None listed
Conditions
Brief summary
Therapy with several drugs simultaneously entails several hazards related to drug interactions and side effects. Analysis of individual patients often reveals that some drugs are either unnecesary, or at least thought to be so, either because the indication for them no longer exists or because they were injudiciously prescribed in the first place. In support of this point of view, up to 25% of all acute medical admissions to hospital are due to a clinical problem related to drug treatment. It has been shown that withdrawal of some drugs can alleviate a tendency to fall in elderly patients, and there is evidence that antihypertensive medication may be "down—titrated" (i.e. the dose may be reduced) without loss of antihypertensive effect. We wish to undertake a formal trial of drug withdrawal as a therapeutic maneouvre. As a preliminary we wish to establish that such a trial is feasible and safe and therefore propose a pilot study in a limited number of patients. We have also adopted a restricted list of drugs for the purposes of the pilot study in order to enhance the safety aspects of the trial. Participants will be randomised to persist with current therapy or to have the target therapy withdrawn. They will be followed up frequently. The end point for the ultimate study will be efficacy and quality of life measures but in this study we are interested in safety and practicability only, though efficacy and QOL will be assessed.
Interventions
Gradual withdrawal of one target medication selected from a defined list of Target Drugs (antihypertensive therapy, anti-anginal therapy, diuretics, non-steroidal anti-inflammatory drugs and COX-2 inhibitors). Dose reductions are made at two weekly intervals by general practitioner if participant remains clinically stable, until target drug has been ceased for two weeks.
Sponsors
Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) participant taking at least one drug included in the Target Drug List (antihypertensive therapy, anti-anginal therapy, diuretics, non-steroidal anti-inflammatory drugs and COX-2 inhibitors); ii) participant has stable chronic disease with respect to the medication targeted for withdrawal iii) patient reports at least one negative symptom ascribable to the drug therapy (effects specific to drug class, or possible adverse effects such as falls, confusion, malaise and nausea), or the patient is taking more than 5 drugs concurrently iv) treating physicians concur with randomisation.
Exclusion criteria
i) patient is taking warfarin
Outcome results
None listed