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Patient group input submissions were received from the following patient groups. Those with permission to post are included in this document. |
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Canadian Diabetes Association — permission granted to post. |
CADTH received patient group input for this review on or before May 24, 2016.
CADTH posts all patient input submissions to the Common Drug Review received on or after February 1, 2014 for which permission has been given by the submitter. This includes patient input received from individual patients and caregivers as part of that pilot project.
The views expressed in each submission are those of the submitting organization or individual; not necessarily the views of CADTH or of other organizations. While CADTH formats the patient input submissions for posting, it does not edit the content of the submissions.
CADTH does use reasonable care to prevent disclosure of personal information in posted material; however, it is ultimately the submitter’s responsibility to ensure no personal information is included in the submission. The name of the submitting patient group and all conflict of interest information are included in the posted patient group submission; however, the name of the author, including the name of an individual patient or caregiver submitting the patient input, are not posted.
Canadian Diabetes Association
Section 1. General Information
Name of the drug CADTH is reviewing and indication(s) of interest | Synjardy (empagliflozin and metformin) Type 2 diabetes |
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Name of the patient group | Canadian Diabetes Association |
Name of the primary contact for this submission: | ▬▬▬ |
Position or title with patient group | ▬▬▬▬▬▬ |
▬▬▬▬▬▬▬ | |
Telephone number(s) | ▬▬▬ |
Name of author (if different) | ▬▬ |
Patient group’s contact information: Email | Canadian Diabetes Association |
Telephone | ac.setebaid@ycacovda |
Address | 613 688 5938 |
Website | http://www |
Permission is granted to post this submission | Yes |
1.1. Submitting Organization
The Canadian Diabetes Association (the CDA) leads the fight against diabetes by helping people with diabetes live healthy lives while we work to find a cure. It has a heritage of excellence and leadership, and its co-founder, Dr. Charles Best, along with Dr. Frederick Banting, is credited with the co-discovery of insulin. The CDA is supported in its efforts by a community-based network of volunteers, employees, health care professionals, researchers, and partners. By providing education and services, advocating on behalf of people with diabetes, supporting research, and translating research into practical applications, the CDA is delivering on its mission.
1.2. Conflict of Interest Declarations
The Canadian Diabetes Association (the CDA) solicits and receives unrestricted educational grants from multiple manufacturers/vendors of pharmaceuticals, supplies and devices for diabetes and its complications. These funds help the CDA to support community programs and services for people with diabetes, fund research and advocacy, across Canada. Sponsors were not involved in developing this submission. The CDA did not have any conflicts of interest in the preparation of this submission.
Section 2. Condition and Current Therapy Information
2.1. Information Gathering
The Canadian Diabetes Association (the CDA) solicited patient input through surveys distributed through social media and email blasts. Content of this submission is derived from three surveys. Two surveys conducted in August 2014 and October 2015, gathered information Canadians with type 2 diabetes and their caregivers about the impacts of diabetes, and aspects of diabetes they want medications to address; the surveys were answered by 376 and 212 individuals, respectively. The third survey, conducted in April 2015 during 3 weeks, provides information from Canadians with type 2 diabetes (n=349) and their caregivers (n=75) about current drug therapies and experience with Jardiance (empagliflozin), and the most important aspects of diabetes they would like medications to address.
2.2. Impact of Condition on Patients
Type 2 diabetes is a chronic (progressive) condition that occurs when the pancreas does not produce enough insulin or when the body does not effectively use the insulin that is produced. Common symptoms of diabetes include fatigue, thirst and weight change. Diabetes requires considerable selfmanagement, including healthy eating, regular physical activity, healthy body weight, taking diabetes medications (oral and/or injection) as prescribed, monitoring blood glucose and stress management. Poor glucose control can result in serious complications, such as heart disease, stroke, blindness, kidney problems, nerve damage and erectile dysfunction. The goal of diabetes management is to keep glucose levels within the target range to minimize symptoms and avoid or delay the complications.
