Pharmacoepidemiology case report studies

All drugs will pose some degree of risk, and completed clinical trials are the primary source of information in this subject. Clinical trials do, of course, have limitations. The principal one concerns the everpresent problem of sample size. Rare side effects, if they exist, cannot generally be detected in clinical trials involving limited numbers of patients. Adverse drug reports and case-reports provide early clues to such effects so-called pharmacoepidemiology studies may be mounted to evaluate such risks. 

Pancreas Case reports and pharmacoepidemiological studies have provided evidence that statins may cause pancreatitis. However, data from the SHARP study, a placebo-controlled study of the effects of a combination of simvastatin and ezetimibe on cardiovascular events in patients with chronic kidney disease, showed a reduction in the number of cases of pancreatitis [75] [40 -]. Recent prospective cohort study with 1062 subjects of whom 92 were taking statins found severe pancreatitis was more common in the statin nonuser than statin user. Pancreatitis-related mortality was higher in the statin nonuser, and among patients who developed severe acute pancreatitis, statin users showed lower Ranson s and APACHE II scores and lower maximal CRP, suggesting that prior statin treatment reduced morbidity and mortality in acute pancreatitis [76]. 

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