Impact of sodium-glucose cotransporter 2 inhibitors on blood pressure

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Term Occurence Count Dictionary
diabetes mellitus 5 endocrinologydiseases
hyperglycemia 3 endocrinologydiseases
hypoglycemia 1 endocrinologydiseases
type 2 diabetes mellitus 4 endocrinologydiseases
Hyponatremia 1 endocrinologydiseases
dapagliflozin 28 endocrinologydiseasesdrugs
diabetic ketoacidosis 1 endocrinologydiseases
metformin 1 endocrinologydiseasesdrugs
pioglitazone 1 endocrinologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
dapagliflozin 766 review summarizes data on the effect of SGLT2 inhibitors marketed in the US (namely canagliflozin, dapagliflozin , or empagliflozin) on BP in patients with T2DM. Boolean searches were conducted that included terms
dapagliflozin 958 conducted that included terms related to BP or hypertension with terms for SGLT2 inhibitors, canagliflozin, dapagliflozin , or empagliflozin using PubMed, Google, and Google Scholar. Data from numerous randomized controlled
dapagliflozin 5302 effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors marketed in the US (namely canagliflozin, dapagliflozin , or empagliflozin) on BP in patients with T2DM. SGLT2 inhibitors that are not marketed in the US and/or
dapagliflozin 5646 conducted that included terms related to BP or hypertension with terms for SGLT2 inhibitors, canagliflozin, dapagliflozin , or empagliflozin using PubMed, Google, and Google Scholar.SGLT2 inhibitors in the treatment of patients
dapagliflozin 7137 three SGLT2 inhibitors are approved in the US for clinical use in the treatment of T2DM: canagliflozin, dapagliflozin , and empagliflozin.[29]–[31] These agents also have marketing approval in the EU, and in other parts
dapagliflozin 11175 comparators in a meta-analysis of 14 RCTs.[51] In a 12-week study of T2DM patients (N=75) receiving dapagliflozin (10 mg/day) versus placebo or hydrochlorothiazide (HTZ; 25 mg/day), hematocrit increased by 2.2 (95%
dapagliflozin 11309 placebo or hydrochlorothiazide (HTZ; 25 mg/day), hematocrit increased by 2.2 (95% CI 1.3–3) in the dapagliflozin group versus changes of –0.2 (95% CI –1 to 0.6) and –0.9 (95% CI –2.3 to 0.6) for the placebo
dapagliflozin 11577 observed loss of plasma volume (median –7.3%; interquartile range [IQR] –12.4 to –4.8) in the dapagliflozin group versus placebo and HTZ groups (median 5.2%, IQR –2.5 to 8.7, and median 2.8%, IQR –10.6 to
dapagliflozin 15282 diastolic BP reported during key Phase III RCTs investigating the efficacy and safety of canagliflozin, dapagliflozin , and empagliflozin in patients with T2DM is presented in Table 1,[67]–[81] and includes analyses of
dapagliflozin 17065 mg versus placebo (5.8% and 6.35% vs 0.2%, respectively).[82] A larger analysis of data pooled from dapagliflozin RCTs (13 Phase IIB/III studies; N=4,655) stratified the patient population into those with and without
dapagliflozin 17399 mmHg).[83] Placebo-subtracted mean differences from baseline to the end of treatment in BP for the dapagliflozin group (10 mg/day) were as follows: systolic BP in hypertensive patients, –3.6 mmHg (95% CI –4.9
dapagliflozin 18119 systolic BP or >10 mmHg in diastolic BP from a supine to a standing position): 17.4% and 15.5% for dapagliflozin and placebo, respectively.[83] Orthostatic hypotension reported as AEs were uncommon (data not stated),
dapagliflozin 19081 efficacy and safety of SGLT2 inhibitors in patients with T2DM and hypertension have been published: the dapagliflozin BP study,[84] the EMPA-REG BP study,[85] and the canagliflozin BP study.[86] The main results from these
dapagliflozin 19755 in the primary BP efficacy outcome,[85],[86] whereas it was used as a secondary BP end point in the dapagliflozin BP trial.[84] ABPM is becoming increasingly recommended for use in the diagnosis and assessment of hypertension.[87]
