DRAFT SLIDES FOR NDA 21-213 Admonitory Board PRESENTATION.


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Could OTC desktop cholesterol screening offer precise cholesterol estimation? ... Prescribed seeing specialist in any event yearly to examine cholesterol treatment arrangement ...
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DRAFT SLIDES FOR NDA 21-213 ADVISORY COMMITTEE PRESENTATION

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Joint Advisory Committee Meeting on OTC Availability of Lovastatin 10 mg Actual Use Trials Andrea Leonard-Segal, M.D. Division of OTC Drug Products

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Outline 3 Actual Use Trials Self-Selection and Compliance issues (trial 076) Compliance issues (trial 079) Self-choice and wellbeing (trial 081)

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Actual Use Studies Background Simulate OTC Use of a Product Exclusion criteria: The less the better! Self-determination: Are individuals picking item legitimately in view of signs and contraindications? Consistence: Are dosing and length of utilization as per headings? Wellbeing: What are the antagonistic encounters? Viability data frequently constrained by open-name, uncontrolled configuration

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Actual Use Issues for Lovastatin Cholesterol: Do individuals know their qualities? Do they comprehend TC, LDL-C, and HDL-C? Do they comprehend when to treat? What is the treatment objective and do purchasers comprehend it?

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Actual Use Issues (Continued) Cholesterol Measurement: Can OTC desktop cholesterol screening offer precise cholesterol estimation? What is the fitting span of quick preceding estimation? What number of estimations ought to be performed to acquire an exact quality? In the event that averaging different cholesterol qualities is suggested, can customers crunch the numbers?

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Actual Use Issues (Continued) Self-Selection: Can shoppers comprehend what basic conditions and attending prescriptions put them at danger on the off chance that they take lovastatin? Do customers know when they are taking contraindicated drugs? Do buyers comprehend when to look for the guidance of a doctor?

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Actual Use Issues (Continued) Compliance: Are buyers adequately agreeable in the OTC setting to infer clinical advantages of lovastatin treatment over the long haul? Advantage and Risk Is observing expected to figure out whether there has been an advantage of utilization and no unfriendly wellbeing occasions? Can customers distinguish manifestations connected with antagonistic occasions?

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Actual Use Issues (Cont\'d) Label: Can a name satisfactorily pass on all fundamental data about lovastatin so it can be utilized legitimately?

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Inclusion Criteria Common to Trials 076, 079, 081 TC = 200-240 mg/dl LDL-C  130 mg/dl HDL-C was not a consideration foundation

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Exclusion Criteria Common to Trials 076, 077, 081 Current or late (< 2 months) investment in medication study Allergy to lovastatin Current or Hx liver infection Contraindicated drugs Other cholesterol prescription

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Exclusion Criteria Common to 076, 079, 081 (Cont\'d) Hx coronary illness FHx MI before age 55 (guardians, kin) Pregnant, bosom encouraging, childbearing potential Inability to peruse English HDL-C was not an avoidance basis

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Sponsor\'s Definitions Persistence = # (%) of subjects who returned for a subsequent visit having taken any of the study tablets Compliance was ascertained in relentless subjects and was characterized as: # tablets taken/# days drug taken amid determined day and age Expressed as a rate

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Open-mark Uncontrolled Multicenter (drug stores) 24-week (4 visits) "Expansion trial" alternative To Evaluate: LDL-C Self-choice Compliance Adverse encounters Study Design - 076

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Criteria - 076 Inclusion (as depicted) in addition to: Age: Men  45; ladies  55 General great wellbeing; no incapacitating sickness Low-fat eating regimen amid earlier year Exclusion (as portrayed) in addition to: Corticosteroid use Peripheral vascular ailment  3 mixed refreshments/day most days

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Label - 076 "Drug store" Label: Lists Inclusion-Exclusion criteria Did not list every single intuitive solution 1 tablet qhs Retest cholesterol following 8 weeks and contact study specialist if level did not diminish

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Recruitment by means of advertisements Review "Drug store" name and settle on self-determination choice Complete Hx structure Pharmacist triage: conceivably qualified or not Cholesterol test (  2-hr quick) Qualified got study drug Study Design - 076

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Study Design - 076 Return visits: tally returned pills record unfriendly occasions lipid profile new medication at visits 2, 3

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Results - 076 (Self-Selection) 722 (12%) of each of the 6095 study members qualified to get drug 981 (16%) of study members self-chose to get and utilize the medication Only 119 (12%) of this self-choice gathering really got drug

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Results - 076 (Self-Selection) 6081 finished self-choice procedure 82% required more than "Drug store" name to choose whether to acquire drug 53% thought they met criteria for TC level, yet did not No data about how well buyers comprehended the significance of the segments of the lipid profile

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Results - 076 (Self-Selection) 5% who were liable to purchase lovastatin were in "danger" group Liver malady (72) Prohibited pharmaceuticals according to name (44) Pregnancy hazard (3) Allergic to lovastatin (8)

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Results - 076 (Compliance) Completion, Persistence and Compliance: 523/722 (72%) finished the study 504/722 (69%) were diligent finally (Visit 4) 441/722 (61%) were taking  75% of medication at Visit 4 No journal, so exact data about how individuals really dosed is inaccessible.

