 05 1;118(5):557-563. Epub 2017 Apr 1.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Background: Despite the use of alfacalcidol in the management of corticosteroid-induced osteoporosis, it has never been considered an adjunct treatment for asthma management. It can target vitamin D deficiency, a possible risk factor for asthma, and, hence, improve pulmonary function of patients with asthma.

Objective: To explore the effect of alfacalcidol administration on pulmonary function and study the pattern of vitamin D deficiency in adults with asthma in Egypt.

Methods: Serum 25-hydroxyvitamin D was measured in 115 adults: 33 healthy subjects and 82 patients with asthma. Then, patients with asthma were randomized to receive standard asthma treatment only (n = 39) or receive it in addition to 1 μg of alfacalcidol daily for 4 months (n = 43). Randomization was stratified by the stage of asthma severity. Spirometry and measurement of 25-hydroxyvitamin were performed at baseline and end of follow-up.

Results: Vitamin D deficiency was more common in patients with asthma (57.3%) than in healthy subjects (21.2%; P < .001). In patients with asthma, alfacalcidol significantly improved forced expiratory volume in the first second and forced vital capacity (P < .001 for the 2 tests). Moreover, more patients in the intervention arm showed improvement in asthma severity stage (P = .04). A nonsignificant difference was observed in improvement of forced expiratory volume in the first second between patients with vitamin D deficiency and those without deficiency in the intervention group (P > .05).

Conclusion: Alfacalcidol supplementation improved the pulmonary function and severity stage of adult patients with asthma regardless of deficiency.

Trial Registration: ClinicalTrials.gov Identifier: NCT02747381.
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http://dx.doi.org/10.1016/j.anai.2017.02.014DOI Listing
May 2017

Efficacy of Different Perioperative Statin Regimens on Protection Against Post-Coronary Artery Bypass Grafting Major Adverse Cardiac and Cerebral Events.

J Cardiothorac Vasc Anesth 2016 Dec 31;30(6):1461-1470. Epub 2016 May 31.

Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Objectives: Comparing different perioperative statin regimens for the prevention of post-coronary artery bypass grafting adverse events.

Design: A randomized, prospective study.

Setting: Cardiothoracic surgical units in a government hospital.

Participants: The study comprised 94 patients scheduled for elective, isolated on- or off- pump coronary artery bypass grafting.

Interventions: Patients were assigned randomly to 1 of the following 3 treatment groups: group I (80 mg of atorvastatin/day for 2 days preoperatively), group II (40 mg of atorvastatin/day for 5-9 days preoperatively), or group III (80 mg of atorvastatin/day for 5-9 days preoperatively). The same preoperative doses were restarted postoperatively and continued for 1 month.

Measurements And Main Results: Cardiac troponin I, creatine kinase, and C-reactive protein (CRP) levels were assayed preoperatively; at 8, 24, and 48 hours postoperatively; and at discharge. CRP levels at 24 hours (p = 0.045) and 48 hours (p = 0.009) were significantly lower in group III compared with the other 2 groups. However, troponin I levels at 8 hours (p = 0.011) and 48 hours (p = 0.025) after surgery were significantly lower in group II compared with group III. The incidence of postoperative major adverse cardiac and cerebrovascular events was assessed, and there was no significant difference among the 3 groups.

Conclusion: The 3 regimens did not result in any significant difference in outcomes, but only simple trends. The higher-dose regimen resulted in a significant reduction in the CRP level. Thus, more studies are needed to confirm the benefit of higher-dose statins for the protection from post-coronary artery bypass grafting adverse events.
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http://dx.doi.org/10.1053/j.jvca.2016.05.046DOI Listing
December 2016

Obesity Does Not Affect Propofol Pharmacokinetics During Hypothermic Cardiopulmonary Bypass.

J Cardiothorac Vasc Anesth 2016 Aug 11;30(4):876-83. Epub 2016 Feb 11.

Clinical Pharmacy Department, Faculty of Pharmacy.

Objective: Because of the lack of data regarding the impact of obesity on propofol pharmacokinetics in patients undergoing cardiac surgery using hypothermic cardiopulmonary bypass (CPB), the authors sought to explore propofol pharmacokinetics and develop a predictive pharmacokinetic model that characterizes and predicts propofol pharmacokinetics in this population.

Design: A prospective, observational study.

Setting: A teaching hospital.

Participants: The study comprised 17 obese and 17 control (nonobese) patients undergoing hypothermic CPB.

Intervention: None.