dapagliflozin 20110 also avoids the so-called white-coat effect that may be associated with office BP measurement.[88]The dapagliflozin BP study (N=449) reported a significant reduction in mean seated systolic BP from baseline to week 12
dapagliflozin 20233 (N=449) reported a significant reduction in mean seated systolic BP from baseline to week 12 in the dapagliflozin 10 mg group compared with the placebo group (placebo-subtracted mean difference for dapagliflozin –4.28
dapagliflozin 20331 the dapagliflozin 10 mg group compared with the placebo group (placebo-subtracted mean difference for dapagliflozin –4.28 mmHg, 95% CI –6.54 to –2.02; P=0.0002).[84] A similar trend was observed for mean seated
dapagliflozin 20568 not statistically significant.[84] Mean reductions from baseline values were more pronounced in the dapagliflozin 10 mg group than in the placebo group (placebo-subtracted mean difference for dapagliflozin –4.45
dapagliflozin 20660 in the dapagliflozin 10 mg group than in the placebo group (placebo-subtracted mean difference for dapagliflozin –4.45 mmHg, 95% CI –7.14 to –1.76; P=0.0012), as revealed by 24-hour ABPM at week 12.[84] With
dapagliflozin 21069 in either treatment group, and mean change in hematocrit at week 12 was 1.7% (95% CI 1.3%–2%) for dapagliflozin 10 mg and 0.3% (95% CI 0%–0.7%) for placebo (assessed as a safety end point, thus P-value not reported).[84]
dapagliflozin 21314 week 12 did not differ meaningfully from baseline values in either treatment group (–1.4 bpm for dapagliflozin 10 mg [baseline 77.1 bpm] vs –0.5 bpm for placebo [baseline 77 bpm]).[84] Orthostatic hypotension
dapagliflozin 21642 was not reported by any patients as an AE at week 12, but was measured in seven (3%) patients in the dapagliflozin 10 mg group and four (2%) patients in the placebo group.[84]EMPA-REG BP (N=825) reported that mean 24-hour
dapagliflozin 26566 assessed their BP-lowering ability, and included evaluations of canagliflozin (nine studies, N=5,607), dapagliflozin (12 studies, N=5,280), and empagliflozin (three studies, N=1,359).[51] Compared with the control, SGLT2
dapagliflozin 26974 from baseline.[51] A meta-analysis of 19 RCTs evaluating canagliflozin (nine studies, N=5,285) and dapagliflozin (eleven studies, N=4,788) reported that these SGLT2 inhibitors had no significant effect on the incidence
dapagliflozin 28856 trial (EMPA-REG OUTCOME) recently reported its results.[98] CV outcomes trials for canagliflozin and dapagliflozin are estimated to complete in June 2017 and April 2019, respectively.[93],[95] During EMPA-REG OUTCOME,
dapagliflozin 30767 given the association between elevated BP and heart failure.[100] The results of the canagliflozin and dapagliflozin CV outcomes trials will determine if there is a class effect for SGLT2 inhibitors regarding CV outcomes,
dapagliflozin 31700 patients with T2DM, including those with hypertension.Table 1Summary of efficacy of canagliflozin, dapagliflozin , and empagliflozin in reducing systolic and diastolic BP in patients with T2DMClinical trial categoriesPlacebo-subtracted
dapagliflozin 40237 monitoring; AE, adverse event; BP, blood pressure; CANA, canagliflozin; CI, confidence interval; DAPA, dapagliflozin ; DB, double-blind; EMPA, empagliflozin; HbA1c, glycated hemoglobin; HTN, hypertension; NA, not applicable;
metformin 33884 BP ≥140 mmHg or diastolic BP ≥90 mmHg.[82]Abbreviations: BP, blood pressure; INS, insulin; MET, metformin ; PIO, pioglitazone; RCT, randomized controlled trial; SU, sulfonylurea; T2DM, type 2 diabetes mellitus.Table
