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Combination Therapy in Hypertension Management

Treating hypertensive patients may leave a physician two ways of approaching the disease: monotherapy or combination therapy. Both are widely practiced by physicians across the globe and yet the question still remains: which is more appropriate to use in most conditions?

The 2007 Guidelines for the Management of Hypertension made by the efforts of the European Society of Hypertension and European Society of Cardiology recommended combination therapy to be given as a “first choice therapeutic approach” for patients who have severe hypertension or with very high cardiovascular risk.

According to the guidelines, the reason behind this recommendation is that with combination therapy, the dosage of both or one of the drugs administered may be lowered, hence may also lower the risk of side effects. Another reason raised is that with combination therapy, the frustration of searching for the right therapy for a patient may be reduced. Also, the availability of different agents in a single tablet could ensure better compliance for patients.

However, one other question remains: among the available combination therapies, which is the best combination for patients, most especially those at high risk?

High-risk patients are those with either a systolic blood pressure of over 180 mmHg and diastolic blood pressure of over 110 mmHg, or those with many risk factors like diabetes, cardiovascular disease, renal disease,among others. Metabolic syndrome may also be a risk factor that many physicians may take into consideration. That is why the process of choosing the right combination for the patient is highly critical.

The most popular among the agents used in combination therapies are the thiazide diuretics. However, these diuretics according to the recently published guidelines, may be risky for patients with metabolic syndrome. Moreover, the guideline also recommends that only angiotensin-converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), and calcium antagonists (CA) are safe to be administered to metabolic syndrome patients.

In the STAR (Study of Trandolapril/ Verapamil-SR and Insulin Resistance) trial, the combination of verapamil-trandolapril was found to be generally effective in reducing risk for new-onset diabetes compared to losartan (ARB)—hydrochlorothiazide (HCTZ) combination.

The STAR trial is a multicenter, prospective, randomized, open-label study with blinded outcome evaluation (PROBE). It involved 240 patients who were randomized and given either a combination of verapamil-trandolapril or losartan—HCTZ combination within a six-month period. The study aimed to test the efficacy of the combinations to find out which may be ideal to lower risk of new onset diabetes.

Another clinical trial, the Bergamo Nephrologic Diabetic Complications Trial (BENEDICT) is a prospective, randomized, double-blind, parallel-group study primarily aimed at evaluating the possibility of preventing the progression of microalbuminuria among patients with type 2 diabetes, hypertension and normal urinary albumin excretion.

Microalbuminuria, when found in the urine could spot possible organ damage due to cardiovascular diseases and diabetes, among others. In the BENEDICT study, 1,240 subjects were given trandolapril plus verapamil, trandolapril and verapamil as monotherapy, or placebo to evaluate possible reduction in the progression of microalbuminuria.

Results revealed that trandolapril plus verapamil significantly reduced the progression or incidence of microalbuminuria,while trandolapril as monotherapy also relevantly decreased the progression of microalbuminuria. The BENEDICT trial also found that patients who received the combination of verapamil-trandolapril were less likely to use other anti-hypertensive drugs.

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