This page shows what was measured, who it was measured in, and what that does not settle.
What O-(DESISOPROPYL) Bisoprolol Acid does in the body
In a failing heart the useful part is different: removing the constant adrenaline drive lets the muscle stop wearing itself out.
Adrenaline speeds the heart and raises blood pressure by landing on a receptor called beta-1, which sits mostly on heart muscle and on the kidney cells that release the hormone that tightens arteries. Bisoprolol covers that receptor and leaves the closely related beta-2 receptor in the lungs largely alone, at least at ordinary strengths. The heart beats slower and less forcefully, the kidney releases less renin, and blood pressure falls.
Why people take it. High blood pressure — and, in most of the world, a weakened heart
What happened in people
Sudden death 3.6% against 6.3% in the same trial (HR 0.56, 95% CI 0.39 to 0.80, p=0.0011)
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
11.8% against 17.3%; hazard ratio 0.66 (95% CI 0.54 to 0.81), p<0.0001; sudden death HR 0.56 (0.39 to 0.80), p=0.0011
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Stopped early at the second interim analysis. The authors state the results should not be extrapolated to severe class IV patients with recent instability, in whom safety and efficacy were not established.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
53 deaths against 67; relative risk 0.80 (95% CI 0.56 to 1.15), p=0.22 over a mean 1.9 years
Repeated elsewhere
Partially Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Functional endpoints separated while survival did not: hospitalisation for decompensation 61 against 90 (p<0.01) and NYHA class improvement in 68 against 48 (p=0.04). A trial can be right about the mechanism and unable to demonstrate the outcome.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
Composite of all-cause mortality or hospitalisation, bisoprolol-first against enalapril-first, non-inferiority margin HR 1.17
✗ The study did not show it
Who was studied
CIBIS-III (Circulation 2005;112:2426-2435)
How many people
1010
Study design
Phase 4, randomised, open-label monotherapy phase with blinded endpoint comparison
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Intention-to-treat HR 0.94 (95% CI 0.77 to 1.16) met the margin; per-protocol HR 0.97 (95% CI 0.78 to 1.21) did not
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. For a non-inferiority question the per-protocol analysis is the conservative one, and it is the analysis that failed. The published conclusion is that non-inferiority was not proven per protocol.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
Death from cardiac causes or non-fatal myocardial infarction within 30 days of major vascular surgery
✓ The study showed what it set out to show
Who was studied
DECREASE (N Engl J Med 1999;341:1789-1794)
How many people
112
Study design
Randomised, open, perioperative trial in high-risk vascular surgery
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Cardiac death 3.4% against 17% (p=0.02) and non-fatal infarction 0% against 17% (p<0.001) in 59 bisoprolol and 53 standard-care patients
Repeated elsewhere
Failed to Replicate
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The DECREASE family of trials is described by the authors of the 2014 meta-analysis as no longer secure. Pooling only the secure trials — 10,529 patients — gives a 27% increase in 30-day all-cause mortality from perioperative beta-blocker initiation, the opposite of this result.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
O-(DESISOPROPYL) Bisoprolol Acid
What a person takes: Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide.
The measurement behind this step
Absorption is about 80% and unaffected by food, and the 9 to 12 hour half-life supports once-daily dosing with steady state in five days. Clearance is divided roughly equally between renal excretion of unchanged drug and hepatic metabolism, so exposure roughly doubles rather than multiplying when either organ is impaired.