pioglitazone 33900 or diastolic BP ≥90 mmHg.[82]Abbreviations: BP, blood pressure; INS, insulin; MET, metformin; PIO, pioglitazone ; RCT, randomized controlled trial; SU, sulfonylurea; T2DM, type 2 diabetes mellitus.Table 2Summary of
Select Disease Character Offset Disease Term Instance
Hyponatremia 20942 treatment groups, and AEs related to renal function or volume depletion occurred in ≤1% of patients.[84] Hyponatremia did not occur in either treatment group, and mean change in hematocrit at week 12 was 1.7% (95% CI 1.3%–2%)
diabetes mellitus 313 /2016Publication date (epub): 10/2016AbstractSGLT2 inhibitors are glucose-lowering agents used to treat type 2 diabetes mellitus (T2DM). These agents target the kidney to promote urinary glucose excretion, resulting in improved blood
diabetes mellitus 2170 advantage for the majority of patients with T2DM, in addition to improving blood glucose control.Type 2 diabetes mellitus and hypertensionHypertension is a common comorbidity in patients with type 2 diabetes mellitus (T2DM),
diabetes mellitus 2265 control.Type 2 diabetes mellitus and hypertensionHypertension is a common comorbidity in patients with type 2 diabetes mellitus (T2DM), with the prevalence of T2DM in US patients ranging from 67% to 87% (where hypertension was defined
diabetes mellitus 33979 MET, metformin; PIO, pioglitazone; RCT, randomized controlled trial; SU, sulfonylurea; T2DM, type 2 diabetes mellitus .Table 2Summary of main results from dedicated Phase III trials of SGLT2 inhibitors in patients with
diabetes mellitus 40484 open-label; PBO, placebo; SD, standard deviation; SGLT2, sodium–glucose cotransporter 2; T2DM, type 2 diabetes mellitus
diabetic ketoacidosis 9303 of diuretic therapy, and elderly patients).[29]–[31] There have also been postmarketing reports of diabetic ketoacidosis (DKA),[44],[45] and product labels were revised to include this safety issue.[29]–[31] Blood glucose
hyperglycemia 6735 is enhanced in individuals with T2DM, resulting in increased glucose reabsorption and maintenance of hyperglycemia .[23],[27] Pharmacologic inhibition of SGLT2 in the kidney reduces glucose reabsorption and promotes
hyperglycemia 6913 reduces glucose reabsorption and promotes urinary glucose excretion, thereby leading to the correction of hyperglycemia .[23] Inhibition of SGLT2 reduces the capacity for renal glucose reabsorption by 30%–50%.[28] Currently,
hyperglycemia 28449 in T2DMThe ability of SGLT2 inhibitors to reduce BP and lower body weight, in addition to decreasing hyperglycemia , is indicative of their potential to reduce CV risk in patients with T2DM; however, the impact of their
hypoglycemia 8842 patients.[29]–[31] Clinical trial data show that SGLT2 inhibitors are associated with a low risk of hypoglycemia , unless coadministered with insulin or an insulin secretagogue.[32]–[34] Osmotic diuresis with subsequent
type 2 diabetes mellitus 306 /2016Publication date (epub): 10/2016AbstractSGLT2 inhibitors are glucose-lowering agents used to treat type 2 diabetes mellitus (T2DM). These agents target the kidney to promote urinary glucose excretion, resulting in improved blood
type 2 diabetes mellitus 2258 control.Type 2 diabetes mellitus and hypertensionHypertension is a common comorbidity in patients with type 2 diabetes mellitus (T2DM), with the prevalence of T2DM in US patients ranging from 67% to 87% (where hypertension was defined
type 2 diabetes mellitus 33972 insulin; MET, metformin; PIO, pioglitazone; RCT, randomized controlled trial; SU, sulfonylurea; T2DM, type 2 diabetes mellitus .Table 2Summary of main results from dedicated Phase III trials of SGLT2 inhibitors in patients with
type 2 diabetes mellitus 40477 OL, open-label; PBO, placebo; SD, standard deviation; SGLT2, sodium–glucose cotransporter 2; T2DM, type 2 diabetes mellitus

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