Would it be appropriate to add lisinopril to a patient with hypertension and diabetes mellitus type II taking Metformin (Met Forman) 500 mg twice daily (BID) and amlodipine 5 mg once daily, with persistent hypertension?

From the Guidelines

Adding lisinopril to the patient's current regimen would be a suitable decision, given the persistent hypertension and the presence of diabetes mellitus type II, as it aligns with the recommendations for blood pressure control in diabetic patients 1. The patient is already taking metformin 500 mg twice daily for type 2 diabetes and amlodipine 5 mg daily for hypertension. Lisinopril, an ACE inhibitor, would be a good addition at a starting dose of 10 mg once daily, which can be titrated up to 20-40 mg daily if needed based on blood pressure response. ACE inhibitors are particularly beneficial in patients with diabetes as they provide renoprotective effects beyond blood pressure control, as suggested by studies such as the HOPE study, which showed substantial absolute reduction in overall mortality despite very small changes in blood pressure 1. The combination of an ACE inhibitor with a calcium channel blocker (amlodipine) provides complementary mechanisms of action for blood pressure reduction. When starting lisinopril, the patient should be monitored for potential side effects including cough, hyperkalemia, and changes in renal function. Blood tests for potassium and creatinine should be checked within 1-2 weeks of initiation, as recommended for patients with diabetes and hypertension who are started on ACE inhibitors or ARBs 1. Key considerations for the management of this patient include:

• Achieving a target blood pressure of no more than 130/80 mm Hg, as recommended for patients with diabetes 1.
• Monitoring for potential side effects of lisinopril and adjusting the dose as necessary.
• Counseling the patient on the importance of lifestyle modifications, such as weight loss, exercise, and smoking cessation, in addition to medication therapy. Given the most recent and highest quality evidence, the addition of lisinopril to the patient's current regimen is supported by guidelines that recommend the use of ACE inhibitors or ARBs in patients with diabetes and hypertension 1.

From the FDA Drug Label

In controlled clinical studies of patients with mild to moderate hypertension, patients were treated with lisinopril 20 mg to 80 mg daily, hydrochlorothiazide 12. 5 mg to 50 mg daily or atenolol 50 mg to 200 mg daily; and in other studies of patients with moderate to severe hypertension, patients were treated with lisinopril 20 mg to 80 mg daily or metoprolol 100 mg to 200 mg daily.

The addition of lisinopril to a patient with hypertension and diabetes mellitus type II taking Metformin and amlodipine may be appropriate, as there is no direct contraindication in the provided drug label. However, it is crucial to consider the patient's specific clinical profile, including renal function, before initiating lisinopril therapy. The drug label does suggest that lisinopril can be effective in reducing blood pressure in patients with mild to moderate hypertension, but it does not provide direct information on its use in combination with Metformin and amlodipine.

• Key considerations:
  • Monitor renal function
  • Adjust dosage as needed
  • Consider potential interactions with other medications 2

From the Research

Patient Profile

• The patient has hypertension and diabetes mellitus type II
• The patient is currently taking Metformin (Met Forman) 500 mg twice daily (BID) and amlodipine 5 mg once daily
• The patient has persistent hypertension

Treatment Considerations

• Adding lisinopril to the patient's treatment regimen may be considered to help lower blood pressure
• Studies have shown that combining an angiotensin-converting enzyme inhibitor (such as lisinopril) with a calcium channel blocker (such as amlodipine) can be effective in reducing blood pressure and improving cardiovascular outcomes in patients with hypertension and diabetes 3, 4
• The combination of lisinopril and amlodipine has been shown to be safe and effective in patients with hypertension and diabetes, with improvements in blood pressure control and reductions in cardiovascular risk factors 3, 4

Key Findings

• A study published in 2015 found that combined antihypertensive therapy with lisinopril and amlodipine in hypertensive patients with diabetes mellitus type 2 resulted in significant improvements in blood pressure control, cardiovascular risk factors, and renal function 3
• Another study published in 2022 found that the combination of lisinopril and amlodipine was effective in reducing blood pressure and improving cardiovascular outcomes in patients with hypertension and arteriosclerosis obliterans 4
• The study published in 2008 found that adding amlodipine to the treatment regimen of patients with hypertension and diabetes who were already receiving either quinapril or losartan as monotherapy resulted in significant improvements in blood pressure control 5

Potential Benefits

• Adding lisinopril to the patient's treatment regimen may help to further reduce blood pressure and improve cardiovascular outcomes
• The combination of lisinopril and amlodipine may provide additional benefits in terms of reducing cardiovascular risk factors and improving renal function 3, 4