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Department: DRUG NEWS

Drug News

doi: 10.1097/01.NURSE.0000668444.77319.a7
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ARBs, ACE inhibitors do not increase risk of death

Because patients with underlying cardiovascular disease (CVD) may be disproportionately affected by COVID-19, questions have been raised about whether angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) contribute to disease severity in critically ill patients with both CVD and COVID-19. ACE inhibitors and ARBs are commonly prescribed for patients with CVD. However, a recent analysis of data on 8,910 patients found no evidence that these drugs increased the risk of in-hospital death in this patient population.

Investigators evaluated the relationship of CVD and drug therapy with in-hospital death among hospitalized patients with COVID-19 admitted to 169 hospitals in Asia, Europe, and North America from December 20, 2019, to March 15, 2020. A total of 515 patients in the study died in the hospital and 8,395 survived to discharge. The analysis showed that use of ARBs or ACE inhibitors did not raise the risk of in-hospital death. Factors independently associated with an increased risk for in-hospital death were age over 65, coronary heart disease, heart failure, cardiac dysrhythmia, chronic obstructive pulmonary disease, and current smoking.

“Our study confirmed previous observations suggesting that underlying cardiovascular disease is associated with an increased risk of in-hospital death among patients hospitalized with COVID-19,” the authors write. “Our results did not confirm previous concerns regarding a potential harmful association of ACE inhibitors or ARBs with in-hospital death in this clinical context.”

Source: Mehra M, Desai SS, Kuy S, Henry TD, Patel AN. Cardiovascular disease, drug therapy, and mortality in Covid-19. N Eng J Med. [e-pub May 1, 2020]


Many products too strong for pain relief

Cannabis products with low tetrahydrocannabinol (THC) concentrations (less than 10%) have been shown to be effective for treating neuropathic pain. THC is the primary psychoactive ingredient in cannabis, and higher THC potencies (more than 15%) are characteristic of recreational cannabis products. An analysis of cannabis products advertised online shows that many have higher concentrations of THC than needed to treat chronic pain, placing patients using these products to manage chronic neuropathic pain at risk for adverse reactions and toxicity.

Researchers evaluated the advertised content of THC and cannabinol (CBD) for cannabis products offered online in US dispensaries. (CBD is another key compound found in cannabis, but its role in pain control is unclear.) Their goals were to determine products' suitability to medicinal use and to compare the strength of products offered in legal medical and recreational programs. The study included over 8,500 cannabis products offered online in 653 dispensaries.

The average THC concentration advertised online in medicinal programs was similar to that for recreational programs when compared between states with different programs, or between medicinal and recreational programs within the same states. Most products, regardless of medicinal or recreational status, were advertised to have more than 15% THC. The authors write, “These stated concentrations seem unsuitable for medicinal purposes, particularly for patients with chronic neuropathic pain....Patients consuming these products may be at risk of acute intoxication or long-term side effects.” They urge development of policies to prevent misconceptions about cannabis products and reduce risks in patients seeking pain relief.

Source: Cash MC, Cunnane K, Fan C, Romero-Sandoval EA. Mapping cannabis potency in medical and recreational programs in the United States. PLoS One. 2020;15(3):e0230167.


Latest review confirms safety, effectiveness

In a Cochrane systematic review, investigators examined evidence from multiple data sources to assess the effectiveness, safety, and long- and short-term adverse reactions associated with the trivalent vaccine containing measles, mumps, rubella strains (MMR), or concurrent administration of MMR vaccine and varicella vaccine (MMR+V), or tetravalent vaccine containing measles, mumps, rubella, and varicella strains (MMRV), given to children up to age 15 years. The analysis was based on 138 studies involving 23,480,668 participants and included 74 new studies not examined in the 2012 version of this review. Fifty-one studies (10 million children) assessed how effective the vaccines were at preventing the diseases, and 87 studies (13 million children) assessed unwanted effects. Results included the following:

  • One dose of vaccine was 95% effective for preventing measles.
  • One dose of vaccine was 72% effective at preventing mumps. Effectiveness rose to 85% after two doses.
  • One dose of vaccine was 89% effective in preventing rubella.
  • After 10 years, the MMRV vaccine was 95% effective at preventing varicella infection.

Analysis of safety data showed that MMR, MMRV, and MMR+V vaccines did not cause autism, encephalitis, or any other suspected unwanted effect.

The authors call for more research to assess whether the protective effect of MMR/MMRV vaccines wanes with time and to determine the effectiveness of a third dose of the MMRV vaccine.

Source: Di Pietrantonj C, Rivetti A, Marchione P, Debalini MG, Demicheli V. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev. [e-pub April 20, 2020]


Targeted therapy for cholangiocarcinoma

The FDA has granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma, a rare cancer of the bile ducts. The new drug is indicated to treat patients with either locally advanced or metastatic cholangiocarcinoma and those with tumors that have a fusion or other rearrangement of a gene called fibroblast growth factor receptor 2 (FGFR2). An estimated 9% to 14% of patients with cholangiocarcinoma have FGFR2 fusions. Administered orally, Pemazyre blocks FGFR2 in tumor cells, preventing their growth and spread.

The accelerated approval was based on a clinical trial involving 107 patients. The overall response rate was 36%, with 2.8% of patients having a complete response and 33% having a partial response. Over 20% of patients experienced adverse reactions, including hyperphosphatemia or hypophosphatemia; alopecia; diarrhea or constipation; nail toxicity; fatigue; dysgeusia; nausea and vomiting; stomatitis; dry eye; dry mouth; anorexia; joint, back, or abdominal pain; and dry skin. Ocular toxicity is also a risk.

Source: US Food and Drug Administration. FDA approves first targeted treatment for patients with cholangiocarcinoma, a cancer of bile ducts. News release. April 17, 2020.

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