Getting in
Swallowed and almost entirely absorbed
The tablet is taken once a day. Almost all of it reaches the bloodstream, food does not change that, and it lasts long enough that one dose covers a day.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Absolute bioavailability after a 10 mg oral dose is about 80% with only about 20% first-pass metabolism; absorption is unaffected by food. Serum protein binding is about 30%, peak concentration comes at 2 to 4 hours, and the plasma elimination half-life is 9 to 12 hours with steady state within 5 days. Clearance is split roughly evenly between renal and hepatic routes, which is why neither organ failing alone transforms the exposure.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
It covers the heart receptor and mostly spares the lung one
Adrenaline works through two similar receptors: one mainly on the heart, one mainly on airways and blood vessels. This drug binds the heart one much more tightly, which is why it is chosen when a lung is a concern.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Competitive antagonism at the beta-1 adrenoceptor with a large selectivity ratio over beta-2, and no intrinsic sympathomimetic or membrane-stabilising activity. The label states the selectivity is not absolute and that beta-2 blockade appears at 20 mg and above.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
With the receptor covered the heart beats slower and less hard. Separately, the kidney stops releasing the hormone that starts the chain tightening the arteries.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Beta-1 blockade reduces heart rate, contractility and cardiac output acutely, and suppresses renin release from juxtaglomerular cells, lowering angiotensin II and aldosterone. The blood pressure effect builds over days as vascular resistance, which rises briefly at the start, settles back.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
In a failing heart, the useful part is what stops happening
A weak heart is kept going by constant adrenaline, and that constant drive is itself destroying the muscle. Blocking it does nothing helpful this week and a great deal over a year.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Chronic beta-1 blockade interrupts catecholamine-mediated myocyte apoptosis and adverse remodelling and reverses receptor downregulation. In CIBIS-II the mortality curves separate after the first months, and sudden death — the mode most directly tied to adrenergic drive — fell proportionally more than total death: 3.6% against 6.3%.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
Receptors multiply while they are being blocked. Removing the block all at once exposes a larger number of them to normal adrenaline, which can trigger angina or worse.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The label records exacerbation of angina and, in some instances, myocardial infarction or ventricular arrhythmia after abrupt cessation in coronary disease, and advises tapering over approximately one week even without known coronary disease. This is receptor upregulation rather than dependence.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
In the United States this drug is licensed for blood pressure and warns against use in overt heart failure. The trial it is famous for measured a third fewer deaths in exactly that condition.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
CIBIS-II reported all-cause mortality of 11.8% against 17.3% (HR 0.66, 95% CI 0.54 to 0.81) in NYHA class III and IV. The United States label lists overt cardiac failure under Contraindications. The two documents are describing different things: one is an evidence base, the other a filing history.
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with high blood pressure everywhere; adults with heart failure and reduced ejection fraction in the many countries where that indication exists, and in the United States on the strength of CIBIS-II rather than the label.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 200ab93b-6ad3-46cb-8f57-db056a14de16 · read 2026-08-30
On older people, the label states: “Bisoprolol fumarate has been used in elderly patients with hypertension.”
US prescribing information · 200ab93b-6ad3-46cb-8f57-db056a14de16 · read 2026-08-30
On people who are pregnant, the label states: “In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively.”
US prescribing information · 200ab93b-6ad3-46cb-8f57-db056a14de16 · read 2026-08-30
On people who are breastfeeding, the label states: “Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats.”
US prescribing information · 200ab93b-6ad3-46cb-8f57-db056a14de16 · read 2026-08-30
Where the result stopped carrying
CIBIS-I could not demonstrate a survival benefit at 641 patients and its authors said so
The DECREASE family of perioperative trials was found not secure, and the meta-analysis of what remained reversed the direction of the effect
CIBIS-III failed its non-inferiority margin in the per-protocol analysis
The United States label still contraindicates the drug in the condition its most-cited trial was conducted in
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Absorption is about 80% and unaffected by food, and the 9 to 12 hour half-life supports once-daily dosing with steady state in five days. Clearance is divided roughly equally between renal excretion of unchanged drug and hepatic metabolism, so exposure roughly doubles rather than multiplying when either organ is impaired.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Contraindicated in cardiogenic shock, overt cardiac failure, second- or third-degree AV block and marked sinus bradycardia. Abrupt cessation can exacerbate angina and precipitate infarction or ventricular arrhythmia; the label advises tapering over about a week. Beta-1 selectivity is lost at 20 mg and above, so bronchospasm risk rises with dose. It masks the adrenergic warning symptoms of hypoglycaemia in diabetes and may alter glucose levels.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Where this came from
CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13 (10023943) · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet at 5 and 10 mg, taken once daily; also sold combined with hydrochlorothiazide
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Clearance is divided roughly equally between renal excretion of unchanged drug and hepatic metabolism, so exposure roughly doubles rather than multiplying when either organ is impaired.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
108 products list this as an active ingredient in the United States drug directory. 63 of them contain it and nothing else.
FDA National Drug Code directory · 71335-9755 · read 2026-08-29
They are sold as powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 71335-9755 · read 2026-08-29
The regulator's established pharmacologic class for it is adrenergic beta-antagonists [moa] and beta-adrenergic blocker [epc].
FDA National Drug Code directory · 71335-9755 · read 2026-08-29
53 published labels name it as an active ingredient. 31 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b9ee689a-ea12-435d-b01c-70d45891e62f · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b9ee689a-ea12-435d-b01c-70d45891e62f · read 2026-08-29
Bisoprolol Fumarate is oral at HOW SUPPLIED Bisoprolol fumarate is supplied as 5 mg and 10 mg tablets., recorded as fda label in effect 2025-05-16 in the United States.
