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  • Drug Class Review

    Calcium Channel Blockers

    Preliminary Scan Report #5

    October 2013

    The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any

    particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.

    Scan conducted by:

    Kim Peterson, MS

    Drug Effectiveness Review Project

    Marian McDonagh, PharmD, Principal Investigator

    Pacific Northwest Evidence-based Practice Center

    Roger Chou, MD, Director

    Marian McDonagh, PharmD, Associate Director

    Oregon Health & Science University

    Copyright 2013 by Oregon Health & Science University

    Portland, Oregon 97239. All rights reserved.

  • Preliminary Scan Report #5 Drug Effectiveness Review Project

    Calcium Channel Blockers Page 2 of 18

    OBJECTIVE

    The purpose of this preliminary updated literature scan process is to provide the Participating

    Organizations with a preview of the volume and nature of new research that has emerged

    subsequent to the previous full review process. Provision of the new research presented in this

    report is meant to assist with Participating Organizations consideration of allocating resources

    toward a full report update, a single drug addendum, or a summary review. Comprehensive

    review, quality assessment, and synthesis of evidence from the full publications of the new

    research presented in this report would follow only under the condition that the Participating

    Organizations ruled in favor of a full update. The literature search for this report focuses only on

    new randomized controlled trials, and actions taken by the U.S. Food and Drug Administration

    (FDA) since the last report. Other important studies could exist.

    Date of Last Update Report

    Update #2, March 2005 (searches through February 2004)

    Date of Last Preliminary Update Scan Report

    April 2009

    Scope and Key Questions

    Key Questions 1. Do CCBs differ in effectiveness in the treatment of adult patients with essential

    hypertension (blood pressure 140/90 mm Hg), angina, supraventricular arrhythmias, or

    systolic dysfunction (left ventricular ejection fraction [LVEF]

  • Preliminary Scan Report #5 Drug Effectiveness Review Project

    Calcium Channel Blockers Page 3 of 18

    Isradipine

    Nicardipine

    Nifedipine

    Nisoldipine

    Verapamil

    OUTCOMES

    Hypertension

    All cause mortality

    Cardiovascular (CV) disease mortality

    CV events (stroke, MI, development of CHF)

    Development of renal failure (end stage renal disease/dialysis/transplant/ clinically

    significant, permanent increase in serum creatinine or decrease in creatinine clearance)

    Quality of Life

    Angina (Follow-up duration 2 months)

    All cause mortality

    Cardiovascular (CV) disease mortality

    CV events (stroke, MI, development of CHF)

    Symptoms

    Quality of Life

    Supraventricular Arrhythmias

    All cause mortality

    Cardiovascular (CV) disease mortality

    Stroke

    Symptoms (rate or rhythm control)

    Quality of Life

    Left-ventricular Dysfunction

    All cause mortality

    Cardiovascular (CV) disease mortality

    CV events (stroke, MI, development of CHF)

    Symptoms

    Quality of Life

  • Preliminary Scan Report #5 Drug Effectiveness Review Project

    Calcium Channel Blockers Page 4 of 18

    METHODS

    Literature Search

    To identify relevant citations, we searched Ovid MEDLINE and Ovid MEDLINE In-Process &

    Other Non-Indexed Citations from January 2009 through October 2013 using terms for included

    drugs. We also searched the FDA website (http://www.fda.gov/medwatch/safety.htm) for

    identification of new drugs, indications, and safety alerts. To identify comparative effectiveness

    reviews we searched the websites of the Agency for Healthcare Research and Quality

    (http://www.ahrq.gov/) and the Canadian Agency for Drugs and Technology in Health

    (http://www.cadth.ca/). All citations were imported into an electronic database (EndNote X3)

    and duplicate citations were removed.

    Study Selection

    One reviewer assessed abstracts of citations identified from literature searches for inclusion,

    using the criteria described above.

    RESULTS

    New Drugs

    New drugs identified in current Preliminary Update Scan

    The current scan did not identify any new drugs.

    New drugs identified in previous Preliminary Update Scan

    In January 2008, FDA approved a change in the formulation of extended-release nisoldipine to

    lower the strengths and replace all current tablets (i.e., 10 mg, 20 mg, 30 mg and 40 mg) with

    new lower, bioequivalent strengths (i.e., 8.5 mg, 17 mg, 25.5 mg and 34 mg)

    New Indications

    New indications identified in current Preliminary Update Scan

    The current scan did not identify any new indications.

