Displaying publications 1 - 20 of 64 in total

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  1. Aziz Z, Huin WK, Badrul Hisham MD, Tang WL, Yaacob S
    Complement Ther Med, 2018 Aug;39:49-55.
    PMID: 30012392 DOI: 10.1016/j.ctim.2018.05.011
    OBJECTIVE: To present a systematic review of randomised controlled trials (RCTs) examining the effects of MPFF in the management of haemorrhoid symptoms.

    METHODS: Electronic databases including CENTRAL, CINAHL, EMBASE, MEDLINE were searched up to April 2018 for relevant RCTs. Journal and conference proceedings were also searched. Two review authors independently selected trials, extracted data, assessed the risks of bias in included trials and graded the quality of evidence. Meta-analyses were conducted for studies presenting similar outcomes.

    RESULTS: Ten RCTs involving 1164 participants were included. These RCTs varied in terms of patients' grade of haemorrhoids, length of trials, and outcome assessed. Most of the studies did not describe adequately the process of randomisation and allocation concealment. The pooled analysis of data from three studies indicated that there was significant difference between groups for the bleeding outcome, favoring the MPFF group (RR 1.46; 95% CI 1.10-1.93; p = 0.008). Except for bleeding, the current evidence did not show MPFF has significant effects on all the other outcomes examined when compared with placebo. Even then, the quality of evidence for bleeding was judged as low due to the small number and inconsistent results among the included studies.

    CONCLUSION: This review highlights the need for further rigorous research if MPFF was to be routinely used for the treatment of haemorrhoid symptoms.

  2. Hwong WY, Bots ML, Selvarajah S, Abdul Aziz Z, Sidek NN, Spiering W, et al.
    PLoS One, 2016;11(11):e0166524.
    PMID: 27846309 DOI: 10.1371/journal.pone.0166524
    BACKGROUND: The increase in angiotensin II (Ang II) formation by selected antihypertensive drugs is said to exhibit neuroprotective properties, but this translation into improvement in clinical outcomes has been inconclusive. We undertook a study to investigate the relationship between types of antihypertensive drugs used prior to a stroke event and ischemic stroke severity. We hypothesized that use of antihypertensive drugs that increase Ang II formation (Ang II increasers) would reduce ischemic stroke severity when compared to antihypertensive drugs that suppress Ang II formation (Ang II suppressors).

    METHODS: From the Malaysian National Neurology Registry, we included hypertensive patients with first ischemic stroke who presented within 48 hours from ictus. Antihypertensive drugs were divided into Ang II increasers (angiotensin-I receptor blockers (ARBs), calcium channel blockers (CCBs) and diuretics) and Ang II suppressors (angiotensin-converting-enzyme inhibitors (ACEIs) and beta blockers). We evaluated stroke severity during admission with the National Institute of Health Stroke Scale (NIHSS). We performed a multivariable logistic regression with the score being dichotomized at 15. Scores of less than 15 were categorized as less severe stroke.

    RESULTS: A total of 710 patients were included. ACEIs was the most commonly prescribed antihypertensive drug in patients using Ang II suppressors (74%) and CCBs, in patients prescribed with Ang II increasers at 77%. There was no significant difference in the severity of ischemic stroke between patients who were using Ang II increasers in comparison to patients with Ang II suppressors (OR: 1.32, 95%CI: 0.83-2.10, p = 0.24).

    CONCLUSION: In our study, we found that use of antihypertensive drugs that increase Ang II formation was not associated with less severe ischemic stroke as compared to use of antihypertensive drugs that suppress Ang II formation.

