Lanoxin

[Digoxin]

The larger study also showed treatment-related benefits in NYHA class and patients’ global assessment. In the smaller trial, these trended in favor of a treatment benefit. The Digitalis Investigation Group (DIG) main trial was a multicenter, randomized, double-blind, placebo-controlled mortality study of 6801 patients with heart failure and left ventricular ejection fraction 0.45. At randomization, 67% were NYHA class I or II, 71% had heart failure of ischemic etiology, 44% had been receiving digoxin, and most were receiving concomitant ACE inhibitor (94%) and diuretic (82%). Patients were randomized to placebo or LANOXIN, the dose of which was adjusted for the patient’s age, sex, lean body weight, and serum creatinine (see DOSAGE AND ADMINISTRATION), and followed for up to 58 months (median 37 months).

The median daily dose prescribed was 0.25 mg. Overall all-cause mortality was 35% with no difference between groups (95% confidence limits for relative risk of 0.91 to 1.07). LANOXIN was associated with a 25% reduction in the number of hospitalizations for heart failure, a 28% reduction in the risk of a patient having at least one hospitalization for heart failure, and a 6.5% reduction in total hospitalizations (for any cause).

Use of LANOXIN was associated with a trend to increase time to all-cause death or hospitalization. The trend was evident in subgroups of patients with mild heart failure as well as more severe disease, as shown in Table 3. Although the effect on all-cause death or hospitalization was not statistically significant, much of the apparent benefit derived from effects on mortality and hospitalization attributed to heart failure.

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LANOXIN (digoxin) Tablets, USP

Table 3: Subgroup Analyses of Mortality and Hospitalization During the First Two Years Following Randomization Risk of All-Cause Mortality or All-Cause Hospitalization* Risk of HF-Related Mortality or HF-Related Hospitalization*
n Placebo LANOXIN Relative risk † Placebo LANOXIN Relative risk † All patients
(EF 0.45) 6801 604 593 0.94 (0.88-1.00) 294 217 0.69 (0.63-0.76)
NYHA I/II 4571 549 541 0.96 (0.89-1.04) 242 178 0.70 (0.62-0.80)
EF 0.25-0.45 4543 568 571 0.99 (0.91-1.07) 244 190 0.74 (0.66-0.84)
CTR 0.55 4455 561 563 0.98 (0.91-1.06) 239 180 0.71 (0.63-0.81)
NYHA III / IV 2224 719 696 0.88 (0.80-0.97) 402 295 0.65 (0.57-0.75)
EF <0.25 2258 677 637 0.84 (0.76-0.93) 394 270 0.61 (0.53-0.71)
CTR >0.55 2346 687 650 0.85 (0.77-0.94) 398 287 0.65 (0.57-0.75)
EF >0.45 ‡ 987 571 585 1.04 (0.88-1.23) 179 136 0.72 (0.53-0.99) * Number of patients with an event during the first 2 years per 1000 randomized patients.
† Relative risk (95% confidence interval).
‡ DIG Ancillary Study.

In situations where there is no statistically significant benefit of treatment evident from a trial’s primary endpoint, results pertaining to a secondary endpoint should be interpreted cautiously.

Chronic Atrial Fibrillation:

In patients with chronic atrial fibrillation, digoxin slows rapid ventricular response rate in a linear dose-response fashion from 0.25 to 0.75 mg/day. Digoxin should not be used for the treatment of multifocal atrial tachycardia.

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