Drug Interactions Clinical Trial
Official title:
Transversal, Multicentric Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software in Córdoba, Argentina
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase
their action, even to a toxic level, or reduce it to its minimum.
People elder than 65 years old have theirs biological ability to metabolized and eliminate
drugs impaired. Even more, they tend to suffer from many diseases, are treated for many
physicians, and receive many drugs for those conditions. If hospitalized older people are
prone to receive a greater number of drugs. This scenario is the worst to suffer from
adverse drug events and DI, which in turn compromise more the health and even life of
hospitalized older people.
Many computerized strategies have been developed to prevent those problems. In this trial
the investigators use on line software to early detect DI that could endanger health or life
of hospitalized older patients.
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase
their action, even to a toxic level, o reduce it to its minimum.
Adverse drug events (ADE) are an important health problem. In the book To Err Is Human:
Building a Safer Health System its authors Kohn, Corrigan and Donaldson from the "Committee
on Quality of Health Care in America, Institute of Medicine" (U.S.A.) expressed that 2 out
of every 100 hospital admissions were due to ADE. That results in an average increase of U$D
4,700 extra for each admission or about to 2.8 million U$D annually for a 700-bed teaching
hospital. In this study were only considered direct costs. No indirect costs were taken into
account, like days out of work, rehabilitation, deaths, lost of quality of life, etc.
In 2003, in a cohort study done in people of Medicare elder than 65 years old, were detected
50.1 ADE / 1000 persons a year. Of that number of ADE 13.8 were considered preventable. In
Switzerland 3.3 % of hospitalisations were considered due to ADE.
Among ADE, DI are a very important part of the problem. In Canada was demonstrated that
certain drug associations were responsible of an increase in the number of hospital
admissions. They would not have occurred if those prescriptions would have been properly
controlled or never done. In Mexico 3.8 % of patients elder than 50 years old received
prescriptions of drugs, which should be avoided according to their interaction. In hospital
setting DI endanger even more health and people's life. In Spain was demonstrated a
prevalence of clinical relevant DI of 3 % in hospitalized patients, and in Switzerland that
percentage rose 11 %. This phenomenon increased in later years, in Rotterdam DI compromising
lethal risk in patients elder than 70 years old, climb from 1.5 % in 1992 to 2.9 % in 2005.
Drug interactions are directly proportional to: the number of administered drugs (> 2 drugs
or > 4 ); the age of patients and the number of prescribing physicians.
Older persons, for its detriment in physical condition and the pathologies they suffer from,
are prone to suffer DI when being prescribed with drugs or even herbal medicines. In Brazil
ambulatory patients elder than 60 years old have 2.5 pathologies diagnosed and consume in
average 1.3 to 2.3 drugs. During hospitalisation the number of prescribed drugs reach 9.9 to
13.6 per patient. In a survey done in six European countries the number of drugs consumed
for each ambulatory patient was 7. In Argentina according to the Instituto Nacional de
Estadísticas y Censos (INDEC) the number of citizens elder than 65 years old was 3,587,620
(9.89% total population). Unfortunately there is no other information about polypharmacy or
prevalent pathologies in INDEC or other medical databases or national institutions web
sites.
In 1995, it was published an article in JAMA that stated the possibility that 28 % of ADE
could be prevented in non-obstetric hospitalized adults. Fifty six percent of those were due
to mistakes done during prescription, 34 % during administration, 6 % during transcription
of indications and 4 % during dispensation. This astonishing results poses on the need to
develop strategies to cut this numbers.
Many lists of drugs with potential to produce ADE were developed to prevent DI and other
related drugs damages. Beers criteria (BC) is one example of them. In Amsterdam it was
demonstrated an 80 % improvement in drug regimens in patients elder than 81 years old of in
whom their therapeutic indications were reviewed and adjusted using BC and the Medication
Appropriateness Index after suffering from ADE. In that study, a list of only 10 drug
combinations was also used but did not showed the same benefits. In Argentina, the
Adminstración Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) publish in its web
page a list of 16 risky drugs, considering the disadvantages of their own pharmacological
action, but there is no information about its usefulness.
Much software was developed in later years to alert physician about DI. Some of them are
even more sensible than the search of DI at the bedside, but this software overestimates the
prevalence of serious DI. The usage of computerized alert systems for prescriptions
significantly reduced potential ADE, however many physicians tend to override them for
different reasons. Finally a Cochrane´s review showed a reduction in hospitalization days
and drug toxic effects when using a computerized warning systems for drug dosing.
The growing number of drugs, apart from its not always well-proven benefits, implies risks
for health; specially in sick and older people and even more during hospitalizations.
Nowadays software to alert physicians about DI or ADE could help to prevent them but its
real contribution is still a matter of debate. For this reasons we developed this trial to
test the usefulness of on line software to detect DI in hospitalized elder patients.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT01925638 -
Effect of Ketoconazole on the Pharmacokinetics of Refametinib
|
Phase 1 | |
| Completed |
NCT00621699 -
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00442585 -
S(+)-Ibuprofen Effects on Asprin Treated Volunteers
|
Phase 1 | |
| Completed |
NCT00200759 -
Drug Interactions and Bioavailability of Cranberry
|
Phase 1 | |
| Active, not recruiting |
NCT06401863 -
Shared Decision for Drug Interactions in Oral Anticoagulation
|
N/A | |
| Completed |
NCT00915746 -
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03748745 -
A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03324685 -
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
|
Phase 1 | |
| Completed |
NCT05433896 -
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
|
Phase 1 | |
| Recruiting |
NCT03307863 -
Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
|
Phase 4 | |
| Completed |
NCT02706535 -
A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
|
Phase 1 | |
| Completed |
NCT02147808 -
A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02097953 -
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
|
Phase 0 | |
| Completed |
NCT01364987 -
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00709982 -
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.
|
Phase 1 | |
| Completed |
NCT00810303 -
Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
|
Phase 1 | |
| Completed |
NCT04252300 -
Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants
|
Phase 1 | |
| Completed |
NCT02576366 -
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
|
Phase 4 | |
| Completed |
NCT02159326 -
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
|
Phase 1 |