Ivabradine (Corlanor)
An add-on for selected adults with heart failure and reduced ejection fraction
Detailed source records support the one-page handout. Different trials, populations, follow-up periods and stopping definitions cannot be compared as a drug ranking.
Who may benefit
Ivabradine slows the sinus node. The US adult indication requires stable symptomatic HF, LVEF at most 35%, sinus rhythm, resting rate at least 70 bpm, and a maximally tolerated beta blocker or a contraindication to its use. SHIFT predates widespread ARNI/SGLT2 therapy; its absolute benefit is not a guarantee for a contemporary individual. Cardiovascular death alone was not significantly reduced. [1] [2]
Stopping definitions
The adherence analysis reports any permanent medication stop separately from follow-up completion. Its analyzable adherence population differs from the US label safety population and the sponsor CSR safety set; denominators must not be swapped. Adverse-event stopping includes medical events without proving drug causation. [3] [4] [5]
POSITIVE is an uncontrolled Chinese observational cohort. The month-6 dose-change denominator is the sum of the reported categories: 423, not the entire 655 enrolled. The 16.5% measure cannot be presented as a cumulative six-month risk in all enrolled patients. [3] [4] [5]
Cost verification
The Blueberry UI estimate for 60 generic 5-mg tablets, two daily, for a nonmember was $34.64 before $3.99 shipping. The calculated shipped total is $38.63. The estimate is manufacturer-specific and can change. The GoodRx lookup was blocked; no unverified number is substituted. Insurance cost depends on the formulary and deductible. No specific CMS negotiated Corlanor price is claimed. [6] [7] [8]
Numerical records
SHIFT: First worsening-HF admission or cardiovascular death
Stable symptomatic HF, LVEF ≤35%, sinus rhythm ≥70 bpm, and a prior-year HF admission; Median 22.9 months. Participants with a first composite event; modified analysis population; background care in both arms
Ivabradine: 793/3,241 (24.5%); Placebo: 937/3,264 (28.7%). [1]
SHIFT adherence analysis: Permanent stopping of study medication for any reason
Participants with available adherence data; Parent trial median 22.9 months. Permanent stop before the final visit or death; study follow-up continued. Denominators are derived by adding Table 1 adherent and nonadherent groups, not original randomized denominators.
Ivabradine: 682/3,232 (21.1%); Placebo: 605/3,259 (18.6%). [3]
SHIFT clinical study report: On-treatment adverse event leading to treatment withdrawal
Sponsor clinical study report safety set; Parent trial median 22.9 months. Withdrawal because of an on-treatment adverse event; separate safety set from the US label. This does not prove each event was drug-caused.
Ivabradine: 467/3,232 (14.4%); Placebo: 416/3,260 (12.8%). [4]
POSITIVE interim observational cohort, China: Stopped since the previous visit at month 6
423 with month-6 dose-change data among 655 enrolled; Month-6 assessment; interval since previous visit. Not a cumulative six-month risk in all 655 participants; no comparator; not adverse-event-only. Denominator: 309 + 25 + 19 + 70 = 423.
Ivabradine: 70/423 (16.5%). [5]
SHIFT US label: Slow pulse
Treated safety set; Median ivabradine exposure 21.5 months. Rounded label-reported percentages; exact event counts not provided
Ivabradine: 10%; Placebo: 2.2%. [2]
SHIFT US label: Raised blood pressure
Treated safety set; Median ivabradine exposure 21.5 months. Rounded label-reported percentages; exact event counts not provided
Ivabradine: 8.9%; Placebo: 7.8%. [2]
SHIFT US label: Atrial fibrillation
Treated safety set; Median ivabradine exposure 21.5 months. Rounded label-reported percentages; exact event counts not provided
Ivabradine: 8.3%; Placebo: 6.6%. [2]
SHIFT US label: Brief visual brightness
Treated safety set; Median ivabradine exposure 21.5 months. Rounded label-reported percentages; exact event counts not provided
Ivabradine: 2.8%; Placebo: 0.5%. [2]