~ Pharmacology News ~
FDA & Pfizer Warn Not to Use Azithromycin for Bronchiolitis Obliterans Following Bone Marrow Transplant
August 3rd, FDA: The FDA has issued a warning against the off-label use of azithromycin to prevent bronchiolitis obliterans syndrome (BOS) in patients with hematological/lymphatic cancers who recently received hematopoietic stem cell transplantation. The warning follows the discontinuation of a clinical trial funded by Pfizer evaluating the use of azithromycin for BOS prevention.
Antihypertensive Medications Associated with Lower Risk of Dementia
July 24, AAIC Meeting: Hypertensive individuals who used blood pressure medications of any class were found to have a 12% lower risk of all-cause dementia and 15% lower risk of Alzheimer’s Disease. Meta-analysis of observational prospective studies (31,090 participants).
Opioids for Low Back Pain More Likely to Be Prescribed Later in Day
July 2nd, Journal of General Internal Medicine: Physicians were 25% more likely to prescribe opioids in the 2nd hour of a 4-hour clinic session compared to the first hour, and 60% more likely to prescribe opioids in the 4th hour compared with the first hour. Observational (2772 patient visits).
More than 1 in 4 First-Time Heroin Users Develop Dependency
August 1st, JAMA Psychiatry: 23-38% of first-time heroin users develop heroin dependency in first 1-12 months after first use, according to an analysis of the National Survey on Drug Use and Health conducted between 2002 and 2016 in the United States. Observational (837,326 patients).
Shorter Course of Rifampin As Good As 9 Months of Isoniazid in Children with Latent Tuberculosis
August 2nd, NEJM: 4 months of rifampin, a bacterial RNA polymerase inhibitor used in the treatment of active mycobacterium tuberculosis (TB) infection, was found to be non-inferior, with similar safety considerations, to the current standard 9 months of isoniazid (INH) therapy in children with latent TB. Adherence to the drug regimen was higher in the rifampin group. RCT, open-label (844 participants).
Lowering Default Pill Count in EMR Associated with Decreased Post-Op Opioid Prescription
July 18th, JAMA Surgery: Lowering the default electronic medical record pill count from 30 to 12 was associated with a reduction in the number of opioid pills prescribed to post-operative patients (effect size ~5 opioid pill reduction). Pre-post interventional (1447 procedures).
Iobenguane I-131 Approved for the Treatment of Unresectable Pheochromocytomas, Paragangliomas
July 30th, FDA: Iobenguane I-131 is the first systemic anticancer therapy approved for patients with metastatic or locally advanced unresectable pheochromocytoma or paraganglioma (adrenal gland tumors). Iobenguane is a norepinephrine analog that accumulates in adrenergically innervated tissues. When radiolabeled with Iodine-123, it is used as a radiolabel in MIBG scaninng for diagnosis of neuroendocrine tumors. When labeled with I-131, iobenguane accumulates in the adrenal medulla and causes local tissue destruction and tumor regression.
FDA Approves Once-Monthly Risperidone Subcutaneous Injection
July 30th, FDA: The FDA has approved the first once-monthly subcutaneous injection of risperidone (Perseris), a 2nd generation antipsychotic, for the treatment of schizophrenia. Other formulations of risperidone require either daily oral medication adherence or biweekly intramuscular injections with a 3 week of oral risperidone bridge. The FDA does not require or recommend oral risperidone administration alongside Perseris except to establish drug tolerability.
More Physicians Using Epidural Methylprednisolone Injections for Back Pain
July 31st, NYTimes: Facing pressure to reduce opioid prescriptions, more physicians are using off-label epidural methylprednisolone injections (Depo-Medrol) despite risks of serious adverse effects including paralysis, stroke, and death. A number of countries, including Australia, France, Brazil and Canada, have already banned this use of Depo-Medrol.
FDA Approves TPO Agonist Lusotrombopag For Patients with Liver Disease Undergoing Procedure
July 31st, FDA: The US FDA has approved lusotrombopag, a small-molecule thrombopoietin (TPO) receptor agonist, for the treatment of thrombocytopenia in patients with chronic liver disease scheduled to undergo a procedure. Other TPO receptor agonists include eltrombopag, romiplostim and avatrombopag.