  3. Hwong WY, Bots ML, Selvarajah S, Kappelle LJ, Abdul Aziz Z, Sidek NN, et al.
    PLoS One, 2016;11(10):e0165330.
    PMID: 27768752 DOI: 10.1371/journal.pone.0165330
    A shortage of computed tomographic (CT) machines in low and middle income countries often results in delayed CT imaging for patients suspected of a stroke. Yet, time constraint is one of the most important aspects for patients with an ischemic stroke to benefit from thrombolytic therapy. We set out to assess whether application of the Siriraj Stroke Score is able to assist physicians in prioritizing patients with a high probability of having an ischemic stroke for urgent CT imaging.
  4. Hwong WY, Abdul Aziz Z, Sidek NN, Bots ML, Selvarajah S, Kappelle LJ, et al.
    BMC Neurol, 2017 Nov 23;17(1):203.
    PMID: 29169331 DOI: 10.1186/s12883-017-0984-1
    BACKGROUND: Evaluation of secondary stroke prevention in low and middle-income countries remains limited. This study assessed the prescription of secondary preventive drugs among ischemic stroke patients upon hospital discharge in Malaysia and identified factors related to the prescribing decisions.

    METHODS: From Malaysian National Stroke Registry, we included patients with non-fatal ischemic stroke. Prescriptions of antiplatelet, anticoagulants, antihypertensive drugs and lipid-lowering drugs were assessed. Multi-level logistic regressions were performed to determine the relation between potential factors and drug prescriptions.

    RESULTS: Of 5292 patients, 48% received antihypertensive drugs, 88.9% antiplatelet and 88.7% lipid-lowering drugs upon discharge. Thirty-three percent of patients with an indication for anticoagulants (n = 391) received it. Compared to patients <=50 years, patients above 70 years were less likely to receive antiplatelet (OR: 0.72, 95% CI: 0.50-1.03), lipid-lowering drugs (OR: 0.66, 95% CI: 0.45-0.95) and anticoagulants (OR: 0.27, 95% CI: 0.09-0.83). Patients with moderate to severe disability upon discharge had less odds of receiving secondary preventive drugs; an odds ratio of 0.57 (95% CI: 0.45-0.71) for antiplatelet, 0.86 (95% CI: 0.75-0.98) for antihypertensive drugs and 0.78 (95% CI: 0.63-0.97) for lipid-lowering drugs in comparison to those with minor disability. Having prior specific comorbidities and drug prescriptions significantly increased the odds of receiving these drugs. No differences were found between sexes and ethnicities.

    CONCLUSIONS: Prescription of antihypertensive drugs and anticoagulants among ischemic stroke patients in Malaysia were suboptimal. Efforts to initiate regular clinical audits to evaluate the uptake and effectiveness of secondary preventive strategies are timely in low and middle-income settings.

  5. Aziz Z, Tang WL, Chong NJ, Tho LY
    J Clin Pharm Ther, 2015 Apr;40(2):177-85.
    PMID: 25630350 DOI: 10.1111/jcpt.12247
    Rutoside (rutin; quercetin rutinoside) is a glycoside found in various plant products, including apples, citrus fruits and cranberries. Hydroxyethylrutosides (HR) are semisynthetic derivatives sold as standardized products for the treatment of chronic venous insufficiency (CVI). Commercially available products include Relvène(®) (France), Venoruton(®) (Switzerland) and Paroven(®) (United Kingdom). However, the evidence for their efficacy is inconclusive. The aim of this systematic review was to evaluate the evidence of efficacy and tolerability of hydroxyethylrutosides for CVI.
  6. Aziz Z, Tey NP
    Complement Ther Med, 2009 Jan;17(1):44-50.
    PMID: 19114228 DOI: 10.1016/j.ctim.2008.04.008
    The aim of this study was to examine the prevalence and identify factors, which predict the use of herbal medicines among Malaysian adults.
  7. Sidek NN, Kamalakannan S, Tengku Ismail TA, Musa KI, Ibrahim KA, Abdul Aziz Z, et al.
    Front Neurol, 2022;13:996620.
    PMID: 36212650 DOI: 10.3389/fneur.2022.996620
    INTRODUCTION: Informal caregivers play a crucial role in supporting the activities of daily living, rehabilitation, and the road to recovery for stroke survivors. However, these informal caregivers are often reported as experiencing neglect and lack of recognition despite their primary contribution to stroke recovery. This study investigated the experiences of the caregivers of stroke survivors and access to stroke care in Malaysia.

