Trial Files Throwback Thursday: Inhalers for Mild Asthma, Naltrexone for AUD, Cytoreduction for PV
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What's the evidence for using as-needed budesonide-formoterol instead of salbutamol for mild asthma?
Controlled Trial of Budesonide–Formoterol as Needed for Mild Asthma (Novel START)
Beasley R et al. NEJM (May 2019)
Bottom line: This 52-week, randomized, open-label, parallel-group, controlled trial compared the effectiveness of budesonide-formoterol to albuterol for the prevention of asthma exacerbations in adults with mild asthma. The study included 668 patients who were randomly assigned to one of three treatment groups: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms), budesonide maintenance (budesonide 200 μg, one inhalation through a Turbuhaler twice daily plus as-needed albuterol), or budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed). The primary outcome was the annualized rate of asthma exacerbations, with a lower rate observed in the budesonide-formoterol group compared to the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001), and a similar rate to the budesonide maintenance group (P=0.65). There were fewer severe exacerbations in the budesonide-formeterol group compared to both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). Thus, the study concluded that budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations in adults with mild asthma.
Why is naltrexone used as first-line pharmacotherapy in the treatment of alcohol use disorder?
A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse
Chick J et al. Alcohol and Alcoholism (November 2000)
Bottom Line: This multicentre controlled study evaluated the efficacy and safety of naltrexone as adjunctive treatment for alcohol dependence or abuse. 175 patients were randomly assigned to receive either naltrexone 50 mg daily or placebo for 12 weeks as an adjunct to psychosocial treatment. The primary outcome was time to first episode of heavy drinking, with secondary outcomes including time to first drink, alcohol consumption, craving, and changes in serum biological markers including GGT, AST, and ALT. Compliance was assessed by tablet counts with > 80% tablet consumption, urinary concentrations of 6-β-naltrexol in the treatment group, and attendance at all follow up appointments. Patients allocated to naltrexone who met the definition of compliance reported consuming half the amount of alcohol (P < 0.05), had greater median reduction in serum GGT activity (P < 0.05), and greater reduction in alcohol cravings (OCDS total score: P < 0.05; Obsessive subscale score: P < 0.05) compared to patients in the placebo group. No safety concerns were reported. In conclusion, naltrexone is an effective treatment for alcohol dependence/abuse in conjunction with psychosocial therapy, in patients who comply with treatment.
What's the rationale for targeting hematocrit <45% in patients with polycythemia vera?
Cardiovascular Events and Intensity of Treatment in Polycythemia Vera (CYTO-PV)
Marchioli R et al. NEJM (January 2013)
Bottom Line: This randomized clinical trial compared the effectiveness of maintaining a hematocrit of less than 45% versus 45 to 50% in patients with JAK2-positive polycythemia vera (PV). A total of 365 adults with PV being treated with phlebotomy, hydroxyurea, or both were randomly assigned to either the more intensive treatment group (target hematocrit, <45%) or the less intensive treatment group (target hematocrit, 45 to 50%). The primary outcome, time until death from cardiovascular causes or major thrombotic events, was significantly lower in the low-hematocrit group (2.7%) compared to the high-hematocrit group (9.8%) after a median follow up of 31 months (hazard ratio in the high-hematocrit group, 3.91; 95% confidence interval [CI], 1.45 to 10.53; P=0.007). There was also a lower incidence of superficial-vein thrombosis in the low-hematocrit group (4.4% versus 10.9% in the high hematocrit group; hazard ratio, 2.69; 95% CI, 1.19 to 6.12; P=0.02). Adverse events were similar between the two groups. In conclusion, patients with a hematocrit target of less than 45% had significantly lower rates of cardiovascular death and major thrombosis in patients with PV.
Trial Files Issue #2024-17
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