Hyperuricaemia is associated with an increased risk of gout, kidney stones and cardiovascular disease. The present post hoc analysis of pooled data from four placebo‐controlled phase III studies assessed the effect of canagliflozin, a sodium‐glucose co‐transporter 2 inhibitor, on serum uric acid levels in patients with type 2 diabetes mellitus (T2DM) and in a subset of patients with hyperuricaemia [defined as baseline serum uric acid ≥475 µmol/l (∼8 mg/dl)]. At week 26, canagliflozin 100 and 300 mg were associated with a ∼13% reduction in serum uric acid compared with placebo. In the subset of patients with hyperuricaemia, placebo‐subtracted percent reductions in serum uric acid were similar to those in the overall cohort. More patients in the hyperuricaemic group achieved a serum uric acid level of <360 µmol/l (∼6 mg/dl) with both canagliflozin 100 mg (23.5%) and 300 mg (32.4%) compared with placebo (3.1%). Incidences of gout and kidney stones were low and similar across groups. In conclusion, canagliflozin treatment decreased serum uric acid in patients with T2DM, including those with baseline hyperuricaemia.
6This randomized, double-blind, placebo-controlled study evaluated the early effects of canagliflozin on blood pressure (BP) in patients with type 2 diabetes mellitus (T2DM) and hypertension. Patients were randomized to canagliflozin 300 mg, canagliflozin 100 mg, or placebo for 6 weeks and underwent 24-hour ambulatory BP monitoring before randomization, on day 1 of treatment, and after 6 weeks. The primary endpoint was change in mean 24-hour systolic BP (SBP) from baseline to week 6. Overall, 169 patients were included (mean age, 58.6 years; glycated hemoglobin, 8.1%; seated BP 138.5/82.7 mm Hg). At week 6, canagliflozin 300 mg provided greater reductions in mean 24-hour SBP than placebo (least squares mean À6.2 vs À1.2 mm Hg, respectively; P=.006). Numerical reductions in SBP were observed with canagliflozin 100 mg. Canagliflozin was generally well tolerated, with side effects similar to those reported in previous studies. These results suggest that canagliflozin rapidly reduces BP in patients with T2DM and hypertension. J Clin Hypertens (Greenwich). 2016;18:43-52. ª 2015 Wiley Periodicals, Inc.Hypertension is a common comorbidity of diabetes mellitus, affecting up to 60% of patients.1,2 Sodiumglucose cotransporter 2 (SGLT2) inhibitors, which have been shown to improve glycemic control in patients with type 2 diabetes mellitus (T2DM), may also reduce blood pressure (BP).3,4 In a meta-analysis of 27 randomized trials (most studies with a followup of 12-52 weeks), treatment with SGLT2 inhibitors was associated with significant reductions in systolic BP (SBP) and diastolic BP (DBP) from baseline. 5 Similarly, a pooled analysis of four randomized trials (duration of follow-up 26 weeks) showed significant placebo-corrected reductions in SBP when canagliflozin was given at doses of 300 mg and 100 mg in patients with T2DM and elevated SBP at baseline. 6 Most studies of SGLT2 inhibitors have evaluated changes in BP after 12, 26, or 52 weeks of therapy. 5-11The immediate effects (ie, less than 12 weeks) of SGLT2 inhibitors on BP have not been well characterized. The current 6-week study 12 was designed to evaluate the early effects of treatment with canagliflozin on BP, including a 24-hour BP assessment after the first dose, using ambulatory BP monitoring (ABPM). METHODS Study Design and Patient PopulationThis randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study consisted of three phases: (1) a pretreatment phase comprising a screening visit and a 2-week single-blind, placebo runin; (2) a double-blind, 6-week treatment phase; and (3) a follow-up phase of 30 days after the last dose of the study drug. Protocol-specified inclusion and exclusion criteria were assessed at the screening visit (day À21).Patients aged from 18 years to less than 75 years were eligible for inclusion in the study if they had: (1) hypertension (defined as a seated office SBP ≥130 mm Hg and <160 mm Hg and seated office DBP ≥70 mm Hg) and were taking stable doses of one to three antihypertensive agents (includin...
OBJECTIVENo guidelines for A1C measurement exist for women with gestational diabetes mellitus (GDM). The aim of this study was to document the rate of A1C decline in women with GDM.RESEARCH DESIGN AND METHODSWomen with GDM in the Santa Barbara County Endocrine Clinic are managed with a carbohydrate-restricted diet and self-monitored blood glucose before and 1-h postprandial. Insulin is started if the preprandial glucose concentration is ≥90 mg/dl and/or a 1-h postprandial glucose concentration is ≥120 mg/dl. Capillary A1C was tested weekly using the DCA2000+ analyzer.RESULTSTwenty-four women with GDM (aged 29.0 ± 7.3 years) with initial A1C ≥7.0% were recruited. Baseline A1C was 8.8 ± 1.8%. Mean A1C decline was 0.47% per week (range 0.10–1.15%); the maximum was 4.3% in 4 weeks.CONCLUSIONSThis study documents rapid decline in A1C during pregnancy and the utility of weekly A1C to guide therapy.
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