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Department: DRUG NEWS

Drug News

doi: 10.1097/01.NURSE.0000827204.95058.30
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In Brief


Nonopioid regimen as effective as opioid use

Managing postoperative pain with an opioid-free approach may be as effective, if not more effective, and safer than pain management with opioids according to the results of two recent studies.

Groups of patients who were receiving either primary anterior cruciate ligament reconstruction (ACLR) or primary rotator cuff repair were randomized into two groups, one that received a traditional therapy regimen with opioids and one that received a nonopioid management regimen.

In the ACLR study, 62 patients were analyzed, with 28 randomized into the opioid group and 34 into the multimodal nonopioid group.1

In the rotator cuff study, 40 total patients were observed, with 23 randomized into the opioid treatment group and 17 randomized into the nonopioid group.2

Nonopioid pain management consisted of pain relievers, nonsteroidal anti-inflammatory drugs, and muscle relaxants.

In both studies, patients in the nonopioid regimen reported equivalent, if not greater, pain control and satisfaction compared with the standard opioid regimen. Patients in the nonopioid regimen in the ACLR study reported significantly lower postoperative visual analogue scale (VAS) pain scores compared with the control (opioid) group. Similarly, patients randomized into the control group on opioid pain management in the rotator cuff study reported a significantly higher VAS pain score on postoperative day 1 (and postoperative day 4).

“The challenge for surgeons is to minimize opioid use while optimizing patients' pain control after surgery,” said Kelechi Okoroha, MD, an orthopedic surgeon and sports medicine specialist at the Mayo Clinic. “I think this is really game-changing research,” Okoroha said. “We've found that it is effective in common sports surgeries. Our plan is to implement it in other surgeries and hopefully decrease the opioid burden worldwide.”3

Common adverse reactions of the nonopioid pain management approach in both studies included drowsiness, dizziness, and gastrointestinal symptoms. Patients in the rotator cuff study reported slightly less adverse reactions than those on the opioid regimen.



    Benefits of individualized approach over race-based guidelines

    An individualized approach to hypertension (HTN) control may be more important than a race-based approach, according to a study published in the Journal of American Board of Family Medicine.

    Researchers conducted a linked retrospective observational cohort study in which they examined 2-years' worth of electronic health record (EHR) data of 10,875 patients between the ages of 18 and 85 with HTN on one- and two-drug regimens. They examined the prescribing differences and HTN control in Black/African American (BAA) patients versus non-BAA counterparts.

    Drugs these patients took included angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), thiazide diuretics, and calcium channel blockers (CCB).

    Of this group, 46.6% had uncontrolled HTN defined as a reading greater than 140/90 mm Hg. Only 39% of their non-BAA peers had uncontrolled HTN.

    About 62% of the BAA population and 68% of the non-BAA population were treated with a one-drug regimen. Just over 45% of the BAA population still had uncontrolled HTN on a one-drug regimen, whereas only 38% of the non-BAA patients on a one-drug regimen still had uncontrolled HTN.

    Of the BAA population receiving monotherapy, 41.3% were on thiazide, 40.1% on CCB, and 18.6% on ACE/ARB. Of the non-BAA population, 7.7% were on thiazide, 30.1% were on CCB, and 42.3% were on ACE/ARB.

    Just over 48% of BAA patients and 41.1% of non-BAA patients on a two-drug regimen sill had uncontrolled HTN at the time of observation.

    The researchers say that each group varied more within itself than between BAA and non-BAA measurements.

    “Our findings suggest that race-based hypertension prescribing guidelines have influenced clinical practice but likely with relatively limited benefit for BAA patients,” the researchers wrote. “Other factors may be more important than the choice of drug based on skin color such as dose titration; the addition of second or third drugs; medication adherence; and dietary and lifestyle interventions like advocating for smoking cessation, reducing alcohol consumption, and achieving weight loss.”

    Limitations of the study include an underestimation of race and ethnicity categorization by EHR systems; the influence of comorbidities that were not accounted for; a lack of access to drug doses and changes in prescribing patterns; inconsistency of BP recording between providers and healthcare clinics; and a lack of medication adherence recorded in EHR data.

    Reference: Holt HK, Gildengorin G, Karliner L, Fontil V, Pramanik R, Potter MB. Differences in hypertension medication prescribing for Black Americans and their association with hypertension outcomes. J Am Board Fam Med. 2022;35(1):26-34. doi:10.3122/jabfm.2022.01.210276.


    JAK inhibitors approved

    The FDA has approved upadacitinib (Rinvoq, AbbVie) and abrocitinib (Cibinqo, Pfizer), both oral Janus kinase (JAK) inhibitors, for atopic dermatitis.

    Upadacitinib is indicated for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis. Approval is based upon three phase-3 studies with more than 2,500 adults and children 12 years of age and older. In the studies, upadacitinib reached primary endpoints at 16 weeks, with some patients achieving higher skin level clearance based on the Eczema Area and Severity Index 90.

    Upadacitinib is contraindicated in patients with known hypersensitivity to the drug or any of its excipients.

    Prescribing information warns that upadacitinib should not be used in patients with active, serious infections; hypersensitivity reactions such as anaphylaxis have been reported; gastrointestinal perforations are a risk of use; embryo-fetal toxicity has been reported in animal studies; and that the drug should not be used with live vaccinations.

    Adverse reactions include upper respiratory tract infections, acne, herpes simplex, headache, increased serum creatine kinase levels, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza-like illness.

    Abrocitinib is indicated only for adults with refractory, moderate-to-severe atopic dermatitis and is available in 50 mg, 100 mg, and 200 mg tablets. Approval was based upon five clinical trials from a large program including more than 1,600 patients.

    It is contraindicated in patients on antiplatelet therapies, except low-dose aspirin, during the first 3 months of treatment.

    Warning and precautions include reports of lab abnormalities including platelets, lymphocytes, and lipids.

    Adverse reactions reported in patients taking 100 mg and 200 mg include nasopharyngitis, nausea, headache, herpes simplex, increased serum creatine kinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, and gastroenteritis.

    Adverse reactions in patients taking 100 mg or 200 mg include impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

    Both upadacitinib and abrocitinib have a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

    References: RINVOQ Prescribing Information. 2022.

    Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (measure up 1 and measure up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. doi:10.1016/s0140-6736(21)00588-2.

    Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (ad up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397(10290):2169-2181. doi:10.1016/s0140-6736(21)00589-4.

    CIBINQO Prescribing Information. 2022.


    FDA approves generic for dry eye

    The FDA has approved the first generic of Restasis for keratoconjunctivitis sicca.

    The generic, cyclosporine ophthalmic emulsion 0.05% single-use vials, is said to increase tear production in patients whose tear production is presumed to be suppressed by ocular inflammation.

    Keratoconjunctivitis sicca occurs when eyes don't make enough tears to stay wet or when tears are not of the correct consistency.

    Adverse reactions reported with the use of Restasis and its generic include ocular burning (most common), conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbances.

    “Restasis has been approved for use in the US for nearly 20 years, but until [this approval], there was no approved generic product that can help the millions of Americans who suffer from dry eyes,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. “[This] approval reflects the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices.”

    Reference: FDA approves first generic of restasis. U.S. Food and Drug Administration. 2022.

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