ADD Study: Assessment of Efficacy and Safety Profile of Irbesartan/Amlodipine Fixed-Dose Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled With Irbesartan 150 mg Monotherapy: A Multicenter, Phase III, Prospec

BACKGROUND: Hypertension guidelines recommend the use of 2 agents with synergistic action when>1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker.

OBJECTIVE: The I-ADD study aimed to demonstrate whether the antihypertensive efficacy of fixed-dose combination irbesartan 300 mg/amlodipine 5 mg (I300/A5) was superior to that of irbesartan (I300) monotherapy in lowering home systolic blood pressure after 10 weeks' treatment.

METHODS: The I-ADD study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-end point study. The main inclusion criterion was essential uncontrolled hypertension (systolic blood pressure ≥145 mm Hg at office after at least 4 weeks of irbesartan 150 mg [I150] monotherapy administered once daily). Patients continued to receive I150 for 7 to 10 days and were randomized to either monotherapy with I150 for 5 weeks then I300 for the next 5 weeks, or to a fixed-dose combination therapy (I150/A5, then I300/A5). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator.

RESULTS: Following enrollment, 325 patients were randomized to treatment, and 320 (mean [SD]age, 56.7 [11.4] years; 41% male) were included in the intention-to-treat analysis: 155 patients treated with I150/A5 then I300/A5, and 165 patients treated with I150 then I300. At randomization, mean home systolic blood pressure was similar in both groups: 152.7 (11.8) mm Hg in the I150/A5 group and 150.4 (10.1) mm Hg in the I150 group. At week 10, the adjusted mean difference in home systolic blood pressure between groups was -8.8 (1.1) mm Hg (P<0.001). The percentage of controlled patients (mean home blood pressure<135 and 85 mm Hg) was nearly 2-fold higher in the I300/A5 group versus the I300 group (P<0.001). Treatment-emergent adverse events were experienced by 10.5% of I300/A5-treated patients and 6.6% of I300-treated patients during the second 5-week period. Three serious adverse events were reported; 2 with monotherapy (1 with I150 and 1 with I300) and 1 with fixed-dose combination I300/A5. All patients affected by serious adverse events made a full recovery.

CONCLUSIONS: These 10-week data from this patient population suggest a greater antihypertensive efficacy of the fixed-dose combination I300/A5 over I300 alone in lowering systolic blood pressure. Both treatments were well tolerated throughout the study. identifier: NCT00957554.


Journal of Health Science

p-ISSN: 2166-5966    e-ISSN: 2166-5990

2015;  5(3A): 1-1



Omar Bin Abdul Aziz Al-AlSheikh

Associate Professor, College of Medicine, King Saud University

Secretary General of Pan Arab League of Dermatologists

Correspondence to: Omar Bin Abdul Aziz Al-AlSheikh, Associate Professor, College of Medicine, King Saud University.



Metformin for the treatment of hidradenitis suppurativa: a little help along the way

Verdolini R, Clayton N, Smith A, Alwash N, Mannello B.


Department of Dermatology, Princess Alexandra Hospital NHS trust, Harlow, Essex, and Department of Dermatology, The Royal London Hospital, London, UK Mannello Statistics, Via Rodi, Ancona, Italy.



Serum microRNAs as biomarkers for recurrence in melanoma

Friedman EB, Shang S, Vega-Saenz de Miera E, Fog JU, Teilum MW, Ma MW, Berman RS, Shapiro RL, Pavlick AC, Hernando E, Baker A, Shao Y, Osman I; Journal of Translational Medicine 10 (1), 155 (Aug 2012)

Source: J Transl Med  





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