Displaying all 10 publications

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  1. Siddiqui S, Zainal H, Harun SN, Ghadzi SMS
    Clin Nutr ESPEN, 2020 10;39:165-172.
    PMID: 32859312 DOI: 10.1016/j.clnesp.2020.06.022
    BACKGROUND: Diabetes mellitus is a leading cause of preventable deaths and becomes a major public health concern in Malaysia. Multiple studies have reported the association between diet quality and glycemic parameters among known diabetic subjects. Its influence in individuals with borderline diabetes (i.e. pre-diabetes) or unknown diabetes is still unclear.

    OBJECTIVE: The objective of this study was to assess the association between diet quality evaluated by healthy eating index (HEI) with the glucose outcome in individuals with distinct diabetes progression stages, as well as to identify causal factors in relation to their diabetes status.

    METHOD: A cross-sectional study was conducted at clinical care setting in Universiti Sains Malaysia (USM) between October 2018-March 2019. Normoglycemic controls (n = 47), at-risk of pre-diabetes (n = 58), pre-diabetes (n = 24) as well as individuals with undiagnosed diabetes (n = 18) were queried about their habitual diet by using Food Frequency Questionnaire (FFQ). Correlation analyses were performed to examine the relationship between HEI score and 1) Fasting plasma glucose (FPG) 2) postprandial blood glucose (2-HPP) and glycosylated hemoglobin (HbA1c). Multinomial regression was performed to identify predictors associated with diabetes status of study participants.

    RESULT: Overall, diet quality of study participants was unsatisfactory with the mean score of 58.05 ± 9.07 that need improvement. Total HEI score was negatively correlated with the 2-HPP levels in pre-diabetic patients (r = - 0.45, p = 0.05). No significant association was revealed between glycemic parameters and total HEI score among other groups. Age, body mass index (BMI), triglycerides and female gender were positively correlated with the risk of pre-diabetes, at-risk of pre-diabetes and undiagnosed diabetes (p 

  2. Ibrahim MMA, Ghadzi SMS, Kjellsson MC, Karlsson MO
    CPT Pharmacometrics Syst Pharmacol, 2018 07;7(7):432-441.
    PMID: 29732710 DOI: 10.1002/psp4.12302
    In antidiabetic drug development, phase I studies usually involve short-term glucose provocations. Multiple designs are available for these provocations (e.g., meal tolerance tests (MTTs) and graded glucose infusions (GGIs)). With a highly nonlinear, complex system as the glucose homeostasis, the various provocations will contribute with different information offering a rich choice. Here, we investigate the most appropriate study design in phase I for several hypothetical mechanisms of action of a study drug. Five drug effects in diabetes therapeutic areas were investigated using six study designs. Power to detect drug effect was assessed using the likelihood ratio test, whereas precision and accuracy of the quantification of drug effect was assessed using stochastic simulation and estimations. An overall summary was developed to aid designing the studies of antihyperglycemic drug development using model-based analysis. This guidance is to be used when the integrated glucose insulin model is used, involving the investigated drug mechanisms of action.
  3. Khaleel MA, Khan AH, Ghadzi SMS, Alshakhshir S
    Data Brief, 2022 Feb;40:107701.
    PMID: 34988273 DOI: 10.1016/j.dib.2021.107701
    A drug dataset containing international proprietary names is essential for researchers investigating different drugs from different countries worldwide. However, many websites on the internet offer free access for a single drug searching service to identify international drug trade names, but not for a list of drugs to be searched and identified. Therefore, it will be problematic if the researcher has a list of hundreds or thousands of drug trade names to be identified. In this project, we have created an International Drug Dictionary (IDD) by curating collected drug lists from open access websites belonging to official drug regulatory agencies, official healthcare systems, or recognized scientific bodies from 44 countries around the world in addition to the European public assessment reports (EPAR) and the DRUGBANK vocabulary published in the public domain. Researchers interested in pharmacovigilance, pharmacoepidemiology, or pharmacoeconomics can benefit from this dataset, especially when identifying lists of proprietary drug names, particularly of multi-national origin. To enhance its adaptability, we also mapped the IDD to the standardized drug vocabulary RxNorm. The IDD can also be used as a tool for mapping international drug trade names to RxNorm. Each drug entity in the IDD mapped to a unique identification number for each entity called Atom Unique Identifier (RXAUI) from RxNorm.
  4. Daud NAA, Mohiuddin SG, Ong YP, Yusof F, Yusoff F, Harun SN, et al.
    J Pharm Bioallied Sci, 2021 05 26;13(2):230-237.
    PMID: 34349484 DOI: 10.4103/jpbs.JPBS_542_20
    Background: Metformin has been added in the Malaysian clinical practice guideline (CPG) as one of the first-line options in the management of gestational diabetes mellitus (GDM); however, the uptake on this practice among healthcare professionals is unknown.

