FDA Approves Cenergemin, First Drug for Corneal Degenerative Disease
August 23rd, FDA: The US FDA has approved cenergemin (Oxervate), a recombinant form of nerve growth factor, for the treatment of neurotrophic keratitis, a rare degenerative condition affecting the cornea.
FDA Approves Anticonvulsant Stiripentol for Dravet Syndrome
August 21st, FDA: The FDA has approved stiripentol (Diacomit), a GABA receptor modulator and GABA synthesis stimulator, for the treatment of patients aged 2 and older with Dravet syndrome who are already taking clobazam.
FDA Approves Twice-Daily Loteprednol Formulation for Eye Pain After Surgery
August 24th, FDA: The US FDA has approved a new formulation of the topical ocular corticosteroid loteprednol etabonate (Inveltys) for twice-daily dosing in patients with eye pain and inflammation following ophthalmic surgery. Other ocular corticosteroid formulations require QID dosing.
FDA Approves Lanadelumab for Hereditary Angioedema
August 24th, FDA: The US FDA has approved lanadelumab (Takhzyro), an anti-kallikrein monoclonal antibody for the treatment of hereditary angioedema.
Lorcaserin Associated with Weight Loss, Lower Risk of Diabetes
August 26th, ESC 2018 Congress: The serotonin receptor agonist lorcaserin was associated with a 19% lower risk of new-onset diabetes over 3 years, compared with placebo. Patients who received lorcaserin also experienced a sustained median weight loss of 2.8 kg. CAMELLIA-TIMI 61 trial (12,000 patients).
Post-Discharge Rivaroxaban Not Associated with Lower Risk of VTE, VTE-Related Death
August 26th, NEJM: Patients who received post-discharge 10 mg of rivaroxaban for venous thromboembolism (VTE) prophylaxis following hospitalization for medical illness were not less likely to experience symptomatic VTE and VTE-related death compared with patients who received placebo post-discharge. RCT, double-blind, MARINER clinical trial (12,024 patients).
Post-Partum Tranexamic Acid Not Associated with Lower Risk of Significant Hemorrhage
August 23rd, NEJM: Post-partum intravenous tranexamic acid was not associated with a significantly lower risk of substantial hemorrhage (>500 mL blood loss) compared with placebo in women who received prophylactic oxytocin after labor. RCT (3891 patients).
Entresto Initiation Pre-Discharge Does Not Increase Risk of Adverse Events
August 25th, Novartis: Combination sacubitril/valsartan (Entresto) initiation prior to hospital discharge following acute myocardial infarction was not found to increase risk of adverse events compared with drug therapy initiation after discharge. Transition RCT (1,002 HFrEF patients).
Amoxicillin, SMX-TMP Most Often Tied to Antibiotic-Related Pediatric ED Visits
August 23rd, JPIDS: Amoxicillin was the most likely antibiotic among children < 9 years old to be associated with emergency department visits for adverse antiobiotic-related reactions. Among pediatric patients 10 years and older, sulfamethoxazole-trimethoprim was the most likely antibiotic therapy to be associated with an adverse drug event leading to an ED visit. Observational (6,542 surveillance cases).
Pregnant Women with Severe Nausea More Likely to Report Prenatal Marijuana Use
August 20th, JAMA Internal Medicine: Pregnant women with severe nausea or vomiting in pregnancy (NVP) were found to have 4 times the odds of reporting prenatal marijuana use compared with women who did not report NVP. (279,457 patients).
Continuous Low-Dose Antibiotics Decrease Risk of Recurrent UTIs
June 28th, Lancet ID: Continuous (once-daily) low-dose administration of nitrofurantoin, trimethoprim, or cefalexin to individuals with a history of recurrent urinary tract infections (UTI) was associated with a 48% lower risk of developing a symptomatic, antibiotic-treated UTI as individuals who did not receive antibiotic prophylaxis. RCT, open-label (404 patients).
Parenteral Antibiotics for Children with UTI Do Not Decrease Revisits Leading to Admission
August 21st, Pediatrics: Administration of parenteral antibiotics to children evaluated for urinary tract infection (UTI) in the ED was not associated with a lower risk of ED revisit leading to admission, compared with children who did not receive parenteral antibiotics. Retrospective observational (29,919 children).
Aspirin Primary Prevention Not Associated with Improved Cardiovascular Mortality
August 26th, The Lancet: Patients at moderate risk of cardiovascular disease who received 100 mg aspirin primary prevention did not experience a lower risk of cardiovascular events compared with patients who received placebo. RCT (12,546 participants).
Oral Anticoagulation Protects Valve Replacement, Is Associated with Increased Mortality
August 27, ESC Meeting: Patients who received oral anticoagulation following transcatheter aortic valve replacement were observed to experience less valve deterioration than patients who received dual antiplatelet therapy, although patients who received oral anticoagulation were also found to have an 18% higher risk of mortality.
Observational (12,804 patients).