US prescribing information · 200ab93b-6ad3-46cb-8f57-db056a14de16 · read 2026-08-30
Recorded price in US: 0.12322–2.60611 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 47 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of O-(DESISOPROPYL) Bisoprolol Acid studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That bisoprolol prevents perioperative death, which rested on a trial family the meta-analysts describe as no longer secure
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the absence of a United States heart failure indication means the heart failure evidence is weak
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That CIBIS-III established bisoprolol-first as non-inferior, when the per-protocol analysis did not meet the margin
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That cardioselectivity makes the drug safe in airway disease at any dose — the label states selectivity is lost at 20 mg and above
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of O-(DESISOPROPYL) Bisoprolol Acid are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
CIBIS-II: a third fewer deaths, and the trial was stopped early because of it
In plain words
Two and a half thousand patients with severe heart failure were randomised to bisoprolol or a dummy tablet. Deaths fell from about one in six to about one in eight, and sudden deaths nearly halved. The trial was stopped before its planned end.
What was measured
All-cause mortality against placebo in chronic heart failure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CIBIS-II randomised 2,647 symptomatic patients in NYHA class III or IV with ejection fraction 35% or less, on standard diuretic and ACE inhibitor therapy, to bisoprolol titrated to a maximum of 10 mg daily or placebo, followed for a mean of 1.3 years. All-cause mortality was 156 (11.8%) against 228 (17.3%), hazard ratio 0.66 (95% CI 0.54 to 0.81, p<0.0001). Sudden deaths were 48 (3.6%) against 83 (6.3%), hazard ratio 0.56 (95% CI 0.39 to 0.80, p=0.0011). Treatment effects were independent of the severity or cause of heart failure. The trial was stopped after the second interim analysis. The authors state explicitly that the results should not be extrapolated to patients with severe class IV symptoms and recent instability, because safety and efficacy were not established there.
Written into the record, not signed off as a reviewed claim
CIBIS-I found the same benefit and could not prove it
In plain words
The first bisoprolol trial, five years earlier, was too small. Fifty-three patients died on the drug against sixty-seven on placebo — the right direction, and nowhere near statistically convincing. The authors wrote that a survival benefit remained to be demonstrated.
What was measured
All-cause mortality against placebo, underpowered at 641 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
CIBIS randomised 641 patients with chronic heart failure and ejection fraction below 40%, 95% in NYHA class III, to bisoprolol (n=320) or placebo (n=321) for a mean 1.9 years. Deaths were 53 against 67; the difference did not reach significance (p=0.22, relative risk 0.80, 95% CI 0.56 to 1.15). Sudden deaths were 15 against 17 and deaths from documented ventricular arrhythmia 4 against 7, neither significant. Functional endpoints did separate: fewer hospitalisations for cardiac decompensation (61 against 90, p<0.01) and more patients improving by at least one NYHA class (68 against 48, p=0.04). The conclusion reads: improvement in survival while on beta-blockade remains to be demonstrated. Reading a positive result into CIBIS-I because CIBIS-II later succeeded is the error the trial record exists to prevent.
Written into the record, not signed off as a reviewed claim
The perioperative evidence was fabricated, and the surviving trials point the other way
In plain words
For a decade, guidelines on two continents told surgeons to start a beta-blocker before an operation, largely on a family of Dutch trials. Those trials were found not to be secure. When the remaining honest trials were pooled, starting a beta-blocker before surgery came out associated with more deaths, not fewer.
What was measured
That starting a beta-blocker before non-cardiac surgery prevents perioperative death — an inference built on trials the field no longer treats as secure, and reversed in sign when only the secure trials are pooled
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Bouri and colleagues analysed the randomised trials of beta-blocker initiation before non-cardiac surgery, separating the DECREASE family — which they describe as no longer secure — from the rest. Nine secure trials totalling 10,529 patients with 291 deaths met criteria. Initiation of a course of beta-blockers before surgery was associated with a 27% increase in 30-day all-cause mortality (p=0.04). The DECREASE studies substantially contradict the secure meta-analysis on mortality (p=0.05 for divergence). Among the secure trials, beta-blockade reduced non-fatal myocardial infarction (RR 0.73, p=0.001) while increasing stroke (RR 1.73, p=0.05) and hypotension (RR 1.51, p<0.00001); these results were dominated by one large trial. The authors conclusion is unusually direct: guideline bodies should retract their recommendations based on fictitious data without further delay. The original DECREASE report had described 112 randomised vascular surgery patients with cardiac death in 3.4% on bisoprolol against 17% on standard care (p=0.02) and non-fatal infarction in 0% against 17% (p<0.001).
Written into the record, not signed off as a reviewed claim
The United States label contradicts the way the drug is used
In plain words
In the United States this drug is licensed for blood pressure only, and its label names overt heart failure as a reason not to give it. It is nevertheless recommended for heart failure by United States guidelines, on the strength of a European trial.