    Objective: The objective of the study is to determine the awareness, attitude, and practice and their predictors on the use of metformin for GDM among healthcare professionals in Malaysia.

    Materials and Methods: This was a multicenter, cross-sectional study in three tertiary hospitals in Malaysia. Medical doctors and pharmacists working in several departments were invited to participate in a survey using self-administered questionnaires.

    Results: From 350 questionnaires distributed, 225 were completed by medical doctors (43.1%), pharmacists (40.4%), and specialists (7.5%). Less than 30% of them were aware on the option of using metformin as one of the first-line agents in GDM. Education level, department, and profession were found to be associated with the awareness level (P = 0.016, P = 0.004, and P = 0.001, respectively). 70.2% of the respondents showed a positive attitude toward metformin use in GDM. Only 64 (28.4%) of the respondents have prescribed/dispensed metformin for GDM before, although more than half will consider doing so in the future. Having postgraduate qualifications increased the likelihood of having a good awareness (odds ratio [OR]: 2.44, 95% confidence interval [CI] 1.23-4.85) and to consider prescribing/dispensing metformin for GDM patients (OR: 2.27, 95% CI 1.08-4.78).

    Conclusion: Despite a positive attitude toward metformin use in GDM among healthcare professionals in Malaysia, their awareness level on this practice was low as they currently prefer the use of insulin over metformin.

  5. Albitar O, Ghadzi SMS, Harun SN, Ahmad SNA, Kjellsson MC
    J Pharmacokinet Pharmacodyn, 2023 Feb;50(1):21-31.
    PMID: 36380133 DOI: 10.1007/s10928-022-09833-9
    Clozapine has superior efficacy to other antipsychotics yet is underutilized due to its adverse effects, such as neutropenia, weight gain, and tachycardia. The current investigation aimed to introduce a pharmacometric approach to simultaneously model drug adverse effects, with examples from schizophrenia spectrum patients receiving clozapine. The adverse drug effects were represented as a function of time by incorporating a mixture model to describe individual susceptibility to the adverse effects. Applications of the proposed method were presented by analyzing retrospective data from patients' medical records in Psychiatric Clinic, Penang General Hospital. Tachycardia, weight gain, and absolute neutrophils count (ANC) decrease were best described by an offset, a piecewise linear, and a transient surge function, respectively. 42.9% of the patients had all the adverse effects, including weight gain (0.01 kg/m2 increase every week over a baseline of 24.7 kg/m2 until stabilizing at 279 weeks), ANC decrease (20% decrease from 4540 cells/µL week 12-20.8), and tachycardia (14% constant increase over a baseline of 87.9 bpm for a clozapine maintenance dose of 450 mg daily). 32.5% of the patients had only tachycardia, while the remaining 24.6% had none of the adverse effects. A new pharmacometric approach was proposed to describe adverse drug effects with examples of clozapine-induced weight gain, ANC drop, and tachycardia. The current approach described the longitudinal time changes of continuous data while assessing patient susceptibility. Furthermore, the model revealed the possible co-existence of ANC drop and weight gain; thus, neutrophil monitoring might predict future changes in body weight.
  6. Siddiqui S, Harun SN, Ghadzi SMS, Wahid NA, Hassan AB, Zainal H
    PMID: 38213389 DOI: 10.51866/oa.125
    INTRODUCTION: Diabetes is closely linked to cardiovascular diseases, with diabetic dyslipidaemia serving as an established marker of the acceleration of complications, contributing to an increased cardiovascular risk among patients. Timely detection and early characterization of lipid abnormalities can help clinicians in implementing effective preventive measures. This study aimed to determine the patterns and associated factors of dyslipidaemia among Malaysian subjects with borderline diabetes.

    METHODS: A retrospective study was conducted among subjects with borderline diabetes aged ≥18 years who visited a primary healthcare centre at Universiti Sains Malaysia from January 2017 to December 2018. Sociodemographic, clinical and laboratory data were obtained from electronic medical records. Data were analysed using SPSS version 25.

    RESULTS: A total of 250 participants with borderline diabetes were included in the analysis. Of them, 93.6% (n=234) had lipid abnormalities. Isolated dyslipidaemia characterised by a high low-density lipoprotein cholesterol (LDL-C) level (38.8%, n=97) was the most common pattern found, followed by combined dyslipidaemia of high LDL-C and triglyceride (TG) levels (22.8%, n=57). The male sex was found to be significantly associated with hypertriglyceridemia (adjusted odds ratio [AOR] = 1.86, 95% confidence interval [CI] =1.09-3.1)(P=0.02). Diastolic blood pressure ≥90mmHg was significantly associated with a low HDL-C level (A0R=2.09, 95% CI=1.0-4.1) (P=0.03).

