august 2015 clinical advisor

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The Clinical Advisor is a monthly journal for nurse practitioners and physician assistants in primary care. Its mission is to keep practitioners up to date with the latest information about diagnosing, treating, managing, and preventing conditions seen in a typical office-based primary-care setting.

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Page 1: August 2015 Clinical Advisor

SAFETY675rdquoSAFETY95rdquo

TRIM775rdquoTRIM

105rdquo

BLEED875rdquoBLEED115rdquo

LARGE TRIM85rdquoLARGE TRIM

11rdquo

THIS ADVERTISEMENT PREPARED BY NeONClient JampJProduct INVOKANA Job 10304019Job Name A-Size Ad Code 033360-150417

PublicationsColors 4CSizes Bleed 875 W x 115 H

Trim 775 W x 105 H Live 675 W x 95 H

12 Page Trim 325rdquo W x 95rdquo H

10304019 Creative evolution ads a-siZe

INSPIRE PATIENTS TOGO FURTHER

In the treatment of type 2 diabetes help

IMPORTANT SAFETY INFORMATION (contrsquod)WARNINGS and PRECAUTIONSgtgt Hypotension INVOKANAreg causes intravascular volume contraction Symptomatic hypotension

can occur after initiating INVOKANAreg particularly in patients with impaired renal function (eGFR lt60 mLmin173 m2) elderly patients patients on either diuretics or medications that interfere with the renin-angiotensin-aldosterone system or patients with low systolic blood pressure Before initiating in patients with ge1 of these characteristics volume status should be assessed and corrected Monitor for signs and symptoms after initiating

gtgt Impairment in Renal Function INVOKANAreg increases serum creatinine and decreases eGFR Patients with hypovolemia may be more susceptible to these changes Renal function abnormalities can occur after initiation More frequent renal function monitoring is recommended in patients with an eGFR lt60 mLmin173 m2

INVOKANAreg (canagliflozin) starting dose 100 mg once daily In patients tolerating the starting dose who have an eGFR ge60 mLmin173 m2 and require additional glycemic control the dose can be increased to 300 mg once daily2

033360-150417_INVOKANA_Journal_ad_A_FR2indd 2 61015 112 PM

SAFETY675rdquoSAFETY95rdquo

TRIM775rdquoTRIM

105rdquo

BLEED875rdquoBLEED115rdquo

LARGE TRIM85rdquoLARGE TRIM

11rdquo

THIS ADVERTISEMENT PREPARED BY NeONClient JampJProduct INVOKANAJob 10304019Job Name A-SizeAd Code 033360-150417

PublicationsColors 4CSizes Bleed 875 W x 115 H

Trim 775 W x 105 HLive 675 W x 95 H

12 Page Trim 325rdquo W x 95rdquo H

10304019 Creative evolution ads a-siZe

INVOKANAreg 300 mg + metformin and a sulfonylurea (n=377)

Januviareg (sitagliptin) 100 mg + metformin and a sulfonylurea (n=378)

ndash066ndash103

813 812Mean baseline

95 CI ndash050 ndash025 P005

Adjusted Mean Change in A1C From Baseline ()

ndash037difference

GREATER REDUCTIONS in body weight2daggerDiff erence from Januviareg 100 mg ndash28 Plt0001

Incidence of hypoglycemia2

INVOKANAreg 300 mg 432 Januviareg 100 mg 407 The incidence of hypoglycemia increases when used in combination with insulin or an insulin secretagogue

GREATER REDUCTIONS in systolic blood pressure3daggerDiff erence from Januviareg 100 mg ndash59 mm Hg Plt0001

Adverse events (AEs)3

Incidences of AEs were similar between groups except for

Malefemale genital mycotic infection INVOKANAreg 300 mg 92153 Januviareg 100 mg 0543 Increased urine frequencyvolume INVOKANAreg 300 mg 1608 Januviareg 100 mg 130

Learn more and register for updates at

INVOKANAhcpcomA randomized double-blind active-controlled 52-week study of patients with type 2 diabetes inadequately controlledon maximally or near-maximally eff ective doses of metformin (ge2000 mgday or ge1500 mgday if higher dose not tolerated)and a sulfonylurea3

INVOKANAreg is not indicated for weight loss or as an antihypertensive treatment daggerAdjusted mean change from baseline

