A Cohort Study to Assess Various Safety Outcomes of Interest in Users of Aliskiren Using Claims Data

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Resilez
• Study drug International non-proprietary name (INN) or common name:
  ALISKIREN

  ALISKIREN HEMIFUMARATE
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  Members of the two U.S. data sources: (1) US MarketScan® Commercial Claims and Encounters database and Medicare Supplement provided by Novartis and (2) UnitedHealth Research Database provided by Brigham and Women’s Hospital as patients who have a first-time recorded dispensing between 1 March 2007 and 31 December 2011 (or latest available from each data source) for aliskiren (aliskiren cohort) or another antihypertensive drug.; Patients at least 18 years old at the time of the first prescription for aliskiren or other antihypertensive drug and who have at least one prescription for aliskiren or another antihypertensive drug, at least 6 months of continuous enrollment prior to (and inclusive of the date of) the first prescription for aliskiren or another antihypertensive drug (to form the baseline period), valid data for age and sex, at least one inpatient or outpatient ICD-9 diagnosis code of hypertension (401.xx -; 405.xx) during the baseline period were included.
• Age groups:
  Adults (18 to < 46 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  67000

Study design details

• Main study objective:
  To assess whether under real-world conditions aliskiren – either as monotherapy or in combination with other antihypertensives (especially with ACEIs or ARBs) – may be associated with an increased risk of certain outcomes of interest as identified in ALTITIUDE compared to other antihypertensive drugs
• Outcomes:
  To quantify incidence rates and relative risks of (i) cerebrovascular accidents, (ii) transient ischemic attack (TIA), (iii) myocardial infarction (MI), (iv) heart failure leading to hospitalization, (v) acute renal failure (ARF), (vi) end stage renal disease (ESRD) in users of aliskiren compared to users of other antihypertensive drugs, To quantify associations between aliskiren and the occurrence of hyperkalemia, hypotension, and death. This study will separately assess the incidence rates and relative risks of (i) hyperkalemia, (ii) hypotension, and (iii) death in users of aliskiren compared to users of other antihypertensive drugs.
• Data analysis plan:
  This study will seek to estimate the relative risk (as a hazard ratio HR) of each outcome comparing patients initiating aliskiren to patients initiating other antihypertensive medications. All analyses will be conducted in propensity score matched cohorts to achieve a high degree of multivariate confounding control. In addition, although many analyses on the outcomes will be performed, no formal adjust for multiple comparisons will be done. Rather than hypothesis testing, this study aims to estimate the association of aliskiren with study outcomes relative to comparison treatments across numerous exposures and exposure subgroups. Estimates and 95% confidence intervals (CIs) for each comparison will be presented without adjustment for multiplicity, and these 95% CIs can be interpreted individually as including the true association value approximately 95% of the time, even where multiple comparisons have been made.

Documents

Study results

SPP100A2414-Redacted-Final-Study-Report