    METHOD: This qualitative study with a phenomenological approach utilized in-depth interviews, including ten primary caregivers, one formal caregiver, and stroke healthcare providers as the participants. The interviews were done until the data saturation was achieved, and the data was analyzed using thematic analysis.

    RESULT: Three primary themes and 14 subthemes were identified from the interviews. The role of primary caregivers of stroke survivors had tremendous physical, mental and social impact on the caregivers. Caregivers had two primary needs. The need for information about comprehensive stroke care at home and the need for psychological support to themselves. The key internal driver for providing care was identified to be the motivation level of the stroke survivor and the external driver was identified to be the societal support with access to comprehensive stroke care.

    CONCLUSION: The role of informal caregivers becomes critical for continuum of stroke care. As caregivers take up the roles and responsibilities of those who contribute to stroke rehabilitation single-handedly soon after hospital discharge. Results of this study highlights the needs for providing systematic support to caregivers for engaging them in effective stroke care, particularly in the community. Stroke service providers, policy makers and program planners must be sensitized to empower caregivers of stroke survivors in effectively supporting stroke survivor in their family on the road of recovery.

  8. Aziz Z, Flemming K, Cullum NA, Olyaee Manesh A
    PMID: 21069672 DOI: 10.1002/14651858.CD002930.pub4
    Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". Electromagnetic therapy (EMT), in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers.
  9. Elhefnawy M, Nazifah Sidek N, Maisharah Sheikh Ghadzi S, Ibrahim B, Looi I, Abdul Aziz Z, et al.
    Cureus, 2024 Jan;16(1):e52574.
    PMID: 38371076 DOI: 10.7759/cureus.52574
    BACKGROUND: Hyperglycaemia (HG) during an acute ischemic stroke (AIS) is not only associated with unfavourable functional outcomes but also associated with stroke-associated pneumonia (SAP). This study aimed to determine the prevalence of SAP among Malaysian patients with AIS and the predictors of SAP among patients with HG during AIS.

    METHODS: This is a retrospective cross-sectional study that included patients with AIS admitted to Hospital Sultanah Nur Zahirah, Malaysia from 2017 to 2020. SAP was defined as infection with pneumonia during the first seven days after IS. HG was defined as a blood glucose level > 7.8 mmol/L within 72 h after admission. Patients with SAP were divided into two groups according to HG status. Multivariate logistic regression analysis was performed using SPSS software, version 22 (IBM Corp., Armonk, NY) to identify SAP predictors among patients with HG. Kaplan-Meier log-rank test was used to compare the survival rate from unfavourable functional outcomes between hyperglycaemic patients with and without SAP.

    RESULTS: Among 412 patients with AIS, 69 (16.74%) had SAP. The prevalence of SAP among patients with HG and normoglycemia during AIS was 20.98%, and 10.65%, respectively. Age above 60 years, leucocytosis, and National Institute of Health Stroke Scale (NIHSS) > 14 on admission were independent predictors of SAP with aOR of 2.08 (95% CI;1.01-4.30), 2.83 (95% CI; 1.41-5.67), and 3.67 (95% CI; 1.53-8.80), respectively. No significant difference in unfavourable functional outcomes survival was found among patients with and without SAP (p = 0.653).

    CONCLUSION: This study demonstrated the prevalence of SAP was higher among patients with HG compared to normoglycemia during AIS. The patient being old, leucocytosis and severe stroke upon admission predict the occurrence of SAP among patients with HG during AIS.

  10. Aziz Z, Huin WK, Hisham MDB, Ng JX
    Complement Ther Med, 2020 Jan;48:102236.
    PMID: 31987256 DOI: 10.1016/j.ctim.2019.102236
    OBJECTIVE: To present a systematic review of randomised controlled trials examining the effects of pomegranate (Punica granatum) on lipid profiles.

