geoffrey modest medical blogs

BMJ just published a network meta-analysis of h pylori eradication by different regimens (see  hpylori   rx  review  bmj2015  in  dropbox , or  BMJ  2015;351:h4052). They identified 143 studies with 14 different treatments. Some varied by length of treatment, some by antibiotics used, some by addition of probiotics, and some by consistent vs sequential therapy.  background (as noted in prior blogs): --H pylori  is associated with an array of GI issues (dyspepsia, PUD, gastric mucosa-associated lymphoid tissue lymphoma or MALT, gastric cancer), as well as Fe-deficiency anemia, ITP, and perhaps due to its systemic inflammatory effects, may be associated with neurologic disorders (alzheimers, parkinsons, stroke) as well as cardiovascular disease --H pylori is the most common human pathogen, infecting about 50% of the global population (about 30% in North America and northern Europe, higher numbers in Eastern Europe, South America, Asia, Africa). --the effectiveness of the initi

The FDA just came out with a warning about DPP-4 inhibitors causing severe joint pain (see  http://www.fda.gov/Drugs/DrugSafety/ucm459579  ). They reviewed their FDA Adverse Event Reporting System (FAERS) database and the medical literature and identified cases of severe joint pain associated with the use of DPP-4 inhibitors, with symptoms starting 1 day to years after starting the DPP-4 inhibitor, and relief of symptoms usually within a month of stopping the med.  results: --they identified 33 such cases, all resulting in "substantial reduction in their prior level of activity", and 10 of whom were hospitalized --in 22 cases, the joint symptoms developed within one month of starting the med --in 23, the symptoms resolved within a month of stopping the med --8 had recurrent symptoms on rechallenge with DPP-4 inhibitor (6 of them with a different DPP-4 inhibitor) --10 of the cases suggested an immunological reaction with fever, chills, rash and swelling.   --8

A recent multi-institutional longitudinal cohort study assessed the use of chemotherapy in patients with progressive metastatic cancer, assessing survival, quality of life (QOL), and the relationship to performance status (see  cancer ctx endoflife jamaonc2015  in dropbox, or doi:10.1001/jamaoncol.2015.2378). background: --the American Society of Clinical Oncology (ASCO) in 2012 published a list of their "Choosing-Wisely" 5 opportunities to improve care and decrease costs, noting that chemotherapy use among patients with no evidence of clinical benefit was the most wasteful, unnecessary and widespread practice in oncology, especially in those with poor performance status with an Eastern Cooperative Oncology Group (ECOG) score of 3 or more ("capable of only limited self-care, confined to bed or chair >50% of waking hours"). Older studies from the 1980s have confirmed that those with poor performance had low response rates to chemotherapy, high rates of toxi

​if you thought that the FDA was approving too many drugs without adequate testing, just look at the approval process for medical devices!!! (see  medical device approval jama2015  in dropbox, or JAMA. 2015;314(6):604-612). The process is a tad complex. Studies are designated as "pivotal" if they were used by the FDA for premarket evaluation of safety and effectiveness as the primary basis for approval; others done premarketing were considered "non-pivotal". Premarket approval is the primary way that novel devices are approved -- those devices which support/sustain life, prevent illness, or prevent unreasonable risk to the patient. The overall process also allows for post-market approval studies, including for changes made to the devices through supplemental applications. The current study assessed this overall process, given the increasing concerns that high-risk devices make it into the market without adequate testing: the FDA has indeed been accepting more “flex

There was a pretty striking analysis of large numbers of elderly patientsinappropriately receiving implantable cardioverter defibrillators (ICDs) during acute hospitalizations (see  chf aicd not help elderly bmj2015   in dropbox, or doi: 10.1136/bmj.h3529​) background: --the US implants more ICDs than any other country: 133,262 implants in 2009: 434 new implants/1M people, 1.5x higher than the second largest implanter --the age of implantation is slowly increasing, with average now of 74 yo --the major trials finding ICD efficacy were in outpatients with stable heart failure, with a mean age of 60 in the SCD-HeFT and 64 in MADIT II trials (in this latter study, there was no difference if symptomatic NYHA class 2-3 symptomatic or asymptomatic). The 23-31% survival benefit in these studies became apparent after 1-1.5 years.   --but 1/3 of older Medicare beneficiaries have ICDs implanted during hospital admissions for heart failure or other acute co-morbidities --the curren