Other safety alerts
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| The United States: New studies show diabetes drug not proven to improve blood sugar control in pediatric patients (Januvia, Janumet and Janumet XR) |
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The US Food and Drug Administration (FDA) announces that it has approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in pediatric patients age 10 to 17 with type 2 diabetes . The drugs are approved to improve blood sugar control in adults age 18 and older with type 2 diabetes.
The labeling changes are based on results from three double-blind, placebo-controlled studies. These studies evaluated sitagliptin’s effectiveness and safety over 54 weeks among 410 patients aged 10 to 17 with inadequately controlled type 2 diabetes. At the beginning of the clinical trials, patients in study 1 were not receiving oral antihyperglycemic therapies (drugs that lower blood sugar); patients in studies 2 and 3 were taking maximally tolerated metformin therapy, a type of oral antihyperglycemic therapy, and 12% to 15% of patients were taking insulin.
The primary endpoint was the decrease in hemoglobin A1c (HbA1c), or blood sugar levels, after 20 weeks of therapy. The primary analyses included data from study 1 and pooled data from studies 2 and 3, regardless of whether patients stopped treatment or received a glycemic rescue therapy (a medicine given to treat blood sugar that remained too high during the trial).
Results showed that patients receiving sitagliptin did not have a significantly different HbA1c result than those taking placebo. In study 1, 95 patients treated with sitagliptin had, on average, a 0.06% increase in HbA1c levels compared with 95 patients taking the placebo, who had an average 0.23% increase. In studies 2 and 3, 107 patients treated with sitagliptin had an average 0.23% decrease in HbA1c levels compared with an average 0.09% increase in HbA1c levels among 113 patients treated with placebo.
Patients who needed glycemic rescue therapy received metformin (study 1 only) and/or insulin (all three trials). In the first 20 weeks, 5% of patients treated with sitagliptin received rescue glycemic therapy compared to 15% of patients treated with placebo. From weeks 20 to 54, the percentages of patients initiating rescue therapy were similar between treatment groups.
Common side effects in pediatric patients were generally similar to those reported in adults, including nasopharyngitis (cold) and upper respiratory tract infection. Pediatric patients had an increased risk of hypoglycemia (blood sugar levels below 54 mg/dL) episodes when they received sitagliptin together with insulin therapy compared to placebo.
Sitagliptin has not been studied in pediatric patients younger than age 10 with type 2 diabetes.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients
In Hong Kong, there are 10 registered Januvia (containing sitagliptin), Janumet (containing sitagliptin/metformin) and Janumet XR (containing sitagliptin/metformin extended-release) products, namley Januvia Tab 25mg (HK-56092), Januvia Tab 50mg (HK-56093), Januvia Tab 100mg (HK-56094), Janumet Tab 50/500mg (HK-56186), Janumet Tab 50/1000mg (HK-56187), Janumet Tablets 50mg/1000mg (HK-64857), Janumet Tablets 50mg/500mg (HK-64858), Janumet XR Tablets 50mg/500mg (HK-63246), Janumet XR Tablets 50mg/1000mg (HK-63249) and Janumet XR Tablets 100mg/1000mg (HK-63250). All products are registered by Merck Sharp & Dohme (Asia) Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to sitagliptin and sitagliptin/metformin.
The local package inserts of the above Januvia, Janumet and Janumet XR products contain information that safety and effectiveness in pediatric patients under 18 years have not been established. The DH will remain vigilant on safety update of the products issued by other overseas drug regulatory authorities.
Ends/Monday, Dec 7, 2020
Issued at HKT 15:00
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