What was measured
That an absent indication means absent evidence — the United States label reflects a regulatory filing history, and the mortality evidence for heart failure exists independently of it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States prescribing information states that bisoprolol fumarate tablets are indicated in the management of hypertension, alone or in combination. Contraindications include overt cardiac failure. The Warnings section reads that beta-blocking agents should in general be avoided in patients with overt congestive failure and, where necessary in compensated failure, used cautiously. CIBIS-II, conducted in Europe, measured a 34% reduction in all-cause mortality in exactly the population the label warns about. Bisoprolol carries heart failure indications in many other jurisdictions. Nothing here is a contradiction in the evidence; it is a gap between what a sponsor applied for in one country and what the evidence shows, and it means every United States heart failure prescription of bisoprolol is off-label.
Source
Bisoprolol fumarate United States prescribing information, Indications and Usage, Contraindications and Warnings sections; CIBIS-II Investigators, Lancet 1999;353:9-13
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
CIBIS-III proved non-inferiority in one analysis and not in the other
In plain words
A trial asked whether heart failure treatment can start with the beta-blocker instead of the usual first drug. In the main analysis the answer was yes. In the stricter analysis — the one that matters most for this kind of question — it was not proven.
What was measured
Composite of all-cause mortality or hospitalisation, bisoprolol-first against enalapril-first, against a non-inferiority margin of HR 1.17
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
CIBIS-III randomised 1,010 patients with mild to moderate heart failure and ejection fraction at or below 35%, on no ACE inhibitor, beta-blocker or angiotensin receptor blocker, to six months of open-label bisoprolol or enalapril monotherapy followed by the combination. Non-inferiority required the upper bound of the 95% CI for the absolute difference to be below 5%, corresponding to a hazard ratio of 1.17. In the intention-to-treat sample the primary composite of all-cause mortality or hospitalisation occurred in 178 against 186 (HR 0.94, 95% CI 0.77 to 1.16) — the bound was met. In the per-protocol sample it occurred in 163 against 165 (HR 0.97, 95% CI 0.78 to 1.21) — the bound was not met. For a non-inferiority trial the per-protocol analysis is the conservative one, because dropouts and crossovers push an intention-to-treat result toward no difference, which is the direction non-inferiority wants. The authors state that non-inferiority was not proven in the per-protocol analysis and that the results indicate it may be as safe and efficacious to start with bisoprolol.
Written into the record, not signed off as a reviewed claim
Cardioselectivity is a property of the dose, not of the drug
In plain words
Bisoprolol is described as heart-selective, which is why it is used where a non-selective beta-blocker would be dangerous. The label says selectivity is not absolute and is lost at higher strengths.
What was measured
That a cardioselective beta-blocker is safe in airway disease at any dose — selectivity is a ratio that narrows with exposure, and the label says so
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label describes bisoprolol as a beta-1 selective adrenoceptor blocking agent without significant membrane-stabilising or intrinsic sympathomimetic activity in its therapeutic range, then adds that cardioselectivity is not absolute and that at 20 mg and above it also inhibits beta-2 adrenoceptors, chiefly in bronchial and vascular musculature, so the lowest effective dose is needed to retain selectivity. The practical consequence is that the safety argument for using a cardioselective beta-blocker in someone with airway disease weakens as the dose is titrated up, and there is no threshold at which it stops applying and starts not applying.
Source
Bisoprolol fumarate United States prescribing information, Clinical Pharmacology section
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
30 documents were read for this substance.
RNAWiki source record
30 of them state the same bioavailability, and they agree.
RNAWiki source record
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What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
30 approved applications cover products containing this substance. The earliest was NDA019982, approved 19920731 to TEVA BRANDED PHARM.
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7 questions this page could not answer
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A beta-1 selective blocker that cut all-cause mortality from 17.3% to 11.8% in 2,647 patients with severe heart failure in CIBIS-II, after its own earlier trial in 641 patients had missed survival entirely at p=0.22 — and whose most-cited use, before non-cardiac surgery, rested on a family of trials later judged not secure by the meta-analysts who then found a 27% increase in perioperative deaths in the trials that survived.
Recorded evidence blocks (8)
Q1
On the O-(DESISOPROPYL) Bisoprolol Acid label: indicated for what?
"INDICATIONS & USAGE BISOPROLOL FUMARATE TABLETS, USP are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.": indications and usage on O-(DESISOPROPYL) Bisoprolol Acid's label. DailyMed label · df37d337-9978-0c31-e053-2a95a90a3258 · 2026-04-21
Q2
72 registered trials of O-(DESISOPROPYL) Bisoprolol Acid — at which phases?
