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Drug News

doi: 10.1097/01.NURSE.0000529812.44278.40
Department: DRUG NEWS

Long-term PPI use associated with gastric cancer...thrombus removal doesn't lower risk of postthrombotic syndrome...short-acting insulin gets fast-track approval...simple pharyngitis remedies aren't effective...monthly injection helps treat opioid use disorder

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Long-term PPI use may increase risks

Commonly used to treat reflux disease and dyspepsia, proton pump inhibitors (PPIs) such as omeprazole and esomeprazole have been associated with worsening gastric atrophy, particularly in patients infected with Helicobacter pylori. Investigating the possible association between PPI use and gastric cancer in H. pylori-infected patients, researchers conducted a study of over 63,390 eligible adults who'd received an outpatient prescription of clarithromycin-based triple therapy between 2003 and 2012. They found a small but statistically significant increase in the risk of gastric cancer from long-term use of PPIs, even after H. pylori eradication therapy. “Clinicians should exercise caution when prescribing long-term PPIs, even to patients who have H. pylori eradicated,” says study coauthor Wai Keung Leung, MD.

Sources: Cheung KS, Chan EW, Wong AYS, Chen L, Wong ICK, Leung WK. Long-term proton pump inhibitors and risk of gastric cancer development after treatment for Helicobacter pylori: a population-based study. Gut. [e-pub Oct. 31, 2017]. Are some heartburn meds tied to stomach cancer? HealthDay. November 1, 2017.

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New approval takes an abbreviated pathway

Admelog (insulin lispro injection) is a rapid-acting human insulin indicated to improve glycemic control in adults and pediatric patients age 3 years and older with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus. It's the first rapid-acting insulin approved as a “follow-on” product submitted through the FDA's 505(b)(2) pathway, an abbreviated approval process intended to reduce drug development expense and lower costs to patients. Approval for Admelog was based on the FDA's previous finding that Humalog, another insulin lispro injection product, was scientifically justified, safe, and effective.

Admelog can be administered via subcutaneous injection, subcutaneous infusion via insulin pump, or I.V. infusion. Because of the risk of hypoglycemia, patients must be closely monitored when insulin dosage changes are made and when Admelog is coadministered with other antidiabetic medications. Healthcare providers should also closely monitor patients at risk for hypokalemia, those with renal or hepatic impairment, and those with hypoglycemia unawareness.

Sources: FDA approves Admeglo, the first short-acting “follow-on” insulin product to treat diabetes. Food and Drug Administration. News release. December 11, 2017. Admelog (insulin lispro injection), for subcutaneous or intravenous use. Prescribing information.

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Simple sore throat remedies disappoint

Responding in part to concerns about antibiotic overuse, clinicians sometimes prescribe probiotics or chewing gum containing xylitol, a birch sugar that inhibits bacterial growth, to relieve signs and symptoms of pharyngitis. To investigate the effectiveness of this treatment approach, researchers conducted a 4-year, randomized controlled trial involving 689 participants in primary care age 3 years or older with pharyngitis. Nurses randomized eligible participants and provided them with intervention packs and treatment advice. Computer-generated random numbers were used to determine three kinds of material and advice for each pack: no offer of chewing gum, advice to use xylitol-based chewing gum, or advice to use sorbitol-based chewing gum. (Chewing sorbitol gum might hypothetically help relieve pharyngitis by generating more saliva.) Half of each group were also randomly assigned to receive either probiotic capsules containing lactobacilli and bifidobacteria, or placebo. Participants used a symptom diary to record the number of probiotic capsules and sticks of chewing gum they used each day and the severity of symptoms.

The results indicated that neither xylitol nor probiotic therapy had any effect on pharyngitis signs and symptoms or recurrence. The study authors write, “The results show that neither probiotics nor xylitol is likely to have a meaningful effect...As such, there is no reason for clinicians to advise patients to use either of these treatments for the symptomatic management of pharyngitis.”

Sources: Little P, Stuart B, Wingrove Z, et al. Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial. CMAJ. 2017;189(50):E1543-E1550. New RCT shows no benefit from probiotics, xylitol chewing gum in alleviating sore throats. Canadian Medical Association Journal. News release, December 18, 2017.

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Monthly injection aids recovery

Recently approved by the FDA, Sublocade (buprenorphine extended-release) injection is administered subcutaneously in the abdomen once a month as a treatment aid for adults with moderate-to-severe opioid use disorder. Buprenorphine is a partial opioid agonist. The new product is indicated for patients who've initiated treatment with a transmucosal buprenorphine-containing product. After at least 7 days, patients may be transitioned to Sublocade. It should be used in combination with a treatment program that includes counseling and psychosocial support.

Sublocade is administered by subcutaneous abdominal injection only, never I.V. or I.M. The risk of serious injury or death from I.V. administration is the subject of a boxed warning in the product labeling.

Only healthcare providers should prepare and administer Sublocade using the syringe and safety needle provided with the drug. Advise patients that they may have a lump at the injection site for several weeks that will diminish with time. Instruct them to avoid rubbing or massaging the injection site, and to protect it from irritation or pressure from belts or waistbands.

Healthcare facilities and pharmacies that order or dispense Sublocade must be certified through a restricted program and comply with its requirements.

Sources: FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. Food and Drug Administration. News release. November 30, 2017. Sublocade (buprenorphine extended-release) injection, for subcutaneous use CIII. Prescribing information.

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Thrombus removal doesn't lower risk

Despite treatment with anticoagulant medication, many patients with proximal deep-vein thrombosis (DVT) develop postthrombotic syndrome. By rapidly removing a thrombus, pharmacomechanical catheter-directed thrombolysis (pharmacomechanical thrombolysis) is hypothesized to reduce the risk of postthrombotic syndrome, but does this strategy work? To test the hypothesis, researchers randomly assigned 692 patients with acute proximal DVT to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis. The primary outcome was development of postthrombotic syndrome between 6 and 24 months of follow-up. In the follow-up period, researchers found no significant differences in the percentage of patients in each group with postthrombotic syndrome. They concluded that “the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding.”

Vedantham S, Goldhaber SZ, Julian JA, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. 2017; 377:2240-2252.

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