Simplified therapeutic intervention to control hypertension and hypercholesterolemia: a cluster randomized controlled trial (STITCH2).

BACKGROUND: Notwithstanding improving rates of hypertension control in North America, management of patients with both hypertension and dyslipidemia remains problematic. Based on evidence of improved control utilizing a simplified algorithm for management of hypertension (STITCH), we questioned whether a simplified comprehensive treatment algorithm featuring initial use of single-pill combinations (SPCs) would improve management of participants with both hypertension and dyslipidemia. METHOD: We randomized 35 primary care practices in Ontario to either Guidelines-care (following current Canadian guidelines) or STITCH2-care (following a treatment algorithm featuring SPCs). Practices each enrolled up to 50 participants with at least one risk factor above target at entry based on Canadian guidelines for BP and LDL-cholesterol control. The primary endpoint was achieving targets for both hypertension and dyslipidemia control after 6 months, assessed at the practice level. RESULTS: The primary endpoint was achieved in 31.3% of participants in STITCH2-care practices, compared with 28.1% in Guidelines-care practices, yielding a difference of 3.2% (P = 0.63). Notably, STITCH2-care practices had a significantly greater reduction in SBP while LDL-cholesterol reduction was only marginally greater in STITCH2 practices. CONCLUSION: The STITCH2 algorithm resulted in significantly greater use of any SPC compared with Guidelines-care and greater use of the SPC of calcium channel blocker/statin. Unwillingness of the prescribing physician to advance treatment beyond a monotherapy threshold was found to be an important determinant for failing to achieve blood pressure control. In contrast, the more important determinant for failing to achieve LDL control appeared to be the unwillingness of the prescribing physician to initiate therapy with a statin.

Barriers to blood pressure control: a STITCH substudy.

Despite improvements in blood pressure (BP) control, a substantial percentage of patients do not achieve target. The relative importance of determinants of poor BP control is unclear. Therefore, the authors conducted a post hoc exploratory analysis to assess determinants of BP control. Data were collected in 45 general practices, which enrolled patients with uncontrolled hypertension. Antihypertensive medication changes throughout the 6-month follow-up period were documented. Baseline and 6-month BPs were recorded. Of the 2030 patients analyzed, 320 had diabetes. Overall, 42% of patients did not achieve BP control. In multivariate analysis, failure to intensify therapy was identified as a significant independent predictor of lesser BP reduction. Of patients unable to reach target after 6 months, only 25% were prescribed ≥ 3 drugs. Patients with diabetes were significantly less likely to reach target than those without (26% vs 64%, P<.001). Antihypertensive therapy prescribed to patients with diabetes was only marginally more intensive than to those without. In patients with hypertension, whether with or without coexisting diabetes, poor BP control appears to be at least partially due to failure to uptitrate antihypertensive therapy. Clinical inertia is likely an important barrier to BP control.

A simplified approach to the treatment of uncomplicated hypertension: a cluster randomized, controlled trial.

Notwithstanding the availability of antihypertensive drugs and practice guidelines, blood pressure control remains suboptimal. The complexity of current treatment guidelines may contribute to this problem. To determine whether a simplified treatment algorithm is more effective than guideline-based management, we studied 45 family practices in southwestern Ontario, Canada, using a cluster randomization trial comparing the simplified treatment algorithm with the Canadian Hypertension Education Program guidelines. The simplified treatment algorithm consisted of the following: (1) initial therapy with a low-dose angiotensin-converting enzyme inhibitor/diuretic or angiotensin receptor blocker/diuretic combination; (2) up-titration of combination therapy to the highest dose; (3) addition of a calcium channel blocker and up-titration; and (4) addition of a non-first-line antihypertensive agent. The proportion of patients treated to target blood pressure (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg for patients without diabetes mellitus or systolic blood pressure <130 mm Hg and diastolic blood pressure <80 mm Hg for diabetic patients) at 6 months was analyzed at the practice level. The proportion of patients achieving target was significantly higher in the intervention group (64.7% versus 52.7%; absolute difference: 12.0%; 95% CI: 1.5% to 22.4%; P=0.026). Multivariate analysis of patient-level data showed that assignment to the intervention arm increased the chance of reaching the target by 20% (P=0.028), when adjusted for other covariates. In conclusion, the Simplified Treatment Intervention to Control Hypertension Study indicates that a simplified antihypertensive algorithm using initial low-dose fixed-dose combination therapy is superior to guideline-based practice for the management of hypertension.