Registered studies posting no result
57 of 72
72 registered studies of O-(DESISOPROPYL) Bisoprolol Acid: 35 phase4, 10 na, 8 phase3, 7 phase1, 6 phase2, 4 early phase1, 4 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Inadequate patient recruitment"; 3 of 72 registered studies
Show the evidence
Trial
NCT00702156
terminated; "Inadequate patient recruitment"
NCT01579058
terminated; "The sponsor discontinued to support the study."
NCT03026088
terminated; "Limited beta-blocker naive participants among newly diagnosed heart failure participants, which led barrier to the recruitments."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of O-(DESISOPROPYL) Bisoprolol Acid used Bisoprolol Fumarate Tablet 10 mg — over how long?
Human studies of O-(DESISOPROPYL) Bisoprolol Acid used "Bisoprolol Fumarate Tablet 10 mg". ClinicalTrials.gov · 2026-09-01
7 recorded entries; human; also "Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)", "Bisoprolol 2.5 mg", "Bisoprolol Fumarate 2.5 MG Oral Tablet"
Show the evidence
human
NCT01741623
Bisoprolol Fumarate Tablet 10 mg
NCT01742702
Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)
NCT02398929
Bisoprolol 2.5 mg
NCT03011775
Bisoprolol Fumarate 2.5 MG Oral Tablet
NCT03850093
bisoprolol 2.5mg
NCT05569382
Bisoprolol "Krka" 2.5 MG
1 more recorded row
humanNCT05569382
Bisoprolol Fumarate 2.5 MG
recorded 2026-09-01 · last checked 2026-09-04
Q5
O-(DESISOPROPYL) Bisoprolol Acid's half-life is 9-12 hours — which schedules were studied?
9-12 hours, the half-life O-(DESISOPROPYL) Bisoprolol Acid's label states: "The plasma elimination half-life is 9-12 hours and is slightly longer in elderly patients, in part because of decreased renal function in that population." DailyMed label · df37d337-9978-0c31-e053-2a95a90a3258 · 2026-04-21
tmax 2-4 hours; bioavailability 80 %.
Show the evidence
half lifeclinical_pharmacology
9-12 hours; The plasma elimination half-life is 9-12 hours and is slightly longer in elderly patients, in part because of decreased renal function in that population.
tmaxclinical_pharmacology
2-4 hours; Peak plasma concentrations occur within 2-4 hours of dosing with 5 to 20 mg, and mean peak values range from 16 ng/mL at 5 mg to 70 ng/mL at 20 mg.
bioavailabilityclinical_pharmacology
80 %; Pharmacokinetics and Metabolism The absolute bioavailability after a 10 mg oral dose of bisoprolol fumarate is about 80%.
metabolismclinical_pharmacology
Pharmacokinetics and Metabolism The absolute bioavailability after a 10 mg oral dose of bisoprolol fumarate is about 80%.
recorded 2026-04-21 · last checked 2026-09-04
Q6
Which running trial of O-(DESISOPROPYL) Bisoprolol Acid could settle vo2max?
NCT05569382 measures Maximal oxygen consumption (VO2 max), reading out 2027-12-31.
2 open trials; n 100; "Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy"
Show the evidence
Trial
NCT05569382
"Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy"; n 100; "Maximal oxygen consumption (VO2 max)"; 2027-12-31
NCT03778554
"Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction"; n 2760; "A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin."; 2035-12-10
Q7
Which 27 trials of O-(DESISOPROPYL) Bisoprolol Acid posted no result?
Posted no result
27 of 27 completed trials
Registrations
NCT03276598, NCT00382421, NCT00323973, NCT01284868, NCT00517725 and NCT01273298, and 21 more
Completion dates
oldest 2004-04-01; newest 2023-06-18
Show the evidence
Trial
NCT03276598
2004-04-01
NCT00382421
2006-04
NCT00323973
2006-07
NCT01284868
2009-11
NCT00517725
2010-05
NCT01273298
2010-10
14 further recorded trials
NCT01762436
2012-02
NCT01741623
2012-11
NCT01744873
2012-11
NCT02106286
2013-12
NCT01939509
2014-11
NCT01656005
2016-07
NCT00882856
2016-12
NCT02171988
2016-12
NCT02832973
2018-03
NCT03485482
2018-03-23
NCT03800264
2018-11-15
NCT03967496
2019-03-31
NCT02380053
2019-04-30
NCT04467931
2020-12-31
Q8
At the median, O-(DESISOPROPYL) Bisoprolol Acid's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
22213
Registered trials counted
71
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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