    METHOD: The Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, EMBASE, SCOPUS and conference proceedings were searched for relevant trials to June 2019. We included randomized controlled trials comparing pomegranate with placebo. The outcomes examined were effects on lipids level. Two authors screened titles for inclusion, extracted data and assessed the quality of the trials using the revised Cochrane risk of bias tool. We used a random effects model to pool data and stratified trials to examine sources of statistical heterogeneity. To assess the quality of the evidence, we used the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach.

    RESULTS: Seventeen trials recruiting 763 subjects met the inclusion criteria. These trials varied in terms of the dosage form of pomegranate used, subjects recruited and trials duration. Meta-analyses of data did not show pomegranate produced a significant effect on the lipids level examined. The quality of evidence for all outcomes was low due to the imprecision of the pooled effect and the inconsistency within the included trials. The limited data on safety suggest only mild, transient and infrequent adverse events with the short-term use of pomegranate.

    CONCLUSION: Current evidence does not show pomegranate has significant effects on serum lipid levels. The quality of evidence is poor to support the increasing use of pomegranate for hyperlipidaemia.

  11. Elhefnawy M, Noor Harun S, Leykhim T, Tangiisuran B, Zainal H, Looi I, et al.
    Cureus, 2023 Dec;15(12):e50794.
    PMID: 38239519 DOI: 10.7759/cureus.50794
    Objectives Compared with the first stroke, neurological impairment caused by stroke recurrence is more serious, more difficult to treat, and has a higher mortality rate, especially among ischemic stroke (IS) patients with diabetes mellitus (DM). Although there are established correlations between factors and IS recurrence, there were some issues regarding the naive hazard of IS recurrence with no risk factor influence, and how does the baseline hazard differ among patients with DM and non-DM? To answer all these questions, two time-to-event (TTE) models of recurrent IS after the index IS were developed among IS patients with DM and non-DM. Method A total of 7697 patients with an index IS attack were extracted from the Malaysian Registry of Neurology and stratified according to DM status. Several parametric survival models were evaluated using nonlinear mixed-effect modeling software (NONMEM 7.5). The final model was determined according to the lowest objective function value, graphical evaluation, numerical diagnostics, and clinical plausibility. Additionally, the final model was validated internally and temporally using Kaplan-Meier visual predictive checks (KM-VPCs). Results One hundred ninety-five (5.82%) of 3493 DM patients and 138 (3.28%) of 4204 non-DM patients developed a recurrent IS with a maximum follow-up of 7.37 years. Gompertz's model best fitted the data. With no influence on risk factors, the index IS attack was predicted to contribute to the hazard of recurrent IS by 0.356 and 0.253 within the first six months after the index IS among patients with and without DM, respectively. Even after six months of index IS, the recurrent IS baseline hazard was not equal to zero among both groups (0.0023, 0.0018). Moreover, after incorporating the time and risk factors, the recurrent hazards increased exponentially during the first three years after the index IS followed by an exponential reduction afterward. The recurrent IS predictors among DM patients were ischemic heart disease (IHD) and hyperlipidemia (HPLD). IHD and HPLD increased the hazard of recurrent IS by 2.40 and 1.88 times, respectively, compared to those without IHD and HPLD before index IS (HR, 2.40 (1.79-3.20)), and (HR, 1.88 (1.44-2.45)) respectively. Conclusion The baseline hazard was the highest during the first six months after the index IS. Moreover, receiving medications for secondary prevention failed to demonstrate a significant association with reducing IS recurrence among IS patients with DM, suggesting a need for more intensive patient screening and new strategies for secondary prevention among IS patients with DM.
  12. Cheah WK, Hor CP, Abdul Aziz Z, Looi I
    Med J Malaysia, 2016 Jun;71(Suppl 1):58-69.
    PMID: 27801388
    Over 100 articles related to stroke were found in a search through a database dedicated to indexing all literature with original data involving the Malaysian population between years 2000 and 2014. Stroke is emerging as a major public health problem. The development of the National Stroke Registry in the year 2009 aims to coordinate and improve stroke care, as well as to generate more data on various aspects of stroke in the country. Studies on predictors of survival after strokes have shown potential to improve the overall management of stroke, both during acute event and long term care. Stroke units were shown to be effective locally in stroke outcomes and prevention of stroke-related complications. The limited data looking at direct cost of stroke management suggests that the health economic burden in stroke management may be even higher. Innovative rehabilitation programmes including braincomputer interface technology were studied with encouraging results. Studies in traditional complementary medicine for strokes such as acupuncture, Urut Melayu and herbal medicine were still limited.
  13. Beshir SA, Aziz Z, Yap LB, Chee KH, Lo YL
    J Clin Pharm Ther, 2018 Apr;43(2):209-219.
    PMID: 29030869 DOI: 10.1111/jcpt.12634
    WHAT IS KNOWN AND OBJECTIVE: Bleeding risk scores (BRSs) aid in the assessment of oral anticoagulant-related bleeding risk in patients with atrial fibrillation. Ideally, the applicability of a BRS needs to be assessed, prior to its routine use in a population other than the original derivation cohort. Therefore, we evaluated the performance of 6 established BRSs to predict major or clinically relevant bleeding (CRB) events associated with the use of oral anticoagulant (OAC) among Malaysian patients.