~ Clinical Trials: New Horizons ~
Ranibizumab Associated with Regression of Diabetic Retinopathy
August 1st, Ophthalmology Retina: Ranibizumab, an anti-VEGF monoclonal antibody, was associated with a three-fold lower risk of new proliferative events compared with sham treatments in patients with baseline diabetic retinopathy (DR). Patients receiving ranibizumab were also significantly more likely to experience clinically meaningful regression of DR compared with those receiving placebo. Post-hoc analysis of RIDE & RISE RCTs (740 patients).
~ Clinical Research ~
Folic Acid Supplementation May Reduce Fetal Side Effects of Antiepileptic Medications
August 1st, Journal Neurology: Folic acid supplementation in women taking antiepileptic medications starting 4 weeks before conception until the end of the first trimester was linked to a decreased risk of later childhood language delays. Observational retrospective (335 AED-exposed children).
Antihypertensive Combination Pill Prescriptions Associated with Higher Risk of Redundant Prescriptions
August 2nd, Journal Heart: Patients who received fixed-dose combination (multiple medications provided in a single pill) antihypertensive prescriptions experienced an up to two-fold increased the risk of therapeutic duplication compared to those who received individual prescriptions. Therapeutic duplication was defined as the simultaneous prescription of multiple drugs from the same class (e.g., two ACE inhibitors). Retrospective observational (459,465 prescriptions).
Idiopathic Inflammatory Myositis Associated with Statin Exposure
July 30th, JAMA Internal Medicine: Patients with histologically confirmed idiopathic inflammatory myositis (IIM) were 79% more likely to have had exposure to a statin medication than control patients who did not have IIM. Observational, 1:3 case:control (883 patients).
Ramipril Impact on Proteinuria Predicts Progression of CKD in Children
August 1st, American Society of Nephrology: In children with chronic kidney disease, the magnitude of proteinuria-lowering by ramipril (an angiotensin-converting enzyme inhibitor) was associated with progression of renal disease. Children who experienced a >60% reduction of proteinuria were 58% less likely to experience a 50% eGFR decline during 5 years of observation compared with children who experienced a 30% decline in proteinuria. Observational (280 children).
Budesonide Irrigation Improves Symptoms in Chronic Rhinosinusitis
July 19th, JAMA Otolaryngology: Addition of budesonide, a synthetic glucocorticoid, to large-volume low-pressure saline sinus irrigation was associated a greater improvement in patient-reported chronic rhinosinusitis (CRS) symptoms (mean effect size ~20%) compared with saline irrigation alone. RCT (80 patients).
Cannabis Use Associated with Decreased Anxiety, Pain Following Diagnosis of Head and Neck Cancer
August 2st, JAMA Otolaryngology: Patients with recently diagnosed head and neck cancer (HNC) who were cannabis users reported 36% lower self-reported anxiety scores and 16% lower pain scores than patients with recent HNC diagnoses who did not use cannabis. Prospective observational (148 patients).
Cannabis Use Associated with Higher Likelihood of Adolescent Psychotic Symptoms
June 6th/August 1st, JAMA Psychiatry: Analysis of a survey study demonstrated a positive association between self-reported cannabis use and the likelihood of experiencing psychosis symptoms in adolescents aged 13-16. Observational (3,966 participants).
Opioids for Chronic Pain Associated with Decreased Sexual Desire
July 2nd, Journal Pain: Individuals with chronic non-cancer pain (CNCP) who used opioids were 81% more likely to report a lack of or low sexual desire compared with individuals with CNCP who did not use opioids. Observational cross-sectional survey (11,517 participants).
Methadone Therapy Engagement Associated with Lower Viral Loads in Individuals with HIV and Injection-Drug Use
July 25th, International AIDS Conference: Individuals with HIV who use injection-drugs who also reported accessing methadone therapy were 30% less likely to have viral loads above 1500 copies/mL than individuals who did not use methadone. Observational prospective (867 participants).
Methadone Treatment Decreases Likelihood of Death in Patients with Criminal Convictions
July 31st, PLOS Med: Individuals with a history of criminal convictions who filled at least one methadone prescription between 1998 and 2015 were observed to have between 59-73% (depending on cause) lower risk of death during periods when they were filling methadone prescriptions compared with periods when they were not taking methadone. Observational retrospective (14,530 participants).
