Pharmacology News Digest, August 28th, 2018



This week in clinical pharmacology news: ​​ FDA approves new drugs for​​ neurotrophic keratitis, Dravet syndrome, and​​ hereditary angioedema. Glutamine shows promise in​​ post-infectious​​ IBS, any level of alcohol intake increases all-cause mortality, and aspirin is not effective in​​ primary prevention of cardiovascular disease.

-​​ August 27th, 2018



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).​​ 





by pharmacologyreview