    METHODS: The pharmacy supply database and the medical records of patients with non-valvular atrial fibrillation (NVAF) receiving warfarin, dabigatran or rivaroxaban at two tertiary hospitals were reviewed. Patients who experienced an OAC-associated major or CRB event within 12 months of follow-up, or who have received OAC therapy for at least 1 year, were identified. The BRSs were fitted separately into patient data. The discrimination and the calibration of these BRSs as well as the factors associated with bleeding events were then assessed.

    RESULTS: A total of 1017 patients with at least 1-year follow-up period, or those who developed a bleeding event within 1 year of OAC use, were recruited. Of which, 23 patients experienced a first major bleeding event, whereas 76 patients, a first CRB event. Multivariate logistic regression results show that age of 75 or older, prior bleeding and male gender are associated with major bleeding events. On the other hand, prior gastrointestinal bleeding, a haematocrit value of less than 30% and renal impairment are independent predictors of CRB events. All the BRSs show a satisfactory calibration for major and CRB events. Among these BRSs, only HEMORR2 HAGES (C-statistic = 0.71, 95% CI 0.60-0.82, P 

  14. Lim JL, Lohmann K, Tan AH, Tay YW, Ibrahim KA, Abdul Aziz Z, et al.
    J Neural Transm (Vienna), 2022 Jan;129(1):37-48.
    PMID: 34779914 DOI: 10.1007/s00702-021-02421-0
    GBA variants are associated with increased risk and earlier onset of Parkinson's disease (PD), and more rapid disease progression especially with "severe" variants typified by p.L483P. GBA mutation screening studies from South-East Asia, with > 650 million inhabitants of diverse ancestries, are very limited. We investigated the spectrum of GBA variants, and associated clinico-demographic features, in a multi-ethnic PD cohort in Malaysia. Patients (n = 496) were recruited from seven centres, primarily of Chinese (45%), Malay (37%), and Indian (13%) ethnicities. All GBA coding exons were screened using a next-generation sequencing-based PD gene panel and verified with Sanger sequencing. We identified 14 heterozygous GBA alleles consisting of altogether 17 missense variants (8 classified as pathogenic or likely pathogenic for PD) in 25 (5.0%) patients, with a substantially higher yield among early (
  15. Tay YW, Tan AH, Lim JL, Lohmann K, Ibrahim KA, Abdul Aziz Z, et al.
    Parkinsonism Relat Disord, 2023 Jun;111:105399.
    PMID: 37209484 DOI: 10.1016/j.parkreldis.2023.105399
    BACKGROUND: About 5-10% of Parkinson's disease (PD) cases are early onset (EOPD), with several genes implicated, including GBA1, PRKN, PINK1, and SNCA. The spectrum and frequency of mutations vary across populations and globally diverse studies are crucial to comprehensively understand the genetic architecture of PD. The ancestral diversity of Southeast Asians offers opportunities to uncover a rich PD genetics landscape, and identify common regional mutations and new pathogenic variants.