Direct quotes below describe the general impact of diabetes on respondents:
Many respondents described fatigue and lack of energy. There was also a frequent emphasis on the psychological and emotional impact of diabetes on the lives of respondents (effect on stress, anxiety, adjusting to changes in diet and lifestyle, medication and treatment management as well as relationships with family). Below are selected quotes that demonstrate challenges due to diabetes:“The most distressing side effect of all of the diabetes drugs is they make you gain weight or prevent weight loss. It is annoying to be told to lose weight then handed a drug that prevents weight loss.”
“I need to be careful with what I eat and how much I eat, especially carbohydrates. Also need to balance out a snack, insulin needs and exercise to ensure I don’t have a hypoglycemic episode while exercising. I also need to monitor my insulin needs while doing errands, again to avoid a hypoglycemic episode.”
“[Diabetes has] affected my family also due to my being not able to work while I was waiting for a kidney transplant, which was given to me by ... my son. Because of being on dialesis [sic] I had to spend most of my life’s savings. Being sick can be very very expensive.”
“It is difficult to lead a normal life when you always need to be taking meds or checking your [blood sugar] levels and reading labels on all your food while your [blood sugar] levels change with or without food intake. The impact of diabetes on all your other organs is another huge problem and when you treat one you harm another. Most difficult disease to manage.”
Surveyed patients were asked which aspects of diabetes were the most important. The majority of patients indicated that daily fluctuations in blood sugar and weight gain were the most important aspects of diabetes to control. The blood sugar fluctuations impact the ability to work, interactions with friends and family, causes stress and worry as well as ability to participate in normal activities of daily living. Weight gain and the stigma associated with the disease can result in reduced quality of life. Maintaining control of diabetes has potential to reduce anxiety and avoid or delay complications as well as improve overall quality of life.“Having diabetes makes me useless. I have no energy or strength to enjoy life anymore. I can’t do partial jobs around house. I can’t enjoy sports anymore. Diabetes has instill (sic) a fear in me.”
“...problems are mostly trying to lose weight...Took 5 Metformin pills (1 a day for 5 days) and put on 2 pounds a day. Took over a month to loose[sic] that 10 pounds.”
“Basically it’s an awful experience, experience highs and lows. Exercising can make my sugars low so I have to always have a snack with me. Eating anywhere besides home is a challenge as you don’t know how things are made. I’m constantly checking my blood and I take 13 pills a day.”
2.3. Patients’ Experiences With Current Therapy
A large proportion of people with type 2 diabetes fail to achieve optimal glycemic control, which places patients at risk for both acute and chronic diabetes complications. The initial therapy is most often metformin, but over time, most patients will require the addition of a second or third agent to reach glycemic targets. Many of the currently available therapies cause significant weight gain while their ability to achieve optimal glycemic control may be limited by hypoglycemia. Weight gain adds to the sense of failure and anxiety in this patient population who frequently blame themselves for their health status.
In our April 2015 survey, a total of 377 Canadians with type 2 diabetes and caregivers for those with diabetes indicated experience taking diabetes medications. The medications taken by respondents at the time of survey included metformin (173), insulin (121), sulfonylureas (73), DPP-4 inhibitors (43), SGLT2 inhibitors (120), GLP-1 agonists (26), DPP-4 inhibitors (43), combinations of DPP-4 inhibitors and metformin (62), meglitinides (13), TZDs (8), rosiglitazone+metformin (8), and acarbose (4). Some people indicated that they had had to stop the following medications for reasons other than the end of clinical trials: metformin (26), sulfonylurea (42), SGLT2 inhibitors (15), DPP-4 inhibitors (20), DPP-4 inhibitors and metformin combination (14), meglitinides (4), TZDs (38), rosiglitazone+metformin (8), GLP1 agonists (2), acarbose (2), and insulin (8).
