About INCLUSIVE study

BACKGROUND The fixed-dose combination pills are recommended from the international guide lines, both because they are very standardized and for the best compliance of the patients, that do not like to assume pills: a greater therapeutic success means less complications and therefore, in last analysis, less expenses for Sanitary Services. AIM OF THE STUDY The ARB association with HCTZ is considered one of more rational and effective one, but some doubt still remains on the dosages of the single component. The aim of INCLUSIVE, a prospective, multicentric, open-label, single-arm study, was to determine the efficacy and safety of irbesartan/HCTZ 150/12.5 mg and 300/25 mg fixed combinations in a diverse population of adults with systolic blood pressure (SBP) uncontrolled on antihypertensive monotherapy. PATIENTS AND METHOD The study started with 1,005 patients (mean age 57.2 ± 11.2 years, 52% women). In line with the aim of the study to recruit patients from subgroups with hard-to-control blood pressure, they included patients with metabolic syndrome, diabetes, African, Hispanic Latinoamericans. After a wash-out period of 4-5 weeks, patients started daily monotherapy with HCTZ 12.5 mg. After 2 weeks, approximately 27% of patients had responded to HCTZ alone and were eliminated from further participation in the study. The remaining 736 patients (intent-to-treat population) were given the combination pill of irbesartan/HCTZ starting with a dose of 150/12.5 mg for 8 weeks. If during this period they did not achieve goal blood pressure (< 140/90 mmHg, or < 130/80 mmHg for patients with diabetes mellitus), the dose of irbesartan/HCTZ was increased to 300/25 mg over the following 8 weeks. CONCLUSIONS At the end of 18 weeks of treatment, the mean change in SBP from baseline, the primary endpoint of the study (< 140 mmHg and 130 mmHg for diabetic type 2), was –21.5 mmHg (n: 77%) (p < .001). The mean SBP change from baseline was also significant at week 10 (–15.1 mmHg, p < .001). Mean change in diastolic blood pressure (DBP) from baseline was –7.2 mmHg at week 10 and –10.4 mmHg at week 18 (both p < .001). Similar changes of about –20 mmHg in SBP and –10 mmHg in DBP were seen in all of the predefined subgroups, with exception of the patients with diabetes mellitus. These latter patients had lower SBP and DBP goals. It is observed however that the study is open-label, single arm and that the administration of 25 mg of HCTZ has been of too much short duration to be accepted without delays, considered that the therapy in hypertensive subject goes on all his life.