Measurements And Main Results: Patients mainly underwent valve surgery. On initiation of hypothermic CPB (28°C-32°C), patients received a propofol (1%) bolus (1 mg/kg) immediately followed by a 2 mg/kg/h infusion. Blood samples were withdrawn at the following times: before dosing; 1, 3, 5, and 7 minutes after the propofol bolus dose; every 20 minutes during infusion; just before discontinuation of the infusion; and at 1, 3, 5, 7, 10, 20, 30, and 60 minutes after discontinuation of the infusion. The plasma propofol concentration was determined using high-performance liquid chromatography, and then data were imported into Monolix (Lixoft, Antony, France) for population pharmacokinetic modeling and pharmacokinetic parameters estimation. A 2-compartment pharmacokinetic model with age as a covariate on the peripheral volume of distribution (V2) best described the pooled data. The pooled data was internally evaluated successfully to describe and predict propofol pharmacokinetics in the addressed population. Propofol clearance, intercompartmental clearance, and central volume of distribution were 805 mL/min, 1140 mL/min and 18.8 L, respectively. V2 was calculated as 9.86×exp.(1.88×[age/40]) L.

Conclusion: Propofol pharmacokinetic parameters were similar in obese and nonobese patients undergoing hypothermic CPB. Age was the major determinant of propofol V2 in the obese population.
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http://dx.doi.org/10.1053/j.jvca.2016.02.003DOI Listing
August 2016

Can zinc levels predict response to pegylated-interferon and ribavirin therapy in hepatitis C genotype 4 infected Egyptian patients?

Acta Gastroenterol Belg 2014 Jun;77(2):217-23

Background And Aims: Zinc has been found to be low in chronic hepatitis patients. Its level was correlated with response to Interferon/ribavirin therapy in patients infected with hepatitis C genotype 1. In Egypt, inexpensive predictors to treatment response in Hepatitis C genotype 4 infected patients are desperately needed. We aim to explore if pretreatment zinc serum levels correlate with response to pegylated- interferon and ribavirin therapy in Egyptian patients.

Methods: This is an observational prospective study where 57 treatment naive hepatitis C genotype 4 infected patients that were Hepatitis B and Human Immunodeficiency virus negative were recruited in a hospital setting. The study was performed from October 2010 till June 2012. Patients had Liver biopsy and basic biochemical profiles were performed pretreatment for all patients. Treatment consisted of 48 weeks of pegylated-interferon-alpha2a and ribavirin therapy. Blood samples were withdrawn from 21 healthy subjects to compare zinc levels and other biochemical markers. Patients were followed up to 72 weeks.

Results: Pretreatment serum zinc levels were significantly lower in hepatitis C infected patients compared to healthy volunteers (p < 0.05). Moreover, zinc levels correlated to sustained virological response in treated patients (p = 0.00).

Conclusion: Serum zinc levels can be used as an inexpensive predictor to effective Pegylated-interferon/ribavirin therapy in Egyptian patients infected with Hepatitic C genotype 4.
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June 2014

A specially tailored vancomycin continuous infusion regimen for renally impaired critically ill patients.

SAGE Open Med 2013 8;1:2050312113507921. Epub 2013 Oct 8.

Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Background: Vancomycin remains the gold standard for treatment of methicillin-resistant Staphylococcus aureus. Specially designed continuous infusion of vancomycin leads to better therapy.

Methodology: A total of 40 critically ill patients who suffered from pneumonia susceptible to vancomycin, had serum creatinine >1.4 mg%, and oliguria <0.5 mL/kg/h for 6 h were included in the study with respiratory culture sensitivity to vancomycin ≤2 mg/L. Patients' clinical, microbiological, and biological data were obtained by retrospective analysis of the corresponding medical files before and after vancomycin treatment. Patients with serum creatinine level ≥4 mg% and patients who received renal replacement therapy during the treatment period were excluded. The patients were divided into two groups-group 1 (intermittent dosing) and group 2 (continuous infusion) based on the following formula: rate of vancomycin continuous infusion (g/day) = [0.0205 creatinine clearance (mL/min) + 3.47] × [target vancomycin concentration at steady state (µg/mL)] × (24/1000). Trough vancomycin serum levels were also assessed using high-performance liquid chromatographic technique. Patients' outcomes such as clinical improvement, adverse events, and 15-day mortality were reported.

Results: Group 2 showed significant reduction in blood urea nitrogen, creatinine serum levels, white blood cells, partial carbon dioxide pressure, body temperature, and Sequential Organ Failure Assessment score, while significant increase in partial oxygen pressure and saturated oxygen was also observed. A significantly shorter duration of treatment with a comparable vancomycin serum levels was also reported with group 2.

Conclusion: After treatment, comparison in patients' criteria supports the superiority of using continuous infusion of vancomycin according to this equation in renally impaired patients.
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http://dx.doi.org/10.1177/2050312113507921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4687768PMC
January 2016