Muthiah Palaniappan1, Sandhiya Selvarajan2, Melvin George3, Ganesan Subramaniyan4, Steven Aibor Dkhar5, Ajith Ananthakrishna Pillai6, Balachander Jayaraman7, Adithan Chandrasekaran8. 1. Safety Reviewer, Accenture , Chennai, India . 2. Assistant Professor, Department of Clinical Pharmacology, JIPMER , Puducherry, India . 3. Assistant Professor, Cardiac Clinical Trials, Department of Cardiology, SRM Medical College Hospital & Research Centre , Kattankulathur, Chennai, India . 4. PhD Scholar, Department of Pharmacology, JIPMER , Puducherry, India . 5. Professor, Department of Pharmacology, JIPMER , Puducherry, India . 6. Associate Professor, Department of Cardiology, JIPMER , Puducherry, India . 7. Senior Professor, Department of Cardiology, JIPMER , Puducherry, India . 8. Senior Professor & Head, Department of Clinical Pharmacology, JIPMER , Puducherry, India .
Abstract
BACKGROUND: Cardiovascular diseases (CVD) are one of the leading causes of non-communicable disease related deaths globally. Patients with cardiovascular diseases are often prescribed multiple drugs and have higher risk for developing more adverse drug reactions due to polypharmacy. AIM: To evaluate the pattern of adverse drug reactions reported with cardiovascular drugs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital. SETTINGS AND DESIGN: Adverse drug reactions related to cardiovascular drugs reported to an AMC of a tertiary care hospital were included in this prospective observational study. MATERIALS AND METHODS: All cardiovascular drugs related adverse drug reactions (ADRs) received in AMC through spontaneous reporting system and active surveillance method from January 2011 to March 2013 were analysed for demographic profile, ADR pattern, severity and causality assessment. STATISTICAL ANALYSIS USED: The study used descriptive statistics and the values were expressed in numbers and percentages. RESULTS: During the study period, a total of 463 ADRs were reported from 397 patients which included 319 males (80.4%) and 78 females (19.6%). The cardiovascular drug related reports constituted 18.1% of the total 2188 ADR reports. In this study, the most common ADRs observed were cough (17.3%), gastritis (7.5%) and fatigue (6.5%). Assessment of ADRs using WHO-causality scale revealed that 62% of ADRs were possible, 28.2% certain and 6.8% probable. As per Naranjo's scale most of the reports were possible (68.8%) followed by probable (29.7%). According to Hartwig severity scale majority of the reports were mild (95%) followed by moderate (4.5%). A system wise classification of ADRs showed that gastrointestinal system (20.7%) related reactions were the most frequently observed adverse reactions followed by respiratory system (18.4%) related adverse effects. From the reported ADRs, the drugs most commonly associated with ADRs were found to be enalapril (17.5%), atorvastatin (14.9%), aspirin (8.4%) and metoprolol (8.4%). CONCLUSION: The cardiovascular drug related adverse effects constituted 18.1% of the total ADRs reported during the study period. Cough, gastritis, fatigue and myalgia by enalapril, aspirin, β-blockers and atorvastatin respectively were found to be the most commonly reported ADRs among the cardiovascular drugs.
BACKGROUND:Cardiovascular diseases (CVD) are one of the leading causes of non-communicable disease related deaths globally. Patients with cardiovascular diseases are often prescribed multiple drugs and have higher risk for developing more adverse drug reactions due to polypharmacy. AIM: To evaluate the pattern of adverse drug reactions reported with cardiovascular drugs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital. SETTINGS AND DESIGN: Adverse drug reactions related to cardiovascular drugs reported to an AMC of a tertiary care hospital were included in this prospective observational study. MATERIALS AND METHODS: All cardiovascular drugs related adverse drug reactions (ADRs) received in AMC through spontaneous reporting system and active surveillance method from January 2011 to March 2013 were analysed for demographic profile, ADR pattern, severity and causality assessment. STATISTICAL ANALYSIS USED: The study used descriptive statistics and the values were expressed in numbers and percentages. RESULTS: During the study period, a total of 463 ADRs were reported from 397 patients which included 319 males (80.4%) and 78 females (19.6%). The cardiovascular drug related reports constituted 18.1% of the total 2188 ADR reports. In this study, the most common ADRs observed were cough (17.3%), gastritis (7.5%) and fatigue (6.5%). Assessment of ADRs using WHO-causality scale revealed that 62% of ADRs were possible, 28.2% certain and 6.8% probable. As per Naranjo's scale most of the reports were possible (68.8%) followed by probable (29.7%). According to Hartwig severity scale majority of the reports were mild (95%) followed by moderate (4.5%). A system wise classification of ADRs showed that gastrointestinal system (20.7%) related reactions were the most frequently observed adverse reactions followed by respiratory system (18.4%) related adverse effects. From the reported ADRs, the drugs most commonly associated with ADRs were found to be enalapril (17.5%), atorvastatin (14.9%), aspirin (8.4%) and metoprolol (8.4%). CONCLUSION: The cardiovascular drug related adverse effects constituted 18.1% of the total ADRs reported during the study period. Cough, gastritis, fatigue and myalgia by enalapril, aspirin, β-blockers and atorvastatin respectively were found to be the most commonly reported ADRs among the cardiovascular drugs.
Entities:
Keywords:
Active surveillance; Causality; Spontaneous reporting
Authors: R Zaidenstein; S Eyal; S Efrati; L Akivison; M Koren Michowitz; V Nagornov; A Golik Journal: Pharmacoepidemiol Drug Saf Date: 2002 Apr-May Impact factor: 2.890
Authors: Saibal Das; Sapan K Behera; Alphienes S Xavier; Srinivas Velupula; Steven A Dkhar; Sandhiya Selvarajan Journal: Clin Drug Investig Date: 2018-03 Impact factor: 2.859