Abuses of FDA Regulatory Procedures — The Case of Suboxone

Autori: Rebecca L. Haffajee, J.D., Ph.D., M.P.H., Richard G. Frank, Ph.D.
Journal: N Engl J Med
Data Publication : 2020; 382:496-498
DOI1: https://www.nejm.org/doi/full/10.1056/NEJMp1906680

Only about 20% of the more than 2 million Americans with an opioid use disorder (OUD) receive treatment in a given year, much of which is not evidence-based.1 Buprenorphine, one of several medications used to treat OUD, substantially reduces the risk of overdose and can be delivered in office-based settings. Various barriers impede widespread access to buprenorphine, however, including federal requirements that clinicians obtain a waiver to prescribe it. In addition, high prices for brand-name buprenorphine formulations strain the budgets of public programs, which cover a disproportionately large share of people with OUD. In 2017, Medicare and Medicaid were responsible for 32% of the $2.58 billion in prescription buprenorphine sales. The bulk of these sales was for Suboxone, a patent-protected buprenorphine–naloxone sublingual film made by Reckitt Benckiser Pharmaceuticals (now separated from its former parent company and known as Indivior).

Alcohol Abstinence in Drinkers with Atrial Fibrillation

Autori: Aleksandr Voskoboinik, M.B., B.S., Ph.D., Jonathan M. Kalman, M.B., B.S., Ph.D., Anurika De Silva, Ph.D., Thomas Nicholls, M.B., B.S., Benedict Costello, M.B., B.S., Shane Nanayakkara, M.B., B.S., Sandeep Prabhu, M.B., B.S., Ph.D., Dion Stub, M.B., B.S., Ph.D., Sonia Azzopardi, R.N., Donna Vizi, R.N., Geoffrey Wong, M.B., B.S., Chrishan Nalliah, M.B., B.S., et al.
Journal: N Engl J Med
Data Publication : 2020; 382:20-28
DOI1: https://www.nejm.org/doi/10.1056/NEJMoa1817591

BACKGROUND

Excessive alcohol consumption is associated with incident atrial fibrillation and adverse atrial remodeling; however, the effect of abstinence from alcohol on secondary prevention of atrial fibrillation is unclear.

METHODS

We conducted a multicenter, prospective, open-label, randomized, controlled trial at six hospitals in Australia. Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline were randomly assigned in a 1:1 ratio to either abstain from alcohol or continue their usual alcohol consumption. The two primary end points were freedom from recurrence of atrial fibrillation (after a 2-week “blanking period”) and total atrial fibrillation burden (proportion of time in atrial fibrillation) during 6 months of follow-up.

RESULTS

Of 140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years), 70 were assigned to the abstinence group and 70 to the control group. Patients in the abstinence group reduced their alcohol intake from 16.8±7.7 to 2.1±3.7 standard drinks per week (a reduction of 87.5%), and patients in the control group reduced their alcohol intake from 16.4±6.9 to 13.2±6.5 drinks per week (a reduction of 19.5%). After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) in the control group. The abstinence group had a longer period before recurrence of atrial fibrillation than the control group (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; P=0.005). The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P=0.01).

CONCLUSIONS

Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of Victoria Operational Infrastructure Support Program and others; Australian New Zealand Clinical Trials Registry number, ACTRN12616000256471. opens in new tab.)

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