    New indications identified in previous Preliminary Update Scan

    Amlodipine indicated for use in patients with angiographically documented coronary artery

    disease expanded population (9/05).

    New Black Box Warnings

    We did not identify any new black box warnings in this or the previous scan.

  • Preliminary Scan Report #5 Drug Effectiveness Review Project

    Calcium Channel Blockers Page 5 of 18

    Comparative Effectiveness Reviews

    We did not identify any new potentially relevant comparative effectiveness reviews in this or the

    previous scan.

    Randomized Controlled Trials

    Trials identified since the most recent Full Report Medline searches from this scan resulted in 341 citations. Of those, there were 20 potentially

    relevant new trials (see Appendix A for abstracts). Together with the 37 potentially relevant

    trials identified in the last scan (Appendix B), now there are a total of 57. Characteristics of these

    trials are shown in Table(s) 2-4, below. The majority are subanalyses from previously included

    or identified trials (Table 4). Shading indicates publications that are new in this scan.

    Table 1. New head-to-head trials Author Year Trial Name Interventions Population

    Melcher 1998 N/A Nisoldipine Coat-

    Core vs Diltiazem

    Retard in

    Combination with a

    Beta-Blocker

    Angina

    Table 2. New active-control trials Author Year Trial Name Interventions Population

    Yamashita 2011 J-RHYTHM II (Japanese

    Rhythm Management Trial

    II for Atrial Fibrillation)

    Amlodipine vs

    candesartan

    Paroxysmal atrial

    fibrillation

    Ogihara 2008 CASE-J (Candesartan

    Antihypertensive Survival

    Evaluation in Japan)

    Amlodipine vs

    candesartan

    High-risk Japanese

    hypertensive patients

    Investigators

    2006

    J-ELAN (The Effect of

    Losartan and Amlodipine

    on Left Ventricular

    Diastolic Function in

    Patients with Mild-to-

    Moderate Hypertension)

    Amlodipine vs

    losartan

    Hypertension

    Nakamura 2008 N/A Amlodipine vs

    telmisartan

    Hypertension with chronic

    kidney disease

    Fogari 2012 N/A Amlodipine vs

    telmisartan

    Hypertensive patients with

    paroxysmal AF and

    normal or increased left

    atrial dimension (LAD)

    Fogari 2012 N/A Amlodipine vs

    telmisartan vs

    ramipril

    Hypertensive patients with

    metabolic syndrome and

    recurrent symptomatic

  • Preliminary Scan Report #5 Drug Effectiveness Review Project

    Calcium Channel Blockers Page 6 of 18

    paroxysmal and persistent

    atrial fibrillation

    Muramatsu 2012 NAGOYA HEART Study Amlodipine vs

    valsartan

    Hypertensive patients with

    glucose intolerance

    Nakamaya 2008 VART (Valsartan

    Amlodipine Randomized

    Trial)

    Amlodipine vs

    valsartan

    Hypertensive patients in

    Japan

    Schmieder 2008 VALUE (Valsartan

    Antihypertensive Long-

    term Use Evaluation)

    Amlodipine vs

    valsartan

    High-risk hypertensive

    patients

    Nissen 2004 CAMELOT (Comparison

    of Amlodipine vs Enalapril

    to Limit Occurrences of

    Thrombosis)

    Amlodipine vs

    enalapril vs

    placebo

    Coronary disease and

    normal blood pressure

    Jamerson 2008 ACCOMPLISH (Avoiding

    Cardiovascular events

    through COMbination

    therapy in Patients LIving

    with Systolic

    Hypertension)

    Amlodipine vs

    HCTZ added to

    benazepril

    Hypertension

    Ruzyllo 2007 N/A Amlodipine vs

    ivabradine

    Angina

    Kojima 2004 N/A Amlodipine vs

    cilnidipine

    Hypertension with renal

    disease

    Koylan 2004 TTS (Turkish

    Trimetazidine Study)

    Diltiazem vs

    trimetazidine

    Angina

    Vora 2004 N/A Diltiazem vs

    amiodarone

    Rheumatic atrial

    fibrillation

    Frishman 2006 M-FACT (Metoprolol

    Succinate-Felodipine

    Antihypertension

    Combination Trial)

    Metoprolol ER,

    felodipine ER, or

    their combination

    Hypertension

    Derosa 2004 N/A Nifedipine GITS

    vs telmisartan

    Hypertension and

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