    OBJECTIVES: This study aimed to investigate the genetic architecture of EOPD in a multi-ethnic Malaysian cohort.

    METHODS: 161 index patients with PD onset ≤50 years were recruited from multiple centers across Malaysia. A two-step approach to genetic testing was used, combining a next-generation sequencing-based PD gene panel and multiplex ligation-dependent probe amplification (MLPA).

    RESULTS: Thirty-five patients (21.7%) carried pathogenic or likely pathogenic variants involving (in decreasing order of frequency): GBA1, PRKN, PINK1, DJ-1, LRRK2, and ATP13A2. Pathogenic/likely pathogenic variants in GBA1 were identified in thirteen patients (8.1%), and were also commonly found in PRKN and PINK1 (11/161 = 6.8% and 6/161 = 3.7%, respectively). The overall detection rate was even higher in those with familial history (48.5%) or age of diagnosis ≤40 years (34.8%). PRKN exon 7 deletion and the PINK1 p.Leu347Pro variant appear to be common among Malay patients. Many novel variants were found across the PD-related genes.

    CONCLUSIONS: This study provides novel insights into the genetic architecture of EOPD in Southeast Asians, expands the genetic spectrum in PD-related genes, and highlights the importance of diversifying PD genetic research to include under-represented populations.

  16. Goh, L.P.W., Chong, E.T.J., Wong, J.J., Abdul Aziz, Z., Surugau, N., Abd. Latip, M., et al.
    MyJurnal
    Paddy is the staple food of local people in Sabah, but its production is affected by a disturbing disease known as blast, which is caused by fungi (i.e., Magnaporthe grisea and Magnaporthe oryzae) infection. Knowledge regarding distribution of blast-resistant (BR) genes among various Sabah traditional paddy varieties in different divisions of Sabah is not clear; hence, molecular identification of BR genes in Sabah traditional paddies is urgently needed. In this study, genomic DNA was extracted from 21 different Sabah traditional paddy varieties collected from three divisions of Sabah including the West Coast Division (WCD), Sandakan Division (SD), and Interior Division (ID). The presence of 11 BR and 2 pathogenesis-related (PR) genes in their genome was molecularly screened using a PCR approach and validated using direct sequencing. Our results showed that high frequencies of Pib (95.2%), pi-ta (100.0%), and RCC2 (100.0%) genes were obtained in all 21 Sabah traditional paddy varieties screened. Interestingly, one of the paddy varieties from ID of Sabah, PBT23, did not contain the Pib gene but carried the Pita/Pita-2 allele in its genome. Besides, only three paddies (PBT08 and PBT07 from WCD, and PBT23) exhibited the Pik-p gene, and no varieties were found to carry the Pik, Pik-m, Pit, Piz, Piz-t, Pi-ta, Pi9, and wwin2 genes. In conclusion, this study serves as the basis for improvement and effectual management of traditional paddies in different divisions of Sabah towards blast resistance with knowledge of BR or PR genes inherited in their genome.
  17. King TL, Tiong LL, Abdul Aziz Z, Law WC
    J Stroke Cerebrovasc Dis, 2023 Sep;32(9):107230.
    PMID: 37478524 DOI: 10.1016/j.jstrokecerebrovasdis.2023.107230
    OBJECTIVES: The study aimed to determine the prevalence of untreated pharmacologically modifiable cardiovascular risk factors (PMRF) among patients with ischaemic stroke and the association with in-hospital mortality and functional outcome.

