Application of the Statin-Associated Muscle Symptoms-Clinical Index to a Cohort of Patients with Type 2 Diabetes Mellitus Undergoing Phlebotomy at an Endocrinology Clinic

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dc.contributor.authorTajudin, NHMen_US
dc.contributor.authorFahrni, MLen_US
dc.contributor.authorGhani, RAen_US
dc.contributor.authorAwang, MHen_US
dc.contributor.authorChopra, Hen_US
dc.contributor.authorAlkhoshaiban, AS.en_US
dc.date.accessioned2025-05-12T10:22:28Z
dc.date.available2025-05-12T10:22:28Z
dc.date.issued2024-12
dc.description.abstractBackground: Statin-associated muscle symptoms (SAMS), the commonest statin-induced adverse effects, could hinder patient adherence and possibly lead to discontinuation of therapy, which then increases patients’ risks for developing cardiovascular events. Although statins are the most frequently prescribed lipid-lowering medication, the occurrence and severity of SAMS among the Malaysian population are less known. Objectives: To examine the likelihood and types of muscle symptoms attributable to statins, and the risk factors for developing the symptoms among statins users. Materials and Methods: This was a cross-sectional study conducted with convenience sampling of patients with type 2 diabetes mellitus undergoing phlebotomy at an endocrinology clinic of a secondary hospital in a suburban city. Demographic and clinical data for the evidence of SAMS were retrieved from the hospital information system. A total of 214 patients were screened, and 50 subjects were recruited for interviews based on the study’s inclusion and exclusion criteria. Muscle symptoms that were evident through clinician notes, and self-reported signs and symptoms by patients during the interview were assessed to determine whether they were SAMS or not. This was done using a pre-structured published questionnaire via patient interview, and the likelihood was then determined using the SAMS-clinical index (SAMS-CI) tool. Results: In this cohort, the probability of having had a statin-associated muscle adverse event was 0.48, i.e., 48% “probable” and “possible” likelihood of SAMS having occurred for a patient who consumed a statin. The mean SAMS-CI score was 6.32 ± 0.470 (±7.4%) [CI: 5.85–6.79], which fell under an “unlikely” category. The most frequent type of muscle symptom was myalgia, which was experienced as muscle aches, stiffness, cramps, symptoms worsening after exercise, muscle tenderness, and trouble moving knees or arm joints. These symptoms were proximal and symmetrical in nature and commonly involved large muscle groups such as the thighs, buttocks, calves, and back muscles. An elevation in creatinine kinase was not commonly observed. Conclusion: A minority (6%) of the patients that we sampled experienced SAMS, which were probably attributable to statins. Nevertheless, caution must be exercised for female patients with a familial history of heart disease being prescribed with the lipophilic statins, atorvastatin, and simvastatin, and those who report aches in the large muscle groups.en_US
dc.identifier.affiliationsDepartment of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi Mara (UiTM), Bandar Puncak Alam, Selangor, Malaysiaen_US
dc.identifier.affiliationsDepartment of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi Mara (UiTM), Bandar Puncak Alam, Selangor, Malaysia; Institute for Big Data Analytics and Artificial Intelligence (IBDAAI), Kompleks Al-Khawarizmi, Universiti Teknologi MARA, Shah Alam, Selangor, Malaysiaen_US
dc.identifier.affiliationsFaculty of Medicine, UiTM Selangor Branch Sungai Buloh Campus, Sungai Buloh, Selangor, Malaysiaen_US
dc.identifier.affiliationsFaculty of Medicine, UiTM Selangor Branch Sungai Buloh Campus, Sungai Buloh, Selangor, Malaysiaen_US
dc.identifier.affiliationsDepartment of Biosciences, Saveetha School of Engineering, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, Indiaen_US
dc.identifier.affiliationsPharmacy Practice Department, College of Pharmacy, Qassim University, Qassim University Medical City, Saudi Arabiaen_US
dc.identifier.citationTajudin NHM, Fahrni ML, Ghani RA, Awang MH, Chopra H, Alkhoshaiban AS.. Application of the Statin-Associated Muscle Symptoms-Clinical Index to a Cohort of Patients with Type 2 Diabetes Mellitus Undergoing Phlebotomy at an Endocrinology Clinic. Journal of Pharmacology and Pharmacotherapeutics. 2024 Dec; 15(4): 389-399en_US
dc.identifier.issn0976-500X
dc.identifier.issn0976-5018
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/247670
dc.languageenen_US
dc.publisherSage Publications India Pvt. Ltd.en_US
dc.relation.issuenumber4en_US
dc.relation.volume15en_US
dc.source.urihttps://doi.org/10.1177/0976500X241268964en_US
dc.subjectStatins-associated muscle symptomsen_US
dc.subjectstatins-associated muscle symptoms-clinical index (SAMS-CI)en_US
dc.subjectpharmacovigilanceen_US
dc.titleApplication of the Statin-Associated Muscle Symptoms-Clinical Index to a Cohort of Patients with Type 2 Diabetes Mellitus Undergoing Phlebotomy at an Endocrinology Clinicen_US
dc.typeJournal Articleen_US
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