    CONCLUSION: The majority of subjects with borderline diabetes have lipid abnormalities. Specifically, isolated dyslipidaemia characterised by a high LDL-C level is alarmingly prevalent. Further large-scale robust studies are needed to confirm the present findings.

  7. Phaisal W, Albitar O, Chariyavilaskul P, Jantarabenjakul W, Wacharachaisurapol N, Ghadzi SMS, et al.
    PMID: 38661209 DOI: 10.1093/jac/dkae059
    OBJECTIVES: Twelve weekly doses of rifapentine and isoniazid (3HP regimen) are recommended for TB preventive therapy in children with TB infection. However, they present with variability in the pharmacokinetic profiles. The current study aimed to develop a pharmacokinetic model of rifapentine and isoniazid in 12 children with TB infection using NONMEM.

    METHODS: Ninety plasma and 41 urine samples were collected at Week 4 of treatment. Drug concentrations were measured using a validated HPLC-UV method. MassARRAY® SNP genotyping was used to investigate genetic factors, including P-glycoprotein (ABCB1), solute carrier organic anion transporter B1 (SLCO1B1), arylacetamide deacetylase (AADAC) and N-acetyl transferase (NAT2). Clinically relevant covariates were also analysed.

    RESULTS: A two-compartment model for isoniazid and a one-compartment model for rifapentine with transit compartment absorption and first-order elimination were the best models for describing plasma and urine data. The estimated (relative standard error, RSE) of isoniazid non-renal clearance was 3.52 L·h-1 (23.1%), 2.91 L·h-1 (19.6%), and 2.58 L·h-1 (20.0%) in NAT2 rapid, intermediate and slow acetylators. A significant proportion of the unchanged isoniazid was cleared renally (2.7 L·h-1; 8.0%), while the unchanged rifapentine was cleared primarily through non-renal routes (0.681 L·h-1; 3.6%). Participants with the ABCB1 mutant allele had lower bioavailability of rifapentine, while food prolonged the mean transit time of isoniazid.

    CONCLUSIONS: ABCB1 mutant allele carriers may require higher rifapentine doses; however, this must be confirmed in larger trials. Food did not affect overall exposure to isoniazid and only delayed absorption time.

  8. Al-Ashwal FY, Kubas M, Zawiah M, Bitar AN, Mukred Saeed R, Sulaiman SAS, et al.
    PLoS One, 2020;15(12):e0243962.
    PMID: 33306750 DOI: 10.1371/journal.pone.0243962
    BACKGROUND: The coronavirus disease of 2019 (COVID-19) represents a difficult challenge and could have devastating consequences for the healthcare system and healthcare workers in war-torn countries with poor healthcare facilities such as Yemen. Our study aimed to evaluate the knowledge, preparedness, counselling practices of healthcare workers regarding COVID-19, and the perceived barriers to adequately prevent and control COVID-19 in Yemen.

    METHODS: Healthcare workers (HCWs) from major healthcare facilities participated in this cross-sectional study. A self-administered questionnaire comprising of five main domains (demographics, knowledge, self-preparedness, counselling practice, perceived barriers) was distributed among HCWs after obtaining informed consent. A convenient sampling technique was used. Descriptive and inferential analyses were applied using SPSS software.

    RESULTS: A total of 1000 participants were initially targeted to participate in the study with 514 (51.4%) responding, of which 55.3% were female. Physicians and nurses constituted the largest proportion of participants, with 39.5% and 33.3%, respectively. The median scores for knowledge, self-preparedness, and counselling practice were 8 (out of 9), 9 (out of 15), and 25 (out of 30), respectively. The physician group showed a statistically significant association with better knowledge compared to the nurse group only, P<0.001. Males had higher preparedness scores than females, p<0.001. Also, the intensive care unit (ICU) and emergency departments presented a statistically significant difference by which the participants from these departments were more prepared compared to the others (e.g. outpatients, paediatrics and surgery) with P < 0.0001. The lack of awareness among the general population about COVID-19 preventive measures was perceived as the most common barrier for the adequate prevention and control of COVID-19 in Yemen (89.1%).

    CONCLUSION: The major highlight of this study is that HCWs have, overall, good knowledge, suboptimal preparedness, and adequate counselling practices prior to the outbreak of COVID-19 in Yemen, despite the high number of perceived barriers. However, urgent action and interventions are needed to improve the preparedness of HCWs to manage COVID-19. The perceived barriers also need to be fully addressed by the local healthcare authorities and international organisations working in Yemen for adequate prevention and control measures to be in place in managing COVID-19.

