Statin induced myalgia on high intensity statin in patients with Acute Coronary Syndrome

Background High intensity statins are recommended in patients with acute coronary syndrome. Statins inhibit atherosclerotic plaque formation in the coronary arteries and reducing the burden of ischemic heart disease, therefore decreasing the morbidity and mortality. Muscle symptoms are most common adverse effect of statins. Hence, the aim of this study is to determine the statin induced myalgia by the statin myalgia clinical score. Purpose To monitor the Statin induced myalgia on high intensity statin in patients with Acute Coronary Syndrome Methods This was an prospective observational study comprised of 418 patients with acute coronary syndrome who were commenced on high intensity statins (Rosuvastatin 20–40mg & Atorvastatin 40–80). These patients were followed at 4 weeks, 8 weeks and 12 weeks subsequently and the clinical myalgia score (SAMS-CI) was calculated at each visit to determine the statin induced myalgia. SAMS-CI was categorized as unlikely (2–6), possible (7–8) and probable (9–11) Results From 418 patients, 327 were males and 91 were females. Mean age was 55.6±11.14. Only 19 (7.63±1.8) patients developed muscle symptoms on high intensity statins (Rosuvastatin 20 mg and Atorvastatin 40 mg) on SAMS-CI Score. 5 patients were unlikely to develop myalgia on SAMS-CI and continued with the same dosage without any new symptoms. 6 patients were possible on SAMS-CI, therefore the dosage of these patients were decreased to moderate intensity statin (Rosuvastatin 10mg, Atorvastatin 20 mg), their symptoms were resolved and continued with the moderate intensity statins. Furthermore, Statin was hold in 8 patients in the probable category for 4 weeks until the resolution of symptoms followed by moderate intensity statins. Conclusion Statin induced myalgia is more reported in old aged and female patients. Most of the patients can better tolerate the lower range of high intensity statins with the similar benefits and should be prescribed in every patient FUNDunding Acknowledgement Type of funding sources: None.

A cross sectional survey of side effects of antiretroviral (ARV) in outpatients HIV by Naranjo Algorithm

Background: The main modality in HIV patients is the administration of long-treatment antiretroviral therapy (ARV). One of the problems from the use of ARV therapy is the side effects that can reduce patient compliance in taking medication, which has the potential to cause treatment failure. Objective: This study aims to examine the side effects and their causality in the use of ARVs in outpatient HIV patients at the VCT Clinic, Bhayangkara H.S. Hospital. Samsoeri Mertojoso Surabaya. Methods: This research was a prospective observational study with a cross-sectional design. Side effect data were taken from HIV patients by interview using the Naranjo algorithm. HIV patients who met the inclusion criteria were included in the study sample using consecutive sampling. This research was conducted from January to March 2020. Results: There were 72 outpatient HIV patients who met the inclusion criteria. The most opportunistic infections found in HIV patients are tuberculosis and Pneumocystis pneumonia. The results showed that the most common side effects experienced by patients were dizziness (43%), nausea and vomiting (31%), and rash (11%) with the highest Naranjo score being in the probable category of 86%. The Naranjo score in HIV patients with opportunistic infections and with comorbidities was significantly smaller than those in HIV patients without opportunistic infections or without comorbidities with independent t-test (P <0.05). Conclusion: The side effects in HIV patients while undergoing treatment with antiretroviral therapy are classified as a minor side effect and the cause of the side effects that occur is thought to be due to the probable category of ARV therapy. Keywords: HIV Patients, Antiretroviral, Side Effects, Naranjo's Algorithm.

Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar

Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.

Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide

Introduction: Dytor plus tablet is a fixed-dose combination of torsemide and spironolactone used for generalized edema. TEN is a serious, potentially life-threatening dermatological disorder. Methods: Here we present a case report of a 47-year-old female who was on Dytor Plus (5/50 mg)therapy once daily for generalized edema; presented to dermatology outpatient department with chief complaints of multiple erosions over oral cavity, swelling of lips with scaling, redness and burning sensation in both eyes, multiple well defined mostly erythematous rashes over the entire body since 2 days. Results: On examination, her vital signs were stable and lab results indicate she had elevated SGOT(140 IU/L), SGPT (228 IU/L), ALP (162IU/L), and blood urea(47 mg/ml) values. The patient was diagnosed to have developed Dytor plus induced toxic epidermal necrolysis. Discontinued the medicine and prescribed with Dexamethasone injection, IgG Injection, Cefotaxime injection, Cloxacilline capsule, Cetirizine tablet, Hydroxypropyl methylcellulose eye drop, and candid mouth paint. The patient had a hospital stay of 25 days. Conclusions: The patient improved symptomatically. Causality was assessed as per the WHO-UMC causality scale and this case was put in the probable category. This case was uploaded via vigiflow under the pharmacovigilance programme of India having report Id 2019-30695.

Individual case safety reports by nursing staff: a retrospective pharmacovigilance analysis

Background: The burden of adverse drug reactions is high and accounts for considerable morbidity which can be prevented if healthcare professionals have proper knowledge. Early and spontaneous reporting of ADRs is the mainstay of pharmacovigilance program. Since staff nurses are closely involved in direct patient care, they can easily identify ADRs in the early stage. This study was done to assess the extent of participation of nurses in pharmacovigilance program in our institution.Methods: Retrospective observational study was conducted by analyzing the 210 Individual Case Safety Reports (ICSR) of 2years duration. Causality assessment in the ICSR was analyzed. Severity of the reactions was categorized into mild, moderate and severe according to Modified Hartwig and Siegel scale. Descriptive statistics were used.Results: There were 177 cases reported by faculties and 33 were by the staff nurses.19 nurses reported 33 adverse effects (1:1.7) whereas 41 faculties 177 events (1:4). On analyzing the severity of reactions, 188 cases were categorized as moderate (89.5%), 20 mild (9.5%) and 2 severe (1%). In moderate category of 188 reports, 82 % reporting was by faculties and 18% by staff nurses. All the 33 reports by nurses were of moderate category (100%). In the mild and severe category, 100% reporting was by faculties. Causality analysis showed that 194 were classified as probable (92%), 14 as Possible (7%) and 2as certain (1%). In probable category 85% of reporting was by faculties and 15% by nurses, in possible group 71 % by faculties and 29% by nurses and 100% by faculties in severe category.Conclusions: Training and dedicated participation of nurses can improve reporting of ICSR.

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Background: Study was done to determine incidence of ADR’s in sputum positive, pulmonary TB patients, on DOTS category I and to determine the effect of ADR’s on sputum conversion.Methods: Open, prospective, observational, non-comparative study conducted in the Department of Pharmacology in collaboration with Department of Tuberculosis and Chest Diseases, Government Medical College, Amritsar for the duration of 18 months (March 2015 to September 2016). One hundred sputum positive patients of pulmonary tuberculosis on DOTS category I, of either sex, in age group of 14 years to 65 years, were recruited and followed up during intensive phase of therapy at end of 1st and 2nd month. Causality and Severity assessment were done by using WHO-UMC causality scale and Hartwig’s severity scale respectively.Results: Out of 100 patients 84 (84%) developed one or more ADR’s and a total of 118 ADR’s occurred in our study. The most common ADR was GI upset 45(38.13%), followed by hepatitis 42 (35.59%), rash 12 (10.16%), CNS 8 (6.77%), arthritic symptoms 5 (4.23%), visual disturbance 2 (1.69%), bleeding problems 2 (1.69%), hyperuricemia 1 (0.84%) and peripheral neuropathy 1 (0.84%). Causality assessment revealed that most of ADR’s(60) were in probable category and severity assessment revealed that most of ADR’s(55) belonged to level 4 (Moderate severity). Most of the ADR’s occurred within 30 days of the start of treatment (84.74%).Conclusions: With such a high incidence of ADR’s there is a need of incorporating pharmacovigilance programme into this vital health programme for more comprehensive monitoring of tuberculosis patients on DOTS for timely prevention, detection, and management of ADR’s. This will decrease non-adherence and dropouts, and thus result in better treatment outcomes.