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Dapagliflozin Significantly Improves Blood Pressure

New study shows benefit for patients receiving calcium channel blocker or beta-blocker.

Dapagliflozin is a sodium-glucose transport proteins inhibitor and indicates for the treatment of type 2 diabetes. By blocking the transport proteins, which absorb glucose in the kidney, dapagliflozin can help the body eliminate glucose through the urine. It was approved by the FDA in January 2014. Many studies showed the effectiveness of the combination of dapagliflozin with other older diabetic medications in the treatment and management of diabetes. Other than its antihyperglycemic, it also shows its effect on cardiovascular disease. Not many studies researched how to use dapagliflozin on the treatment of both diabetes and hypertension. A new study published in The Lancet in November 2015 stated dapagliflozin can lower blood pressure and HbA1c in the patient with poorly controlled type 2 diabetes and hypertension.

This is a double-blind, placebo-controlled, phase 3 study that included 449 patients who were from 311 centers in 16 countries between October 2010 and October 2012. Participants with uncontrolled type 2 diabetes and hypertension had HbA1c range from 7.0% to 10.5% and a mean 24-hour blood pressure of greater than 130/80 mmHg. The antihypertensive medications they received included beta-blockers, calcium-channel blockers, thiazide diuretic, and renin-angiotensin system blockers. They were randomly assigned 1:1 to two groups. The intervention group received dapagliflozin 10 mg once a day with additional antihypertensive drugs and insulin use. This study focused on the changes in seated systolic blood pressure and HbA1c.

The results showed at 24 weeks patients who received dapagliflozin had lower seated systolic blood pressure (-11.9mmHg [95%Cl -13.97 to -9.82]), compared with the placebo group (-7.62mm Hg [95%Cl -9.72 to -5.51]). Regarding diabetes control, the intervention group had significant reduction in HbA1c concentration (-0.63% [95% Cl -0.76 to -0.50]). In the intervention group, the reduction of blood pressure in patients who receive beta blockers or calcium-channel blockers was greater than the result in patients who receive a thiazide diuretic. In this study, similar adverse events were observed in both groups.

This study led to the conclusion that patients with type 2 diabetes and hypertension can use dapagliflozin to control their glycemic level and blood pressure. If patients already receive a beta blocker or calcium blocker, taking dapagliflozin may further lower their blood pressure. Healthcare providers should reduce the dose of antihypertensive medication in accordance with the target blood pressure of the patient.

Type 2 diabetes is one of the most challenging health problems that can cause other complications, such as heart problems and renal disease. An increased mortality rate is associated with this disease. In type 2 diabetes, macrovascular disease was known as the main cause of mortality, followed by renal disease and cerebrovascular disease. Other than this study, another study published in Diabetes Care in April 2015 also reported the efficacy and safety of dapagliflozin in type 2 diabetic patients with pre-existing cardiovascular disease and a history of hypertension. The study stated dapagliflozin could not only help patients control their blood glucose level, but also reduce cardiovascular risks. When dapagliflozin was added to metformin for 102 weeks, it enabled sustained reductions in HbA1c, FPG, and weight without increased risk of hypoglycemia in patients with type 2 diabetes who were inadequately controlled on metformin alone.  So now we have a treatment that can treat hyperglycemia and hypertension and even possibly help the patient to possibly lose some weight, which will help to control those two major problems in diabetes. But, with any new drug, we also need to be aware and watch for UTI’s.

Type 2 diabetes and its related complications reduced patients’ life expectancy. It is important to let patients maintain good glycemic levels and target blood pressure. Dapagliflozin may be considered one option to treat both diseases. Healthcare professionals should help those patients optimize their treatments for the atherogenic risk factors, which can cause heart disease. Since this was a phase 3 study, more studies are required to prove these findings.

Practice Pearls:

  • A double-blind, placebo-controlled, phase 3 study of dapagliflozin accessed the reduction of HbA1c and blood pressure in patients with uncontrolled type 2 diabetes and hypertension
  • The results showed dapagliflozin achieved a greater reduction of HbA1c and blood pressure in patients.
  • Since SGLT-2 inhibitors are a new class of diabetic medications, more research is needed to further prove these findings.

Weber MA et al. “Blood pressure and glycemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomized, double-blind, placebo-controlled, phase 3 study”. The Lancet. 2015 Nov 24

Cefalu WT et al. “Dapagliflozin’s Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension.” Diabetes Care. 2015 Apr 7.