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Multicenter Open-Label Uncontrolled Storefront 8 weeks "Augmentation trial" alternative To test: Mean change in LDL at 8 weeks Ability of shoppers to stay on lovastatin Tolerability of lovastatin as measured by AE rate Study Design - 079

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Study Design - 079 Recruitment through advertisements Telephone history screening

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Criteria Inclusion (as depicted) in addition to: men  40; ladies  55 Exclusion (as portrayed) in addition to:  3 mixed refreshments most days ; diabetes; angina; fringe vascular infection; TIA; stroke; obtrusive methods (PTCA, CABG); taking >1 BP drug; diastolic BP  100 or systolic BP  180 mm/Hg; subjects who knew their TC was < 190 mg/dl or > 250 mg/dl; corticosteroids

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Study Label - 079 "Limited Access" Label Designed to fortify fitting post-buy conduct, not to guide self-determination Contained trial incorporation and avoidance criteria More sweeping rundown of contraindicated meds than "Drug store" name Recommended seeing specialist at any rate yearly to talk about cholesterol treatment arrangement

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Study Design - 079 Storefront arrangement for possibly qualified (Visit 1) Lipid profile (6-hour quick) BP Weight, Height Eligible got drug with "Confined Access" name and study data card

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Study Design - 079 Visit 2 (roughly week 8) Lipid profile (6-hour quick) Collect outstanding medication tablets Adverse experience data gathered

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Results - 079 4878 called phone number 1312 (27%) conceivably qualified and went to customer facing facade 60% of these were not qualified (cholesterol) 460 (9%) got study drug

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Results - 079 Persistence and Compliance 363 individuals took some medication (were relentless) 265 were consistent no less than 75% of the time over the 8-week concentrate No journal, so exact data about how individuals really dosed is occupied. Trial did not test the capacity of shoppers to legitimately self-select

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Study Design - 081 Open-name Uncontrolled Multicenter Storefront clinical locales 4 Weeks "Augmentation trial" choice

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Study Design - 081 Objectives To test: Effectiveness of an upgraded "Red Arrow" mark & fortification devices (tape, flyer, embed) Effectiveness of these in 3 hazard subsets: drug hazard 1° aversion subjects (cholesterol > 240 mg/dl) high cardiovascular danger bunch Tolerability of lovastation 10 mg as measured by frequency of unfriendly occasions.

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Criteria Inclusion Men  40; ladies  1 year post-menopausal Express enthusiasm for obtaining lovastatin Exclusion Employed in human services Diabetes Stroke Taking > 1 hostile to hypertension drug Participated in cholesterol bringing down study < 2 years

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Label - 081 " Red Arrow" name Flip-up back board plan Warnings stressed with red bolts and stop signs Examples of muscle torment, delicacy or shortcoming added to medication association "Notices" go before "who ought to utilize" Boxed cautioning to "deliberately read bundle before self-selecting and call an item pro for help understanding the name"

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Study Design - 081 Recruitment through advertisements Visit 1 - Storefront site: Participants read item idea & mark; then settled on self choice If "yes" paid $15 for lovastatin 10 mg and addressed particular danger questions Contraindicated meds Current liver infection Childbearing potential Allergy to lovastatin

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Study Design - 081 If member self-chose, "yes," yet was prohibited for danger: second opportunity to audit name and fortifications and to settle on self-determination choice No medication was given

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Study Design - 081 Cholesterol test offered to the individuals who required before could self-choose, then: Repeat self choice Answered danger questions Medical Hx performed on all who left retail facade site without drug: Self-chose "no" Failed danger avoidance questions Did not have any desire to buy

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Study Design - 081 Eligible Participants Received 4-week supply of open-name lovastatin 10 mg Were advised to take drug as indicated by name

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Study Design - 081 Were offered impetus to call sans toll # Those who did were asked therapeutic Hx utilizing screening script (incl-excl criteria) If esteemed wrong for medication, were advised to: D/C return remaining medication and bundling

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Study Design - 081 Visit 2 (Week 4) Returned bundling and unused medication For the individuals who had not called sans toll #, attendant managed medicinal Hx and decided fittingness of Rx Lipid testing for those i

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