van Kraaij DJW, Jansen RWMM, Bouwels LHR, et al. Furosemide withdrawal in elderly heart failure patients with preserved left ventricular systolic function. American Journal of Cardiology 2000;85:1461-66.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/10856393
Full text article: https://www.sciencedirect.com/science/article/pii/S0002914900007955?via%3Dihub
van Kraaij DJW, Jansen RWMM, Bouwels LHR, et al. Furosemide withdrawal improves postprandial hypotension in elderly heart failure patients with preserved left ventricular systolic function. Archives of Internal Medicine 1999;159:1599–605-99–605.
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/10421283
Full text article: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/485090
van Kraaij DJW, Jansen RWMM, Sweep FCGJ, et al. Neurohormonal effects of furosemide withdrawal in elderly heart failure patients with normal systolic function. European Journal of Heart Failure 2003;5:47–53-47–53.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/12559215
| Methods | Study design: Randomized placebo-controlled double-blind controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 32 randomized, 29 completed
· Intervention deprescribing group: 21 enrolled, completed · Control group: 11 enrolled, completed Age: 75 ± 1 years Sex: 17 female, 15 male Participants with dementia: No Inclusion criteria · Current heart failure New York Heart Association functional class I–III Use of furosemide 20–80 mg/day · Previous history of congestive heart failure · At least two of dyspnea on exertion or at rest, orthopnoea, paroxysmal nocturnal dyspnea, or peripheral edema · At least one of jugular venous distension, rales, or pulmonary vascular congestion on chest X-ray Exclusion criteria: · Systolic blood pressure 170 mmHg and/or · Diastolic blood pressure 90 mmHg · Absence of regular sinus rhythm · Angina pectoris (New York Heart Association class II or higher) · Current overt congestion · Significant valvular disease · Any mitral valve stenosis · Aortic valve stenosis · Pulmonary hypertension · Myocardial ischemia on stress testing with or without anginal complaints Concomitant medicines: 4.8 ± 2.8 medicines Country: The Netherlands Setting: Community |
| Interventions | Medicine: Diuretic
Withdrawal schedule: Dose halved for one week, and thenplacebo Comparator: Placebo compared to continued treatment |
| Outcomes | Successful deprescribing
Changes at three months Blood pressure Temporary differences |
| Dates | Dates: Not stated
Follow-up duration: Three months |
| Funding sources | Netherlands Program for Research on Aging (NESTOR), Utrecht, The Netherlands, which is funded by the Ministry of Education, Culture, and Science, and the Ministry of Health, Welfare, and Sports, The Hague, The Netherlands. |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | Probably done, however, method not adequately described.
“… patients were randomly assigned in a 2:1 ratio to a withdrawal group and a continuation group, respectively, balancing for age, gender, cardiovascular medications, and daily furosemide dose.” “Appropriate independent randomization was tested with chi-square and Fisher’s exact tests for proportions and t-tests for continuous variable.” |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) | Unclear risk | Placebo not described, but probably done.
“Patients then began a 1-week dose-halving regimen followed by placebo in the withdrawal group; patients in the continuation group matched furosemide dosages with the previous dosage.” “…Canisius-Wilhelmina Hospital Nijmegen, for preparing blinded medication sets…” |
| Blinding of outcome assessment (detection bias) | Unclear risk | Blinding method not described, but claimed.
“The echocardiographic assistants and cardiologists were blinded to the randomization result.” |
| Incomplete outcome data (attrition bias) | Unclear risk | It appears to have complete outcome data though many outcomes pertinent to the systematic review are only presented in figures, or as the change from baseline rather than absolute numbers. |
| Selective reporting (reporting bias) | Unclear risk | A study protocol was written and approved by a Human Research Ethics Committee via to starting, however, it is unclear if the outcomes reported were those in the pre-specified data-analysis plan.
There were three papers written from the one study that included 32 participants, so it is possible that additional outcomes have been reported that were not originally intended. |
| Confounding (non-randomized) | Unclear risk | |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Selected group of users |
| Selection of the non-exposed cohort | Selection of the non-exposed cohort: drawn from a different source | |
| Ascertainment of exposure | Ascertainment of exposure: secure record | |
| Demonstration that outcome of interest was not present at start of study | Demonstrated that outcome of interest was not present at start of study | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for withdrawal of falls inducing drugs |
| Outcome bias | Assessment of outcome | Assessment of outcome by self-report |
| Was follow-up long enough for outcomes to occur | Follow-up not long enough for outcomes to occur (at least 1 year needed) | |
| Adequacy of follow-up of cohorts | Follow-up rate adequate 1% in the first paper but no statement about the second | |
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