Citation: Buller HR, Gallus AS, Pillion G, Prins MH, Raskob GE. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet. 2012;379:123-129.
Triple Therapy Better than Double for COPD
Clinical question: Does addition of tiotropium to inhaled corticosteroids and long-acting beta-agonists (LABA) have an additive benefit in reducing mortality, hospital admissions, and exacerbations in COPD?
Background: Triple therapy in COPD involves adding LABA and long-acting antimuscarinics (LAMA), such as tiotropium, to inhaled corticosteroids (ICS). Despite the guidelines recommending triple therapy for severe COPD, most studies have evaluated either LAMA or LABA plus ICS, but not all three together.
Study design: Retrospective cohort.
Setting: Tayside, Scotland’s National Health Services database.
Synopsis: Patients with severe COPD were divided into two groups: 1,857 patients had received ICS+LABA (double therapy) and 996 had received ICS+LABA+tiotropium (triple therapy), with follow-up of 4.65 years.
All-cause mortality was 35% lower in the triple therapy group (HR 0.65, 95% CI 0.57-0.75). Corticosteroid use was 29% lower (HR 0.71, 95% CI 0.63-0.80), and hospital admissions were 15% lower (HR 0.85, 95% CI 0.73-0.99) in the triple-therapy group. These results were adjusted for smoking, age, sex, socioeconomic status, and history of diabetes, cardiovascular, and respiratory disease.
This study is limited by its observational retrospective design but provides good evidence of the need for randomized controlled trials to validate the clinical benefits of triple therapy.
Bottom line: Adding tiotropium to ICS plus LABA is associated with lower all-cause mortality, hospitalizations, and corticosteroid use when compared with ICS plus LABA, validating its current use in management of severe COPD.
Citation: Short PM, Williamson PA, Elder DHJ, Lipworth SIW, Schembi S, Lipworth BJ. The impact of tiotropium on mortality and exacerbations when added to inhaled corticosteroids and long-acting β-agonist therapy in COPD. Chest. 2012;141:81-86.
Above-Knee Compression Stockings Not Better than Below-Knee Stockings for Protection Against Post-Thrombotic Syndrome
Clinical question: Do above-knee compression elastic stockings prevent post-thrombotic syndrome (PTS) better than below-knee stockings?
Background: PTS—characterized by leg pain, cramps, edema, and hyperpigmentation—occurs in 25% to 50% of patients after an episode of deep venous thrombosis (DVT). Previous studies demonstrated a 50% reduction in the incidence of PTS when patients used below-knee stockings.
Study design: Open-label, randomized clinical trial.
Setting: Eight hospitals in Italy.
Synopsis: A total of 267 patients with their first episode of DVT were randomized to thigh-length or below-knee compression elastic stockings, as well as therapeutic anticoagulation, with a primary endpoint of three-year incidence of PTS. Assessment was done by study personnel who were blinded to the type of stocking the patients had been prescribed. Severity of PTS was graded by a scoring system incorporating objective and subjective criteria with an independent adjudicator.
The intention-to-treat analysis showed no significant difference in the three-year incidence of PTS between thigh- and knee-length stockings (32.6% vs. 35.6%, respectively). Compliance was better in the knee-length (82.6%) than in the thigh-length (66.7%) group due to the significantly lower rate of stockings-related side effects.
The study is limited by a lack of blinding in the study participants.
Bottom line: Knee-length stockings offer equal similar protection against PTS with better compliance when compared with thigh-length stockings.
Citation: Prandoni P, Noventa F, Quintavalla R, et al. Thigh-length versus below-knee compression elastic stockings for prevention of the post-thrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012;119:1561-1565.