Drug exposure and perceived adverse drug events reported by liver-transplant patients.
BACKGROUND
Posttransplant patient outcome and quality of life are affected by different factors, such as post-graft context, psychological state, and polymedication. Many surveys have been carried out to study immunosuppressant ADRs, and have mainly used a questionnaire completed by patients, but few have asked patients about their drug exposure. The aim of this study is to describe drug exposure and adverse drug events (ADEs) reported by liver-transplant patients (LTP).


METHODS
This observational, retrospective study assessed questionnaires from LTPs concerning demographic data, drug exposure, and ADEs.


RESULTS
118 LTPs exposed to 5.9 (+/- 2.8) drugs with immunosuppressive regimens, consisting mainly of tacrolimus (79.3%), cyclosporine (18.1%), or sirolimus (2.6%), were also exposed to antihypertensive drugs (43.2%), protonpump inhibitors (30.5%), statins (28.8%), drugs acting on bile composition (26.3%), and diuretics (19.5%). 1,389 ADEs were reported: 30.1% neurological, 13.4% cutaneous, 12.4% hematological, 11.1% digestive, 10.1% osteomuscular, 6.6% cardiovascular, and 16.3% others. Significantly more ADEs were reported by patients exposed to cyclosporine than those receiving tacrolimus (p < 0.05). Patients with a transplant for < 18 months had more tremors and those with a transplant for > 79 months reported more hirsutism, gingival hypertrophia, and arterial hypertension.


CONCLUSIONS
This study shows the value of patient-reporting via structured interviews for both drug exposure and ADEs, and the importance of this approach to complement total data collection.
Espinasse
G
G
Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse.
Kamar
N
N
Hurault
C
C
Suc
B
B
Fourtanier
G
G
Montastruc
J L
JL
Rostaing
L
L
Bagheri
H
H
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002648:Child; D002756:Cholagogues and Choleretics / Q000627:therapeutic use; D016572:Cyclosporine / Q000009:adverse effects* / Q000627:therapeutic use; D004232:Diuretics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016031:Liver Transplantation / Q000276:immunology / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012189:Retrospective Studies; D020123:Sirolimus / Q000009:adverse effects* / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016559:Tacrolimus / Q000009:adverse effects* / Q000627:therapeutic use
D000959:Antihypertensive Agents; D002756:Cholagogues and Choleretics; D004232:Diuretics; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007166:Immunosuppressive Agents; D054328:Proton Pump Inhibitors; D016572:Cyclosporine; D020123:Sirolimus; D016559:Tacrolimus