Idea for this study was conceived after observation form three cases. Amlodipine, a potent CCB Antihypertensive drug often causes pedal edema secondary to arteriolar dilatation leading to intracapillary hypertension and fluid extravasation. Edema usually do not resolve with diuretics and frequently needed to withdraw amlodipine. Selected subjects were patients having DM2 and hypertension, who developed pedal edema after they were prescribed amlodipine (2.5/5/10mg/d) for hypertension. Total 112 subject (60 study cases and 62 comparators) were enrolled. Patients were randomized one to one between study cases and comparators. Without changing dose of amlodipine cases were given Sodium-glucose co-transporter 2 (SGLT2) inhibitor (Canagliflozin) 100 mg once a day with individualized simultaneous reduction of other OHA’s to avoid hypoglycemia. In comparator group Amlodipine was withdrawn, replacing with other antihypertensive drug not affecting study results. Both groups were followed for 4 weeks with subjective grade of edema and weight recorded before and after study duration. 48 out of 60 study cases, whereas 24 out of 62 comparators showed complete remission of pedal edema. Fisher exact value calculated to be 0.0008 at P< 0.05. Average weight loss in 4 weeks of 60 cases was 3.8 Kg, whereas 1.6 Kg in control (Z-Score is -6.3668. The p-value is 0. The result is significant at p≤ 0.05). Due to development of clinical hypotension, 10 (16.6%) study cases needed dose reduction of amlodipine whereas, 16 (25%) comparators needed another antihypertensive drug for blood pressure control. No major side effects observed during study in both groups except one female who developed polyuria and urogenital infection in study group which resolved with oral antibiotics and antifungal.
A judicious co-prescription of Amlodipine and SGLT2 inhibitor can avoid fluid overload and pedal edema in diabetes mellitus with hypertension.
A. Gautam: None. P.K. Agrawal: None. N. Pursnani: None. A. Jain: None.