Lower Dose of Azathioprine Effective in Crohn’s Maintenance Therapy
August 25th, Medicine: 1.5 mg/kg daily oral azathioprine was as effective as 2 mg/kg in inducing and maintaining remission in Crohn’s disease. Observational retrospective (226 patients).
Triple Therapy De-Escalation in COPD Safe in Most Patients
August 1st, AJRCCM: In COPD patients on long-term triple therapy (inhaled corticosteroid[fluticasone] + long-acting beta-agonist[salmeterol] + long acting muscarinic antagonist[tiotriopium]), de-escalation to indacaterol/glycopyrronium was associated with a mild decrease in lung function but did not increase exacerbation rate. In the high blood eosinophil (>300/uL) subgroup, de-escalation did increase COPD exacerbation risk. RCT, double-blind (527 patients).
1x Weekly Ciprofloxacin as Effective as Daily Norfloxacin in For Peritonitis Prevention
June 27th, AJG: In patients with cirrhosis and ascites, weekly ciprofloxacin was as effective at preventing spontaneous bacterial peritonitis as daily norfloxacin. RCT, open-label (124 patients).
Dexmedetomidine Adjunct Improves Anesthesia During Hemorrhoidectomy
August 25th, Medicine: Addition of the α2-agonist dexmedetomidine to ropivacaine during caudal block for hemorrhoidectomy increased the duration of anesthesia and improved post-operative analgesia compared with ropivacaine + saline. RCT double-blind (50 patients).
Apixaban Safer than Rivaroxaban, Warfarin in Atrial Fibrillation Patients
July 4th, BMJ: In patients with atrial fibrillation, apixaban was associated with a decreased risk of major bleeding and GI bleeding compared with warfarin and rivaroxaban, however low dose apixaban was associated with a higher all-cause mortality than warfarin. Observational study (103,270 patients with atrial fibrillation).
Sleep Apnea + Intraoperative Neuromuscular Blockers Increases Risk of Pulmonary Complications
July 19th, BMC Anesthesia: Patients with obstructive sleep apnea who receive intraoperative neuromuscular blockers (IONB) had a higher likelihood of experiencing postoperative respiratory complications like hypoxemia, compared with sleep apnea patients who did not receive neuromuscular blockers. Some evidence suggests that sugammadex (a selective relaxant binding agent) administration may decrease the risk of adverse pulmonary events in OSA patients who IONB. Systematic review and meta-analysis (5 studies, 1126 patients).
Stopping Oxytocin During Labor Associated with Better Control of Contractions, Fetal Heart Rate
August 20th, Cochrane: Discontinuation of intravenous oxytocin during the active phase of labor was associated with a lower risk of large contractions that could affect the fetal heart rate. Limited evidence suggests that it may also decrease the risk of having a c-section. Systematic review and meta-analysis (10 RCTs, 1888 women).
Glucocorticoids Associated with Improved Disease Course in Croup
August 22nd, Cochrane: Glucocorticoid (e.g., beclomethasone, betamethasone, budesonide, dexamethasone, fluticasone, and prednisolone) administration was associated with improved croup symptoms and decreased rates of return visits and hospital admissions compared with placebo. Meta-analysis and systematic review (43 studies, 4565 children).
Alcohol Consumption Associated with Increased All-Cause Mortality
August 23rd, The Lancet: Any quantity of alcohol use was attributed to increased risk of all-cause mortality and was the 7th leading cause of death and DALYs in 2016, according to a Global Burden of Disease study. Observational (694 data sources, 592 studies).
Moderate Tea Drinking Associated with Lower Risk of Gallstones
August 22nd, EJCN: Individuals who reported drinking between 1-240 mL per day of tea drinking were found to have a 33% lower risk of gallstones compared to individuals who drank no tea or greater than 240 mL/day. Observational (14,555 participants).
Glutamine Shows Efficacy in Post-Infectious Irritable Bowel Syndrome
August 14th, Journal Gut: Patients with post-infectious IBS-D experienced greater improvement in symptoms following three-times daily oral supplementation of glutamine compared with patients who received placebo. RCT (56 patients).
Omega-3 Fatty Acids Do Not Decrease Cardiovascular Risk in Patients with Diabetes
August 26th, NEJM: Omega-3 (n-3) fatty acid supplementation did not decrease the risk of cardiovascular events compared with olive oil placebo in patients with diabetes mellitus. RCT ASCEND trial (15,480 patients).
Pregabalin Prescription Increases Risk of Opioid-Related Death
August 21st, Annals of Internal Medicine: Patients who were co-prescribed pregabalin and opioids were at higher risk of opioid-related death than those who were prescribed opioids alone. Observational (6400 patients).
Tighter Opioid Restrictions Associated with More Postoperative Hydrocodone Prescriptions
August 23rd, JAMA Surgery: Following a change in the controlled substance category of hydrocodone from schedule III to schedule II, hydrocodone prescription rates increased by 35 mean morphine equivalents. Observational (22,000 insurance claim records).