What is the clinical evidence from this study?

Study design: Cohort. Population: Hypertension (n=60685). Intervention: Hydrochlorothiazide vs. Valsartan. Primary outcome: Treatment discontinuation (HR 1.53, 95% CI 1.47-1.61, p=<0.001).

January 1, 2007Open Access

Persistence, Adherence, and Risk of Discontinuation Associated with Commonly Prescribed Antihypertensive Drug Monotherapies

Q: What are the key findings of this study?

Valsartan was associated with a significantly lower risk of treatment discontinuation over 1 year compared to hydrochlorothiazide, amlodipine, and lisinopril in patients initiating antihypertensive monotherapy.

Q: What does this research mean for the field?

Valsartan is associated with a significantly lower risk of treatment discontinuation over 1 year compared to hydrochlorothiazide, amlodipine, and lisinopril in patients initiating antihypertensive monotherapy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

WEW.J. ElliottGeneral / Preventive / Lipids CPCraig PlauschinatEisai (United States)GSGrant H. SkrepnekMassachusetts College of Pharmacy and Health Sciences

Key Result

Valsartan was associated with a significantly lower risk of treatment discontinuation over 1 year compared to hydrochlorothiazide, amlodipine, and lisinopril in patients initiating antihypertensive monotherapy.

Study Design

Type

Cohort (n=60,685)

Structured PICO

Does valsartan improve 1-year persistence and adherence compared to hydrochlorothiazide, amlodipine, or lisinopril in adults initiating antihypertensive monotherapy?

Population

60,685 adults (≥18 years) initiating antihypertensive monotherapy, mean age 57.7, 48.2% male, United States. Key inclusion: continuous insurance eligibility for ≥24 months, no prescription claim for a diuretic, CCB, ACE inhibitor, or ARB in the 12 months prior, and received a new prescription for hydrochlorothiazide, amlodipine, lisinopril, or valsartan monotherapy.

Intervention

Valsartan monotherapy (n=9,314)

Comparator

Hydrochlorothiazide (n=18,713), amlodipine (n=11,520), or lisinopril (n=21,138) monotherapy

Outcome

1-year persistence (remaining on the index therapy and not discontinuing before the end of the 12-month post-index date)

In a large US cohort, initiation of antihypertensive monotherapy with valsartan was associated with significantly better 1-year persistence and adherence compared to hydrochlorothiazide, amlodipine, or lisinopril.

Main Result

Effect estimate: HR 1.53 (95% CI 1.47-1.61)

Absolute Event Rate: 44.2% vs 30.6%

p-value: p=<0.001

Limitations

Retrospective design and potential for confounding by indication bias
No information regarding drug-related adverse events and other potential factors influencing drug selection
Characteristics of the prescribing health care provider, copayment differences, and formulary availability were unavailable
No information about individuals who received an initial sample in a clinic setting but never filled a prescription
Included only subjects with medical and pharmacy benefit coverage, limiting generalizability
Refill history is a proxy for persistence and adherence, without assurance that filled prescriptions were taken as directed

Abstract

OBJECTIVE: To assess 1-year persistence and adherence with monotherapy using the most commonly dispensed individual agent in 4 antihypertensive drug classes: hydrochlorothiazide (HCTZ), amlodipine, lisinopril, or valsartan. DESIGN: Retrospective, longitudinal analysis of initial prescriptions during 2001 to 2002 from a nationwide administrative claims database representing 11 million covered lives in the United States. MEASUREMENTS: Drug utilization following initiation. Cox proportional hazards regression models controlled for demographics, case-mix, and concomitant treatments. RESULTS: Records for 60,685 subjects were included: HCTZ (n = 18,713), amlodipine (n = 11,520), lisinopril (n = 21,138), or valsartan (n = 9314). Over 1 year, 31% to 44% of subjects utilized no treatment for at least 60 days. Medication possession ratio (MPR) and adherence measures ranged from 73% to 90%. Valsartan was associated with significantly (P < .001) more favorable measures of persistence, length of therapy, time to discontinuation, MPR, and risk of discontinuation, compared with HCTZ, amlodipine, or lisinopril. The risk of discontinuation was 53%, 32%, and 14% greater for HCTZ, amlodipine, and lisinopril, respectively, versus valsartan (all comparisons P < .001). CONCLUSION: Among antihypertensive agents studied, valsartan was associated with the most favorable utilization patterns. Health care providers and systems should evaluate the use of antihypertensive drugs within their populations to identify and manage treatment discontinuation.

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