Adverse effects of PPIs: Fact or Fake News

Gastroenterology consultation may be indicated when patients with psoriasis present with bowel symptoms (JAMA Dermatology, Oct. 24, 2018).

Adverse effects of PPIs: Fact or Fake News? (Curr Opin Gastroenterol. 2018;34(6):451-457)

Proton pump inhibitors (PPIs) are well tolerated and effective. Despite the ever-increasing number of associations and the widespread media coverage the quality of the evidence linking PPIs to a wide range of serious adverse effects is very low. When PPIs are prescribed appropriately, the benefits greatly outweigh potential adverse effects. The absolute risk to an individual is extremely low (less than 1 in 500) and fear of these risks should not dictate prescribing habits. PPIs should be prescribed for patients with GERD, especially those with erosive esophagitis and strictures, as well as for patients at an increased risk for ulcer-related bleeding from NSAIDs, aspirin, and dual antiplatelet therapies. In those patients without a valid indication, PPIs should be discontinued.

Most of the recent highly publicized serious adverse effects ascribed to proton pump inhibitors are not based on demonstrable evidence.

Not only has the information derived from these observational studies been unhelpful, but also the unattended consequence is that patients who require PPIs to prevent UGI bleeding are not receiving these medications, mainly due to fear on the part of the patient and provider.

Now, investigators must ‘sell’ their research in order to get published and funded, and journals are more than willing to publish controversial less than optimally executed studies in an effort to improve their impact factor. Although one may argue that these studies, with overstated conclusions that imply but cannot demonstrate cause and effect, ought not to be published, perhaps it can be more strongly argued that, if published, authors must be mandated to strongly indicate that such associations are weak and more likely to be caused by confounding variables both in the study itself and media interviews, conclusions should be tempered and derived the data without added hyperbole, articles should not be published, especially in high impact journals, for the sake of publicity for the journal, and editorials should accompany the papers that place the findings in appropriate context and caution about misinterpretation. When PPIs are prescribed long-term, they should be used at the lowest effective doses and the need for their use should be periodically reassessed. (Medscape)

Trial suspends enrolment: A phase 2 trial of cell therapy for patients with heart failure and reduced ejection fraction has suspended enrollment in the wake of an ongoing scandal that has led to at least one journal article retraction and calls for many others. The National Heart, Lung, and Blood Institute (NHLBI) has paused the Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF) trial comparing the two cell therapies, alone or together, with a placebo control. The New England Journal of Medicine recently retracted a publication and issued an expression of concern about two others based on work led by Piero Anversa, MD, the former Harvard Medical School professor who left the institution amid suspicions that much of his published data had been manipulated or fraudulent. The retraction closely followed recommendations from Harvard and the affiliated Brigham & Women’s Hospital that 31 publications from Anversa be retracted because they are based on fabricated or falsified data.

Administration of the high-dose influenza vaccine was associated with 8% fewer first hospitalizations than the standard-dose vaccine in 2016-17. In 2015-16 there was no difference by vaccine type although statistical power was limited, with only 8% of patients receiving high dose that year, compared with 61% in 2016-17 (October 23 in Clinical Journal of the American Society of Nephrology).

Proactive use of high-dose intravenous (IV) iron can reduce the amount of erythropoiesis-stimulating agent needed to treat anemia in dialysis patients with no short-term increase in the risk for vascular complications or infections, the first randomized trial of its kind suggests (David Wheeler, MD, from Virginia Commonwealth University in Richmond).

Adults spent 5.9 hours per day on digital media in 2017, up from 5.6 hours in 2016.

One can opt for referral to a Heart Valve Team to assess the feasibility and potential benefit and risk of transcatheter mitral valve repair (TMVR) for most patients with moderate-to-severe or severe (3+ to 4+) chronic secondary mitral regurgitation (MR) and heart failure despite optimum management.

In patients with acute metabolic acidosis, an arterial pH 7.1 to 7.2, and severe acute kidney injury give IV sodium bicarbonate therapy, rather than no alkali therapy

Do not give sodium bicarbonate to patients with arterial pH 7.1 or higher, if they do not have severe acute kidney injury.

For HIV-infected women who become pregnant while on a cobicistat-containing regimen, switch to a different regimen.

Video to watch: TEDx Video: Doctor-patient relationship watch?v=i9ml1vKK2DQ

Dr KK Aggarwal