    METHODS: We analysed the data from ischaemic stroke cases admitted to Sarawak General Hospital between June 2013 and June 2021. We matched the underlying PMRFs with prior medications and categorised them as treated, untreated, or no PMRF. We calculated the prevalence and assessed the association between untreated PMRFs and in-hospital mortality or favourable functional outcome (FFO) at discharge, which was adjusted for age, sex, and other covariates in multivariable models.

    RESULTS: We included 1963 patients [65.4% male, 59.8 (SD 13.4) years]; 43.8% who had at least one untreated PMRF had triple the odds of in-hospital mortality [adjusted OR (aOR) 2.86, (95%CI 1.44, 5.70)], whereas 30.2% who had all PMRFs treated showed no significant association. Untreated hypertension [aOR 2.19 (95%CI 1.21, 3.98)], treated [aOR 3.02 (95%CI 1.32, 6.92)], and untreated atrial fibrillation [aOR 1.89 (95%CI 1.18, 3.03)] were significantly associated with more in-hospital death, whereas treated prior stroke was associated with fewer in-hospital death [aOR 0.31 (95%CI 0.11, 0.84)]. Treated diabetes [aOR 0.66 (95%CI 0.49, 0.88)] and untreated prior stroke [aOR 0.53 (95%CI 0.33, 0.83)] were associated with fewer FFO.

    CONCLUSION: The high prevalence of untreated underlying PMRFs was significantly associated with poorer outcomes among Malaysian patients with ischaemic stroke in Sarawak. Efforts are needed to promote early screening and treatment of cardiovascular risk factors to reduce the burdens and improve stroke outcomes in this region.

  18. Mohd Sani N, Aziz Z, Kamarulzaman A
    Ther Innov Regul Sci, 2021 05;55(3):490-502.
    PMID: 33231863 DOI: 10.1007/s43441-020-00243-y
    INTRODUCTION: Biosimilars are a cost-effective alternative to original biologic medicines that allow patients access to biologic therapies for various chronic diseases. Our paper aims to provide an overview of biosimilars in Malaysia with emphasis on the comparison of Malaysian guidelines with guidelines from well-established regulatory agencies, a review of biosimilars' market approval and their reported adverse effects (AEs) as well as clinical trials conducted in Malaysia.

    METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.

    RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.

    CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.

  19. Watan Pal A, Aziz Z, Kamarulzaman A
    J Clin Pharm Ther, 2021 Dec;46(6):1531-1548.
    PMID: 34159618 DOI: 10.1111/jcpt.13449
    WHAT IS KNOWN AND OBJECTIVE: Opioid Use Disorder (OUD) has a high mortality rate and affects millions of people worldwide. Many organizations and societies develop Clinical Practice Guidelines (CPGs) to serve as a framework for healthcare providers to decide and support best practice to manage and treat OUD. However, not all CPGs sufficiently address all the important aspects of optimal care for managing OUD. This study aims to review current CPGs for management of OUD, evaluate their methodological quality and summarize their recommendations.

    METHODS: We conducted this systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Various databases were searched for CPGs and Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument was used to assess the methodological quality. We also summarized the treatments plans of CPGs across continuum of care (diagnosis and assessment, treatment initiation, pharmacotherapy and psychosocial).

    RESULTS: This review included 28 CPGs of varying qualities. CPGs from high-income countries and international organizations rated high for their methodological quality. Most CPGs scored high for the scope and purpose domain and scored low for applicability domain. Recommendations for the continuum of care for OUD varied across CPGs. Buprenorphine was recommended in most of the CPGs, followed by methadone. Recommendations for psychosocial interventions also varied, with cognitive behaviour therapies and counselling or education being the common recommendations in many CPGs WHAT IS NEW AND CONCLUSION: We found most CPGs have scope and purpose and clarity of presentation. However, the methodological rigour and applicability scored low. CPGs need to frame health questions in a comprehensible manner and provide an update as evidence grows. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations.

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