Drinking Alcohol While Breastfeeding Associated with Lower Cognitive Scores in Children
July 30th, Pediatrics: Exposure of infants to alcohol through breastmilk was associated with mildly decreased cognitive performance (Matrix Reasoning evaluation) at age 6 and 7 compared with those who were not exposed to alcohol. No difference in cognitive scores was observed at age 10 and 11. Observational prospective (5107 infants).
Both Excessive and Abstinent Alcohol Use Associated with Higher Dementia Risk
August 1nd, BMJ: Abstinence from alcohol intake in midlife was associated with a 47% higher risk of dementia compared with consumption of 1-14 units/week. For those drinking more than 14 units/week, for each 7-unit increase in alcohol consumption the risk of dementia increased by 17%. 14 United Kingdom alcohol units is equivalent to approximately 1.5 bottles of wine. Prospective cohort, Whitehall II study follow-up (9087 participants).
Pre-operative Antiviral Treatment in Hepatitis B-Related Liver Cancer Lowers Risk of Tumor Recurrence
August 1st, JAMA Surgery: Pre-operative antiviral therapy was associated with a 24% lower risk of hepatitis B (HBV)-related microvascular invasion and a 27% lower risk of early tumor recurrence in patients with hepatitis B-associated hepatocellular carcinoma undergoing tumor resection. Prospective observational (2362 patients).
Comparison to Peers Lowers Physicians’ Quetiapine Prescription Rates
August 1st, 2018: Physicians who frequently prescribe the atypical antipsychotic agent quetiapine reduced their prescription frequency to 11% fewer quetiapine days (per prescriber) following the receipt of a letter contrasting their prescription practices to their peers. In the control group, high-frequency quetiapine prescribers received a placebo letter. Up to 75% of all quetiapine prescriptions are estimated to be inappropriate or lack evidence-basis. RCT (5055 highest-volume primary care prescribers of quetiapine).
Antipsychotics in Adolescents with Behavioral Disorders Associated with Metabolic Changes
August 1st, JAMA Psychiatry: The 2nd generation antipsychotic medications aripiprazole, olanzapine, and risperidone (dopamine/serotonin antagonists) were associated with increased total body fat during a 12-week trial in adolescents diagnosed with disruptive behavioral disorders. Patients treated with olanzapine experienced the most significant increase (+4.12%) in body fat. Randomized 1:1:1 risperidone:olanzapine:aripiprazole (144 participants).
~ Reviews ~
Prenatal Acetaminophen Exposure Associated with Increased Risk of ADHD, Autism
April 23rd/August 1st, American Journal of Epidemiology: Children born to women who were exposed to acetaminophen during pregnancy were 34% more likely to have attention deficit hyperactivity disorder, 19% more likely to have autism spectrum disorder, and 24% more likely to have hyperactivity symptoms. Systematic review and meta-analysis (7 retrospective observational studies, 132,738 mother-child pairs).
Natalizumab Effective in Moderate-Severe Crohn’s Disease, Increases Risk of Viral Encephalopathy
August 1st, Cochrane: Patients with Crohn’s disease who received natalizumab, an anti-integrin monoclonal antibody, were up to 34% more likely to achieve clinical disease remission than patients who received placebo. Natalizumab was associated with the development of progressive multifocal encephalopathy in some patients, raising serious concerns about its practical use in most settings. Systematic review and meta-analysis (5 RCTs, 1771 participatns).
Antenatal Corticosteroids May Decrease Respiratory Risk Following Elective C-Section
August 3rd, Cochrane: Antenatal, maternal intramuscular corticosteroid injections (dexamethasone or betamethasone) were associated with a lower risk of neonatal respiratory complications when administered to women undergoing elective Cesaerean-section surgeries at 37 weeks of gestation or earlier. Meta-analysis (3956 women, 3893 babies).
Chocolate Consumption Associated with Lower Risk of Cardiovascular Disease
July 30th, Journal Heart: Limited chocolate consumption (<100g/week) was associated with a decreased risk of cardiovascular disease, with the largest effect observed at 45 g/week. Standard-size chocolate bars generally weigh 100 g. Meta-analaysis (23 observational studies, 405,304 participants).
Antibiotics Effective for Chronic Wet Cough in Children
July 31st, Cochrane: A 7-14 day course of amoxicillin/clavulanate or erythromycin was associated with improve outcomes in children with persistent (> 10 days) wet cough. The cure rate for antibiotic therapy was estimated to be one child cured for every three children treated. Meta-analysis (3 RCTs, 190 children).