Among the 173 people who were on metformin at time of survey, a large proportion were taking additional medications to manage their diabetes: 49 were also taking a sulfonylurea, 72 were taking a SGLT2 inhibitor, 32 were taking a DPP-4 inhibitor, 11 were taking a combination drug of DPP-4 inhibitor and metformin, 19 were taking a GLP-1 agonist, 7 using meglitinides, 2 on acarbose, 3 using TZDs, 3 using combined rosiglitazone+metformin, and 70 were on insulin. These sub-groups are not mutually exclusive as some patients were taking multiple drugs.
The majority of respondents—63% (218 people)—stated they were satisfied or very satisfied with their current therapies whereas 18% indicated dissatisfaction. They indicated they were better or much better at keeping blood glucose and A1C levels at target. However, a significant number of respondents have not found it easier to avoid low blood sugar (“the same,” “worse” or “much worse” for 38%), weight gain (“the same,” “worse” or “much worse” for 52%), GI effects (“the same,” “worse” or “much worse” for 57%); 59% and 55% indicating “same,” “worse” or “much worse” for dehydration and urinary tract/yeast infection, respectively.
Surveyed patients were also asked to rate the importance of following benefits/side effects when choosing diabetes medications, using a five-point scale from “not at all important” to “very important.” Over 90% of respondents indicated “quite important” or “very important” regarding the following benefits of therapy:
- blood sugars kept at satisfactory levels in the morning/after fasting (96%),
- blood sugars kept at satisfactory levels during the day/after meals (95%),
- avoiding low blood sugar during the day/overnight (90%).
The following aspects are also considered important by the vast majority:
- avoiding weight gain (89%),
- avoiding GI effects (84%),
- reducing high blood pressure (83%),
- avoiding fluid retention (82%),
- avoiding urinary tract infection (81%).
Other aspects deemed important when choosing medications include “avoiding kidney strain and heart problems” and “depression.” Some respondents simply wanted drugs to “allow them to lead as normal a life as possible” and provide a “life without concerns about complications because of diabetes.”
Section 2 — Condition and Current Therapy Information
3.1. Information Gathering
The Canadian Diabetes Association (the CDA) solicited patient input on the drug being reviewed, through a survey distributed through social media and email blasts. Conducted in April 2015 during 3 weeks, the survey provides information from Canadians with type 2 diabetes (n=349) and their caregivers (n=75) about current drug therapies and experience with empagliflozin specifically, and the most important aspects of diabetes they would like new medications to address.
3.2. What Are the Expectations for the New Drug or What Experiences Have Patients Had With the New Drug?
Empagliflozin belongs to a new class of drugs that lower blood glucose through inhibition of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. The SGLT2 inhibition stabilizes blood glucose, reduces blood pressure and promotes weight loss. Recently published results of the first cardiovascular outcome trial of this drug class demonstrate lower rates of cardiovascular-related hospitalization and mortality in patients who used empagliflozin. The availability of empagliflozin offers an alternative treatment option for people with type 2 diabetes, as well as those at higher risk for cardiovascular events.
Only 14 respondents indicated they had taken empagliflozin in as part of a clinical trial; 136 had taken other drugs in the same class i.e. Invokana (canagliflozin) or Forxiga (dapagliflozin). Patients who have taken empagliflozin noted its effectiveness in keeping blood sugar levels at target and minimizing sides effects (e.g. diarrhea, stomach ache, weight gain), and provide “better quality of life” from their perspective. A patient who has used empagliflozin in a past trial and now on another class of drugs expressed his wish that he could access it because “it worked...[other drugs] cause weight gain and do not work as well as empagliflozin.”
For people who have not had experience with empagliflozin, they reported challenges with some of the current medications such as GI effects associated with metformin use, and indicated the following as important aspects to address with new drugs:
- Maintain blood glucose levels & reduce instances of hypoglycemia (“managing levels becomes less stressful”)
- Better A1C
- Weight loss/no weight gain
- Minimal side effects (“without increasing risk of renal damage”)
- Slow the progression of disease/complications (“reduce vascular risks”, “reduce number of patients on dialysis, losing limbs, heart problems, organ failures”)
- Better blood pressure
- Reduction of other diabetes meds
- Avoid or delay insulin
- Lower cost/fully covered under public drug plans (“for retired persons with limited budgets”)
- Cure the disease
- Combat depression (“If these meds can help you feel better it will help with the depression of Diabetes. It may reduce the fear of future serious complications.”)
