geoffrey modest medical blogs

​​​ ​​The FDA just released a drug safety communication on clarithromycin: "Potential increased risk of heart problems or death in patients with heart disease". see  https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm ​ ​ Details: --this safety alert is based on the results of a 10-year  followup  study (the CLARICON study) finding that clarithromycin was associated with increased risk of heart problems or death in those with underlying coronary heart disease Background: --the initial study was the CLARICON study, published in BMJ in  2005 (see doi:10.1136/bmj.38666.653600.55), which was testing the hypothesis that a 2-week course of clarithromycin would  decrease cardiac event s. 4373 patients aged 18-85 who had a diagnosis of MI or angina and stable CAD were randomized to  clarithro  500 mg/d vs placebo.  the impetus for this study was the well-documented association between Chlamydia pneumoniae and CAD, even

A new randomized control trial in younger vitamin D-deficient postmenopausal women found that vit D supplementation led to a reduction in markers of bone turnover (see  vit d dec bone turnover postmenop OsteopIntl2018  in dropbox, or doi.org/10.1007/s00198-018-4395-y ). Details: --160 menopausal women aged 50-65 and normal bone mineral density (BMD) were randomized to 1000 IU vitamin D3 vs placebo for 9 months --mean age 59, menopause age 47, BMI 29, dietary calcium intake 750 mg/d, BMD 0.5 spine/0.4 femoral neck, 25(OH)D 16 ng/mL, calcium 9.5, PTH 58, alk phosph 92 Results: --vitamin D supplement vs placebo, comparing basal levels vs at 9 months (only statistically significant changes noted):     --25(OH)D levels increased from 15.0 to 27.5 ng/mL (p<0.0001) vs decrease from 16.9 to 13.8     --PTH levels decreased from 57.8 to 45.5 pg/mL (21.3% reduction, p<0.0001) vs increase from 57.7 to 63.0     --Alkaline phosph levels: no significant change     --24-h

​ ​ A couple of new articles shed some more light on prevention of osteoporotic fractures (following a recent blog  on 2/5/18:  http://gmodestmedblogs.blogspot.com/2018/02/prolonged-bisphosphonates-and-increased.html  ). i will divide them over today and tomorrow.  ----------------- A Medicare claims analysis of hip fractures found a higher than projected incidence from 2012-2015  ( see  osteoporosis hip fracture trends OsteopIntnl2018  in  dropbox , or doi.org/10.1007/s00198-017-4345-0 ) Details: --hip fracture sample included 149,964 women annually from Medicare claims data from 2002-2015 in women ≥ 65 years old --proportion of fractures by age group:     --65-69: 5.5     --70-74: 7.8     --75-79: 13.8     --80-84: 22.1     --85-89: 25.8     --90+: 24.9 Results: --age-adjusted hip fracture rates, weighting to the 2014 population​, decreased linearly each year from 2002-2012 at about -1.8%/year, then plateaued at higher than projected from 2013-2015, with a

Patients with atrial fibrillation and chronic kidney disease (CKD) may not benefit from anticoagulants (see  afib CKD outcomes BMJ2018 in dropbox , or doi.org/10.1136/bmj.k342  ). this follows on the tails of a recent blog finding no benefit and perhaps harm in those getting ICDs for heart failure but have CKD (see below) Details: --large database from the Royal College of General Practitioners (2.73 million patients from 110 general practices across England and Wales), evaluated over the 11 year period of 2006-2017 -- 6977 patients aged >65yo, with chronic kidney disease (eGFR <50)and newly diagnosed atrial fibrillation were identified     ​--2434 on anticoagulants within 60 days of developing atrial fib were compared to 4543 not anticoagulated (ie, only  35% of patients in the overall cohort were put on anticoagulation), followed for a median of 506 days.     --anticoagulation was by vitamin K antagonists (1739 patients, 72%), rivaroxaban (307 pts, 13%), apixaban

another meta-analysis just came out finding that omega-3 fatty acid supplementation had no significant benefit in patients with known cardiovascular disease, but the devil is in the statistics.... (see  fish oils and CAD jamacardiol2018  in  dropbox , or doi:10.1001/jamacardio.2017.5205 ).  Thanks to Steve Stovitz for bringing the article to my attention, as well as  the issue of yielding to an arbitrary measure of "statistical significance" Details: --10 trials with 77,917 individuals at high cardiovascular risk --mean age 64, 61% males, 66% prior CHD/28% stroke/37% diabetes, 83% on statins (but these are averages, the actual numbers varied pretty widely from study to study) --over mean of 4.4 years, 6273 coronary heart events (2695 CHD deaths, 2276 nonfatal MIs) and 12,001 major vascular deaths Results: --randomization to omega-3 fatty acids was associated with:     ​--coronary heart disease rate, 7% decrease, RR 0.93 (0.83-1.03), p=0.05, nonsignificant

​2 issues: dramatic increased in crystal methamphetamine use and deaths; and an FDA report on kratom, finding more evidence that it is an opiate with no therapeutic benefit (see  https://www.nytimes.com/2018/02/13/us/meth-crystal-drug.html ). Details: --crystal meth was a huge issue in the early 2000's, with domestic meth labs all over the place, largely using OTC pseudoephedrine to synthesize meth --in 2005 Congress passed the Combat Methamphetamine Act, which severely restricted pseudoephedrine sales by requiring pharmacies to monitor and limit sales. Some states (eg Oregon and Mississippi) required a prescription for it. --meth use plummeted, to be replaced by opiates --over the past several years there has been a resurgence, from imported incredibly cheap ($5/hit), pure (>90%) and strong meth from Mexico (there continues to be domestic production, though mostly small quantities produced), such that:     --meth-related deaths in Oregon (232 in 2016) was more