Indicated trademarks are registered trademarks of their respective owners

Secondary endpoint Secondary endpoint

INVOKANAreg 300 mg demonstrated greater reductions in A1C vs Januviareg 100 mg

at 52 weeks in patients inadequately controlled on metformin + a sulfonylurea2

GREATER REDUCTIONS in A1C2

gtgt Hyperkalemia INVOKANAreg can lead to hyperkalemia Patients with moderate renal impairment who are taking medications that interfere with potassium excretion or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia Monitor serum potassium levels periodically in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions

gtgt Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues INVOKANAreg can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANAreg

gtgt Genital Mycotic Infections INVOKANAreg increases risk of genital mycotic infections Patients with history of these infections and uncircumcised males were more likely to develop these infections Monitor and treat appropriately

gtgt Hypersensitivity Reactions Hypersensitivity reactions (eg generalized urticaria) some serious were reported with INVOKANAreg these reactions generally occurred within hours to days after initiation If reactions occur discontinue INVOKANAreg treat per standard of care and monitor until signs and symptoms resolve

Please see additional Important Safety Information and briefsummary of full Prescribing Information on the following pages

033360-150417_INVOKANA_Journal_ad_A_FR2indd 3 61015 112 PM

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Page 2: August 2015 Clinical Advisor

SAFETY675rdquoSAFETY95rdquo

TRIM775rdquoTRIM

105rdquo

BLEED875rdquoBLEED115rdquo

LARGE TRIM85rdquoLARGE TRIM

11rdquo

THIS ADVERTISEMENT PREPARED BY NeONClient JampJProduct INVOKANAJob 10304019Job Name A-SizeAd Code 033360-150417

PublicationsColors 4CSizes Bleed 875 W x 115 H

Trim 775 W x 105 HLive 675 W x 95 H

12 Page Trim 325rdquo W x 95rdquo H

10304019 Creative evolution ads a-siZe

INVOKANAreg 300 mg + metformin and a sulfonylurea (n=377)

Januviareg (sitagliptin) 100 mg + metformin and a sulfonylurea (n=378)

ndash066ndash103

813 812Mean baseline

95 CI ndash050 ndash025 P005

Adjusted Mean Change in A1C From Baseline ()

ndash037difference

GREATER REDUCTIONS in body weight2daggerDiff erence from Januviareg 100 mg ndash28 Plt0001

Incidence of hypoglycemia2

INVOKANAreg 300 mg 432 Januviareg 100 mg 407 The incidence of hypoglycemia increases when used in combination with insulin or an insulin secretagogue

GREATER REDUCTIONS in systolic blood pressure3daggerDiff erence from Januviareg 100 mg ndash59 mm Hg Plt0001

Adverse events (AEs)3

Incidences of AEs were similar between groups except for

Malefemale genital mycotic infection INVOKANAreg 300 mg 92153 Januviareg 100 mg 0543 Increased urine frequencyvolume INVOKANAreg 300 mg 1608 Januviareg 100 mg 130

Learn more and register for updates at

INVOKANAhcpcomA randomized double-blind active-controlled 52-week study of patients with type 2 diabetes inadequately controlledon maximally or near-maximally eff ective doses of metformin (ge2000 mgday or ge1500 mgday if higher dose not tolerated)and a sulfonylurea3

INVOKANAreg is not indicated for weight loss or as an antihypertensive treatment daggerAdjusted mean change from baseline

Indicated trademarks are registered trademarks of their respective owners

Secondary endpoint Secondary endpoint

INVOKANAreg 300 mg demonstrated greater reductions in A1C vs Januviareg 100 mg

at 52 weeks in patients inadequately controlled on metformin + a sulfonylurea2

GREATER REDUCTIONS in A1C2

gtgt Hyperkalemia INVOKANAreg can lead to hyperkalemia Patients with moderate renal impairment who are taking medications that interfere with potassium excretion or medications that interfere with the renin-angiotensin-aldosterone system are more likely to develop hyperkalemia Monitor serum potassium levels periodically in patients with impaired renal function and in patients predisposed to hyperkalemia due to medications or other medical conditions

gtgt Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues INVOKANAreg can increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with INVOKANAreg

gtgt Genital Mycotic Infections INVOKANAreg increases risk of genital mycotic infections Patients with history of these infections and uncircumcised males were more likely to develop these infections Monitor and treat appropriately

gtgt Hypersensitivity Reactions Hypersensitivity reactions (eg generalized urticaria) some serious were reported with INVOKANAreg these reactions generally occurred within hours to days after initiation If reactions occur discontinue INVOKANAreg treat per standard of care and monitor until signs and symptoms resolve

Please see additional Important Safety Information and briefsummary of full Prescribing Information on the following pages

033360-150417_INVOKANA_Journal_ad_A_FR2indd 3 61015 112 PM

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Page 3: August 2015 Clinical Advisor
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