In general, all patients hope to have blood glucose levels under control, avoid hypoglycemia, avoid long term complications. A large number of respondents also hope to reduce the number of drugs taken, as well as insulin injections. One respondent stated: “if medications can help reduce the amounts or frequency of injections without the risk of serious side effects I would welcome that.” Another respondent puts it in perspective: “I hope one day to be able to take only one or two medications to control my diabetes rather than the 3 injectables and 2 tablet medications I take now.” Other respondents would like the new drug to help “reduce the number [and] types of pills that a type 2 diabetic takes,” “keep away from the needle,” “reduce/eliminate/replace the need for insulin.” Ultimately, people with type 2 diabetes hope for the least number of medications possible at an affordable cost: “I hope that it would be a one tablet or injection instead of multiple medications to treat type 2 diabetes and that everyone can afford to use it.” Given the wishes expressed by many respondents with type 2 diabetes to reduce the number of medications, the availability of Synjardy, as a fixed dose combination of metformin with empagliflozin, for people with type 2 diabetes stabilized on metformin, empagliflozin (with or without a sufonylurea or insulin) would serve the purpose of offering effective therapy while reducing pill burden and promoting adherence to prescribed therapy. This would offer a significant advantage for doctors and patients working together to achieve optimal treatment with the lowest effective dose.
In summary, diabetes requires intensive self-management. To achieve optimal blood glucose levels, individualization of therapy is essential, including selecting the drug or combination of drugs, route of administration (oral, injection, pen or pump), how frequently the patient monitors blood glucose and adjusts dosage, the benefits and risks that the patient experiences and/or tolerates, and the lifestyle changes the patient is willing or able to make.
There are clear expectations that any new drugs should offer good blood glucose control to prevent hyperglycemic and hypoglycemic episodes, as well as longer term control, with minimal side effects and long term damage to organs, and at affordable costs. Given the challenge that many patients have with weight loss and the enormous sense of failure experienced with weight gain, diabetes drugs that promote weight loss can be an important part of care.
Responses to this survey reinforce the understanding that different people living with diabetes require different options in terms of medications to help effectively manage their disease. Their clinical profile, preference and tolerance of therapy can direct physicians to the most appropriate drug therapy. The patients who had experience with empagliflozin described good results in terms of glucose control and less side effects such as weight gain/GI effects. Several respondents identified taking several medications as a concern, hoping to have access to combined medicines which would reduce the number of medications taken. The availability of a combined empagliflozin and metformin (Synjardy) may promote adherence to prescribed treatment by reducing pill burden and can offer some patients a good alternative for effective management of diabetes.
Appendix. Organizations and foundations that made donations to the Canadian Diabetes Association in 2015. Source: CDA 2015 Annual Report, available at http://www.diabetes.ca/getmedia/0204ddb9-8942-4033-9dca-21547d2d8007/2015-cda-annual-report.pdf.aspx
Corporate Supporters $5,000 – $24,999
Abakhan & Associates Inc.
ADI Development Group
Agway Metals Inc.
Alberta Blue Cross
AM Roofing Simcoe-Bluewater Ltd.
Army Navy & Airforce BC
Ascensia Diabetes Care
Associated Auto Auction Ltd.
Association Portugaise d'Aylmer
ATB Financial
ATCO Electric
ATCO Gas
BST Estevan Gun Show Corp.
Bank of Nova Scotia
Basant Motors
Bazil Developments Inc.
Benevity Inc.
Bermuda Tan
Beverly Charity Classic Golf - Hamilton
Boulangerie St-Méthode
Briarlane Direct Property Management Inc.
