OBJECTIVES: Cardiovascular drugs are the most often prescribed drug class in Germany. The objective of this study is to analyze the adverse drug reaction (ADR) profiles of these drugs and to identify some targets for prevention of ADR. METHOD: Since 1997 specially trained medical staff members of five Pharmacovigilance Centers in Germany prospectively screened all hospital admissions at the departments of internal medicine of five large teaching hospitals. ADR leading to hospital admission were registered and reported. Especially ADR caused by cardiovascular drugs and all factors, which could have been important for their occurrence were analyzed. RESULTS: 559 of 2270 (24.6%) registered ADR cases were related to cardiovascular drugs. The drugs most frequently related to ADR were angiotensin inhibitors (17.9%), digitalis (17.3%), calcium channel blockers (13.9%), beta blockers (12.8%), and diuretics (12.2%). The most often observed ADR were arrhythmias (27.1%), syncopes and blood pressure dysregulations (25.1%), gastrointestinal symptoms (12.4%), and metabolic disorders (10.2%). 72% of patients were older than 65 years. Older patients were on a significantly higher number of drugs (6.2 +/- 2.4 vs 5.5 +/- 3.2; p < 0.001) than the younger ones. Furthermore, they were hospitalized significantly longer (13.2 +/- 9.9 vs 15.3 +/- 9.3 days; p < 0.01). Eleven patients (2%) died because of ADR due to cardiovascular drugs. CONCLUSIONS: Cardiovascular drugs are frequently used. They are prescribed mainly to older patients. Often observed ADR can be prevented effectively by considering their indication, by a clear definition of the therapeutic target, by a dose adjustment to the individual clinical parameters of the patient and by regular control investigations. The large number of drug-induced rhythm disorders--in particular bradycardia--show that extraordinary attention should be paid to rhythm-affecting drugs. The detailed instruction of the patient about therapeutic aims, risks and a concrete guideline for the therapy/drug handling is generally necessary.
OBJECTIVES: Cardiovascular drugs are the most often prescribed drug class in Germany. The objective of this study is to analyze the adverse drug reaction (ADR) profiles of these drugs and to identify some targets for prevention of ADR. METHOD: Since 1997 specially trained medical staff members of five Pharmacovigilance Centers in Germany prospectively screened all hospital admissions at the departments of internal medicine of five large teaching hospitals. ADR leading to hospital admission were registered and reported. Especially ADR caused by cardiovascular drugs and all factors, which could have been important for their occurrence were analyzed. RESULTS: 559 of 2270 (24.6%) registered ADR cases were related to cardiovascular drugs. The drugs most frequently related to ADR were angiotensin inhibitors (17.9%), digitalis (17.3%), calcium channel blockers (13.9%), beta blockers (12.8%), and diuretics (12.2%). The most often observed ADR were arrhythmias (27.1%), syncopes and blood pressure dysregulations (25.1%), gastrointestinal symptoms (12.4%), and metabolic disorders (10.2%). 72% of patients were older than 65 years. Older patients were on a significantly higher number of drugs (6.2 +/- 2.4 vs 5.5 +/- 3.2; p < 0.001) than the younger ones. Furthermore, they were hospitalized significantly longer (13.2 +/- 9.9 vs 15.3 +/- 9.3 days; p < 0.01). Eleven patients (2%) died because of ADR due to cardiovascular drugs. CONCLUSIONS: Cardiovascular drugs are frequently used. They are prescribed mainly to older patients. Often observed ADR can be prevented effectively by considering their indication, by a clear definition of the therapeutic target, by a dose adjustment to the individual clinical parameters of the patient and by regular control investigations. The large number of drug-induced rhythm disorders--in particular bradycardia--show that extraordinary attention should be paid to rhythm-affecting drugs. The detailed instruction of the patient about therapeutic aims, risks and a concrete guideline for the therapy/drug handling is generally necessary.