This is a prospective, randomized, crossover study, examining antihypertensive medication requirements in 26 hypertensive insulin dependent diabetic patients. These patients were randomized intotreatment and control groups. All patients were stabilized prior to the study on four shots of insulin daily and antihypertensive medications (ACE inhibitors, calcium channel blockers, loop diuretics, and alpha two agonists).

Following three months in either the treatment or control group, the patients were crossed over into the other group. Total antihypertensive medication requirements were then tabulated.

Antihypertensive dosage requirements decreased significantly (46%, p<0.0001) and linearly over time during the treatment phase, while remaining stable in the control group. Following the crossover, the previously treated patients (now controls) returned to their baseline antihypertensive needs within the subsequent three months.

Accordingly this study demonstrates that APS has an ameliorative effect on hypertension in the diabetic patient. While the pathophysiology of hypertension is not well known, it is generally understood that hypertension is a comorbidity factor with other diabetic complications including kidney disease. Thus it might be said that the effects of APS on kidney disease may well be associated with hypertension.

It may well be that hypertension is a subset of diabetes which would provide insight into why the mechanisms of action for hypertension have never been satisfactorily described.

Effect of chronic intravenous insulin therapy on antihypertensive mediation requirements in IDDM subjects with hypertension and nephropathy. Diabetes Care (1995): 1260-1265.