Calgary Roadrunners Club
Cameco Corporation
Canada’s Building Trades Unions
Capital Cosmopolitan Club
Cenovus Energy Inc.
Chadi & Company
Chartwell Seniors Housing Reit
CMG Computer Modelling Group Ltd.
Connect Hearing
Construction Labour Relations Association NL
Cooperators – Cumis
Cornerstone Properties Ltd.
Dairy Farmers
Dakota Dunes Community Development Corporation
Dauphin Clinic Pharmacy
Egli’s Sheep Farm Ltd.
Engineering Society B, Faculty of Engineering
Excelleris Technologies Inc.
Ford Drive 4UR Community & School Program
Forest City Road Races
Fraternal Order of Eagles — BC Provincial Auxiliary
Gamma Dynacare Medical Laboratories
General Mills Canada Ntl.
General Presidents’ Maintenance Committee
Gerrie Electric Wholesale Ltd.
Gibbons Ride & Drive—Brantford
Giffen-Mack Funeral Home
HCI Holdings
Holy Spirit Charitable Society
Husky Energy Lloyd Charitable Campaign
Impact Security
International Credit Experts
Irish Society of Westman
Iupat Canadian Regional Conference
Janzen’s Pharmacy
Jarrod Oils Ltd.
John Zubick Ltd.
Kal Tire
Kinsmen BC
Kinsmen Club of Saskatoon
Kinsmen Club of Thunder Bay (Hill City Kinsmen)
Kiwanis Club of Vancouver
Kiwanis Clubs of BC
Knights Therapeutics
Leon’s Furniture Ltd.
Leslie Street (FGH) Inc.
Manitoba Association of Health Care Professionals
Manitoba Health
Manitoba Housing and Community Development
Marshes Golf Club
Matec Consultants Limited
Medtronic of Canada Ltd.
Mihealth Global Systems Inc.
Nashwaaksis Lions Club Inc.
Northern [#468]
Northland Properties Corporation
Ontario Automotive Recyclers Association
Ontario Pork
PD Management & Services Inc.
PricewaterhouseCoopers LLP
RBC Dominion Securities
Regina Capital Cosmopolitan Club
Regina Queen City Kinsmen
Resources Development Trades Council
Richmond Hill Italian Social Club
Roche
Rosmar Drywall Ltd.
Royal Canadian Legion BC
Royal Regina Golf Club (Ladies Section)
Royal Scenic Holidays Ltd.
Saskatchewan Indian Gaming Authority
Saskatoon Downtown Lions Club
SaskCanola
Shaw Communications Inc.
Sherwood Co-Op Association
Signex Manufacting Inc.
Skyway Canada Ltd.
Sudbury Rocks Running Club
Sunrise Soya Foods
Sun-Rype Products Ltd.
Tangerine
TD Waterhouse Canada Inc.
Teck Resources
Telus
Thunder Bay Real Estate Board
UBC Alpha Gamma Delta
Universel Collision Centre
Vale Newfoundland & Labrador Ltd.
Vancouver Courier
Wellington Laboratories Inc.
World Healtn Edmonton
Zone 6 Lions Clubs
Corporate Supporters $25,000 – $49,999
Alberta Building Trades
Blistex
Brandt Tractor Inc.
Connect Marketing Group
Egg Farmers
GlaxoSmithKline Inc.
Group SEB — T-Fal
Lions Clubs of BC
Lions Clubs of Saskatchewan
MEDEC [Diabetes Committe]
Rogers Communications
Rogers Radio Vancouver
Rubicon Pharmacies Canada Inc.
Taste of Kingston
Ventas Inc.
Corporate Supporters $50,000 – $99,999
Abbott Nutrition
Canola
First Nations Health Authority
J&J Consumer
Lions Clubs of Canada
Corporate Supporters $100,000 – $174,999
Eli Lilly Canada Inc.
Janssen Inc.
Loblaws
MEDT
Nestle Canada
Provincial Health Services Authority
Royal Bank of Canada
Sanofi — Aventis Canada Ltd.
