Patient drug history subjective data

The first attempt at estimating interindividual pharmacokinetic variability without neglecting the difficulties (data imbalance, sparse data, subject-specific dosing history, etc.) associated with data from patients undergoing drug therapy was made by Sheiner et al. " using the Non-linear Mixed-effects Model Approach. The vector 9 of population characteristics is composed of all quantities of the first two moments of the distribution of the parameters the mean values (fixed effects), and the elements of the variance-covariance matrix that characterize random effects.f " " ... 

The above study was based on information derived from the General Practice Research Database in the UK. Subjects who had been given at least one prescription for dexfenfluramine, fenfluramine, or phentermine after 1 January 1988, and who were 70 years or younger at the time of their first prescription were included. Subjects were considered to have a new cardiac abnormality if they had no history, on the basis of clinical records, of cardiac valvular abnormahties and if there was evidence of a new valvular disorder on the basis of echocardiography or chnical examination after exposure to appetite suppressants. All the data had been recorded before the pubhcation of recent reports of an association between appetite suppressants and cardiac valve disorders (25,27,30-32) or primary pulmonary hjq)ertension (14). Hence, it was possible to exclude the possibihty that enhanced awareness of possible serious adverse effects of appetite suppressants had led to closer surveillance of patients who were taking these drugs. Nevertheless, the study did not provide information on the frequency of idiopathic cardiac valve disorders that are asymptomatic or otherwise not chnicaUy diagnosed. 

---