Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study †
Highlights• Compared with glimepiride, Sita/Met as an initial treatment showed a great improvements in glycemic control and FPG levels after 30 weeks. And Sita/Met led to slight reduction of body weight and less hypoglycemia than glimepiride.• The present study is the first to evaluate the safety and efficacy of Sita/Met FDC compared with glimepiride in patients with T2D as initial management in Korea. Abstract Background: Early initiation of combination therapy using antihyperglycemic agents is recommended for treating type 2 diabetes (T2D). The present multicenter double-blind randomized parallel-group study examined the efficacy and safety of a sitagliptin and metformin fixed-dose combination (Sita/Met) compared with glimepiride in T2D patients as initial treatment. Methods: Type 2 diabetes patients (aged ≥18 years) were randomized to Sita/Met or glimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseline (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose (FPG). Safety assessments comprised weight gain from baseline and the incidence of adverse events (AEs).Results: In total, 292 patients were randomized to Sita/Met (n = 147) or glimepiride (n = 145). After 30 weeks, Sita/Met demonstrated superiority over glimepiride in reducing HbA1c (À1.49 % vs À0.71 %, respectively; between-group difference À 0.78 %; P < 0.001). A significantly higher proportion of patients achieved the target goal with Sita/Met (81.2 %) than with glimepiride (40.1 %; P < 0.001). Greater reduction in FPG occurred with Sita/Met than with glimepiride (least-squares mean difference À 23.5 mg/dL; P < 0.001). Both drugs were generally well tolerated. Hypoglycemia events and weight gain were significantly lower in patients with Sita/Met than with glimepiride (5.5 % vs 20.1 % and À0.83 vs +0.90 kg, respectively; both P < 0.001). No serious drug-related AEs or deaths were reported. Conclusions: Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks.Keywords: glimepiride, hypoglycemia, metformin, sitagliptin phosphate. Significant findings of the study: Compared with glimepiride, Sita/Met showed a greater reduction in HbA1c and FPG levels after 30 weeks as an initial treatment. Glimepiride treatment resulted in patients gaining weight, whereas treatment with Sita/Met led to slight weight loss and less hypoglycemia. What this study adds: The present study is the first to evaluate safety and efficacy of Sita/Met compared with glimepiride monotherapy in the initial treatment of T2D in Korea.
IntroductionThe clinical and economic burden associated with diabetes and its management remains an ...
Amyloid deposition in the thyroid is found in about 30-80% of the patients with primary or secondary amyloidosis. In a few patients with amyloidosis, the thyroid is enlarged and so called amyloid goiter occurs. The thyroid function usually remains normal, but occasionally hypothyroidism or thyrotoxicosis occurs in patients with thyroid amyloidosis. We have experienced one case of thyroid amyloidosis due to bronchiectasis and the patient developed painful goiter and transient thyrotoxicosis resembling subacute thyroiditis. Biopsies from the gastric antrum, duodenum, colon, kidney and thyroid were positive for deposition of amyloid. When patients have signs and symptoms of subacute thyroiditis, but they develop an unusual course, then the diagnosis of thyroid amyloidosis should be considered.
Hypothyroidism can cause a variety of signs and symptoms of the neuromuscular system. However, ptosis in a patient with hypothyroidism is very rare. We report here on a case of central hypothyroidism that was due to Sheehan's syndrome and it manifested as bilateral ptosis in a 51-yr-old woman. She complained of exertional dyspnea and weakness. About 25-yr ago, she had a history of severe postpartum vaginal bleeding. The laboratory studies demonstrated hypopituitarism with secondary hypothyroidism. The ptosis was improved by replacement of thyroid hormone. Hypothyroidism should be considered in the differential diagnosis of patients who manifest with ptosis and that prompt replacement of hormone can lead to a complete recovery.
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