The North West Company LP
Diabetes Champion $175,000 – $249,999
Bayer Inc.
Merck Canada Inc.
Diabetes Catalyst $250,000 – $349,999
LifeScan Canada Ltd.
Shaw Media
Sun Life Financial
Diabetes Visionary $400,000+
AstraZeneca
Novo Nordisk Canada Inc.
Foundations
Airlie Foundation
Alice & Murray Maitland Foundation
Alpha Gamma Delta Foundation
Aqueduct Foundation
AWB Charitable Foundation
Brantford Community Foundation – City of Brantford
Brian & Susan Thomas Foundation
Burrows Colden Family Foundation
Butler Family Foundation
Cal Wenzel Family Foundation
Calgary Shaw Charity Classic Foundation
Cambridge & North Dumfries Community Foundation
Canadian MedicAlert Foundation
Cenovus Employee Foundation
Chickadee Trust
Chimp Foundation
Colin & Lois Pritchard Foundation
Community Foundation for Kingston & Area
Community Foundation of Ottawa-Carleton
Crabtree Foundation
Deloitte Foundation Canada
Edmonton Community Foundation
Edwards Charitable Foundation
EnCana Cares Foundation
Ernst Hansch Foundation/Terracon Development
Eva T. Villanueva Charitable Fund at the Strategic Charitable Giving Foundation
Flaman Foundation
Fleming Foundation
Frederiction Community Foundation Inc.
G Grant & Dorothy F Armstrong Foundation
Gift Funds Canada
Gill Family Charitable Trust
Glenn’s Helping Hand Foundation Inc.
Greygates Foundation
Halifax Protestant Infants' Foundation
Halifax Youth Foundation
Hamber Foundation
Harry P. Ward Foundation
Infinity Community Fund
Jewish Community Foundation
Jewish Foundation of Manitoba
John M. & Bernice Parrott Foundation Inc.
KPMG Foundation
Lagniappe Foundation
Leslie & Irene Dube Foundation
Manitoba Hydro Charitable Fund
Medavie Health Foundation
Mister Blake Foundation
Napanee District Community Foundation
Newfound Foundation
NL Retired Teachers Foundation
Northern Ontario Heritage Fund Corporation
NWM Private Giving Foundation
Oakville Community Foundation
Orville & Alvera Woolacott Foundation
PepsiCo Foundation
Prince Albert & Area Community Foundation
Private Giving Foundation
Raymond James Canada Foundation
RBC Foundation
Rexall Foundation
Salesforce Foundation
Saskatchewan Community Initiatives Fund
Saskatoon Community Foundation
Sayal Charitable Foundation
Scotiabank Community Program
Sherry & Sean Bourne Family Charitable Foundation
South Saskatchewan Community Foundation Inc.
Strategic Charitable Giving Foundation
The Barrett Family Foundation
The Brockville Community Foundation
The Calgary Foundation
The Charles Norcliffe Baker & Thelma Scott Baker Foundation
The Chatham-Kent Community Foundation
The Dr. Charles & Margaret Brown Foundation
The Edith Lando Charitable Foundation
The Guelph Community Foundation
The Gyro Club of Vancouver Charitable Foundation
The Home Depot Foundation
The Horn Family Fund
The John and Judy Bragg Family Foundation
The Kitchener & Waterloo Community Foundation
The Lawrason Foundation
The Mariano Elia Foundation
The Poker for Diabetes Foundation
The Ryley Family Foundation
The Tenaquip Foundation
The Virmani Family Charitable Foundation
The Walker Lynch Foundation
The WB Family Foundation
The Winnipeg Foundation
Toronto Star Fresh Air Fund
Valero Energy Foundation of Canada
Vancouver Foundation — Ann Claire Angus Fund
Vancouver Foundation — McFarlane-Karp Fund
Victoria Foundation
VOCM Cares Foundation
William James Henderson Foundation
Windsor Foundation
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