  9. Mohiuddin SG, Sulaiman SAS, Albitar O, Iqbal MS, Obaidullah M, Ghadzi SMS, et al.
    J Pharm Bioallied Sci, 2022;14(3):140-146.
    PMID: 36506726 DOI: 10.4103/jpbs.jpbs_473_21
    BACKGROUND: Extrapulmonary tuberculosis represents about 14% of all cases of tuberculosis (TB) in Malaysia. The aim of the study includes the evaluation of sociodemographic factors, clinical manifestations, comorbidities among patients with tuberculous lymphadenitis and their treatment outcomes.

    METHODS: The retrospective study was conducted from 2006 to 2008. Data on sociodemographic along with histopathological results were collected. The signs and symptoms were also recorded from TB registers, treatment cards, and TB medical personal files using the standard data collection tool. Among multiple variables, the significant factors identified by univariate analysis were included in the multivariate logistic regression to estimate the odds ratios with the 95% confidence intervals. The statistically significant P value was considered <0.05.

    RESULTS: There were 348 (57%) males, and on the other hand, 262 (43%) females which shows almost equal incidence rate of lymphadenitis in both genders. The age group was observed from 2 to 83 years old. Therefore, the age group between 26 and 35 years showed 194 (31.8%) patients diagnosed with lymphadenitis and followed by 16-25 years (21%). The mean age was found as 34.3 ± 14.6 years were majorly reported with positive diagnosis. One hundred and ninety-six (32.1%) Malay population were found with tuberculous lymphadenitis followed by the Chinese population of 148 (24.3%). The other prominent races were Pilipino, Indonesians, and other expatriates. Geographically, patients were from 386 (63.3%) urban population were found positive for lymphadenitis and over 224 (36.7%) population of the rural region. The treatment outcome was observed 444 (72.8%) with successful treatment. The World Health Organization states the types of treatment failures, and accordingly, 85 (13.9%) patients were continued with the therapy that can be due to noncompliance or relapse of TB. Among the unsuccessful outcomes, 194 patients of age group 26-35 years, 65 (33.5%) were reported and 38 (29.7%) patients out of 128 between ages of 16-25 years. Blood test results showed erythrocyte sedimentation rate >10 in 280 (45.9%) patients. Therefore, among 280, there were 115 (41.1%) patients were found to have unsuccessful treatment showing very strong association with P < 0.001.

    CONCLUSION: The finding signifies that effect of weight loss on poor treatment outcomes' and active screening measures for patients with comorbidities are therefore recommended in patients with tuberculous lymphadenitis along with improvements in the diagnosis and early management of comorbidities complications. As young age group was found to have poor or unsuccessful treatment outcomes and required aggressive strategy together with educating patients can further increase the treatment success rate.

  10. Albitar O, Harun SN, Abidin NE, Tangiisuran B, Zainal H, Looi I, et al.
    J Stroke Cerebrovasc Dis, 2020 Oct;29(10):105173.
    PMID: 32912507 DOI: 10.1016/j.jstrokecerebrovasdis.2020.105173
    BACKGROUND: Diabetes and obesity are established risk factors for stroke. The current study aimed to assess risk factors of ischemic stroke recurrence in diabetic patients based on their body mass index (BMI).

    METHODS: A total of 4005 diabetic patients who had a history of ischemic stroke were identified in a retrospective cross-sectional dataset from the Malaysian National Neurology Registry. Patients were classified based on BMI, and multivariable regression analysis was used to evaluate the association between risk factors and recurrent ischemic stroke.

    RESULTS: Among obese patients, those with ischemic heart disease (aOR, 1.873; 95% CI, 1.131-3.103), received formal education (aOR, 2.236; 95% CI, 1.306-3.830), and received anti-diabetic medication (aOR, 1.788; 95% CI, 1.180-2.708) had a higher stroke recurrence risk, while receiving angiotensin receptors blockers (aOR, 0.261; 95% CI, 0.126-0.543) lowered the odds of recurrence. Overweight patients with hypertension (aOR, 1.011; 95% CI, 1.002-1.019) for over 10 years (aOR, 3.385; 95% CI, 1.088-10.532) and diabetes prior to the first stroke (aOR, 1.823; 95% CI, 1.020-3.259) as well as those received formal education (aOR, 2.403; 95% CI, 1.126-5.129) had higher odds of stroke recurrence, while receiving angiotensin-converting enzyme inhibitors (aOR, 0.244; 95% CI, 0.111-0.538) lowered the recurrence risk. Normal weight East Malaysians (aOR, 0.351; 95% CI, 0.164-0.750) receiving beta-blockers (aOR, 0.410; 95% CI, 0.174-0.966) had lower odds of stroke recurrence.

    CONCLUSIONS: Ischemic heart disease, hypertension, receiving anti-hypertensive agents, and educational level were independent predictors of recurrent stroke in obese patients. Managing the modifiable risk factors can decrease the odds of stroke recurrence.

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